Pharmaceutical Tablet and Capsule Technology
Formulation and Manufacturing of Pharmaceuticals
An Important Two & Half Day Interactive Conference with Case Studies and
Workshops Discussions On:
- Regulations and goals for formulation and production
- Raw Materials Considerations for Pharmaceutical Manufacturing
- Particle Characterization Methods & Mechanisms of Particle Size Reduction
- Mixing and Blending of Powders
- Granulation
- Powder Flow
- Mixing Strategy and Minimizing segregation
- Fluid Bed Technology
- Properties of wet and dry assemblies of particles
- Drying-Cooling
- New Trends in Dosage Form Design and Process Development
- Functions & stages of the tablet compression process
- Tableting Principles and Troubleshooting
- Coating Formulations and Processes
- Modifying Release by Coating
- Filling and Formulation of Hard Capsules
- Liquid Filling
- Punches and Dies
- Application of Process Analytical Technology (PAT)
- Dosage Form Evaluation
Workshops and Case Study Discussions
- Problem Solving and Common Challenges in Tableting
- Trouble shooting for Coating Equipment and Coating
Distinguished Course Leaders
Mr. Gary Bubb
Vice President and Director of Engineering,
Specialty Measurements Inc.
Gary Bubb is Vice President and the Director of Engineering of Specialty Measurements in Whitehouse N.J.
Gary graduated with an undergraduate degree in mechanical engineering from Northeastern University in 1966. His work experience started as an engineer with the Department of Defense where he was assigned the task of standardizing the measurement systems at the various Army Proving Grounds in order to better correlate the data. While in that position Gary pursued a Graduate program in Measurements Engineering and Mechanical Vibrations during which he attended a variety of schools including Stevens, Arizona State, Trenton State, Tuffs, and UCLA.
In 1982 Gary was one of the co-founders of SMI, Specialty Measurements Inc., with a focus on developing specialized transducers and instrumentation systems for Industry. SMI grew to become the largest independent testing laboratories on the East Coast, with major projects including all of the East and Hudson River Bridges in New York and the Delaware River Bridges in Philadelphia. In 1984 SMI developed the first PC based system for instrumented tablet presses that was the precursor for the SMI 3600, a computer-based data acquisition system designed and manufactured by SMI. Ultimately, the SMI 3620 and evolved into the SMI 3620, 3630, and 3640 using Motorola processors and a unique operating system called OS-9. When the IBM series of computers proved to be powerful enough, SMI introduced a PC based system called the PC-30 with a DOS operating system. The current product is called “The Director”, a Windows 95 or higher based system.
In 1998, SMI introduced the Piccola, the first table top rotary tablet press, into the US market. To date over 250 of these machines have been made and are sold throughout Europe, North and South America, and Asia.
Today SMI specializes in solid dosage machines with a complete line of tablet presses, high shear granulators, roller compactors, cone mills, and the latest addition, a fluid bed granulator. All of these products serve the needs of pre-formulation through R&D, pilot plant and production. These products reflect engineering and instrumentation excellence drawn from Gary’s background and education.
Mr. Stephen Closs
Manager
Pharmaceutics and Process Technology, Patheon
Stephen is the Manager of Process Development Engineering with the Patheon Pharmaceutical Development Services Group in Whitby, Ontario, Canada. Patheon is a leading global provider of dosage from manufacturing and development services to the pharmaceutical and biotechnology industries. Stephen has over 16 years of pharmaceutical production and development experience. He is a member of ISPE, the AAPS PDFG steering committee, and ASTM E55 PAT initiative. He is the author of multiple publications in industry magazines and journals, as well as a presenter at industry forums and conferences.
Mr. Dale Natoli
Vice President
Natoli Engineering Company
Dale Natoli has 30 years of experience training the tablet compression industry worldwide. Dale currently presents lectures for universities, pharmaceutical associations and tablet manufacturers on topics related to tablet designs, tool configurations and troubleshooting. He has authored many articles for major pharmaceutical trade publications in the United States as well as in Europe. Dale is the driving force behind establishing new technologies and special tool configurations to the tablet compression industry; providing enhanced tablet quality as well as extended tooling and press longevity.
Pranav Pandya, M.Pharm
Project Manager
Pharmaceutical Development Services, Patheon Inc.
During his 10 years in the pharmaceutical industry, Pranav has gained significant experience in the formulation development and process development of various kinds of dosage forms within the industry.
