Gamlen Tablet Press GTP-1
Transcription
Gamlen Tablet Press GTP-1
Gamlen Tablet Press GTP-1 World’s first portable bench top computer controlled tablet press and hardness tester Features • Operates under compaction force control • Flexible and easy to use • Real time acquisition of force, ejection and displacement data • Portable and lightweight Benefits • Easy to compare formulations • Can make multi-layer tablets • Improved understanding of lubrication behaviour • Manufacture preclinical and phase 1 product www.gamlen.co.uk Gamlen Tablet Press GTP-1 The Gamlen Tablet Press GTP-1 is the world’s first computer controlled bench top tablet press. Simple and easy to use, the GTP-1 is uniquely controlled by measurement of real time compaction force making it the ideal tool for rapid drug development. Key features • Easy to use – can be linked to any laptop/PC • Virtually maintenance free, extended warranty available • High product yield – >95% • Real time data recording • Tablet compression and ejection force measurement • Accurate tablet tensile strength measurement • Predicts behaviour on high speed tablet press • Small footprint • Portable and lightweight • (20kg with flight case) Product types • Tablets 2-10mm diameter • Effervescent and orally dissolving tablets • Multilayer tablets with precise force control of individual layers • Dry coated tablets The simplest instrument for tableting - in 3 easy steps 1 Dispense powder 2 Compact on press 3 Eject tablet Key Benefits • Make and test formulations quickly - including multilayer/dry coated tablets. • Evaluate small quantities of material without need for scale-up. • Flexible - its easy to use features and portability make it ideal for travel and training. • Accurate-force reproducibility +1%, thickness reproducibility +3µm Applications include • Manufacture of test product batches • Pre-formulation studies • Formulation comparisons • Troubleshooting tableting problems such as capping • Salt selection studies • Intrinsic dissolution studies • Excipient compatibility samples • Manufacture of phase one clinical trials material www.gamlen.co.uk GTP-1 Compaction GTP-1 Ejection GTP-1 Fracture The GTP-1 tablet press uniquely controls force Description The Gamlen Tablet Press is a small purpose built portable tablet press working under computer control at punch speeds of 1.0-60mm/min using a V shape compression waveform and dwell time of 100ms. • • • Uniquely it has two modes – working as a tablet press (Compaction Mode) and also as a tablet hardness tester (Fracture Mode). The press can be operated in a glove box under precise humidity and temperature control. It is ideal for materials testing and tablet research, development and small scale manufacture. In operation the die is manually filled and the machine operates under automatic compression force or displacement control. Ejection is in the same direction as compression; tablets are pushed through the bottom of the die into a tablet holder which is removed from the machine. The GTP-1 accurately applies a specified force to the measured weight of powder in the die In contrast, other tablet presses can only record the value of the force applied. This is determined by the position of the compression rollers, or punches, and the amount of material in the GTP-1 principle die. The force applied on a tablet press cannot be specified by the operator The compaction force applied determines important tablet properties such as dissolution Rotary press hardness and friability Typical data generation from the Gamlen Tablet Press GTP-1 Formulation comparison of direct compression excipients to replace wet granulation. KEY: 100 1.8 Wet Granulated (400kg) 1.6 1.4 1.2 1 0.8 0.6 0.4 0.2 0 Wet Granulated (200kg) 80 % drug dissolved Tensile fracture stress (MPa) 2 Sieved Lactose 80 (400kg) Sieved Lactose 80 (200kg) 60 Spray Dried Lactose (400kg) Spray Dried Lactose (200kg) Extra MCC (400kg) 40 Extra MCC (200kg) Agglomerated Lactose 80 (400kg) 0 20 40 60 80 100 120 140 20 Agglomerated Lactose 80 (200kg) Compaction pressure (MPa) Partial Pregelatinized Starch (400kg) KEY: Extra Avicel Wet granulated Agglomerated lactose 80 Sieved lactose Spray dried lactose Lactose powder 200 0 Partial Pregelatinized Starch (200kg) 0 10 20 Time (min) 30 40 Lactose Powder 200 (400kg) Lactose Powder 200 (200kg) • Rapid compressibility data generation together with dissolution profiles facilitated selection of the best direct compression formulations as a possible substitute for wet granulation. www.gamlen.co.uk Specification of standard machine Tablet punch size Material capacity of the die Data collection rate Tablets/min Maximum load Choice of 4 output units Load cell resolution Width between pillars Load Cell travel Test Height Load indication Inputs & Outputs Test Speed Range Fast down and return speed Calibration Power requirements Machine dimensions Machine weight (without accessories) Shipping size Shipping weight approx 2-13mm diameter 2-400mg 10-2000Hz 1 500 kg Kilogram (kg) as standard; Kilopond (kp), Newton (N) or Pound (lb) on request 1:5000 60 mm 30 mm Depends on pillar extension length. Maximum extension of 300 mm. Via PC software USB interface. Load cell. 1.0 – 60 mm/min. 60 mm/min Dead weights in kg or proving ring. 110/120 VAC 3.15 A or 220/240 VAC 1.6 A (External selection via fuse holder) 310(w) x 270(d) x 375(h) 16 kg 390 x 350 x 390 or 460 x 430 x 480 20 kg Patent Pending Additional Options • Powder pipette for accurate and reproducible dispensing • Controlled humidity glove box, RH controlled to +1%, temperature to +1% • • Ejection rig for manual tablet recovery (useful for manufacturing) Extension pillars and ram system to enable use as a ram extruder. • Bespoke design punch and die set • Flight case for transport • 3 and 4 point bend tablet fracture rigs. • Others on request. Sales and Customer Service Gamlen Tableting Ltd, Biocity Nottingham, Pennyfoot Street, Nottingham, NG1 1GF UK Tel: +44 (0) 115 912 4271 | Fax: +44 115 912 4278 | E-mail: sales@pharmdservices.com www.gamlen.co.uk
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Gamlen Tablet Press GTP-1
(External selection via fuse holder) 310(w) x 270(d) x 375(h) 16 kg 390 x 350 x 390 or 460 x 430 x 480 20 kg
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