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.
Highlights
Received: 10 July 2021Accepted: 2 August 2021Published: 6 August 2021Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations.Dry powder inhalers (DPIs) are widely utilized for the treatment of multiple lung diseases including asthma [1], chronic obstructive pulmonary disorder (COPD) [2], cystic fibrosis (CF) [3], and CF-related Pseudomonas aeruginosa infections [4], virus-related lung infections [5] and systemic diseases like diabetes [6]
Specific to capsulebased DPIs (cDPIs), critical material attributes (CMA) relate to API and excipients including the material present in the thecapsule, interaction of the powder formulation with mechanism the capsule.preproperties anddevice, designand of the the capsule piercing/powder release sent in the device, and the interaction of the powder formulation with the capsule
The results showed a capsule shell formulation of hydroxypropyl methylcellulose (HPMC) that included a gelling agent and an additional plasticizer (PEG-3350) performed better than other more standard capsule shells with regards to fine particles fraction (FPF) and drug powder retention [130]
Summary
Brunaugh 1 , Sven Stegemann 2 , Scott V. Herpin 1 , Justin Kalafat 3 and Hugh D. A Quality by Design Framework for Capsule-Based Dry Powder Inhalers
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