Softgel Capsules: Formulation Design and Troubleshooting

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Course Offering #
1502-202
Softgel Capsules: Formulation Design and
Troubleshooting
February 12, 2015 • Millbrae, CA
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(Please use this code when registering)
520
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February 12, 2015
Millbrae, CA
Softgel Capsules:
Formulation Design
and Troubleshooting
Accreditations
The Center for Professional Advancement
(CfPA) has been approved as an Authorized
Provider by the International Association for
Continuing Education and Training (IACET),
7918 Jones Branch Dr., Suite 300, McLean
VA 22102. In obtaining this approval, CfPA has demonstrated that
it complies with the ANSI/IACET Standards which are widely
recognized as standards of good practice internationally. CfPA
therefore authorized to offer IACET CEUs for itsprograms that
qualify under the ANSI/IACET Standards. CEUs will be awarded for
participation in CfPA’s courses at the rate of .1 CEU per contact
hour upon successful completion of the entire course and 70%
accuracy in the required Learners’ Assessment.
Pharmaceutical/Nutraceutical
Dosage Forms
Course Topics Include:
Terminology
n Focus on the API needs
n Softgel Processing and Equipment
n Softgel Ingredient/ Test Methods
n Development of Softgel Formulations
n Softgel Problem Investigation and Troubleshooting
n Coating of Softgels
n Design of Experiments and QbD for Softgels
n
Directed by:
Dr. Cecil W. Propst
Director R&D
SPI Pharma, Inc., Grand Haven, MI
and
• Design and Troubleshooting of the Granulated Product and Processes
course id# 2560
Ronnie Bayless
• Formulation Design and Troubleshooting of Pharmaceutical Dosage
Forms: Tablets
Consultant/Owner Bayless Technologies, Inc.
course id# 2593
• GMP for Dietary Supplements
course id# 2094
• GMPs In-Depth Analysis for Pharmaceutical Life Cycle Management
course id# 2474
course id# 541
• Pharmaceutical Quality Assurance and Control
____________________________________________________________________
The Center for Professional Advancement (CfPA) is the
largest accredited technical training organization in the world with
a curriculum of approximately 450 short courses in 15 industries
including Pharmaceutical, Biotechnology, Medical Device, Chemical,
Cosmetics, Food and more.
Courses of Interest
• Granulation, Tabletting and Capsule Technology
____________________________________________________________________
Who We Are
course id# 224
The Center for Professional Advancement
190 State Highway18, Suite 203, East Brunswick, NJ 08816
Phone: 732.238.1600 • Fax: 732.238.9113
E-mail: info@cfpa.com
www.cfpa.com
www.cfpa.com
Who Should Attend
This broadly based course is intended for operators,
troubleshooters and all scientists and technologists
concerned with the development and processing of softgels
capsules products and with related regulatory affairs.
The material will be presented in such a way as to be of value
to a varying level of expertise. This course will especially
benefit those in:
• Formulating
• Engineering Support
• Quality Assurance
• Validation
• Regulatory Affairs
• Manufacturing/Production
• R&D
• Marketing
• Purchasing
Learning Objectives
Upon completion of this course, you will be able to:
• Describe the basic design, development and processes
involved in the manufacture of contemporary softgel
encapsulated products
Course Description
The main aim of this course is to review the science relating
to softgel encapsulated pharmaceutical and nutritional
products. The course begins with a consideration of the
basic aspects of softgel manufacturing process, progresses
through raw material/ingredients and their properties to the
formulation of these ingredients for softgel both the fill and
the shell materials to meet the needs of the manufacturing
process. Experimental designs and QbD is considered
in determining robustness of the prodcuct/process. The
program concludes with key aspects of the evaluation of
finished products and the investigation and troubleshooting to
solving problems.
Formal sessions of the course are supplemented with
informal discussion periods between lecturers and course
participants and problem-solving sessions are held on both an
open and private basis.
Course Location
This course will be held at The Westin Hotel in Millbrae,
California. Participants must make their own reservations;
the cost of hotel accommodation is not included in the course
fee. Hotel information will be included with your acceptance.
For reservations call 650.692.3500.
