Topical pharmacokinetics of brinzolamide suspensions in rabbits and variability analysis for sample size and design considerations.

Analysis of variance Brinzolamide Coefficient of variation Ophthalmic suspension Pharmacokinetics

Journal

International journal of pharmaceutics
ISSN: 1873-3476
Titre abrégé: Int J Pharm
Pays: Netherlands
ID NLM: 7804127

Informations de publication

Date de publication:
25 Jul 2023
Historique:
received: 04 04 2023
revised: 23 06 2023
accepted: 24 06 2023
medline: 24 7 2023
pubmed: 28 6 2023
entrez: 27 6 2023
Statut: ppublish

Résumé

Identifying critical attributes for complex locally acting ophthalmic formulations and establishing in vitro-in vivo correlations can facilitate selection of appropriate thresholds for formulation changes that reflect lack of impact on in vivo performance. In this study the marketed antiglaucoma product Azopt® (1% brinzolamide suspension) and five other brinzolamide formulations varying in particle size distributions and apparent viscosities were topically administered in rabbits, and their ocular pharmacokinetics was determined in multiple ocular tissues. Statistical evaluation with ANOVA showed no significant differences between the formulations in the peak drug concentration (C

Identifiants

pubmed: 37369289
pii: S0378-5173(23)00603-8
doi: 10.1016/j.ijpharm.2023.123183
pii:
doi:

Substances chimiques

brinzolamide 9451Z89515
Suspensions 0
Sulfonamides 0
Ophthalmic Solutions 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

123183

Informations de copyright

Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Auteurs

Vatsala Naageshwaran (V)

University of Eastern Finland, School of Pharmacy, Yliopistonranta 1, 70210 Kuopio, Finland; Pharmaron, 7901 Vickers Street, San Diego, CA 92111, USA; 436 Creamery Way, Exton, PA, USA.

Hélène Bigonne (H)

University of Eastern Finland, School of Pharmacy, Yliopistonranta 1, 70210 Kuopio, Finland.

Glenwood Gum (G)

Pharmaron, 7901 Vickers Street, San Diego, CA 92111, USA.

Spundana Malla (S)

Pharmaron, 7901 Vickers Street, San Diego, CA 92111, USA; 436 Creamery Way, Exton, PA, USA.

Charity Del Sol (C)

Biostudy Solutions, LLC, 4008 Caesar Court, Wilmington, NC 28405, USA.

Charles Bon (C)

Biostudy Solutions, LLC, 4008 Caesar Court, Wilmington, NC 28405, USA.

Xiaoming Xu (X)

Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.

Anh Vo (A)

Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.

William Smith (W)

Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.

Andre O'Reilly Beringhs (A)

Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.

Darby Kozak (D)

Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.

Ming-Liang Tan (ML)

Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.

Andrew Babiskin (A)

Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.

Arto Urtti (A)

University of Eastern Finland, School of Pharmacy, Yliopistonranta 1, 70210 Kuopio, Finland; University of Helsinki, Faculty of Pharmacy, Viikinkaari 5 E, 00790 Helsinki, Finland.

Eva M Del Amo (EM)

University of Eastern Finland, School of Pharmacy, Yliopistonranta 1, 70210 Kuopio, Finland. Electronic address: eva.delamo@uef.fi.

Veli-Pekka Ranta (VP)

University of Eastern Finland, School of Pharmacy, Yliopistonranta 1, 70210 Kuopio, Finland.

Articles similaires

Robotic Surgical Procedures Animals Humans Telemedicine Models, Animal

Odour generalisation and detection dog training.

Lyn Caldicott, Thomas W Pike, Helen E Zulch et al.
1.00
Animals Odorants Dogs Generalization, Psychological Smell
Animals TOR Serine-Threonine Kinases Colorectal Neoplasms Colitis Mice
Animals Tail Swine Behavior, Animal Animal Husbandry

Classifications MeSH