Pranav was a Senior Process Specialist at Skye Pharma Canada. He developed formulations and the processes for several NDA candidates, and one of which is already launched in the market. The Skye Pharma Canada utilized their IDD-D® and IDD-P® technologies for improving the bioavailability of the suitable drug candidates and Pranav gained extensive experience in designing drug formulation from early phase development to commercial production.
Pranav was a Manager of Process Development at Labopharm Inc.. He gained extensive experience in designing the manufacturing processes for drug candidates with control release application. Labopharm uses their Contramid® technology for extending the release of the drug molecules. One of the drug candidates that Pranav had worked for over two years at Labopharm got its approval in Europe and is also submitted for NDA in United States. Pranav was also designated as a Project Team Leader and led a team of formulation scientists, analytical chemists and clinical scientist for a developing controlled release formulation.
Pranav was a Technical Project Leader at Patheon Inc., and took care of developing manufacturing process of different kinds of drug formulations which often involves solid and semi-solid dosage forms. Pranav is currently working as Project Manager in Pharmaceutical Drug Development services at Patheon Inc., where he takes care of internal and external team management and client working relationship.
Pranav is also a part-time instructor and program coordinator of Industrial Pharmaceutical Technology course at Seneca college-Toronto. He is currently a part time teaching faculty of the Pharmaceutical Manufacturing methods (PFT 501), Product formulation (PFT 907), Process and Equipment Validation (PFTA 860), Industrial Drug Legislation (PFT 930) and Quality Assurance Team (PFT 929) at Seneca (York university campus), Pranav also teaches Apotex employees at Apotex training center as a faculty of Seneca College under Apotex employee continuing education program.
Dr. Alan Rawle
Malvern Instruments Inc.
Dr. Alan Rawle has more than a quarter of a century’s experience in various aspects of technology. He started his academic life in industrial chemistry gaining a Ph.D in supported alloy catalysts where colloidal sized material was the norm. After a career in liquid crystal displays engineering he moved onto technology transfer and thence on to electro-optics, lasers, signal processing and ultimately particle sizing characterization techniques. He has spent many years working on the ISO TC24/SC4 (Particles Sizing techniques excluding sieving) committee which has been responsible for such standards as ISO 13320-1 dealing with laser diffraction and ISO 13321 dealing with photon correlation spectroscopy. After his move across the pond from the U.K. to the U.S.A., he has also become involved in ASTM activities. He is currently CoChair of E 56.02, the Characterization SubCommittee of the ASTM E56 Committee on Nanotechnology and is also a member of 3 other ASTM committees.
He and his team are involved in supporting Malvern Instruments’ customers worldwide.
Mr. Victor H. Shulman
President, Darvic Consulting Inc.
Victor Shulman is a third generation pharmacist with over forty years of international experience in GMP and industry compliance. He has gained hands-on experience at both brand name and generic companies. His projects have included redesigning of tooling engraving, implementation of aqueous ultrasonic cleaning, scale up, reformulation, SOP development, process validation, and process and efficiency improvement.
In January 1999 he decided to take semi-retirement to consult and train operators in the pharmaceutical industry. He currently lectures on Basic Pharmaceutics for operators at Seneca College’s Industrial Pharmaceutical Technology Department and at the Academy of Applied Pharmaceutical Sciences. His consulting activities include consulting for and making applications for site licences, for clients under the new Health Canada Health Food Directorate.
Victor is a registered Pharmaceutical Chemist and member of the Pharmaceutical Society of Great Britain. He holds a diploma in pharmacy from the Witwatersrand Pharmacy School and a diploma in production management.
Mr. Tim Sopko
Senior Field Engineer
Capsugel (div. of Pfizer)
Tim has been involved in the Pharmaceutical industry for over three decades and currently is a Senior Field Service Engineer within Capsugel’s Technical Service Department. He is responsible for Technical and Quality issues arising at all Capsugel users’ plants within Canada and deals with both the Nutraceutical and Pharmaceutical industries.
Tim began his career at Bristol-Myers Squibb in 1974 and during his 24-year tenure, worked in various areas including; Product Development, Oral Solid Dosage, Aseptic Anti-Neoplastic, Formulation, Scale-up, and Worldwide Clinical Manufacturing. He authored the majority of site SOP’s at BMS, as well as performing the role of senior cGMP/SOP Trainer of site staff. Between 1998 and 2000, Tim served as Supervisor at Novartis in Granulation, Packaging, and Maintenance departments, and then moved to his current position at Capsugel where he continues sharing his knowledge with his customers and co-workers.
