Chapter - I 1 1.1. Introduction to amino acids
Transcription
Chapter - I 1 1.1. Introduction to amino acids
Chapter - I 1.1. Introduction to amino acids Although over 300 amino acids have been described in nature, only twenty of these are typically found as components in human peptides. Of the twenty coded for by human DNA, ten are considered essential since human metabolic pathways are insufficient to synthesize them at adequate rates from other precursors. The essential amino acids are arginine, histidine, methionine, threonine, valine, isoleucine, phenylalanine, tryptophan, leucine, and lysine. However, arginine and histidine are essential only during periods of high anabolic activity, such as tissue growth during childhood. Although amino acid function is usually linked to peptide structure and function. Free essential amino acids play a significant role in both primary metabolism and in the formation of specialized nitrogen containing products. Some contribute to intermediates of the Glycolytic and Krebs (Tricarboxylic Acid Cycle) cycles. Hence, amino acids are used as a source of energy when carbohydrate or fatty acid levels have been depleted [1]. Some tissues, such as muscle, have the capacity to directly catabolize the branched chain essential amino acids valine, leucine, and isoleucine [2]. Others play a part in neurotransmitter formation and can alter significant physiological characteristics such as mood. Tryptophan, for example, is a precursor of the neurotransmitter 5hydroxytryptamine (serotonin) [3]. Methionine is an example of an essential amino acid that has a significant role in formation of special products requiring single carbon transfers. Modifications occur to methionine which produces a high energy Sadenosylmethionine product. This metabolite has an important role in the formation of choline, a significant part of many other high-energy metabolic intermediates [4]. There is a tremendous amount of literature dealing with the physiological significance of free 1 Chapter - I amino acids and their effects on a variety of metabolic and physiological systems. Their importance is often illustrated when a nutritional deficiency occurs or an important enzyme is defective. Deficiencies in essential amino acid metabolism give rise to a plethora of pathological conditions. The absence of an essential amino acid in the diet or a genetic defect in a key enzyme can render other metabolites essential, such as phenylalanine [5]. Tyrosine is not essential so long as an adequate supply of both phenylalanine and the necessary enzyme to convert phenylalanine to tyrosine is present [6]. However, tyrosine becomes an essential amino acid when a deficiency or genetic defect occurs in this system. Some enzymatic deficiencies are benign, but others are debilitating and life-threatening. An understanding of the pathways of essential amino acid metabolism is vital for effective treatment of genetic defects altering these reactions. These defects provide insight into the important roles essential amino acids have in human metabolism. Amino acids and their metabolic and physiological ramifications are among the most investigated topics in biomedical science. Many current studies focus on the therapeutic applications of exogenous amino acids. The essential amino acid metabolism and therapeutic modalities, the focus will be to describe the effects of exogenous amino acid administration on each physiological system. Although amino acids most importantly give rise to complex peptides such as immunoglobulins, carrier proteins, and neurotransmitters, they also have unique biological and metabolic qualities as free amino acids. 2 Chapter - I 1.1.1. Overview of the physical properties of the essential amino acids Amino acids, as the building blocks of the most diverse biological compounds, have a characteristic structure. With the exception of proline, all twenty amino acids have an amino group and a carboxyl group with a functional group covalently bound to the alpha carbon. In the essential amino acids, the functional groups are used to classify the amino acids into polar, non-polar, or basic side chains. The chemical nature of the side chain found on a particular amino acid plays a very important role in determining where the amino acid is found in the tertiary structure of a peptide chain. There are several ways to classify amino acids, the most prevalent being the chemical nature of the side chains. Most essential amino acids have nonpolar functional groups. These include valine, leucine, isoleucine, phenylalanine, tryptophan, and methionine. The side chains in this category do not accept or donate protons (H+) at physiological pH. Also, there is no participation in hydrogen bonding. Amino acids with nonpolar side chains tend to be located on the interior of protein molecules where they interact with other non polar (aliphatic) amino acids, and are shielded from polar entities, including water [6]. One exception to this is proteins located in lipid rich environments like cellular membranes, where a reverse arrangement occurs and the nonpolar amino acids are located peripherally to the peptide [6]. Threonine has an uncharged polar side chain, which is neutral (uncharged) at the physiological pH of 7.4. Threonine contains an uncharged polar hydroxyl group and is capable of hydrogen bonding, which contributes to the tertiary structure of peptides. The hydroxyl substituent can serve as an important site of attachment for other molecules during biochemical reactions. Threonine can undergo a dehydration reaction with an 3 Chapter - I oligosaccharide to form glycoproteins. The specific three-dimensional location of threonine in a peptide is a determining factor as to whether or not the hydroxyl group will be glycosylated. This type of reaction usually occurs as a peptide is being transferred from the endoplasmic reticulum to the Golgi apparatus [7]. Histidine, lysine and arginine are classified according to their basic side chains. By convention, these amino acids are proton acceptors at physiological pH (7.4). At this pH of 7.4, lysine and arginine are protonated and positively charged. Histidine, however, has a pKa of 6.0 for the imino nitrogen and is weakly basic. As a result, histidine in primarily in an uncharged state as a free amino acid at physiological pH (7.4) [8]. Histidine may have either a positive or neutral charge depending upon the microenvironment of the component peptide it is a part of. The pKa of amino acid side chains is a reliable predictor of which will be an effective physiological buffer. Usually, a weak acid and its conjugate base will effectively buffer a solution within ±1 pH unit of its pKa. For histidine, the pKa of the imidazole nitrogen in the side chain is approximately 6.0 [8]. When the pH is lower than the pKa, the protonated form is most abundant, and when pH is above pKa, the deprotonated form predominates. This physical quality enables histidine to be a significant physiological buffer. Although the most effective pH at which histidine can buffer a solution corresponds to the pKa, 6.0 in this case, the concentration of the acid and conjugate base are important as well. The more concentrated they are the greater the "buffering capacity". Side chain characteristics, the ionic form present at a particular pH, and the acid/base qualities of free amino acids help develop a picture of how these biological molecules 4 Chapter - I function in their diverse roles. The nature of the histidine side chain explains how plasma pH is protected from dangerous fluctuations. Reactivity of the hydroxyl component of the threonine side chain illustrates that when oligosaccharides are added in a hydrolysis reaction, the result is the formation of glycoproteins [5]. 1.1.2. Metabolism of essential amino acids The purpose of this section is to provide a general overview of the basic processes that allow the essential amino acids to participate in intermediate metabolism as well as form special products. 1.1.2.1. Nutritional considerations Essential amino acids must be obtained from the diet. A controversy currently exists as to the appropriate dietary quantity for each of the essential amino acids. The debate is partly due to inadequate previous technology for measuring amino acid requirements, such as nitrogen balance and growth [9]. Most estimates of essential amino acid requirements, based on nitrogen balance appear too low [9,10], with the exception of the sulfurcontaining methionine [11]. Other techniques used to estimate amino acid requirements are: plasma amino acid concentration, direct amino acid oxidation and indicator amino acid oxidation [9]. Protein metabolism in the body causes the elimination of nitrogen by urea production, which is the quantitatively most important catabolite. The conversion of the remaining amino acid carbon skeletons to intermediates of energy-producing pathways and other intrinsic metabolic consumption creates a steady need for dietary essential amino acids. The minimal nutritional requirement for humans and other mammals is heavily effected by age, stage of growth and metabolic state. For example, 5 Chapter - I children and patients in a catabolic state (i.e. burn, surgery) have a greater basal metabolic requirement for the essential amino acids than does a healthy adult [10]. 1.1.2.2. Digestion In the American diet, the typical consumption of dietary amino acids is approximately 100 g/day [7]. These amino acids initially enter the body in the form of proteins and are subsequently hydrolyzed by chemical reagents and enzymes. Most of the proteolytic enzymes responsible for degrading dietary protein come from the stomach, pancreas and small intestine [12]. Dietary protein digestion begins in the stomach as a result of gastric juice secretion. Gastric juice contains both hydrochloric acid and pepsin. Although the stomach pH is not sufficiently acidic to hydrolyze most peptides, it does denature them, making enzymes more efficient at hydrolyzing the peptide bonds. Pepsin is secreted as the proenzyme pepsinogen. Upon exposure to the acidic environment in the stomach, pepsinogen is converted to the active form and is referred to as pepsin. Pepsin is unique in that other active pepsin molecules can autocatalytically activate pepsinogen as well. Pepsin cleavage of peptides releases a few free amino acids and smaller peptides which then enter the duodenum of the small intestine [7]. Pancreatic proteases act in the small intestine to further degrade the peptides produced by the action of pepsin in the stomach. The pancreatic proteases are also released as inactive proenzymes which are all activated by the active form of trypsin, which is converted from the inactive form, trypsinogen, by a brush border enzyme called enteropeptidase [12]. All the pancreatic proteolytic enzymes have specificity regarding the peptide bonds they cleave [12]. Details about the specific enzymes and amino acids cleaved are not 6 Chapter - I essential to this overview of digestion. However, the end result is the production of oligopeptides (smaller peptides) and additional free amino acids. The final stage of peptide digestion involves aminopeptidase, an enzyme located at the luminal border of the small intestine. This enzyme repeatedly cleaves the N-terminal amino acid of the oligopeptides to produce free amino acids and some dipeptides [12]. Although both the free amino acids and dipeptides are absorbed into the epithelial cells of the small intestine, only free amino acids are found in the portal system. While in the cytosol of the intestinal epithelial cells the dipeptides are hydrolyzed to free amino acids. After release into the portal system, the free amino acids are either metabolized by the liver or released into the general circulation [12]. 