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Selection & 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. This 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 techniques are currently being used to guide excipient and/or process choice during the development of a solid dosage form. The first presentation will focus on identifying important powder properties and related analytical techniques. The second will describe the use of powder property data for selecting the right excipients and manufacturing process. The third presentation will cover specific examples of API and functional excipient powder properties to use in oral solid formulations in order to produce the desired quality attributes.
Moderators
Jatin M. Patel, Ph.D.
Bristol-Myers Squibb Company
Sailesh A. Varia, Ph.D.
Bristol-Myers Squibb Company
Critical Powder Properties and Measurement Techniques
Kenneth R. Morris, Ph.D.
Purdue University
Interpretation of Powder Property Data to Design Quality in Formulations and Processes
Bruno C. Hancock, Ph.D.
Pfizer, Inc.
The Use of Powder Properties to Guide Formulation Design – Case Studies
Sanjeev Kothari, Ph.D.
Bristol-Myers Squibb Company