{"title":"Proposals for Global Harmonization of Regulations for Testing of Spacers and Valved Holding Chambers for Pressurized Metered Dose Inhalers","authors":"Jolyon P. Mitchell","doi":"10.1208/s12249-025-03110-x","DOIUrl":null,"url":null,"abstract":"<div><p>Thought should be given to the desirability for similar approaches for the present transition to low global warming potential (LGWP) propellants for pressurized metered dose inhalers (pMDIs) to be adopted by both European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) for the performance testing of pMDIs that include the evaluation with an add-on spacer or valved holding chamber as part of the <i>in vitro</i> component for product registration. If such an add-on device was to be included as part of the registration package in either US or European regulatory environments, the content of United States Pharmacopeia (USP) chapter <1602> could support the process.</p></div>","PeriodicalId":6925,"journal":{"name":"AAPS PharmSciTech","volume":"26 5","pages":""},"PeriodicalIF":4.0000,"publicationDate":"2025-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"AAPS PharmSciTech","FirstCategoryId":"3","ListUrlMain":"https://link.springer.com/article/10.1208/s12249-025-03110-x","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
Thought should be given to the desirability for similar approaches for the present transition to low global warming potential (LGWP) propellants for pressurized metered dose inhalers (pMDIs) to be adopted by both European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) for the performance testing of pMDIs that include the evaluation with an add-on spacer or valved holding chamber as part of the in vitro component for product registration. If such an add-on device was to be included as part of the registration package in either US or European regulatory environments, the content of United States Pharmacopeia (USP) chapter <1602> could support the process.
期刊介绍：
AAPS PharmSciTech is a peer-reviewed, online-only journal committed to serving those pharmaceutical scientists and engineers interested in the research, development, and evaluation of pharmaceutical dosage forms and delivery systems, including drugs derived from biotechnology and the manufacturing science pertaining to the commercialization of such dosage forms. Because of its electronic nature, AAPS PharmSciTech aspires to utilize evolving electronic technology to enable faster and diverse mechanisms of information delivery to its readership. Submission of uninvited expert reviews and research articles are welcomed.
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