465077 In silico Formulation Development of Oral Solid Dosage Forms Using a Material Property Database

Friday, November 18, 2016: 3:15 PM
Continental 5 (Hilton San Francisco Union Square)
Maxx Capece1, Ping Gao1, Raimundo Ho2, David O'Brien2, Ahmad Sheikh3, John C. Strong1 and Divya Sunkara2, (1)AbbVie, Abbott Park, IL, (2)AbbVie, North Chicago, IL, (3)Process Research & Development, Abbott Laboratories, North Chicago, IL

Motivated by the desire to lessen the empirical nature of oral solid dosage formulation and to pursue a quality by design framework, a material property database (MPD) and a material science interface (MSI) were recently developed at Abbvie. The MPD contains critical material properties of common excipients along with the lot-to-lot variability and humidity dependence of these properties. The centralization of these material properties in the MPD, collected in a standardized and reliable manner, also facilitate the use of predictive modeling via the MSI. The MSI is a user-friendly graphical interface which allows access to the MPD and associated modeling tooling used to aid in formulation development. Currently, the MSI contains models to predict blend uniformity, powder flowability, and compactability of pharmaceutical formulations intended for a direct compression process by making use of material properties contained within the MPD. Examples utilizing the MSI models will be given for the formulation development of a model active pharmaceutical ingredient (acetaminophen). The examples given herein show the utility of the MPD and MSI for providing in silico exploration of formulation design space, better guidance and scientific rational for experimentation, and improved understanding in the relationship between material properties, manufacturability, and product performance.

Disclosures:

All authors are employees of AbbVie. The design, study conduct, and financial support for this research was provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the publication.


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