Dr. Gerard F. Thone
Manager, Technical Services, North America/Latin America
FMC Corporation
Dr. Thone earned his doctorate at Purdue University. He has roughly 25 years experience in the pharmaceutical industry in the area of formulation and product development, as well as in the preformulation area. Over the course of his career, he has had the opportunity to work on a wide range of dosage forms including oral solids for immediate and controlled release (both tablets and capsules). In conjunction with this work he has gained experience in coating operations, both functional and aesthetic coatings as well as spray congealing of waxes. In addition, he has developed and troubleshot liquid, suspension, and suppository dosage forms. Immediately prior to joining FMC he was heavily involved in the development of iontophoretic transdermal dosage forms.
Dr. Thone has experience in the manufacture of clinical supplies and has worked closely with pharmaceutical production in the introduction and evaluation of various products. He is particularly interested in the formulation, development and processing of spheroids for use in controlled release dosage forms.
Hamp Warner
Manager, Compliance and Regulatory
Capsugel
Hamp is the Manager, Compliance and Regulatory, for Capsugel in Greenwood, South Carolina and has worked with Capsugel for over 28 years in both the Quality Assurance and Quality Control areas. He has worked with pharmaceutical customers throughout Canada for many years. His areas of expertise involve both the manufacture of hard gelatin capsules as well as all testing aspects for hard gelatin capsules.
Hamp has both BS and MS degrees from Clemson University and is a ASQ Certified Quality Engineer.
Program Agenda
| Day 1 |
Monday, May 12th, 2008 |
| 8:00 AM - 8:45 AM |
Registration and Continental Breakfast |
|
8:30 AM - 10:15 AM |
cGMP’s for Pharmaceutical Manufacturing
- Review and discussion of cGMP’s and regulatory considerations
- Regulations and goals for formulation and production
Raw Materials Considerations for Pharmaceutical Manufacturing
- Bulk Properties
- Sampling and Testing
- Particle-particle interactions
- Powder flow
- Porosity, density and methods of measurements
|
|
10:15 AM - 10:30 AM |
Mid-Morning Refreshment Break |
|
10:30 AM - 12:30 PM |
Particle Size, Shape and Rheological properties of Formulations
- Size – the Equivalent Sphere
- Particle Characterization Methods
- Number and Volume Distributions
- Size and Shape are not separate Issues
- Size and Shape influences the Rheological Properties of Formulations
Mixing and Blending of Powders
- Principles of Mixing
- Fluid Mixing
- Solid Mixing
- Mixing Ingredient functions
- Mixing Strategy and Minimizing segregation
- Types of Equipments
- Using Binders, Fillers, Glidants, Lubricants, Disintegrants in formulations
- Particle size reduction Screening and Sieving
Strategies for Handling and Milling
- Hoppers and Powder Transfer Methods
- Mechanisms of Particle Size Reduction
- Types of Mills
- Common challenges and strategies
Questions and Answers
|
| 12:30 PM - 1:45 PM |
Luncheon |
|
1:45 PM - 3:15 PM |
New Technology - (IBC) In-bin blending
- Benefits
- Elimination of cross contamination
- Cycle time reduction with serious cost reductions
Best Practices for Granulation
Comparison of Granulation Equipment:
- Low and high shear mixers
- Types of tumbling and impeller mixers
- Mechanics of powder mixing
- Design and scale-up issues
- Maintenance practices
Granule Properties Elements of granulation technology
- Dry Granulation – Roller Compaction, Chilsonation
- Wet Granulation - High Shear, Low Shear, Spray Granulation
- Key technological considerations
- Particle size distributions
- Properties of wet and dry assemblies of particles
Understanding Granule Formation
- Mechanisms in mixer agglomeration – mechanisms of size enlargement, effects of liquid
distribution, binder selection, control of granule size
- Fluid bed Technology – Granulation, Drying, Coating
-
Mechanisms in fluidised bed agglomeration – effects of liquid distribution and atomisation,
effects of binder properties, control of granule size
|
|
3:15 PM - 3:30 PM |
Mid-Afternoon Refreshment |
|
3:30 PM - 4:45 PM |
Drying-Cooling
- Methods and Equipments for Powders and Granules
- Flow sheet for the process, drying/cooling, classification and recycle, sensors
for control of the process
Case studies and Workshop Discussions
|
|
4:45 PM - 5:00 PM |
Questions and Answers
|
| |
| Day 2 |
Tuesday, May 13th, 2008 |
| 8:00 AM - 8:30 AM |
Registration and Continental Breakfast |
|
8:30 AM - 10:15 PM |
Filling and Formulation of Hard Capsules
- Powder Filling and Formulation Theory and practice
- Filling and Machines
- Filling, Other Dry Forms
Manufacture and Formulation for Hard and Soft Capsules
- Shell Manufacture and Properties
- Liquid Filling, Theory and practice
- Formulation Comparison of Hard and Soft Capsule
|
|
10:15 AM - 10:30 AM |
Mid-Morning Refreshment Break |
|
10:30 AM - 12:00 PM |
Punches & Dies
Abstract to be posted shortly
|
| 12:00 PM - 1:15 PM |
Luncheon |
|
1:15 AM - 2:45 PM |
Tablet Coating
- Types of Coating
- Coating Formulations and Processes
Modifying Release by Coating
- Methods and Processes
- Influence on Release Characteristics
- Coating of Multi-particulates
- Coating Equipment and Coating Trouble shooting
|
|
2:45 PM - 3:00 PM |
Mid-Afternoon Refreshments |
|
3:00 AM - 4:15 PM
|
Workshop : Tablet Problem Solving, Common Problems
- Principles and Equipment Utilized in Tableting
- The Seven Stages of Compression
- Functions & stages of the tablet compression process
- Tight punches, Weight Variation, Capping, Sticking.
