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Selection and Use of Pharmaceutical Powder Properties to Design Product Quality
Thursday, November 15
8:30 am – 11:00 am
Symposium
ACPE #073-999-07-578-L04
To meet the continued demands of accelerating drug development, there has been a need to introduce the “commercial” dosage form in clinical studies within 12 - 18 months after selection of a compound for development. Selection of a suitable formulation and drug product manufacturing process is required with limited amounts of drug substance available. In order to ensure the development of a suitable formulation/manufacturing process, there has been an increased focus on early characterization of the drug substance and to determine critical powder properties as it relates to the formulation performance as well the manufacturing process. The proposed symposium is aimed towards covering the various facets of development involved in the characterization of powder properties to build quality by design during development of a formulation and manufacturing process. Various compaction techniques are currently being used to guide excipient and/or process choice during the development of a solid dosage form. The first two presentations would focus on the analytical techniques and the use of results in picking the right excipients and manufacturing process. Recent advances in crystal engineering would be covered in the third presentation with suitable examples to show the utility of these techniques in selecting the appropriate drug substance crystallization and/or drying processes. The last two presentations would focus on the establishment of specifications for the “critical” parameters and monitoring techniques that could be used to confirm the process suitability.
Moderator
Jatin M. Patel, Ph.D.
Bristol-Myers Squibb Company
Designing Pharmaceutical Unit Operations Based On Critical Powder Properties
Bruno C. Hancock, Ph.D.
Pfizer, Inc.
Recent Advances in Powder Characterization Techniques & Applications
Kenneth R. Morris, Ph.D.
Purdue University
Use of Powder Properties to Guide Formulation Design
Sanjeev Kothari, Ph.D.
Bristol-Myers Squibb