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Biomedical Sciences - Pharmacology & Toxicology | AAPS PharmSciTech (Societies)

AAPS PharmSciTech

AAPS PharmSciTech

An Official Journal of the American Association of Pharmaceutical Scientists

Editor-in-Chief: Robert O. Williams III

ISSN: 1530-9932 (electronic version)

Journal no. 12249

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New York | Heidelberg, 14 February 2014

Implementing QbD Principles for Biopharmaceutical Development

Congratulations to the 2015 AAPS PharmSciTech Outstanding Manuscript Award winners Sven Stegemann, Paul Connolly, Wayne Matthews, Rodger Barnett, Mike Aylott, Karin Schrooten, Dominique Cadé, Anthony Taylor, and Massimo Bresciani for their work on Application of QbD Principles for the Evaluation of Empty Hard Capsules as an Input Parameter in Formulation Development and Manufacturing.

QbD assessments provide evidence that hard capsules are a suitable type of excipients  

The approach of QbD (quality-by-design) guidelines and concepts can be used to determine the variation of CQAs (critical quality attributes) in hard gelatin capsules. This study by Sven Stegemann (et al.) analyzed hard capsules for potential variation within specification, identified any seasonality and impact of supply from different supplier manufacturing sites, and evaluated the criticality of the material attributes and characteristics of the empty capsules in consistently achieving the respective performance criteria. This is an Open Access article in Springer’s AAPS PharmSciTech journal.
Understanding the product and process variable on the final product performance is an essential part of the quality-by-design (QbD) principles in pharmaceutical development. The hard capsule is an established pharmaceutical dosage form used worldwide in development and manufacturing. The empty hard capsules are supplied as an excipient that is filled by pharmaceutical manufacturers with a variety of different formulations and products. To understand the potential variations of the empty hard capsules as an input parameter and its potential impact on the finished product quality, a study was performed investigating the critical quality parameters within and in between different batches of empty hard gelatin capsules. The variability of the hard capsules showed high consistency within the specification of the critical quality parameters. This also accounts for the disintegration times, when automatic endpoint detection was used. Based on these data, hard capsules can be considered as a suitable excipient for product development using QbD principles.
The study concludes: “The hard capsule is a suitable excipient for QbD drug development and manufacturing with acceptable variability within a consistent and narrow range, well defined by its specifications.”

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    AAPS PharmSciTech is a peer-reviewed, online-only journal committed to serving those pharmaceutical scientists and engineers interested in the research, development, and evaluation of pharmaceutical dosage forms and delivery systems, including drugs derived from biotechnology and the manufacturing science pertaining to the commercialization of such dosage forms. Because of its electronic nature, AAPS PharmSciTech aspires to utilize evolving electronic technology to enable faster and diverse mechanisms of information delivery to its readership. Submission of uninvited expert reviews and research articles are welcomed.


    AAPS PharmSciTech publishes six issues a year. 

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