Course Co-Directors
Softgel Capsules: Formulation Design and Troubleshooting
Course Outline
February 12, 2015 • Millbrae, CA | Offering# 1502-202
8:00 a.m.: Registration/Continental Breakfast
8:30–8:45 a.m.: Introductions and Course Overview/Review of
Learning Objectives
8:45–9:30 a.m.: Softgel Design and Testing Strategy
• Introduction to softgels: Types and designs of softgels; Fill
accuracy; Why choose
• Softgel evaluation: In Process vs final; Shape, seal, burst testing,
elasticity, moisture, and stress relief
• Dissolution testing issues: Special units and USP/EP enzyme use
for crosslinking
9:45–10:45 a.m.: The Softgel Process:
• Rotary Die Process: Description, timing/alignment, pump type/
role/accuracy
• Process conditions requirements
• Tooling: Design, setup and positioning; Die roll, wedge and sealing
designs
• Ribbon: Control of thickness; Choice of type of lubricant and
amount
• Preparation of gelatin solution: Solution vs Melting; Time and
temperature of process; Hot vs cold process; Degassing
• Preparation of fill:
• Drying steps: Effect of drying rate; Humidity and temperature
requirements, drying optimization
• Lubricant removal and printing
• In process testing and controls
11:00–12:00 noon: Softgel Shell Design/ Ingredient Selection
for Shell
• Structural properties of gelatin: Types, sources and molecular
weight; Change of properties with pH, temperature, moisture,
addition of plasticizer, added ions; Role of Ti, Tm, Ts and Tg in
process and functionality of shell
• Material testing: pH, bloom strength and viscosity
• Role and impact of plasticizers: Gelatin structure and flexibility
• Making of bench shell samples for testing; Film applicator/casting
• Testing: Elongation, tensile strength, and tensile modulus
1:00–2:00 p.m.: Development of Softgel Capsule Formulation
• Formulating fill for the API/ nutritional stability:
• Roles of Types of fills: Oils, SEDDs, SMEDDs, Oil free fills;
Hydrophilic, hydrophobic
• Use of HLB, pH compatibility with fill
• Fill ingredients, Interaction and compatibility rules
• Incorporating/Stabilizing Softgels: Hydrophobic/hydrophilic/
amorphous APIs, prevention of migration
• API solubility and permeability enhancement
• Adding insoluble materials to fill
• Compatability: Crosslinking, esterification
• Example softgel formulations: Use of solvency, micelle
enhancement
2:15–3:15 p.m.: Softgel Problems/Troubleshooting
• Causes of defects and process/formulation adjustment to remedy
issue
• Appearance: Shape/dimensional, color/ air in fill
• Weight/ weight uniformity:
• Structure: Firmness; Leakers and seal integrity; Brittleness/
Cracked; Sticky, adhesion issues; Wall stretching
• Chemical changes: Loss of dissolution; Esterification:
• Migration; Sweating, blooming
• Stability Testing: ICH and Open bottle humidity studies
3:30–4:30 p.m.: Process Investigation/Optimization of Softgels
• Design characterization/Risk assessment: Humidity and
temperature exposure; Temperature cycling; Using PALS
and DSC to study gelatin structure; Relationship of water and
plasticizer to structure; Migration
• Process investigations: Example investigation process; Risk
elimination, isolation of variability and selection of test vs defect to
be eliminated
• Optimization: Use of expandable DOE models in design and
investigations to solve issue and map space, proven acceptance
range test to verify changes vs design, analyze variability and
process capability.
4:30–5:00 p.m.: Open session/ wrap up/short topics/discussion
Assessment Opportunity
Breaks will be approximately every hour.
Two in morning and two in the afternoon.
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© The Center for Professional Advancement 2015
Dr. Cecil W. Propst is Director of R&D for SPI Pharma (Grand
Haven site), a processor of a variety of specialty ingredients
for the food, drug, cosmetic and related industries. He was
Director of Quality Assurance and Technical Development
at Fleming and Company and President of Manufacturing
Chemists. His duties included system design, product and
process development, and regulatory affairs. Previously,
he served as cGMP Facilities Director for the University of
Maryland at Baltimore in connection with the University’s
contract with the FDA.
Dr. Propst also served as Director of Technical Development
for Stellar Manufacturing, Director of Quality Compliance
for SmithKline Beecham, Director of Quality Assurance for
Norcliff Thayer (a Revlon Company), Group Leader/Product
Development and Manager/ Quality Control for Lewis Howe
Company.
Ronnie Bayless, a consultant/owner in the area of Softgel
development/processing for Bayless Technologies, Inc. in
Plant City, Florida, has over 25 years of practical, handson experience in many areas of polymer science from
Research and Development to solving manufacturing
process problems. Mr. Bayless specializes in the areas of
paintball and pharmaceutical softgel technologies, medical
polymers, and polymer characterization. He is experienced in
employing scientific methods to develop new technologies,
products, and processes including complete implementation
into manufacturing and the application of Statistical Process
Control and Design of Experiments methods to improve
process quality.
Mr. Bayless’ has also:
• Worked in research project management, scheduling,
budgeting, and resource allocation
• Developed gelatin solution manufacturing processes for use
in pharmaceutical softgel capsules
• Validated processes for use in a FDA approved facility
• Developed and implemented paintball product compositions
from concept to stabile manufacturing
• Established and administered Quality Control systems for
raw materials used in the manufacture of paintballs and
cosmetic capsules
• Established raw material specifications, test methods and
documentation
• Established finished product standards and test methods.
United States
• Been granted patent for paintball fill composition
• Participated in ASTM meetings and contributed proposals to
establish paintball standards