1.1.2.3. Removal of nitrogen and excretion Since there is no storage form of dietary nitrogen, any nitrogen not immediately required for the metabolic processes must be eliminated from the body. Transamination and oxidative deamination reactions are responsible for the initial step of amino acid catabolism. The alpha-amino nitrogen is removed by either of these processes [13]. With transamination, there is the production of an alpha-ketoacid and glutamate. Of the essential amino acids, only lysine does not undergo a transamination [7]. The alphaketoacids may participate in the synthesis of other non essential amino acids, while the glutamate formed can be deaminated to form alpha ketoglutarate. Alpha-ketoglutarate is the receptor of the alphaamino group in transamination reactions [13]. Oxidative deamination results in the direct elimination of the alpha-amino group as ammonia. The ammonia produced in this reaction acts as a source of nitrogen in urea production. None of the essential amino acids undergo rapid oxidative deamination. 7 Chapter - I However, the glutamate formed by transamination is converted to ammonia by the glutamate dehydrogenase enzyme. This indirect mechanism provides a method for converting the amino group of most amino acids to ammonia. In this way, glutamate acts as a funnel by which many amino acids can be converted to intermediates of the TCA cycle [5]. The ammonia produced by oxidative deamination provides a source of nitrogen in the Urea Cycle, which is the major pathway for elimination of amino acid nitrogen. Production of urea occurs in the liver and is excreted in the urine [5]. 1.1.3. Special products and systemic effects of essential amino acid metabolism Aside from their important roles in enzymes and other proteins, essential amino acids are also precursors for many physiologically significant nitrogencontaining molecules. Among the special products are; neurotransmitters, hormones, and nucleotide bases. This section describes briefly the roles of essential amino acids in the formation of these and other physiologically significant products. 1.1.3.1. Arginine During catabolism, arginine is cleaved by arginase to produce ornithine which is then transaminated to yield glutamate semialdehyde and is subsequently converted to alpha ketoglutarate via glutamate. Arginine can be converted to creatine when combined with glycine and a methyl group from Sadenosylmethionine. Creatine is reversibly phosphorylated to creatine phosphate, which is a high energy derivative that reversibly donates a phosphate group to ADP in the formation of ATP. This reaction provides a small but rapidly mobilized energy reserve in muscle [8]. In the liver arginine serves an important role in the excretion of nitrogen containing compounds. As an intermediate in 8 Chapter - I the urea cycle, arginine is cleaved into ornithine and urea. The urea is excreted in the urine while the ornithine reenters the urea cycle [5]. The arginine is the primary component in the synthesis of nitric oxide (NO) [14]. Nitric oxide is synthesized from arginine, molecular oxygen, and NADPH by the enzyme nitric oxide synthase. Arginine, through nitric oxide (NO), is a mediator in a variety of biological systems. Since nitric oxide is functionally identical to endothelium-derived relaxing factor, it causes vasodilation by relaxing vascular smooth muscle [15,16,17]. Studies with mineralocorticoid-salt hypertensive rats and corticotropininduced high blood pressure have found that L-arginine has an antihypertensive effect. The mechanisms of action for arginine are through the vascular effects of NO and the reduction of serum corticosterone concentrations respectively [15,17]. In addition, arginine's inhibition of the reninangiotensin system helps to cause a decrease in the systolic blood pressure [18]. In a study of healthy men it was found that oral administration of L-arginine prevented platelet aggregation. Its inhibition was directly correlated to plasma levels of arginine, while heart rate and fasting lipid levels were unaffected [19]. Another effect of arginine, D- and L-stereoisomers, is the production of hormonal responses [20]. Systemic infusion of arginine increases the plasma insulin, glucagon, and prolactin levels [21]. Also, arginine, through nitric oxide (NO), stimulates the release of dopamine from the striatum in gerbils [22], increases the tumoricidal and bactericidal actions of macrophages [23], stimulates wound healing [24], and has neurotransmitter functions in the brain [25]. 1.1.3.2. Tryptophan Tryptophan is converted into two products: niacin and the neurotransmitter serotonin [26]. Serotonin has many diverse physiological functions such as pain perception [27,28], 9 Chapter - I affective disorders and sleep [29], temperature [30] and blood pressure [31]. In the formation of serotonin, tryptophan is converted to 5-hydroxytryptophan in which tetrahydrobiopterin and molecular oxygen are necessary for this reaction. 5hydroxytryptophan is then decarboxylated to serotonin. Although niacin is readily available from lean meat, cereals and enriched grains, it can also be synthesized inefficiently from tryptophan [26]. The metabolic pathway producing niacin from tryptophan only produces 1 mg of nicotinic acid for every 60 mg of tryptophan consumed. The production of niacin is only functional when a relative overabundance of the amino acid is available. This in vivo inefficiency renders dietary niacin as the primary source [26]. An increase in tryptophan levels leads to an increased concentration of 5hydroxytryptamine (serotonin) in the brain. This effect can be observed in neurons which are related to sleep function [29]. An excess of serotonin in brain tissue is known to increase the mental effort necessary to maintain physical exercise [1,32]. Acute ethanol consumption is known to decrease circulating tryptophan availability [33]. One of the major systemic effects of tryptophan is through its 5-hydroxytryptamine metabolite [7]. Serotonin has been implicated in various psychiatric disorders [34]. Tryptophan depletion has been used successfully to evaluate central serotonin levels in depression and other neuropsychiatric disorders. Tryptophan depletion reduces brain serotonin function, which in turn reduces the therapeutic effects of specific serotonin reuptake inhibitors, but not drugs that inhibit noradrenaline reuptake. Rather than having a neurotransmitter function, tryptamine has been suggested to play a neuromodulatory role. A decrease in erythrocyte tryptophan uptake in schizophrenic patients is correlated with a loss of impulse control 10 Chapter - I [35]. The decrease in tryptophan uptake is a reflection of peripheral tryptophan metabolism. The majority of scientific literature indicates that 5-hydroxytryptamine acts directly as a neurotransmitter. Tryptophan has been implicated as a possible explanation of central fatigue [1,32]. During extended exercise free tryptophan levels are elevated and, therefore, serotonin [1]. This increases activity in the brain of neurons that can induce sleep. 1.1.3.3. Phenylalanine Pietz et al. found that when phenylketonuria (PKU) patients were administered a bolus of 100 mg/kg phenylalanine, both the plasma and brain concentrations of phenylalanine increased significantly with no impairment of attentional and fine motor scores on neurophysiological tests for up to 20 hours postload [36]. However, most of the systemic effects of phenylalanine are a result of the enzyme phenylalanine hydroxylase converting phenylalanine to tyrosine [37]. Thus, this nonessential amino acid tyrosine overlaps substantially with phenylalanine. L-tyrosine is ultimately converted to fumarate and acetoacetate intermediates which join primary metabolic pathways as both glucogenic and ketogenic precursors [6]. Phenylalanine and tyrosine form the initial two biosynthetic steps of dopamine formation [38]. The rate limiting enzyme that catalyzes dopa, the immediate precursor to dopamine, is tyrosine hydroxylase [39]. This enzyme is abundant in the adrenal medulla, sympathetic nervous ganglia and in the central nervous system [40,41]. Dopamine serves as a neurotransmitter in the brain whose importance is illustrated by Parkinson's disease where nuclei in the subthalmic region fail to produce adequate quantities of this neurotransmitter [42]. Deficiency of phenylalanine causes a 11 Chapter - I diminished synthesis of dopamine which has adverse effects on performance of mental tasks [37]. Dopamine, a precursor of epinephrine and norepinephrine, when hydroxylated forms norepinephrine [43]. Norepinephrine is a catecholamine that is released as a neurotransmitter from postganglionic sympathetic nerves and also functions as a hormone, along with epinephrine, when released by the adrenal medulla. Sadenosylmethionine, a metabolite of the essential amino acid methionine, donates a methyl group to norepinephrine to form epinephrine (i.e. adrenalin) [44]. 1.1.3.4. Histidine Histidase deaminates histidine to form N-formiminoglutamate (FIGlu), which transfers the formimino substituent to tetrahydrofolate and forms glutamate [5]. A dietary deficiency of folic acid results in increased urinary elimination of FIGlu and is the basis of the FIGlu excretion test [45,46]. Tetrahydrofolic acid (THF), a metabolite of histidine and the active form of folic acid, serves an important role in one carbon metabolism. Dihydrofolate reductase converts the inactive folic acid to its active form with the addition of two protons (H+) and two molecules of NADPH. The various forms of THF are essential in methionine, thymidine, purine-C8, and purine-C2 synthesis. Unlike humans, some microorganinsms synthesize folic acid directly. In humans, methotrexate inhibits the conversion of folic acid to its active form and is a useful regimen for patients with acute lymphocytic leukemia [47,48]. Histidine has effects on a variety of organisms and physiological systems. As a free radical scavenger, histidine quenches hydroxyl and hydrogen peroxide, but not 12 Chapter - I superoxide anions [49]. The total free energy of cells is increased as the adenine nucleotide pool is elevated following histidine administration [49]. Histidine plays an important role in the modulation of oxidative DNA degradation. Protonation of the imidazole component of histidine abolishes the capacity of histidine to modulate the oxidative degradation of DNA [50]. Evidence suggests that at low hydrogen peroxide levels, the protective effect of histidine may be a result of its ability to bind hydroxyl free radicals. Histidine also reduces ischemia induced by myocardial injury in isolated perfused rat hearts [49]. An important metabolite of histidine is the chemical messenger histamine. Histidine is decarboxylated to form this powerful component of many allergic and inflammatory reactions. Histamine mediates a variety of cellular actions such as gastric acid secretion [51], vasodilation [52], and allergic reactions [53]. Histamine has also been suggested as a possible neurotransmitter in the brain [53]. Although histamine is not used clinically, histamine antagonists have important therapeutic functions. 