Montreal February 7-8, 2008
Holiday Inn-Airport
6500 Cote de Liesse , Montreal , Quebec , Canada.
Tel: (514) 739-6440 Fax (514) 738-3189
Organized by:
proGamma Science Corporation:
6600 TransCanada suite 452, Pointe Claire, Quebec, Canada H9R 4S2Tel (514) 695-8622 Fax (514) 697-4355 e-mail infoteck@progamma.ca
Course Objectives
Pharmaceutical technologies are changing and evolving very rapidly. Many companies are involved in improving and enhancing older processes and exploring alternative that are more efficient and deliver quality products.
By staying current with the latest good practices and new advances you help ensure your organization competitiveness.
This new intensive 2-day course will provide you with an update of practices and technologies that are shaping today’s pharmaceutical tableting industry
Who will Benefit?
Ø Product/Process Development
Ø Pharmaceutical research and development scientists
Ø Process Improvement
Ø Process Validation
Ø Manufacturing personnel
Ø Process engineers
This course is also of interest to Equipment Contractors and Consultants.
Why You Should attend?
1. Learn from recognized experts and share with you their insights and knowledge of recent advances in modern tablet technology.
2. Learn about new trends in Quick dissolve tablet formulation
3. Learn how to integrate basic principals and current industrial practices of pharmaceutical tablet production
4. Learn state of the art technologies and cost-effective approaches
5. Get in depth understanding of Wet and how to scale-up and dry granulation
6. Increase and establish sound understanding of excipients and lubricants there role and modern concepts.
7. Examine and learn about tablet tooling design and what are the factors involved.
8. Learn about the different type of coating and the factors involved in choosing a particular coating for your tablet.
9. Learn about troubleshooting blend and content uniformity problems
10. Understand and examine new formulation technology strategies
Day 1
8:00 Registration – Continental Breakfast
8:30 Pre-formulation
-Drug product design
- Factors influencing effectiveness of drug products
- Basics properties and pre-formulations
- Quality evaluation
-Physical/chemical characterization
Quick Dissolve Technology
-Why quick dissolve formulation?
-What type of excipients used?
-Different techniques used?
-Typical formulation
Tablet Lubricants
- Types
-Behavior and defects of lubricants
12:00 Lunch
Formulation Development Strategies
-What is the modern approach?
-Quality by design
-Multivariate methods in the development of a new tablet formulation
Solid Oral Dosage Forms
- Compressed tablets as oral delivery systems
- Necessary Unit operations
- Advantages and disadvantages
- Ingredients used in tablet formulation
-Granulation methods
- Slugging or roll compaction
- Bonding mechanisms
- Advantages and Disadvantages of dry granulation
- Reasons for wet granulation
- Wet granulation procedure
- Granule Characterization
-Direct Compress
4:30 End of day 1
8:00 Registration – Continental Breakfast
8:30 Pre-formulation
-Drug product design
- Factors influencing effectiveness of drug products
- Basics properties and pre-formulations
- Quality evaluation
-Physical/chemical characterization
Quick Dissolve Technology
-Why quick dissolve formulation?
-What type of excipients used?
-Different techniques used?
-Typical formulation
Tablet Lubricants
- Types
-Behavior and defects of lubricants
12:00 Lunch
Formulation Development Strategies
-What is the modern approach?
-Quality by design
-Multivariate methods in the development of a new tablet formulation
Solid Oral Dosage Forms
- Compressed tablets as oral delivery systems
- Necessary Unit operations
- Advantages and disadvantages
- Ingredients used in tablet formulation
-Granulation methods
- Slugging or roll compaction
- Bonding mechanisms
- Advantages and Disadvantages of dry granulation
- Reasons for wet granulation
- Wet granulation procedure
- Granule Characterization
-Direct Compress
4:30 End of day 1
Day 2
8:00 Continental Breakfast
8:30 Process Optimization and Troubleshooting
- Optimization vs. validation
- Process variables
- Troubleshooting processes
Dry Granulation
- Why choose dry granulation?
