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Integrated Tablet Formulation Development
and Tablet Process Development and Validation
Course Dates: 28, 29 & 30 April 2009 POSTPONED to October/November
Venue: to be advised
Cost: any 1 day - £600.00, any 2 days £1160.00, 3 days £1584.00
Speaker: Dr Michael Gamlen
This unique 3 day course introduces and integrates the key elements of tablet development based on the principles of Quality by Design (QbD) set out in ICH Q9:
- Preformulation studies
- Formulation development
- Process development and validation
and explains the important links between each of these. Proper integration of these elements is essential to achieve “Quality by Design” because data from each phase of development is used to control the next step in the development process. By achieving proper integration based on sound scientific principles, many development and production problems can be avoided. The course includes case studies of tablet development at the preformulation and formulation development phases as well a detailed, step by step analysis of all elements of the tablet manufacturing process. Key process parameters and their control are identified.
Who will benefit from the course?
The course is designed for people new to tablet and process development, and those requiring a refresher in the area. It will also benefit Process Development experts wishing to extend their understanding of why processes can go wrong, and regulatory and quality personnel who need to understand the development process.
Programme
Registration and coffee are available each day from 8.30am and course proper starts at 9.15am
Day 1: Preformulation
9.00 Welcome and introductions
9.10 Introduction to preformulation for product development
10.00 Coffee
10.30 Preformulation studies in context
* Making use of your data
11.30 Material Characterisation techniques (1)
12.30 Lunch
14.00 Material Characterisation techniques (2)
14.45 Tablet components and their roles
15.30 Tea
16.00 Excipient compatibility testing
16.45 Case study - applying preformulation in tablet formulation
17.50 Close
18.00 Evening reception
Day 2: Tablet formulation - an introduction
9.00 Introduction to tabletting operations
10.30 Coffee
11.00 Tabletting operations (cont'd)
11.30 Tablet formulation development
12.30 Lunch
13.45 Formulation development case study
14.30 Formulation development case study (2)
15.15 Tea
15.30 Compression testing and use of the Precision Compression Tester
16.30 Preparation for formal stability testing
17.00 Q and A
17.30 Close
16.00 Evening reception
Day 3: Process development and validation
9.00 Workshop introduction
9.20 Quality by design - the basis for process development and validation
10.30 Coffee
11.00 Key Manufacturing processes - purpose, equipment and control (1)
* Blending and lubrication
* Dry Granulation - Roller compaction and slugging
* Wet Granulation
* Granulation end-point control
12.15 Discussion, Review and Q & A
12.30 Lunch
13.30 Case study - blending for direct compression, implementation of recent FDA guidance on blend
sampling. We follow the development of a formulation from hand filled capsules to production tablet
manufacture, reviewing blending options and actual results, and examine the effect of FDA guidance
on blend sample
15.00 Key manufacturing processes - purpose, equipment and control (2)
* Drying
* Sieving
* Tablet compression
* Film coating
16.30 Process control case study - granulation end-point control
* Developing a self-controlling process
17.15 Course ends
18.00 Evening reception
Additional Resources:An extremely comprehensive memory stick will be provided containing extensive resources on preformulation and tablet formulation, as well as colour copies of all presentations and case studies
6 comments:
Choosing the right and best Pharmaceutical Company in India for contract Maufacturing is the wisest choice.The one which can provide high quality pharmaceutical drug development services like Contract formulation development,pharmaceutical formulation development , analytical methods development, Contract analytical method validation, Contract process development and validation, Contract stability studies and Pharma vigilance services.
One of the best pharmaceutical company for manufacturing Amoxycillin + Clavulanic Acid Combination along with Cephalosporins and some other general products.A pharma company whereFormulation and Development is always a priority for growth and are the leading Pharmaceutical Formulation Manufacturers in India .Research are carried out by the organization to upgrading Formulation efficiency
One of the best Pharmaceuticals Manufacturers in India have products which includes Antiasthmatic,Antibiotics,Anti-diabetic, Antifungal,Antihistamine, etc and which strives to continuously upgrade the quality of its processes and products and are the leading Pharmaceutical Formulation Manufacturers in Mumbai.It is the leading Importers,exporters and manufacturers of pharmaceuticals in domestic and international market and Indenting of Active Pharmaceutical Ingredients.
Ciron pharmaceuticals Inc is one of the leading USA based Pharmaceutical company involved in new generation antibiotics, generic formulations, liquid orals and dietary supplements and are exploring new strategies to create efficiency and one of the best for pharmaceutical toll manufacturing USA.It is one of the best Pharma Formulations in India and It seeks to penetrate into a strategic partnerships with high-quality and strategic vision based emerging companies that specialize in drug development and manufacturing.
Formulation Development Services: utilizing Quality by Design (QbD) principles in the development of pharmaceutical products for various dosage forms. These forms include parenteral dosage forms such as liquids, lyophilized, liposomal, suspension, and emulsion formulations, as well as topical, ophthalmic, and nasal dosage forms. QbD is a systematic approach to product development that involves designing and controlling the manufacturing process to ensure the desired quality of the final product.
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