1.1.3.5. Branched chain amino acids (valine, leucine, isoleucine) The branched chain essential amino acids (BCAA) have similar characteristics, properties and physiological actions. These amino acids are unique metabolically in that they are primarily catabolized by peripheral tissues (i.e. skeletal muscle) and have similar catabolic pathways [2]. They are first transaminated to alpha ketoacids by the enzyme, branched chain alpha-ketoacid dehydrogenase. This step requires the aid of several coenzymes, thiamine pyrophosphate being the most prevalent. The end result is succinyl CoA for valine, acetyl CoA for leucine (the second of two exclusively ketogenic amino 13 Chapter - I acids) and succinyl CoA or acetyl CoA for leucine and succinyl CoA or acetyl CoA for isoleucine [2]. BCAA have a protein sparing effect when their levels are increased through infusion or oral administration. An overnight infusion of BCAA was associated with a 20-60% decline in arterial concentrations of the other amino acids. This suggested that the BCAA inhibit proteolysis in skeletal muscle and other body tissues [54,55]. In addition to the protein sparing effects, leucine and the other BCAA exert their effects on respiratory functions. Investigations have shown that respiratory drive increased and diaphragm function improved when BCAA were administered [56]. Increased levels of BCAA have been shown to decrease pCO2 and to stimulate the ventilatory response to hypercapnia. Also, a decrease in episodes of apnea in premature infants was found with an increase in BCAA [57]. Leucine metabolism has demonstrated an effect in the brain. Astrocytes in the brain metabolize leucine and its nitrogen furnishes the alpha amino group for glutamate synthesis. Glutamate sequesters free ammonia in the brain which is very sensitive to hyperammonemia. During this process, glutamate is converted to glutamine [58,59]. This is an important step in the brain because glutamate functions as a neurotransmitter, regulates ammonia levels, serves as a constituent for glutathione and folic acid and serves as a precursor of gammaamino butyric acid (GABA) and other Krebs Cycle intermediates [58,59]. However, glutamate is unable to cross the blood brain barrier. Hence, leucine levels are significant in the overall nitrogen metabolism in the brain. 14 Chapter - I 1.1.3.6. Methionine Methionine undergoes an important metabolic reaction when it is converted to S adenosylmethionine (SAM). SAM is the primary methyl group donor in one carbon metabolism [2]. In SAM synthesis, L-methionine is coupled with ATP by the enzyme Sadenosylmethionine synthase with magnesium as a cofactor [8]. This produces the high energy SAM, which is unusual in that it contains no high energy phosphate bonds. All three high energy phosphate bonds in ATP are cleaved during the synthesis of SAM. The methyl group attached to the tertiary sulfur in SAM is irreversibly transferred to other molecules in a step catalyzed by methyltransferases. Subsequent to transfer of the one carbon unit, SAM is hydrolyzed to homocysteine and adenosine by the addition of water to one of the sulfur bonds [8]. Homocysteine reacts with serine through cystathione synthase to form cystathione. Where as cysteine and alphaketobutyrate are oxidated to form propionyl CoA and then subsequently succinyl CoA. The metabolism of valine, isoleucine, threonine, and methionine converge at succinyl CoA to enter the Krebs Cycle [2]. Methionine is another example of an amino acid that is not essential as long as its essential precursor is present. That is, a decrease in methionine will cause a deficiency in cysteine [7]. Homocysteine may also be used in the resynthesis of methionine, the initial precursor in the pathway. N5-methyl-THF donates a methyl group to homocysteine in a reaction requiring methylcobalamin. This results in the resynthesis of methionine and production of tetrahydrofolate. Methylcobalamin, the coenzyme, is a metabolite of vitamin B12 [2]. Methionine is also an important factor in the synthesis of choline [4]. Synthesis of choline requires the addition of three methyl groups from the activated form or SAM. 15 Chapter - I Methionine deficiency causes an insufficient supply of choline even though choline can be resynthesized from phosphatidylserine in membranes [4]. 1.1.3.7. Lysine The catabolism of lysine results in the formation of acetoacetate. It is unique in that neither of its amino groups undergo transamination as the first step in their catabolism. In the mammalian liver, lysine first forms alphaaminoadipate-delta semialdehyde before it is converted to acetoacetate [5]. In rats, excess dietary lysine has a significant effect upon the distribution of carnitine and trimethyllysine (TML), a carnitine precursor. In a high lysine diet, plasma concentration of carnitine is decreased while the concentrations of trimethyllysine are increased in the plasma and in skeletal muscle [60]. TML has been shown to stimulate cell proliferation in bone marrow, intestinal tissues and in cultured lymphocytes [61]. L-lysine has also been shown to depress the central nervous system and to have antiseizure properties. Similar to babiturates, lysine enhances [3H]flunitrazepam binding in the brain [62]. 1.1.3.8. Threonine When catabolized, threonine is dehydrated first to alpha-ketobutyrate, which is then converted to propionyl CoA, the precursor of succinyl CoA. Through threonine metabolism pyruvate is formed, which also enters the Krebs cycle [5]. In diet-induced hyperthreoninemia, increased quantities of threonine and glycine were found in brain tissue. When moderate levels were administered, glycine did not increase in the brain. It was discovered that glycine was increased only at high levels of dietary threonine [63]. In the peripheral tissues, increased glycine concentrations again resulted from a high threonine diet. Hepatic threonine dehydrogenase activity was induced in these studies 16 Chapter - I [64]. Rats fed a threonine imbalanced diet exhibited altered hepatic metabolism of longchain free fatty acids [65]. There was a 2-4 fold increase in triglyceride levels as well as enlarged livers. Excess threonine may be a causative factor in hypertension. Rats given and 8% threonine solution exhibited an elevated systolic blood pressure and a thickening of their small arterial walls [66]. 1.1.4. Overview of the therapeutic effects of the essential amino acids The therapeutic application of essential amino acids has received considerable attention in respiratory physiology, cardiology, renal failure, neurological disorders, and congenital defects. The benefits of exogenous essential amino acid therapy lie in the relative abundance and economy of these biologically active materials. This section deals with an overview of essential amino acid therapeutic applications. 1.1.4.1. Methionine As discussed previously, methionine, a sulfur containing amino acid, is also very important in single-carbon metabolism in the activated SAM form. Methionine also plays a role in detoxification in the liver [67,68]. In chronic alcoholics, methionine metabolism is significantly altered [68,69], producing a deficiency of SAM. This deficiency, observed in cirrhotic subjects, is located at the Sadenosylmethionine synthase step in methionine metabolism [70]. Investigators have considered the feasibility of giving exogenous doses of the methionine derivative, SAM to ameliorate many of the complications observed in chronic liver diseases and cirrhosis [68,70]. Through therapeutic doses of SAM, glutathione would also be increased, leading to protection against oxidant stress from druginduced hepatotoxicity [70,71]. Preliminary studies regarding this application have given promising results in both the improvement in liver 17 Chapter - I function tests and biochemical parameters of choleostasis [70]. Dietary supplementation of methionine also increases levels of other free-radical scavengers and lowers the succeptability to lipid peroxidation [72]. Jaundiced patients showed a decrease in extrahepatic membrane cholesterol deposition due to exogenous SAM administration [73]. However, some liver pathology, such as patients with intrahepatic choleostasis, has no response to SAM administration [74]. Amino acids have been known to enhance the pharmacological effects of some other drugs when given in together [75]. One such application of methionine has been observed in animal experiments involving lead intoxication in rats [76]. Ethylenediamine tetra acetic acid is a chelating agent used clinically in patients with heavy metal poisoning. Supplementation of this regimen with zinc and methionine increased urinary excretion of lead. However it did not reverse the lead-induced biochemical alterations [76]. Therapeutically, methionine may be used clinically as a prophylactic to guard against congenital defects from teratogen exposure. Exogenous methionine has been shown to reverse the teratogenic effect of trans-retinoic acid in mice [77]. Some cancer cells displayed a methionine-dependant growth pattern [78,79]. The relationship between methionine dependency and the metastatic potential of a rat cancer line has been demonstrated experimentally. The greater the metastatic potential, the greater the concentration of methionine required to maintain growth [78]. That is, methionine dependent cancer cell lines lost their tumorigenicity when they were injected into rats fed a methioninedeprived diet. However, this special diet substituted homocysteine for methionine to maintain growth of normal cells. Exploiting this metabolic defect in the cancer cell lines may be of possible therapeutic value [78]. 18 Chapter - I Similar anticarcinogenic effects were observed in other studies [80]. Also the reestablishment of physiological SAM levels in rats has been shown to inhibit protooncogene expression and prevent lesion development in vivo [81]. A derivative of methionine, methionine sulfoxamine, reduces cortical infarct size in rats after middle cerebral artery occlusion [82]. The mean volume of the infarct in the cortex was reduced by 33 % in the group treated with the sulfoxamine analogue. Sulfoxamine also enhances brain glycogen stores [82]. This finding could provide a new therapeutic approach for stroke patients. 1.1.4.2. Tryptophan Tryptophan is the precursor of 5-hydroxy-tryptophan (serotonin), a potent effector of mood and behavior as well as a neurotransmitter or neuromodulator [83]. Peripheral tryptophan metabolism directly affects plasma tryptophan availability and consequently serotonin synthesis [35]. Therefore, tryptophan levels have an effect on depression and mood. Serotonin, a monoamine, is related to the catecholamine hormones norepinephrine and epinephrine. The therapeutic applications of tryptophan and its tryptamine metabolite are dependent on their physiological actions of regulating mood, sleep, motor activity, thermoregulation, sexual activity, aggression, feeding, learning, and memory. Hence, tryptophan is a highly significant biological molecule [84]. The determinations of tryptophan and serotonin concentrations in plasma have been a valuable diagnostic aid in the study of drugs that alter serotonin metabolism [85,86]. One of the main therapeutic applications for tryptophan is its enhancement of monoamine oxidase inhibitors in the treatment of depression [75]. Tryptophan levels are one of the most frequently used end-points in diagnostic and neuropsychopharmacological studies 19 Chapter - I of serotonin function [87]. Tryptophan depletion, which reduces brain serotonin function, is known to reverse the pharmacological action of particular serotonin reuptake inhibitors (SRI), but not drugs that inhibit norepinephrine reuptake [86,88]. Examples of drugs in this SRI category which are altered by reduced tryptophan levels include paroxetine and clomipramine [88]. Rapid depletion of tryptophan in the diets of untreated depressed patients did not result in an immediate change of mood, but did increase serotonin levels on the day after the depletion test [89]. Other investigators reported little change in depressed mood upon tryptophan depletion in drug-free depressed and healthy subjects [86]. This suggests that reduced serotonin levels does not linearly relate to depression, but may have a predisposing effect. Pathological and immunological effects have been reported from exogenous L-tryptophan administration. Eosinophilia-myalgia syndrome (EMS), associated with the ingestion of exogenous tryptophan, is characterized by myalgia, eosinophilia, chronic cutaneous lesions, progressive neuropathy, and myopathy [90,91,92]. Ingestion of exogenous Ltryptophan has also been found to induce pancreatic atrophy [93]. L-tryptophan, along with other amino acids, has been shown to induce cholecystokinin (CCK) production and subsequent pancreatic enzyme production in dogs and humans [94]. Tryptophan is the most potent amino acid for stimulating pancreatic synthesis activity in dogs. Other studies have implicated tryptophan and its metabolites in fibrosing illnesses like carcinoid syndrome, eosinophilic fasciitis and scleroderma [95,96,97,98]. Although tryptophan may have therapeutic applications in combination with antidepressants, other therapeutic uses should be considered with caution due to the possible deleterious effects observed from exogenous tryptophan ingestion. 