Systematic Evaluation of the Effect of Formulation Variables on In Vitro Performance of Mometasone Furoate Suspension-Metered Dose Inhalers.

cascade impactor critical quality attributes delivered dose empirical correlations fine particle dose mean dissolution time metered dose inhalers mouth-throat models

Journal

The AAPS journal
ISSN: 1550-7416
Titre abrégé: AAPS J
Pays: United States
ID NLM: 101223209

Informations de publication

Date de publication:
07 12 2021
Historique:
received: 12 04 2021
accepted: 17 08 2021
entrez: 7 12 2021
pubmed: 8 12 2021
medline: 5 4 2022
Statut: epublish

Résumé

The therapeutic benefits of metered dose inhalers (MDIs) in pulmonary disorders are mainly driven by aerosol performance, which depends on formulation variables (drug and excipients), device design, and patient interactions. The present study provides a comprehensive investigation to better understand the effect of formulation variables on mometasone furoate (MF) suspension-based MDI product performance. The effects of MF particle size (volume median diameter; X

Identifiants

pubmed: 34874508
doi: 10.1208/s12248-021-00638-1
pii: 10.1208/s12248-021-00638-1
pmc: PMC10662261
mid: NIHMS1942909
doi:

Substances chimiques

Aerosols 0
Suspensions 0
Mometasone Furoate 04201GDN4R

Types de publication

Journal Article Research Support, U.S. Gov't, P.H.S.

Langues

eng

Sous-ensembles de citation

IM

Pagination

9

Subventions

Organisme : FDA HHS
ID : U01 FD004943
Pays : United States

Informations de copyright

© 2021. The Author(s), under exclusive licence to American Association of Pharmaceutical Scientists.

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Auteurs

Sagar S Bachhav (SS)

Department of Pharmaceutics, College of Pharmacy, University of Florida, 1600 SW Archer Road, Gainesville, Florida, 32610, USA.

Poonam Sheth (P)

Recipharm, Morrisville, North Carolina, USA.
AstraZeneca, Durham, North Carolina, USA.

Dennis Sandell (D)

S5 Consulting, Blentarp, Sweden.

Mårten Svensson (M)

Emmace Consulting AB, Lund, Sweden.

Sharvari Bhagwat (S)

Department of Pharmaceutics, College of Pharmacy, University of Florida, 1600 SW Archer Road, Gainesville, Florida, 32610, USA.

Denise S Conti (DS)

Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.

Oluwamurewa Oguntimein (O)

Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.

Sneha Dhapare (S)

Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.

Bhawana Saluja (B)

Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.

Lawrence Winner (L)

Department of Statistics, University of Florida, Gainesville, Florida, USA.

Jürgen B Bulitta (JB)

Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Orlando, Florida, USA.

Guenther Hochhaus (G)

Department of Pharmaceutics, College of Pharmacy, University of Florida, 1600 SW Archer Road, Gainesville, Florida, 32610, USA. hochhaus@ufl.edu.

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Classifications MeSH