273020 Development of API Target Attribute Profile

Thursday, November 1, 2012: 10:10 AM
Allegheny II (Westin )
Weili Yu, Drug Product Design, Pfizer Inc., Groton, CT and Subodh Deshmukh, Drug Product Design, Pfizer Inc, Groton, CT

API physical attributes play an important role in drug product design and development. These attributes often have a direct impact on the performance, stability and manufacturability of drug products of various dosage forms. Identification and characterization of these critical attributes is important for successful design and manufacture of API optimized for the targeted dosage form. While the importance of API properties is commonly recognized in the industry, the integration of API and drug product design during the development process is not nearly as common. The API Target Attribute Profile (TAP) is a venue that facilitates discussions between the API designers (chemical development groups) and the drug product designers (formulation groups) and ensures that the key API physical properties and acceptable ranges are agreed upon and optimized for the dosage form. Case studies will be presented to demonstrate the process for establishing the TAP along with advanced material characterization techniques used to support the process.

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