20 Chapter - I 1.1.4.3. Branched-chain amino acids Valine, leucine and isoleucine are similar in both their metabolism and therapeutic applications. Neurophysiological therapeutic effects have been found with branched chain amino acid (BCAA) administration. Patients who suffered from chronic liver failure or portal circulation defects showed a variety of neurological symptoms due to an increase in nitrogenous ammonia in the systemic circulation. This condition is commonly referred to as hepatic encephalopathy and is characterized by mood or personality changes, drowsiness, coma, dysphasia, and asterixis [99]. Clinical trials have explored the psychotropic effects of the BCAA and their antagonistic action in encephalopathy [99]. Neurophysiological improvements have been confirmed in quantitative psychometric tests [100,101]. Dietary restriction of phenylalanine is essential in preventing brain damage in (phenylketonuria) PKU patients [102]. BCAA have been used to treat phenylketonuria by inhibiting the entry of phenylalanine into the brain [102]. Thus, there is a reduction of central nervous systems (CNS) toxic effects caused by phenylalanine. The data from clinical experimentation has shown that BCAA are useful and effective in maintaining low serum phenylalanine levels [102]. Since BCAA have an inhibitory effect on proteolysis, they have also been used as a treatment in septic patients and those with catabolic disorders [103]. Leucine has a metabolic application in the determination of protein turnover rate, where patients are primed with isotopes of leucine [104]. A synthetic analog of leucine is successfully used in the clinical treatment of duodenal peptic ulcer hemorrhage [105]. Patients in this study were administered a 3 mg dose 21 Chapter - I daily. Only 8% of the subjects failed to respond to this treatment while 32% had a positive result. Isoleucine has a very low toxicity at pharmatological levels up to 8% solution concentration in rats. Body weight, hematology and food consumption by rats were not altered, although an increase in urine output and relative kidney size was observed [106]. Conversely, when BCAA were eliminated from diets in the treatment of Maple Syrup Urine Disease, increased proteolysis was observed with isoleucine deficiency [107]. This suggests that there is a risk when specific amino acids are eliminated from the diet without adequate supplementation with other intermediates. Besides phenylalanine, BCAA have an inhibitory effect on the transport mechanism of other amino acids. Valine inhibits the transport of tryptophan across the blood-brain barrier [108]. Since tryptophan is the precursor of 5-hydroxytryptamine (serotonin), a mild decrease in brain serotonin neurotransmission was observed with subsequent lowering of mood [108]. Valine deficient diets were shown to increase calcium excretion in urine with a reduction in bone mass in chicks [109]. BCAA deficient diets have been studied for possible use in anti-tumor therapy [110]. These investigators have demonstrated that valine and leucine deficient diets had the most desirable effect in decreasing tumor growth with minimal loss of body mass. However, diets deficient in all three BCAA had less effect on inhibiting tumor growth and negatively impacted host development. This suggests that selective removal of amino acids from the diet would be more beneficial in tumor therapy with less weight loss than elimination of all three BCAA. Vitamin B12 deficiency causes neurological deterioration if left untreated. The administration of valine and isoleucine, 22 Chapter - I two precursors in the propionic acid pathway, protected against neurological damage in a study group of B12 deficient bats [111]. It appears in this study that valine and isoleucine circumvented this by stimulating the propionic acid pathway. 1.1.4.4. Arginine The therapeutic applications of arginine are numerous systemically. As previously discussed, arginine is converted to nitric oxide (NO) which acts as a mediator in vasodilation [112], congestive heart failure [113], inflammatory response [114], chemotherapy [115], inflammatory pulmonary disease [116], pulmonary hypertension [117], and axon growth [118]. Arginine reduces postischemic injury in the heart and exerts antihypertensive and antiproliferative effects on vascular smooth muscle [16]. Arginine also prevents local vasospasms, unwanted proliferation of smooth muscle cells and helps to control blood coagulation [119]. The nitric oxide synthase pathway in which arginine is a precursor has been implicated in the pathogenesis of septic shock, hypertension and atherosclerosis [120]. Studies in dogs have shown that a cardioplegic solution supplemented with L-arginine reduces the infarct size, preserves postischemic systolic and diastolic regional function and prevents arterial endothelial dysfunction [121]. Without L-arginine supplementation, ischemic damage and contractile dysfunction remained [121]. This study suggests that L-arginine may be a possible treatment in heart attack patients. Capillary reperfusion with exogenous arginine after ischemic conditions in hamsters further illustrates its effect on vascular function [122]. Arginine has been used in the treatment of necrotic colitis, which is caused by an enterotoxin whose symptoms exhibit an infarction of the mucosa, edema and hemorrhage [99]. The neuroeffector action causes smooth muscle relaxation, while nitric oxide 23 Chapter - I maintenance of the intestinal mucosa protects the gut from blood-born toxins and tissue destructive mediators. Thus, L-arginine may be considered as a potential therapy for necrotic enterocolitis [23]. Arginine supplementation has also been used in the prevention and treatment of osteoporosis. When pharmacological doses of arginine are administered, growth hormone, IGF-1 and NO responses are induced [123]. Both GH and IGF-1 are important mediators of bone deposition [124]. Therefore, L-arginine administration may be part of an effective treatment to increase bone mass. Arginine is also involved in the inflammation, tissue repair and fibrogenesis processes in the kidney as described by [125]. Arginine is essential for the synthesis of several metabolites that are secreted in the kidney such as creatine, urea and nitric oxide which is excreted as nitrates and nitrites [126]. Dietary supplementation of arginine has resulted in improvements of several kidney pathologies. These pathologies include subtotal nephrectomy, diabetic nephropathy, cyclosporine A administration, salt-sensitive hypertension, uretal obstruction, puromycine amino nucleoside nephrosis, kidney hypertrophy due to high-protein diets and glomerular thrombosis [126]. 1.1.4.5. Lysine Lysine has been used in the treatment of recurrent herpetic lesions [127]. The herpes simplex virus requires high concentrations of arginine to synthesize proteins and replicate. Lysine acts as an anglogue of arginine and competes at the site of absorption in the small intestine. Consequently, lysine prevents the development of the herpes labialis lesions. Additionally, lysine is effective in the treatment of recurrent aphthous ulcers [127]. 24 Chapter - I Lysine acetylsalicilate (lysine aspirin) and bendazac lysine (a lysine salt), both derivatives of lysine, have been investigated for their therapeutic effects on migraine headaches [128], acute respiratory infections [129] and rheumatoid arthritis [130]. Given in combination with metoclopramide, lysine aspirin proved to be an effective treatment for migraine headaches [128]. In the treatment of acute respiratory infections (laryngitis, tracheitis, bronchitis, pneumonia) the effects of lysine aspirin was comparable to that of nimesulide [129]. However, patients did incur more gastrointestinal side effects [129]. When comparing lysine aspirin with ibuprofen for the relief of rheumatoid arthritic symptoms, more side effects were found with the lysine aspirin [130]. However, the majority of patients preferred the lysine aspirin therapy over ibuprofen since there was improved mobility and the alleviation of pain [130]. The bendazac derivative of lysine may be useful in delaying the progression of cataract formation since it inhibites the denaturation of proteins [131]. It has been reported that L-lysine supplementation can significantly enhance intestinal calcium absorption and improve renal resorption of filtered calcium [132,133]. Since agerelated bone loss is due to calcium deficiency, L-lysine may prove to be an effective treatment modality. 1.1.4.6. Histidine Histidine is a precursor of histamine, the mediator of many inflammatory and allergic responses [7]. Histidine also has oxygen free radical scavenging qualities. An investigation of the antioxidative properties of histidine in myocardial injury in rat hearts showed that histidine prevented postischemic reperfusion injury [128]. Hearts treated with histidine showed greater functional recovery with increased high-energy phosphates. 25 Chapter - I Histidine was shown to quench hydroxyl radicals and hydrogen peroxide, but not superoxide anions [49]. Another study involving subarachnoid hemorrhage in rabbits showed that histidine attenuated cerebral vasospasm [134]. In a study on the effects of histidine on brain edema and cardiac function after thrombotic ischemia in rats, it was found that diminished histidine decreased brain water content and enhanced left ventricular function in animals [135]. Histidine-containing dipeptides, carnosine and anserine, had an anti-inflammatory effects and may be valuable in the wound healing process [136]. It is believed that these dipeptides interact with oxygen radicals and lipid peroxidation products to prevent membrane damage. 1.1.4.7. Phenylalanine Phenylalanine and its metabolite tyrosine are involved in the initial metabolic steps in dopamine synthesis. An abundance of research has focused on the modulation of phenylalanine in patients with phenylalanine hydroxylase deficiency [36,38,137]. As a result of this genetic aberration, clinical literature concerning phenylalanine is involved in the manipulation and metabolism of phenylalanine hydroxylase deficiency patients [138]. Analysis of nucleic material coding for the phenylalanine hydroxylase gene has been of some benefit in predicting the outcome and severity of phenylketonuria (PKU) in humans [139,140]. Some success has been achieved in correcting the phenylalanine hydroxylase genetic deficiency through transduction of mice hepatocytes in vitro to produce dramatically higher levels of phenylalanine hydroxylase [141]. Another genetic aberration in phenylalanine metabolism has been elucidated in its predisposition for 26 Chapter - I hypertension and stroke, which might be related to excessive stimulation of the sympathetic nervous system [142]. A derivative of phenylalanine, 4-borono-2-[18F] fluoro-D, L-phenylalanine has shown promise as a tracer in positron emission tomography (PET) for imaging of cancer cells [143,144]. Phenylalanine has also been used diagnostically to determine protein synthesis in visceral tissue [145]. This method of measuring protein synthesis represents an improvement over continuous infusion methods in visceral tissues. Cirrhosis of the liver is associated with elevated phenylalanine levels due to increased proteolysis and decreased splanchnic extraction of dietary phenylalanine [146]. In Cirrhosis, the ratio of branched-chain amino acids to phenylalanine is altered although the mechanism for this is not completely understood [147]. The phenylalanine metabolites, phenylethylamine and phenylacetic acid, are involved in encephalopathy in sepsis and hepatic failure [148]. 