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Pharmaceutics
Volume 13
Issue 8
10.3390/pharmaceutics13081213
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Review

A Quality by Design Framework for Capsule-Based Dry Powder Inhalers

by
Li Ding
1,
Ashlee D. Brunaugh
1,
Sven Stegemann
2,
Scott V. Jermain
1,
Matthew J. Herpin
1,
Justin Kalafat
3 and
Hugh D. C. Smyth
1,*
1
Division of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, The University of Texas at Austin, Austin, TX 78712, USA
2
Institute for Process and Particle Engineering, Graz University of Technology, 8010 Graz, Austria
3
ACG North America, LLC, 262 Old New Brunswick Road, Suite A, Piscataway, NJ 08854, USA
*
Author to whom correspondence should be addressed.
Pharmaceutics 2021, 13(8), 1213; https://doi.org/10.3390/pharmaceutics13081213
Submission received: 10 July 2021 / Revised: 29 July 2021 / Accepted: 2 August 2021 / Published: 6 August 2021
(This article belongs to the Special Issue Methodology, Design and Regulatory Considerations for the Bioequivalence of Oral Inhaled Products)
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Abstract

Capsule-based dry powder inhalers (cDPIs) are widely utilized in the delivery of pharmaceutical powders to the lungs. In these systems, the fundamental nature of the interactions between the drug/formulation powder, the capsules, the inhaler device, and the patient must be fully elucidated in order to develop robust manufacturing procedures and provide reproducible lung deposition of the drug payload. Though many commercially available DPIs utilize a capsule-based dose metering system, an in-depth analysis of the critical factors associated with the use of the capsule component has not yet been performed. This review is intended to provide information on critical factors to be considered for the application of a quality by design (QbD) approach for cDPI development. The quality target product profile (QTPP) defines the critical quality attributes (CQAs) which need to be understood to define the critical material attributes (CMA) and critical process parameters (CPP) for cDPI development as well as manufacturing and control.
Keywords: quality by design; inhalation capsule; dry powder inhalers; capsule activation; capsule manufacturing; capsule filling; capsule storage quality by design; inhalation capsule; dry powder inhalers; capsule activation; capsule manufacturing; capsule filling; capsule storage

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MDPI and ACS Style

Ding, L.; Brunaugh, A.D.; Stegemann, S.; Jermain, S.V.; Herpin, M.J.; Kalafat, J.; Smyth, H.D.C. A Quality by Design Framework for Capsule-Based Dry Powder Inhalers. Pharmaceutics 2021, 13, 1213. https://doi.org/10.3390/pharmaceutics13081213

AMA Style

Ding L, Brunaugh AD, Stegemann S, Jermain SV, Herpin MJ, Kalafat J, Smyth HDC. A Quality by Design Framework for Capsule-Based Dry Powder Inhalers. Pharmaceutics. 2021; 13(8):1213. https://doi.org/10.3390/pharmaceutics13081213

Chicago/Turabian Style

Ding, Li, Ashlee D. Brunaugh, Sven Stegemann, Scott V. Jermain, Matthew J. Herpin, Justin Kalafat, and Hugh D. C. Smyth. 2021. "A Quality by Design Framework for Capsule-Based Dry Powder Inhalers" Pharmaceutics 13, no. 8: 1213. https://doi.org/10.3390/pharmaceutics13081213

APA Style

Ding, L., Brunaugh, A. D., Stegemann, S., Jermain, S. V., Herpin, M. J., Kalafat, J., & Smyth, H. D. C. (2021). A Quality by Design Framework for Capsule-Based Dry Powder Inhalers. Pharmaceutics, 13(8), 1213. https://doi.org/10.3390/pharmaceutics13081213

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