Maximum allowable Punch Tip Loading Overload systems
|
|
4:15 PM - 4:30 PM |
Questions and Answers |
| |
| Day 3 |
Wednesday, May 14th, 2008 |
|
8:00 AM - 8:30 AM |
Registration and Continental Breakfast |
|
8:30 AM - 10:15 AM |
New Trends in Pharmaceutical Manufacturing, Dosage Form Design, and Process Development
Dosage Form Evaluation
- Methods of Assessment
- Physical Test Methods and Dissolution
- Relating results to formulation & Processes
Moisture Activated Dry Granulation (MADG)
Moisture activated dry granulation (MADG) is an alternative granulation process
which has all the advantages of wet granulation, e.g. good powder flow, good content
uniformity and good compactibility, but avoids the expensive and time consuming
step of drying. A portion of the requisite powders are wet granulated and form a
wet mass similar to that commonly seen in wet granulation. Dry components are then
added which disperse the water and result in a granulation which is ready for compaction
without having to be dried.
|
|
10:15 AM - 10:30 AM |
Mid-Morning Refreshments |
|
10:30 AM - 12:15 PM |
Process Analytical Technology (PAT) and Quality by Design during Process Development
Abstract to be posted shortly
Automated Sugar Coating
Sugar coating is a coating process which produces tablets which are unmatched esthetically and are unsurpassed in customer appeal, especially for OTC products. Unfortunately, until sugar coating was an artsy process which required up to a week for application. The lack of specialized skills and long application times limited feasible applications of this very unique coating and has resulted in it being relegated to specialty products and limited applications. Recent developments have facilitated the application of this coating and removed the artsiness and allowed for five hour application times.
|
|
12:15 PM - 12:30 PM |
Questions and Answers |
|
12:30 PM |
Conslusion of Program |
Who Should Attend?
This two day & half day program, with case studies and workshops is directed toward
Managers, Supervisors, and operators in Pharmaceutical, Biopharmaceutical, Nutraceutical
and allied industries with daily responsibilities in the following areas:
- Manufacturing
- Formulation
- Technical Operations
- Product Development
- API
- R&D – Product Submission
- Contract Manufacturing
- Process Development
- Process Engineering
- Quality Control
- Quality Assurance
- Regulatory Affairs
- API Purchasing and Supply
- Documentation and Technical Writing
- Project Management
- Technical Reviewers
- Training
Registration Information:
Registration Fee: $1,100.00 + GST
Online Registration
Payment Information
Registration Fee Includes:
Presentation Materials, Luncheon and Refreshments
Cancellation/Substitutions Policy:
CANCELLATION POLICY: Cancellation is accepted in
writing (by mail, or fax) up to 4 weeks before the program start date, after
which cancellations are not accepted and do not qualify for refund or credit.
All Cancellations are subject to a $212.00 CAD (incl. GST)/person processing
fee. Substitution of delegate/s with the member/s of the same organization is
permitted at any time. IPA reserves the right to postpone an event, prior to
which time all the registered attendees will be notified a minimum of 2 weeks in
advance. IPA shall not be responsible for any air fare, hotel or transportation
costs incurred by registrant/s.
Certificate of Attendance:
All participants will receive a certificate of attendance upon completion of
the course
For registration or any further information, please contact us
at:
Tel: (416) 410-7402
Fax: (416) 491-5810
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