Impact of Apparatus and Adapter on In vitro Drug Release of Ophthalmic Semisolid Drug Products.

Drug Liberation Ointments Drug Compounding Administration, Ophthalmic
dissolution apparatus in vitro release test membrane ointment

Journal

Pharmaceutical research
ISSN: 1573-904X
Titre abrégé: Pharm Res
Pays: United States
ID NLM: 8406521

Informations de publication

Date de publication:
Sep 2023
Historique:
received: 31 05 2023
accepted: 09 08 2023
medline: 5 10 2023
pubmed: 8 9 2023
entrez: 7 9 2023
Statut: ppublish

Résumé

In vitro release testing (IVRT) is a widely used tool for evaluating the quality and performance of drug products. However, standardized sample adaptors or drug release apparatus setups for IVRT studies are still lacking for ophthalmic ointments. The aim of this study was to provide a better understanding of the impact of apparatus and sample adaptor setups on IVRT of ophthalmic ointments. Dexamethasone (DEX), a steroidal ingredient commonly used in ophthalmic drug products, was selected as a model drug. Ointments were prepared by mixing DEX in white petrolatum using a high shear mixer. A novel two-sided adapter was developed to increase the drug release surface area. DEX ointment was placed in one-sided or two-sided release adaptors coupled with 1.2 μm polyethersulfone membrane, and the drug release was studied in different USP apparatuses (I, II, and IV). The sample adaptor setups had a minimal impact on cumulative drug release amount per area or release rate while USP IV apparatus with agitated flow enhanced drug release rates. The USP apparatus I with a two-sided semisolid adapter, which uses membranes on both sides, showed dramatically higher cumulative drug release and discriminative release profiles when evaluating ophthalmic formulations. USP apparatuses and sample adaptors are critical considerations for IVRT. Two-sided semisolid adapter provides higher cumulative release, facilitating the discrimination between low drug content ophthalmic ointment formulations with good sensitivity and repeatability without affecting the drug release rate.

Identifiants

DOI: 10.1007/s11095-023-03586-x PMID: 37679656
pubmed: 37679656
doi: 10.1007/s11095-023-03586-x
pii: 10.1007/s11095-023-03586-x
doi:

Substances chimiques

Ointments 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

2239-2251

Subventions

Organisme : FDA HHS
ID : HHSF223201810114C
Pays : United States
Organisme : FDA HHS
ID : HHSF223201810114C
Pays : United States

Informations de copyright

© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

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Auteurs

Catheleeya Mekjaruskul (C)

Department of Pharmaceutical Sciences, School of Pharmacy, University of Connecticut, Storrs, CT, USA.
Integrative Pharmaceuticals and Innovation of Pharmaceutical Technology Research Unit, Faculty of Pharmacy, Mahasarakham University, 44150, Maha Sarakham, Thailand.

André O'Reilly Beringhs (A)

Division of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Bin Qin (B)

Division of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Yan Wang (Y)

Division of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Pallabita Chowdhury (P)

Department of Pharmaceutical Sciences, School of Pharmacy, University of Connecticut, Storrs, CT, USA.

Xiuling Lu (X)

Department of Pharmaceutical Sciences, School of Pharmacy, University of Connecticut, Storrs, CT, USA. xiuling.lu@uconn.edu.
ORCID: 0000-0002-1961-8156

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Classifications MeSH

questionsmedicales.fr › Phénomènes physiologiques › Phénomènes pharmacologiques et toxicologiques › Pharmacocinétique › Libération de médicament › Impact of Apparatus and Adapter on In vitro...
questionsmedicales.fr › Préparations pharmaceutiques › Onguents › Impact of Apparatus and Adapter on In vitro...
questionsmedicales.fr › Techniques d'investigation › Préparation de médicament › Impact of Apparatus and Adapter on In vitro...
questionsmedicales.fr › Thérapeutique › Traitement médicamenteux › Voies d'administration de substances chimiques et des médicaments › Administration par voie topique › Administration par voie ophtalmique › Impact of Apparatus and Adapter on In vitro...