- Advantages and disadvantages
- Dry Granulation by slugging
- Roller compaction
- Factors affecting the compatibility of different materials
-Comparison of wet and dry granulation.
Wet granulation and Scale-up strategies
-Utility of Granulation
-Granulation defined
- Aims of Granulation
-Methods of granulation
-Techniques of wet granulation scale-up
Tablet Coating
- Principles
- Types of coating
- Advantages and disadvantages
- Sugar coating
- Film coating
-Enteric Coating
Excipient Considerations
- Original concept
- Modern Concept
-Desirable characteristics of excipients
Manufacturing Quality
- Steps involved in the manufacturing process
- Essentials of Good Quality Manufacturing
4:30 End of course
Speakers
Shams Rustom , M.Pharm, R.Ph. is Sr. Director of Product Development & Manufacturing at Labopharm Inc., has more than 20 years in experience in solids and novel formulation and process development, holding several positions in product development and technology transfer projects at Wyeth-Ayerst and Carter-Horner Inc
Shams has been extensively involved in many validations and his extensive experience extends from formulation development to scale up commercial batches. His unique approach to simplifying quite complicated technical formulation and operational matters has gained him extensively exceptional reputation as a formulation R&D scientist and as a speaker.
Mortuza Bakshi , M.Sc. Pharm Director of Pharmaceutical Research and Development with Pharmetics Inc. He has more than 20 years of formulation development to pilot GMP mfg and technology transfer to various commercial manufacturing sites . Previously, Mortuza was heavily involved with several important formulation development positions with pharmascience, Yamanouchi Pharma Technology US, Patheon and Apotex. In addition to his keen industrious formulation development experience, he has taught a formulation development solid dosage form course for several years at Seneca college, York University campus, Toronto.
Ady Sadek , M.Sc., P.Chem is president of proGamma Science Corporation ,previously he spent 20 years in the pharmaceutical industry with BioResearch ,Schering-Plough and Novartis Pharmaceuticals , holding positions such as Manager of Analytical & Development Labs ,Manager of Quality and Manager of Quality Audit. He holds two master degrees in Organic and analytical chemistry . Ady’s vast experience in process design and validation started in 1981,when developing new formulations for FDA submissions. He has been involved in many validations and his experience extends from formulation development to scale up commercial batches and technology transfer. He has consulted and lectured throughout Canada, USA and Europe to several multinationals.
Shams Rustom , M.Pharm, R.Ph. is Sr. Director of Product Development & Manufacturing at Labopharm Inc., has more than 20 years in experience in solids and novel formulation and process development, holding several positions in product development and technology transfer projects at Wyeth-Ayerst and Carter-Horner Inc
Shams has been extensively involved in many validations and his extensive experience extends from formulation development to scale up commercial batches. His unique approach to simplifying quite complicated technical formulation and operational matters has gained him extensively exceptional reputation as a formulation R&D scientist and as a speaker.
Mortuza Bakshi , M.Sc. Pharm Director of Pharmaceutical Research and Development with Pharmetics Inc. He has more than 20 years of formulation development to pilot GMP mfg and technology transfer to various commercial manufacturing sites . Previously, Mortuza was heavily involved with several important formulation development positions with pharmascience, Yamanouchi Pharma Technology US, Patheon and Apotex. In addition to his keen industrious formulation development experience, he has taught a formulation development solid dosage form course for several years at Seneca college, York University campus, Toronto.
Ady Sadek , M.Sc., P.Chem is president of proGamma Science Corporation ,previously he spent 20 years in the pharmaceutical industry with BioResearch ,Schering-Plough and Novartis Pharmaceuticals , holding positions such as Manager of Analytical & Development Labs ,Manager of Quality and Manager of Quality Audit. He holds two master degrees in Organic and analytical chemistry . Ady’s vast experience in process design and validation started in 1981,when developing new formulations for FDA submissions. He has been involved in many validations and his experience extends from formulation development to scale up commercial batches and technology transfer. He has consulted and lectured throughout Canada, USA and Europe to several multinationals.
