Development of an Accelerated Rotator-based Drug Release Method for the Evaluation of Bupivacaine Multivesicular Liposomes.
bupivacaine
generic development
in vitro release method
liposomes
multivesicular liposomes
Journal
Pharmaceutical research
ISSN: 1573-904X
Titre abrégé: Pharm Res
Pays: United States
ID NLM: 8406521
Informations de publication
Date de publication:
Feb 2024
Feb 2024
Historique:
received:
03
10
2023
accepted:
22
12
2023
medline:
21
2
2024
pubmed:
12
1
2024
entrez:
11
1
2024
Statut:
ppublish
Résumé
A multivesicular liposome (MVL) is a liposomal vehicle designed to achieve sustained release characteristics for drugs with short half-lives. For example, a commercial MVL formulation of bupivacaine has been approved by the U.S. Food and Drug Administration for local and regional analgesia. For complex formulations like those containing MVLs, challenges in developing an in vitro release testing (IVRT) method may hinder generic development and regulatory approval. In this study, we developed an accelerated rotator-based IVRT method with the ability to discriminate bupivacaine MVLs with different quality attributes. Three IVRT experimental setups including mesh tube, horizontal shaker, and vertical rotator were screened to ensure that at least 50% of bupivacaine can release from MVLs in 24 h. Sample dilution factors, incubation temperature, and the release media pH were optimized for the IVRT. The reproducibility of the developed IVRT method was validated with commercial bupivacaine MVLs. The discriminative capacity was assessed via comparing commercial and compromised bupivacaine MVL formulations. The rotator-based release setup was chosen due to the capability to obtain 70% of drug release within 24 h. The optimized testing conditions were chosen with a 50-fold dilution factor, a temperature of 37ºC, and a media pH of 7.4. An accelerated rotator-based IVRT method for bupivacaine MVLs was developed in this study, with the discriminatory ability to distinguish between formulations of different qualities. The developed IVRT method was a robust tool for generic development of MVL based formulations.
Identifiants
pubmed: 38212593
doi: 10.1007/s11095-023-03651-5
pii: 10.1007/s11095-023-03651-5
doi:
Substances chimiques
Liposomes
0
Delayed-Action Preparations
0
Bupivacaine
Y8335394RO
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
293-303Subventions
Organisme : U.S. Food and Drug Administration
ID : 75F40120C00127
Informations de copyright
© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.
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