1.1.4.8. Threonine Therapeutically, threonine has been used as a treatment for spinal spasticity and multiple sclerosis [149,150]. Threonine enhances the glycinergic postsynaptic inhibition of the motor reflex arc in the spinal cord with no toxic or adverse effects. When compared with commonly used antispastic drugs, which commonly cause sedation and increased motor wakness, threonine appears to be an appealing alternative [149]. In Amyotrophic Lateral Sclerosis, a fatal neurological disease with no known cure [150], patients administered threonine complained less frequently about disease-related respiratory failure [151]. Although threonine consumption at levels of four times that normally found in the diet of rats did not impair their behavioral development [152], threonine metabolism may have a 27 Chapter - I role in mediating hypertension. Specifically, ethanol and threonine are precursors of acetaldehyde. Upon long-term dietary supplementation of threonine in rats, smooth muscle cell hyperplasia increased while luminal diameters of small arteries and arterioles decreased [66]. Thus it is apparent that acetaldehyde may be is implicated as the mediating factor in both ethanol and threonine induced hypertension. The ten essential amino acids are responsible for a vast array of metabolic, physiologic, and therapeutic effects throughout the body. In addition to their roles in peptide and protein structure, these free amino acids have significant functions as specialized nitrogen containing products, neurotransmitters and as alternate energy sources via the Krebs Cycle. Unique therapeutic uses of these biologically significant molecules are currently being explored and could become an economic alternative to more expensive clinical approaches. Since these biologically active amino acids must be obtained from the diet, an over abundance or deficiency in just one of these may have severe pathological consequences. Even though the metabolic, physiologic and therapeutic effects of these essential amino acids have been extensively explored in some areas, they still remain an important modality in clinical medicine. The negative systemic effects observed with pharmacological doses of some amino acids, such as tryptophan, may limit their use clinically. However, the diverse physiological and metabolic applications of many of the essential amino acids will certainly yield a significant body of cost-effective alternative therapeutic applications. 1.2. Introduction to peptides Numerous small and large peptides, which are sequence and length-specific polymers composed of amino acids, represent compounds with significant therapeutic applications. 28 Chapter - I Peptides and their higher relatives proteins play a crucial role in almost all processes of the living cell. cholecystokinin, Representative endorphin, examples enkephalin, include angiotensin somatostatin, II and substance endothelin. P, As neurotransmitters, neuromodulators and hormones peptides are responsible for the regulation of biochemical processes in complex organisms such as cell-cell communication and control of vital functions like metabolism, immune response, digestion, respiration, sensitivity to pain, reproduction, behaviour and electrolyte levels. Since so many peptides possess potent pharmacological properties they are of enormous medicinal interest. Peptides are defined as polypeptide chains of less than 50 amino acids or 5000 Da molecular weight, which often exhibit a high degree of secondary structure and lack tertiary structure. Peptide leads have traditionally been derived from three sources: isolated from nature (also known as bioactive peptides); chemical libraries or genetic/recombinant libraries. To date, nearly all peptide therapeutics have been derived from natural sources. One explanation is that bioactive peptides have undergone natural selection and, as a result, have enhanced in vivo stability [153]. Bioactive peptides are also highly functional with many serving as potent agonists and antagonists against several receptors involved in disease progression. Some well-known bioactive peptides include glucagon-like peptide-1 (GLP-1) for the control of diabetes, ghrelin to treat obesity, gastrin-releasing peptide used in cancer treatments, and defensin, which has found use as an antimicrobial agent. In the past, stable and potent peptides have been difficult to discover from chemical and genetic/ recombinant peptide libraries. With the 29 Chapter - I creation of highly diverse structured peptide libraries, however, peptides can now be found that rival those found in nature. Although peptides have several advantages over small molecules (e.g. higher affinity/specificity to target and lower toxicity profiles) and antibodies (e.g. room temperature storage and better tissue penetration owing to their smaller size), they have been hampered in the past by several key issues that have prevented them from becoming a mainstream source of drug candidates [154]. The short half-life of peptides has been one of the major issues of peptide therapeutics. Peptides are typically cleared from the bloodstream within minutes to hours after administration. As a result, there can be insufficient exposure in the target tissue to have an in vivo effect. Short peptide half-lives typically result from fast renal clearance (for peptides <5 kDa) and/or from enzymatic digestion in the blood, kidneys or liver. To address this issue, numerous technologies have been developed to increase the in vivo plasma residence time of peptides. These approaches have reached wide acceptance and should help to appease peptide skeptics. Peptide-based drug candidates that target intracellular proteins face an enormous challenge in that they have to cross the plasma membrane. The hydrophobic nature of the plasma membrane renders it impenetrable to proteins, nucleic acids and hydrophobic peptides that lack specific membrane receptors or transport proteins. Nevertheless, highly cationic, naturally occurring peptide sequences of low molecular weight that contains basic amino acids or proline-rich and completely synthetic molecules, such as model amphipathic peptides, are able to cross the lipid bilayer [155]. These cell-penetrating peptides (CPPs) or protein transduction domains (PTDs) efficiently translocate through 30 Chapter - I the cell membrane without the need for a receptor, often delivering a hydrophilic cargo (peptide or protein) into cells. This ability of these domains, together with their low toxicity, makes them promising potential delivery vectors [156,157]. Their penetrating capacity depends on the peptide composition and length. CPPs can be classified into two distinct classes. One class contains predominantly arginine residues (e.g. Antp and Tat), whereas the other contains predominantly lysine residues [158,159]. CPPs have shown great potential in a range of therapeutic applications, both in vitro and in vivo. This is partly owing to the ease with which they can be coupled to nucleic acids, proteins and small-molecule drugs. Synthetic peptides are essential tools in various areas of biomedical research, as well as for the development of diagnostics and pharmaceuticals. Over the past decade, the need for large numbers of synthetic peptides has lead to the development of synthetic methods able to generate thousands of individual peptides or peptide analogs for large screening programs. The peptides or peptide like molecule can serve in principle as building blocks for new vaccines, diagnostics and drugs. Compared to large recombinant proteins, peptide drugs offer advantages: they can be made far more specific than biological molecules by precisely engineered properties due to the absence of constraints imposed by biological production systems. On top of that peptide drugs will be more robust and, most of all, not immunogenic. Peptides drugs have, when compared to small molecules, various advantages: high specificity, often high activity, no accumulations in organs, low toxicity and no immunogenicity. 31 Chapter - I Numerous linear bioactive peptides derived from large proteins, with potential as peptide drugs, have been around for a long time [160,161,162]. Recently a special subclass, linear peptide drug candidates derived from antibodies, have been added [163,164,165]. On top of that multiple peptidelike molecules that mimick complex bioactive sites of large proteins molecules, have been described recently [166,167,168]. Some of these potential peptide drugs are in advanced development, while one of them Enfuvirtide [169], a HIV fusion inhibitor peptide, that represents a complex binding site of gp41 of HIV, is on the market. This issue illustrates that peptide drugs are emerging and will form a novel and growing class of pharmaceutical molecules with exiting new potential, not met by classical drugs based on small molecules or recombinant proteins [170]. The role of proteins as physiologically active components in the diet is being increasingly acknowledged. Many of the proteins that occur naturally in raw food materials exert their physiological action either directly or upon enzymatic hydrolysis in vitro or in vivo. In recent years it has been recognized that dietary proteins provide a rich source of biologically active peptides. Such peptides are inactive within the sequence of the parent protein and can be released in three ways: (a) through hydrolysis by digestive enzymes, (b) through hydrolysis by proteolytic microorganisms and (c) through the action of proteolytic enzymes derived from microorganisms or plants. It is now well established that physiologically active peptides are produced from several food proteins during gastrointestinal digestion and fermentation of food materials with lactic acid bacteria [171,172]. Bioactive peptides have been defined as specific protein fragments that have a positive impact on body functions or conditions and may ultimately influence health 32 Chapter - I [173]. Upon oral administration, bioactive peptides, may affect the major body systems namely, the cardiovascular, digestive, immune and nervous systems depending on their amino acid sequence. For this reason, the potential of distinct dietary peptide sequences to promote human health by reducing the risk of chronic diseases or boosting natural immune protection has aroused a lot of scientific interest over the past few years. These beneficial health effects may be attributed to numerous known peptide sequences exhibiting, e.g., antimicrobial, antioxidative, antithrombotic, antihypertensive and immunomodulatory activities [174]. The activity is based on their inherent amino acid composition and sequence. The size of active sequences may vary from two to twenty amino acid residues, and many peptides are known to reveal multifunctional properties [175]. Today, milk proteins are considered the most important source of bioactive peptides and an increasing number of bioactive peptides have been identified in milk protein hydrolysates and fermented dairy products [176,177,178]. 1.2.1. Peptides and biological activity Biologically active peptides range in size from small molecules containing only two or three amino acids to large molecules containing several tens of amino acids. Among them, neuropeptides, hypothalamic hormones [179], proteohormones of the pituitary, thyroid hormones, gastrointestinal peptides, muramyl peptides, peptides of immunological significance, peptide vaccines, plasma kinins, atrial nutriuretic peptides, peptide antibiotics, peptide toxins, peptide insecticides and herbicides are some of the important classes. 