Pressurized Metered Dose Inhaler Technology: Manufacturing

Ernest Vallorz; Poonam Sheth; Paul Myrdal

doi:10.1208/s12249-019-1389-9

Pressurized Metered Dose Inhaler Technology: Manufacturing

Ernest Vallorz, Poonam Sheth, Paul Myrdal

Pharmacy Practice and Science

Research output: Contribution to journal › Review article › peer-review

20 Scopus citations

Abstract

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.

Original language	English (US)
Article number	177
Journal	AAPS PharmSciTech
Volume	20
Issue number	5
DOIs	https://doi.org/10.1208/s12249-019-1389-9
State	Published - Jul 1 2019

Keywords

cold filling
critical quality attribute (CQA)
manufacturing
pressure filling
pressurized metered dose inhaler (pMDI)

ASJC Scopus subject areas

Pharmaceutical Science

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10.1208/s12249-019-1389-9

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title = "Pressurized Metered Dose Inhaler Technology: Manufacturing",

abstract = "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.",

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Pressurized Metered Dose Inhaler Technology: Manufacturing

Abstract

Keywords

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