Steps toward nebulization in-use studies to understand the stability of new biological entities.

Autor: Montefusco-Pereira CV; Independent Researcher. Electronic address: cmontefusco@gmail.com.
Jazyk: angličtina
Zdroj: Drug discovery today [Drug Discov Today] 2023 Feb; Vol. 28 (2), pp. 103461. Date of Electronic Publication: 2022 Nov 28.
DOI: 10.1016/j.drudis.2022.103461
Abstrakt: The need for novel biological drugs against respiratory diseases has been highlighted during the Coronavirus (COVID-19) pandemic. The use of inhalation presents challenges to drug product stability, which is especially true for delivery using nebulizers (jet versus mesh technologies). The late-stage process of drug development in the pharmaceutical industry requires the investigation of in-use stability. In-use studies generate data that are guided by the requirements of regulatory authorities for inclusion in the clinical trial application dossier. In this review, I introduce the initial aspects of in-use stability studies during the development of an aerosol formulation to deliver biologics with a nebulizer. Lessons learned from this experience can guide future development and planning for formulation, analytics, material compatibility, nebulization process, and clinical trial preparations.
(Copyright © 2022 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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