33 Chapter - I 1.2.1.1. Peptide hormones Among the plethora of peptide hormones, peptides which are already in clinical use and a few others described in this section. Among the peptides present in the brain, thyrotropin releasing hormone (TRH) 1 was the first to be isolated from 1, 00,000 pig hypothalami. This is the molecule by which the hypothalamus through the pituitary regulates the functions of the thyroid gland. Later, the first isolation of 800 mg of luteinizing hormone releasing hormone (LHRH or gona-doliberin, pGlu-His-Trp-Ser-Tyr-Gly-Leu-Arg-ProGly-NH2) from ventral hypothalami of 1,65,000 pigs was achieved by 12 successive purification steps by Andrew V Schally and Roger Guillemin, who were awarded the Nobel Prize for Medicine and Physiology in 1977. LHRH acts on the pituitary to promote rapid release of LH and follicle-stimulating hormone (FSH), which in turn regulates ovulation and spermatogenesis. Among several of its clinical applications, LHRH and its analogs, find use as a nonsteroidal male and female contraceptive or as fertility agents. Somatostatin, the tetra-decapeptide hormone released by the hypothalamus, plays an important physiological role as an inhibitor for the release of several hormones (glucogon, growth hormone, insulin, and gastrin). The octapeptide angiotension II (AspArg-Val-Tyr-Ile-His-Pro-Phe) causes increase in blood pressure. A melanocyte stimulating hormone (a-MSH) also called as a-melanotropin (Ac-Ser-Tyr-Ser-Met-GluHis-Phe-Arg-Trp-Gly-Lys-Pro-Val-NH2), is secreted in the anterior lobe of the pituitary gland. It exerts its activity at peripheral receptors, which are primarily responsible for its pigmentation properties. The other hormone secreted in the anterior lobe is a 39 residue peptide corticotrophin or adrenocorticotropin hormone (ACTH). This finds use in medicine for the treatment of hypophyseal insufficiencies and inflammatory processes. 34 Chapter - I The gastrin family of peptides plays a significant role in gastrointestinal functions including secretion, motility and absorption. Cholecystokinin is an important hormone, which belongs to this family mediating digestive functions and feeding behavior. In the course of the isolation of oxytocin, the second hormone of the pituitary, vasopressin, a peptide with pressor and antidiuretic effects, was also isolated. The deficiency of vasopressin causes diabetes insipidus [180]. Persons affected by it have excessive excretion of water, which is controlled by applying a solution of the peptide in the form of nasal spray. The vital regulation of the level of Ca2+ ions in the blood is controlled by parathyroid hormones. These hormones raise the level of calcium concentration in blood by mobilizing calcium uptake from the bones. On the other hand, the thyroid hormone, calcitonin directs the flow of calcium ions in the opposite direction. Thus a constant level of calcium ions is maintained in the blood. O O N H N HN N O N NH2 O 1 [Primary structure of TRH (pGlu-His-Pro-NH2)] 1.2.1.2. Neuropeptides There are about 50 neuropeptides whose molecular structures are known; many of them exist within closely related families of molecules. Several endogenous opioid pep-tides [endorphins, enkephalins, dynorphins, dermorphins, deltorphins, dermorphin gene associated peptide (DGAD)] possessing morphinomimetic properties are very well 35 Chapter - I studied. Enkephalins (meaning isolated from the brain), two pentapeptides (Tyr-Gly-GlyPhe-Met/Leu) are found in varying amounts in almost all regions of nervous system. A large number of their analogs have been synthesized to find out their role in pain transmission, since they act as transmitters of the paininhibitory neurons on the spinal cord. These brain morphins have been well studied which is known to allow analgesia to be separated from the development of addiction and dependence. 2 Gramicidin S (Active against gram-positive but not against gram-negative bacteria) 1.2.1.3. Peptide leukotrienes: The peptide leukotrienes cause contraction of the bronchial smooth muscle and probably play an important role as mediators in allergic reactions (eg. asthma) and inflammations. 1.2.1.4. Peptide antibiotics: The peptidic nature of penicillins has long been recognised. Penicillins and cephalosporins inhibit final stages of the enzymatic construction of the bacterial peptidoglycan cell wall component, a network of peptides and polysaccharides. The 36 Chapter - I depsipeptide, valinomycin has been found to be active against a number of bacteria, yeasts and fungi. 1.2.1.5. Peptides of immunological significance: Immune responses to synthetic peptides constitute another imporant field of study. Serums raised against synthetic peptides are highly specific reagents for the corresponding native proteins from which the peptide amino acid sequence was derived. These antipeptide serums are powerful reagents for the detection and characterization of proteins. S S NH2-Cys-Tyr-Phe-Gln-Asn-Cys-Pro-Arg-Gly-CONH2 3 Human vasopressin (antidiuretic harmone) S S NH2-Cys-Tyr-Ile-Gln-Asn-Cys-Pro-Lue-Gly-CONH2 4 Human Oxytocin (Uterine contraction) Two hormones 3 & 4 of the posterior pituitary gland are identical in all but two residues exhibit very different biological activity 1.2.1.6. Poisonous peptides: The most important component of snake venoms are polypeptide neurotoxins such as cobrotoxin, which produce lethal flaccid paralysis through a neuromuscle block. The peptides of amanita mushrooms such as antamanides are among the best known peptide poisons. The smallest dose of 50 mg can kill a 20 gm mouse within a few hours. (2.5 mg 37 Chapter - I /kg of body weight). A search for inhibitors or antidotes through antagonists can be predicated. 1.2.1.7. Others: Actinomycin belongs to a class of chromopeptides and is characterized by its cytostatic growth inhibition in tumors and for antibacterial action. The cyclic despipeptides, destruxins act as insecticides whereas bialaphos (phosphinotricylalanyl alanine) has a strong herbicidal action. Peptides can be either sweet or bitter. The bitter peptide ArgGly-Pro-Pro-Ile-Val, isolated from casein hydrolysates and delicious tasting peptides from fish proteins has gained practical importance in the food industry. Nisin, produced by Streptococcus lactis is used as a food preservative. The antrial natriuretic peptides have diuretic properties. The phosphopeptide, (S)-alanyl-(R)-1-aminoethyl-phosphoric acid (alafosfalin) is effective against both gram positive and gram negative microorganisms. Albomycins are nucleopeptides which possess iron-complexing properties. Several muramyl peptides (glycopeptides) have the possibility of being used as adjuvants in combination with vaccines or with antibiotics. 1.2.2. Examples of peptides and their bioactivity 1.2.2.1. Somatostatin Somatostatin analogue infusion improved memory for patients with AD, perhaps through modulation of the insulin content 1.2.2.2. Neuropeptide Y (NPY) It may be involved in aluminium metabolism in animal models, and aluminium accumulation has been associated as a risk factor for AD, mainly in combination with fluorine. 38 Chapter - I 1.2.2.3. Galanin Galanin levels increase with the duration of AD. Galanin inhibits cholinergic transmission and long term potentiation in hippocampus. Galanin’s excitatory action on cholinergic neurons may play a compensatory role by augmenting the release of acetylcholine from remaining cholinergic basal forebrain neurons. 1.2.2.4. Insulin like growth factor I (IGF I) IGF I protects in vitro primary neurons from cytotoxic mechanism of the London type Abeta PP mutant. 1.2.2.5. Interleukin-6 and interleukin-11 Both interleukins attenuate cytotoxicity of the London type Abeta PP mutant. 1.2.2.6. Apoptosis-antagonizing transcription factor (AATF) AATF protects neurons against Abeta-induced apoptosis in PC 12 cells. 1.2.2.7. SAL (SALLRSIPA) SAL is active fragment of ADNF and prevents neuronal cell death produced by electrical blockade, N-methyl-Daspartate, and Abeta. 1.2.2.8. Activity -dependent neuroprotective protein (ADNP) The protein implicated in maintenance of cell survival through modulation of p53 expression. The ADNP was identified as a molecule that may mediate protection offered by lipophilic analogues against ischemia cell death. 1.2.2.9. Bcl-w Bcl-w is a member of the Bcl-2 anti-apoptic protein family that promotes cell survival, significantly protects neurons against stauroporine and Abeta induced apoptosis. 39 Chapter - I 1.2.2.10. Gly-Pro-Arg This tripeptide effectively protects and rescues cell death induced by Abeta. 1.2.2.11. RER peptides Peptides containing the palindromic tripeptide RER sequence (Arg-Glu-Arg), present in the amyloid precursor protein, protects against memory loss cause by Abeta and acts as a cognitive enhancer. 1.2.2.12. Autocamtide-related inhibitory peptides (AIP) These peptides inhibit Ca/Calmodulin dependent protein kinase II, inhibit Abeta triggered activation of caspase 2 and 3, decrease tau phosphorylation and protect neuron against Abeta toxicity. 1.2.2.13. Substance P This short peptide interacts with cholinergic ascending system of the nucleus basalis Meynert, resulting enhancement effects. Patients with AD show a marked loss of cholinergic neurons and diminished brain substance P expression. Synthetic peptides are essential tools in various areas of biomedical research, as well as for the development of diagnostics and pharmaceuticals. Over the past decade, the need for large number of synthetic peptides has lead to the development of synthetic methods able to generate thousands of individual peptides or peptide analogs for large screening programs [181]. There are multiple examples in nature, where peptides are used as ligands to influence the function of specifically binding target proteins. Also, cellular regulatory mechanisms are dependent on numerous inhibitory proteins that function through allosterism or inhibition of protein interactions. 40 Chapter - I Currently, proteins and peptides experimentally selected for high affinity intracellular interactions with pre-determined target structures are emerging as important molecules, which could serve to extend conventional druggability. In a few model systems, peptides have already been used to manipulate crucial regulatory networks in cancer cells [182,183,184,185]. They can target specific intracellular proteins required by cancer cells for proliferation and invasion. Additional essential signalling components in cancer cells are being discovered and it is conceivable that individual peptides can be derived to inhibit their function in a targeted fashion. These peptides can be used for mono therapy or in combination with conventional chemotherapeutic agents. Since multiple pathways are dysfunctional in different cancers, and cancer cells accumulate oncogenic mutations as they progress, the greatest and most durable benefit will likely be achieved by combining therapeutic agents, which address different hallmarks of cancer. This concept, also called ‘multi-focal signal modulation therapy’ (MSMT), is promising, since combinations of signal modulators have already achieved dramatic suppression of tumour growth [186,187,188] This is exemplified by the design of a peptide binding to TRAF6 (tumour necrosis factor (TNF) receptor associated factor 6), which was derived from the sequence of two natural binders. TRAF6 participates in signal transduction mediated by TNF receptors as well as the IL-1 receptor family and plays a role in immunity and bone homeostasis. This peptide inhibits TRAF6 signalling and osteoclast differentiation and has the potential as a therapeutic modulator for the treatment of osteoporosis or cancer-induced bone lesions. The use of peptides as drugs is limited by a number of biological properties, which have to be altered and manipulated in order to enhance efficacy. These include their metabolic 41 Chapter - I instability, the inability to cross cell membranes and their potential immunogenicity. In the past years, considerable progress has been made to convert peptides into therapeutically useful molecules. This includes the increase in stability by chemical modifications. Peptides assembled partly or totally from D-amino acids are more stable and less susceptible to proteolytic degradation