Evaluating the sensitivity, reproducibility and flexibility of a method to test hard shell capsules intended for use in dry powder inhalers

Chong, Rosalind Hui, Jones, Brian, Díez, Fernando, Birchall, James Caradoc ORCID: https://orcid.org/0000-0001-8521-6924 and Coulman, Sion ORCID: https://orcid.org/0000-0002-1277-7584 2016. Evaluating the sensitivity, reproducibility and flexibility of a method to test hard shell capsules intended for use in dry powder inhalers. International Journal of Pharmaceutics 500 (1-2) , pp. 316-325. 10.1016/j.ijpharm.2016.01.034

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Abstract

Pharmaceutical tests for hard shell capsules are designed for orally administered capsules. The use of capsules in dry powder inhalers is widespread and increasing and therefore more appropriate tests are required to ensure quality and determine if these capsules are fit for purpose. This study aims to determine the flexibility, reproducibility and sensitivity of a quantitative method that is designed to evaluate the puncture characteristics of different capsule shell formulations under different climatic conditions. A puncture testing method was used to generate force displacement curves for five capsule formulations that were stored and tested at two different temperatures (5 °C and 19 °C). Force-displacement puncture profiles were reproducible for individual capsule shell formulations. The methodology was able to discriminate between capsules produced using different primary materials i.e. gelatin versus hypromellose, as well as more minor changes to capsule formulation i.e. different material grades and excipients. Reduced temperature increased the forces required for capsule puncture however further work is required to confirm its significance. Results indicate the method provides a reproducible and sensitive means of evaluating capsule puncture. Future studies should validate the methodology at different test sites, using different operators and with different capsule shell formulations.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Pharmacy
Subjects:	R Medicine > RS Pharmacy and materia medica
Additional Information:	This is an open access article under the CC BY license
Publisher:	Elsevier
ISSN:	0378-5173
Date of First Compliant Deposit:	30 March 2016
Date of Acceptance:	14 January 2016
Last Modified:	03 May 2023 14:27
URI:	https://orca.cardiff.ac.uk/id/eprint/86636

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