A Quality by Design Framework for Capsule-Based Dry Powder Inhalers
| Autor: | Ashlee D. Brunaugh, Li Ding, Sven Stegemann, Hugh D. C. Smyth, Matthew J. Herpin, Justin Kalafat, Scott V. Jermain |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Lung deposition
quality by design business.industry Computer science capsule filling media_common.quotation_subject Inhaler Critical factors dry powder inhalers Pharmaceutical Science Capsule Review capsule manufacturing capsule activation Quality by Design RS1-441 Pharmacy and materia medica Dry powder capsule storage inhalation capsule Quality (business) Critical quality attributes Process engineering business media_common |
| Zdroj: | Pharmaceutics Pharmaceutics, Vol 13, Iss 1213, p 1213 (2021) |
| ISSN: | 1999-4923 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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