than peptides made from natural L-amino acids. D-peptides are obtained by synthesising D-amino acids in the reverse order from those in the parent peptide and replacing L-amino acids. They usually closely resemble the structure of the L-variants or even show increased affinity [189,190,191]. Short peptides (<40 mer) can be chemically synthesised on a small scale. Chemical modifications of the peptides can be also incorporated to increase the binding efficacy. This has been achieved with non naturally occurring or phosphorylated amino acids or by protection of the N- and C-terminus. This improved the systemic and intracellular stability of the recombinant peptides. However, synthesis of longer and highly structured peptides is laborious and expensive. E. coli and insect systems are now available, which allow peptides and proteins to be obtained in a recombinant setting. With such systems it is even possible to incorporate non-natural amino acids into proteins or to modify coded ones by post-translational modifications [192,193]. A peptide molecule exists in either a compact folded state or a variable and open unfolded state. One way of shifting the equilibrium toward the folded state is by inserting peptides with both ends in a platform or a so called scaffold protein or by attaching them on one side to a support protein (like SUMO-1). This not only increases stability but also constrains the conformation, improving binding affinities by decreasing their flexibility in solution (entropy) before binding [194]. For most screening methods mentioned above, 42 Chapter - I peptides are usually presented in a constrained setting. Critical factors in the development of effective scaffolds that can be used in cancer therapy include absence of regions prone to aggregation or susceptible to proteolysis. The scaffold should also offer low immunogenicity, high affinity and specificity, solubility and stability to the peptide. Meanwhile multiple scaffolds have been described, each displaying their own advantages and applicabilities. One of the most popular scaffolds for peptide library display is the bacterial thioredoxin A protein (Trx). This protein is characterised by a stable structure and can be easily purified in large quantities from E. coli extracts. Efficient purification is an important parameter for determination of aptamer structure as well as for protein transduction experiments. It might become the basis for cost effective production of potential therapeutics. Numerous peptide aptamers integrated into this scaffold have been identified, which bind to various target proteins [195,196,197,198]. It was even possible to show that the binding domain of a natural interaction partner can be displayed in a proper interacting conformation by the Trx scaffold [199]. Other proteins that are suitable for the presentation of peptides, a catalytically inactive derivative of Staphylococcus nuclease, and the cellular transcription factor SP1 have been described [200,201]. The recent reports suggest that cell-penetrating peptides might be able to transport macromolecules across the blood brain barrier [202]. The peptides or peptide like molecule can serve in principle as building blocks for new vaccines, diagnostics and drugs. Compared to large recombinant proteins, peptide drugs offer advantages: they can be made for more specific than biological molecules by precisely engineered properties due to the absence of constraints imposed by biological 43 Chapter - I production systems. On top of that peptide drugs will be more robust and most of all not immunogenic. Peptides drugs have, when compared to small molecules, various advantages: high specificity, often high activity, no accumulations in organs, low toxicity and no immunogenicity. Various approaches have also been used to rigidly an active structure by cyclization or by introduction of constraints into regular peptide molecules in order to amplify conformational and functional features beneficial to enzymatic stability and biological activity. Diverse peptidomimetics have found applications in immunology [203] receptor binding interactions [204] and in the design of enzyme inhibitors [205]. The development of conceptual approaches for synthetic modification of the molecule in order (i) to endow the analog ideally with only one specific activity (i.e to change the activity profile of the peptide so that only the desired biological property is expressed, whether agonistic (or antagonistic) and (ii) to increase the resistance of the peptide to enzymatic inactivation and to alter tissue distribution, with the hope of prolonging the duration of hormonal action [206]. The neuroprotective potential of different peptides has become a matter of intensive investigation in many animal models. Many in vitro studies reveal that peptides protect neurons against apoptosis occurring naturally during CNS development and apoptosis induced by a series of neurotoxins, prion protein, Abeta, HIV envelope glycoprotein (gp120), potassium ion deficit and high glutamate concentrations [207]. 44 Chapter - I The development and successful application of soluble peptide combinatorial libraries have demonstrated the power of combinatorial approaches for basic research and for the identification of highly active compounds having therapeutic potential [208]. Proteins and peptides are fundamental in life with an extensive array of functions born of the multitude of possible structures. Consisting of common fragments the primary, secondary and tertiary structures formed through intra- and inter-molecular interactions provide innumerable variations of structure and resultant activity in biological systems. However, the serial nature of synthetic peptide synthesis leads to the perpetual problem of long synthetic routes when investigating residue effects through analogue synthesis. While the ability to modify individual residues of peptides and complex molecules selectively and reliably leads to a number of exciting possibilities in chemical biology and synthetic strategies. Currently, the majority of methods applied to the modification of biological systems are based on biochemical techniques [209], however, examples of modifications achieved through small molecule (chemical) reactivity is increasing [210]. Peptides have multiple biological actions in the brain, and are potentially valuable as neuropharmaceuticals in the treatment of various disorders of the CNS. Possible roles of peptides in the CNS include; 1) involvement in neurotransmission and neuromodulation; 2) regulation of the neuroendocrine axis; 3) regulation of cerebral blood flow; 4) regulation of (cerebro spinal fluid) CSF secretion; 5) mediation of the integrity of the BBB; 6) modulation of the BBB permeability to nutrients; 7) regulation of water and electrolyte contents of the brain; 8) regulation of the expression of specific proteins at the BBB [211]. 45 Chapter - I Thus, peptide drugs may be useful to treat or to diagnose brain disease. However, delivery of peptide drugs to the brain is an essential prerequisite for therapeutic effectiveness, since distribution of peptides and proteins to the brain is generally very low because of the blood-brain barrier (BBB) that prevents many molecules from crossing into the brain. 1.3. Introduction to heterocyclic compounds 1.3.1. Introduction to benzimidazole derivatives One of the goals of medicinal chemistry research and drug discovery is to provide a rational basis for the design of new medicinal agents. Organic compounds and their reactions have been utilized by people since antiquity. When leaves or tree bark or plant roots are mixed with water to make a medicinal potion, a complex mixture of organic products is actually extracted for its biologically active components. In 1960s, a broad spectrum group of drugs, known as benzimidazoles, were discovered with a big-gang having specific activity. Due to the increasing demand for bioactive molecules, organic chemists are increasingly required to synthesize new compounds of biological interest. There has been an unlimited expansion of molecular diversity in synthetic organic compounds by the application of combinatorial methodology. The benzimidazole nucleus is an important pharmacophore in drug discovery [212] and it is a fused aromatic imidazole ring where a benzene ring is fused to 4 and 5 positions of an imidazole ring. H N N 5 Benzimidazole 46 Chapter - I Benzimidazoles are very useful intermediates for the development of molecules of pharmaceutical or biological interest. Substituted benzimidazole derivatives have found applications as in diverse therapeutic agents including antiulcer, antihelmintic, antihypertensive, anticoagulant, antiallergic, analgesic, antiinflammatory, antipyretic, antibacterial, antifungal, antiviral, antiparasitic, antioxidant, anticancer and antianxiolytic. Because of their significant medicinal importance, the synthesis of substituted benzimidazoles has become a focus of synthetic organic chemistry. Benzimidazoles are listed with various effects on human body and are used to treat multiple system disorders. 1.3.1.1. Benzimidazole derivatives as anticancer agents Cancer is most common cause of death next only to heart disease. Accounting for 22.3%. The cancer death rate per 100,000 populations in 1930 was 143; in 1950, it was 157; and in 1986, it was 171. Lung cancer was the major cause for this increase, and in 1986, the deaths from lung cancer were approaching 50% of all reported deaths from cancer. Most multicellular organisms can be afflicted by cancer and cancerous lesions have been found in dinosaur bones. Only in the twentieth century, however, has there been much concern over the disease. Progress in the cure of the former major causes of death has inevitably led to a risen in the incidence of cancer. The outlook for survival rates from cancer shows improvement. Those who are alive 5 years after diagnosis were 1 in 5 in the 1930s, 1 in 4 in the 1940s, and 1 in 3 in the 1960s. More recently, 4 in 10 patients survive 5 years. In terms of normal life expectancy, 50% of cancer patients are now alive after 5 years. Poor Americans, regardless of race, have a 5-year survival rate that is 10 to 15% lower than the average [213]. 