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Selecting and controlling API crystal form for pharmaceutical development--strategies and processes.

Shawn X Yin¹, John A Grosso

¹Bristol-Myers Squibb Company, Analytical Research & Development, Research & Development, One Squibb Drive, New Brunswick, NJ 08903, USA. shawn.yin@bms.com

Current Opinion in Drug Discovery & Development

|October 24, 2008

Summary

Selecting the right active pharmaceutical ingredient (API) crystal form is crucial for stable and bioavailable oral drug products. This review details knowledge-based API form selection strategies within the Quality by Design (QbD) framework.

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Area of Science:

Pharmaceutical Sciences
Solid-State Chemistry
Drug Development

Background:

Oral dosage form development requires careful selection of the active pharmaceutical ingredient (API) form for stability and bioavailability.
Solid-state chemistry, excipient interactions, and manufacturing processes are critical factors in API form selection.
Understanding API solid-state properties is essential for successful drug product development.

Purpose of the Study:

To review knowledge-based approaches for selecting crystalline API forms.
To highlight studies aligning with the Quality by Design (QbD) framework for pharmaceutical development.
To discuss potential API crystal form transformations during manufacturing and formulation.

Main Methods:

Literature review of recent publications and author experiences.
Description of concepts and approaches for knowledge-based API form selection.
Analysis of case studies demonstrating API crystal form transformations.

Main Results:

Outlines a systematic approach to API crystalline form selection.
Integrates Quality by Design (QbD) principles into the selection process.
Illustrates API form transformation risks at various development stages.

Conclusions:

A knowledge-based approach to API form selection, guided by QbD, ensures product quality and bioavailability.
Awareness of potential API crystal form changes is vital throughout crystallization, post-crystallization, and formulation.
Effective API form selection is a cornerstone of successful oral dosage form development.