Smart Specification Setting for Dry Powder Inhalation Carriers

被引：0

作者：

Janssen, Pauline H. M. ^{[1
,2
]}

Bastiaansen, Marly ^{[1
]}

Buijvoets, Lisa B. ^{[1
]}

Frijlink, Henderik W. ^{[2
]}

机构：

[1] DFE Pharm, Klever Str 187, D-47574 Goch, Germany

[2] Univ Groningen, Dept Pharmaceut Technol & Biopharm, Antonius Deusinglaan 1, NL-9713 AV Groningen, Netherlands

来源：

JOURNAL OF PHARMACEUTICAL SCIENCES | 2023年 / 112卷 / 08期

关键词：

Excipients; Inhalation; Formulation; Interactive mixtures; Lung drug delivery; Particle size; Physical characterization; Pulmonary drug delivery;

D O I：

10.1016/j.xphs.2023.02.018

中图分类号：

R914 [药物化学];

学科分类号：

100701 ;

摘要：

The specifications of excipients are important to pharmaceutical manufacturers to ensure that the final product can be manufactured robustly over the entire lifecycle of a drug product. Particle size specifications are key for dry powder inhalation excipients and they should be agreed between users and suppliers. The current paper evaluates two development strategies to set particle size specifications. It is shown that the application of quality-by-design principles to specification setting could result in broader specifications, while it guarantees that efficacy, safety and manufacturing of the medication is not affected. A multitude of reasons exist to keep specifications broader than the production capability range, including improved risk-mitigation and potentially reduced regulatory challenges during and after registration. & COPY; 2023 The Authors. Published by Elsevier Inc. on behalf of American Pharmacists Association. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)

引用

页码：2301 / 2306

页数：6

共 7 条

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