47 Chapter - I Tapas Mukhopadhyay et. al., reported the Mebendazole, a derivative of benzimidazole, induces a dose and time-dependent apoptotic response in human lung cancer cell lines. Mebendazole arrested cells at the G2-M phase before the onset of apoptosis, as detected by using fluorescence-activated cell sorter analysis [214]. Xiaofen Huang et. al., reported the antitumor (melanoma, non-small-cell lung) activity of Pyrrolo[1,2-a]benzimidazoles [215]. Laura Garuti et. al., reported the antiproliferative activity of some benzimidazole4, 7-dione derivatives, compound 6 possess the best antiproliferative effect. Such activity is strong against SUPT1 cells, although lower than that of the MMC. Moreover, compound 6 is more active than MMC on human lymphoblastic leukemia, whereas high antiproliferative activity of 6 on leukemia and lymphoma cells [216]. The DNA minor groove binders, Hoechst 33258 and Hoechst 33342, have been reported to protect against radiation-induced DNA-strand breakage, but their mutagenicity and cytotoxicity limit their use as protectors of normal tissue during radiotherapy and as biological radioprotectors during accidental radiation exposure [217,218]. Dyes Hoechst 33258 and Hoechst 33342 are frequently used in cytometry to stain chromosomal materials in situ because these two compounds become highly fluorescent upon bonding to DNA [219]. Edmunds Lukevics et. al., reported the antitumour activity of trimethylsilylpropyl substituted benzimidazoles, N-trimethylsilylpropylbenzimidazole (8) exhibits high cytotoxic activity [220]. John Mann et. al., reported the antitumor activity of symmetric bisbenzimidazole-based DNA minor groove-binding agents, the compound 2,2-bis-[4¢(3¢¢-dimethylamino-1¢¢-propyloxy)phenyl]-5,5-bi-1H-benzimidazole possesses promising 48 Chapter - I in vitro antitumor growth inhibitory properties, with the concentration required for 50% inhibition being around 200-300 nM [221]. Seref Demirayak et. al., reported the anticancer activity of 1-methylene-2,3-diaryl-1,2dihydropyrazino[1,2-a]benzimidazole and some 1-(2-arylvinyl)-3-arylpyrazino[1,2- a]benzimidazole derivatives [222]. Ahmed Kamal et. al., reported the DNA-binding affinity and in vitro anticancer activity of C8-linked pyrrolo[2,1-c] [1,4] benzodiazepine– benzimidazole conjugates [223]. El-Sayed A. M. reported the antineoplastic activity of cycloalkyl pyrido[1, 2-a] benzimidazoles, the p-fluorophenylamino derivative 10 was the most active candidate against K-562, Molt-4 and RPMI-8226 leukaemic cell lines [224]. Antonio Da Settimoa et. al., reported the DNA binding and in vitro antiproliferative activity of purinoquinazoline, pyridopyrimidopurine and pyridopyrimidobenzimidazole derivatives [225]. Shu-Ting Huang et. al., reported the anticancer evaluation of bis benzimidazoles [226]. Chandra Kumar et. al., reported the inhibition of angiogenesis and tumor growth by benzimidazole derivatives [227]. Kristina Starcevic et. al., reported the antitumor activity of 2-substituted-5-amidino-benzimidazoles. The most pronounced antiproliferative activity was shown with compounds having imidazolinylamidino-substituent [228]. Interestingly another promising group of antitumor compounds is represented by benzimidazo[t,2-c]quinazolines and thiazolo[3,4-a]benzimidazoles [229,230]. Chronic lymphocytic leukemia is a cancer of the white blood cells (lymphocytes). Treanda is indicated for the treatment of patients with chronic lymphocytic leukemia. 49 Chapter - I O H3C N N N N SCH3 7 Hoechst 33258 O 6 H3C H3C NH NH N H OH CH3 Si H3C N N N N NH NH N OCH2CH3 9 Hoechst 33342 8 Cl CN COOH Cl N N N N N HN HCl CH3 11 Treanda 10 F Benzimidazole derivatives with potent anticancer activity and Hoechst 33258 and Hoechst 33342, are used to protect against radiation-induced DNA-strand breakage The more spectacular advances in medicinal chemistry have been made when heterocyclic compounds played an important role in regulating biological activities. Among various heterocycles, sulfur-nitrogen heterocycles have maintained the interest of reaserchers through decades of historical development of organic synthesis. The grounds of this interest were their biological activities and unique structures that led several applications in different areas of pharmaceutical and agrochemical research or, more recently in material sciences [231]. 50 Chapter - I 1.3.2. Introduction to morpholine arecholine derivatives Arecoline is a natural organic compound which is an alkaloid found in betel nuts from the betel palm (Areca catechu) It is an oily liquid that is soluble in water, alcohols, and ether [232]. 12 In many Asian cultures, the betel nut is chewed to obtain a stimulating effect. Arecoline is the primary active ingredient responsible for the central nervous system affects which are roughly comparable to those of nicotine, which has a similar chemical structure. Arecoline is known to be an agonist of muscarinic M1, M2 and M3 receptors [233], which is believed to be the primary cause of its parasympathetic effects (such as pupillary constriction, bronchial constriction, etc.). Arecoline has also been used medicinally as an antihelmintic [234] (a drug against parasitic worms). Pedersen et al [235] have investigated muscarinic receptor affinity as well as estimated relative efficacy and subtype selectivity of bicyclic arecoline bioisosteres 13(a-d) using rat brain membranes and a number of tritiated muscarinic receptor ligands. OR a: CH3 b: C2H5 c: -CH2-CH=CH2 d: -CH2CN HN N S 13(a-d) 51 Chapter - I The effects at the five cloned human muscarinic receptor subtypes of a selected series of chiral analogues, with established absolute stereochemistry, were studied using receptor selection and implication technology. The potency, relative efficacy, and receptor subtype selectivity of these compounds were related to the structure of the O-substituents and the position and stereo chemical orientation of the piperidine ring methyl substituents. A series of derivatives of arecoline were synthesized in an effort to develop M1 muscarinic agonists [236]. The arecoline derivatives stimulated phosphoinositide turnover through muscarinic receptors in the rat hippocampus. Molecular mechanics calculations indicate that the anti form of the 1,2,5-thiadiazole derivatives of arecoline may be active at M1 receptors. In addition, a series of arecoline derivatives were synthesized and tested for muscarinic activity in receptor binding assays using [3H]-oxotremorine-M (3H-OXO-M) and [3H]pirenzepine (3H-pZ) as ligands. Potential muscarinic agonistic or antagonistic properties of the compounds were determined using binding studies measuring their potencies to inhibit the binding of 3H-OXO-M and 3H-PZ. Preferential inhibition of 3H-OXO-M binding was used as an indicator for potential muscarinic agonistic properties; this potential was confirmed in functional studies on isolated organs. All compounds with agonistic properties showed 3H-pZ / 3H-OXO-M potency ratios in excess of 20. N N N Br N I N N 14a 14b 52 Chapter - I In contrast, for antagonists this ratio was found to be close to unity. Mono-halogenation resulted in compounds (14a and 14b) with M3 agonistic properties as shown by their atropine sensitive stimulant properties in the guinea pig ileum, but with very little or no Ml activity. Some minor in vivo effects were observed for both these compounds, with the iodinated compound 14b inducing salivation. Compound 14a also showed some positive mnemonic properties in rats where spatial short-term memory had been compromised by temporary cholinergic depletion. These data indicate that some M3 agonism may be desired in therapeutic agents aimed at the treatment of the cognitive deficits of Alzheimer's disease patients. 1.3.3. Introduction to 1,2-benzisoxazoles derivatives Many reports ascribe interesting biological activities of 1,2-benzisoxazoles and their derivatives. The chemistry of substituted 1,2-benzisoxazole amides occupies an extremely important role in the field of pharmaceuticals and in medicinal fields. Compounds containing amide bond, benzisoxazoles, chromans and fluorine atom substitution can alter the chemical properties, disposition, and biological activities of drugs [237]. Many fluorinated compounds, 1,2-benzisoxazole derivatives and various amides are currently used in the treatment of diseases [238]. These include, antidepressants, anti-inflammatory agents, antimalarial drugs, antipsychotics, antiviral agents, steroids, and general anaesthetics. 1,2-benzisoxazole ring containing in the drugs namely Zonisamide (15) and Risperidone (16) an anticonvulasants [239]. The fluorine substitution can also have a profound effect on drug disposition, in terms of distribution, drug clearance, route(s), and extent of drug metabolism [240]. 53 Chapter - I O N N O N O S N NH2 N O 15 O F 16 Benzisoxazoles are currently the most important building blocks in drug discovery, with a high number of positive hits encountered in biological screens of this heterocycle and its congeners. The benzisoxazole template forms the molecular backbone, possesses versatile binding properties with a frequently occurring binding motif, and provides potent and selective ligands for a range of different biological targets in Medicinal Chemistry. The benzisoxazole scaffold and its analogues are important pharmacophores that can be found in biologically active compounds across a number of different therapeutic areas such as anti-HIV [241], anticancer [242], anti-inflammatory [243], dopamine and serotonin receptors [244], anticonvulsants [245], acetylcholineesterase [246] and antimicrobial [247]. 1.4. Scope of the present work The study of heterocycles is an evergreen field in the branch of organic chemistry and always attracts the attention of scientists working not only in the area of natural products but also in the synthetic organic and medicinal chemistry. Moreover, many useful drugs have emerged from the successful investigations carried out in this branch. Besides, spectacular advances have been made to furtherance the knowledge of relationship between chemical structure and biological activity. In fact, this tendency is reflected by the voluminous data available in literature on heterocyclic chemistry. 54 Chapter - I There is a large amount of literature dealing with the physiological significance of free amino acids and their effects on a variety of metabolic and physiological systems. Amino acids and their metabolic and physiological ramifications are among the most investigated topics in biomedical science. The synthesis of substituted amino acids has attracted the attention of chemists due to their biological activities and the interesting structural properties of their molecules. For example NS5B polymerase inhibitors against the hepatitis C virus, anti inflammatory bradykinin B1 receptor antagonists, anticancer matrix metalloproteinase (MMP-12) inhibitors or analgesic endomorphin-1 analogue tetrapeptides. (S)- β-Phenylalanine has been applied in the synthesis of novel antibiotics. Some amino acids are reported to have strong antioxidant activity in linoleic acid and methyl linoleate model systems. The salient features of the usefulness of conjugation of amino acids with drugs are as follows. (i) Amino acids are normal dietary constituent and they are non-toxic in moderate doses as compared to other promoities; (ii) amino acids have healing effect on gastric toxicity; (iii) being a nutritional substance, the use of amino acids as a derivatizing group might also permit more specific targeting site for enzymes involved in the terminal phase of digestion; (iv) many amino acids possess marked anti-inflammatory activity against carrageenan induced hind paw edema in rats; and (v) by using different types of amino acids, viz. non-polar, polar, acidic and basic, the drug molecule can be made more or less polar, or more or less soluble in given solvent One of the most important problems of modem organic chemistry is the search for highly effective bioregulators having a broad spectrum of biological action at comparatively low toxicity. Modification of the structure of heterocyclic compounds by conjugate with 55 Chapter - I amino acids and peptides is one of the routes for constructing new classes of biologically active substances. Introducing an amino acid or peptide into a heterocyclic compound can increase the hydrophilicity or lipophilicity, decrease the toxicity, and prolong its action. Furthermore, such modification can change the selectivity of its action. The conjugation of heterocyclic compounds with peptides leads to potent analgesics, highly active antimicrobials, enzyme inhibitors, highly specific antigenic determinants, and inhibitors of melittin's hemolytic activity. Peptides conjugated drugs have multiple biological actions in the brain, and are potentially valuable as neuropharmaceuticals in the treatment of various disorders of the CNS. Possible roles of peptides and its conjugates in the CNS include; 1) involvement in neurotransmission and neuromodulation; 2) regulation of the neuroendocrine axis; 3) regulation of cerebral blood flow; 4) regulation of cerebro spinal fluide (CSF) secretion; 5) mediation of the integrity of the Blood brain barrier (BBB); 6) modulation of the BBB permeability to nutrients; 7) regulation of water and electrolyte contents of the brain; 8) regulation of the expression of specific proteins at the BBB. Thus, the successful applications in various fields ensure a limitless scope for the development of structurally novel amino acid and peptide conjugates of heterocyclic compounds with a wide range of physico-chemical and biological properties. 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