Pressurized Metered Dose Inhaler Technology: Manufacturing

被引：16

作者：

Vallorz, Ernest ^{[1
]}

Sheth, Poonam ^{[2
]}

Myrdal, Paul ^{[1
]}

机构：

[1] Univ Arizona, Dept Pharmacol & Toxicol, Coll Pharm, 1703 E Mabel St,Skaggs Bldg,Rm 437, Tucson, AZ 85721 USA

[2] AstraZeneca Pharmaceut LP, Durham, NC 27703 USA

来源：

AAPS PHARMSCITECH | 2019年 / 20卷 / 05期

关键词：

manufacturing; pressurized metered dose inhaler (pMDI); critical quality attribute (CQA); cold filling; pressure filling; FORMULATION; 134A;

D O I：

10.1208/s12249-019-1389-9

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

While first introduced in the 1950s, pressurized metered dose inhalers (pMDIs) remain as a first line treatment of pulmonary conditions. With expanding applications of pMDIs beyond asthma and chronic obstructive pulmonary disease (COPD), the development of therapies utilizing the pMDI platform will undoubtedly continue. Recent guidances and the introduction of quality by design initiatives further emphasize the requirement of formulators to understand the relationships between product attributes and production strategies and their impact on product performance. This review summarizes common manufacturing processes of pMDIs across multiple stages of the development cycle, from academia to commercial production, and provides insight as to the benefits and limitations of each process in regard to formulation type.

引用

页数：11

共 42 条

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