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

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• 作者：Rosalind H.E. Chong^a ; Brian E. Jones^a ; ^b ; Fernando Dí ; ez^b ; James C. Birchall^a ; Sion A. Coulman^a ; ^{coulmansa@cardiff.ac.uk" class="auth_mail" title="E-mail the corresponding author}
• 关键词：Capsule ; Hypromellose ; Gelatin ; Dry powder inhaler ; Quality Assurance ; Puncture
• 刊名：International Journal of Pharmaceutics
• 出版年：2016
• 出版时间：16 March 2016
• 年：2016
• 卷：500
• 期：1-2
• 页码：316-325
• 全文大小：2394 K

文摘

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.