Fingolimod: Assay analysis of US generic capsule products reveals variation in fingolimod content beyond the recommended acceptance criteria.
Assay
Content
Fingolimod
Generic
Gilenya®
Multiple sclerosis
S1P
Sphingosine-1-phosphate receptor
Tascenso ODT®
Journal
Multiple sclerosis and related disorders
ISSN: 2211-0356
Titre abrégé: Mult Scler Relat Disord
Pays: Netherlands
ID NLM: 101580247
Informations de publication
Date de publication:
14 Oct 2023
14 Oct 2023
Historique:
received:
22
09
2023
accepted:
13
10
2023
medline:
22
10
2023
pubmed:
22
10
2023
entrez:
21
10
2023
Statut:
aheadofprint
Résumé
The immunomodulating agent fingolimod is a sphingosine-1-phosphate receptor modulator used in the treatment of multiple sclerosis (MS). We analyzed three FDA approved fingolimod 0.5 mg generic capsule products for fingolimod content. Assay results demonstrated a wide variation in fingolimod content between manufacturers, with one product demonstrating a fingolimod content of 76.8 % of the approved dose. This falls significantly below the FDA acceptance criteria of 90.0-110.0 % of label claim.
Identifiants
pubmed: 37864877
pii: S2211-0348(23)00578-3
doi: 10.1016/j.msard.2023.105077
pii:
doi:
Types de publication
Letter
Langues
eng
Sous-ensembles de citation
IM
Pagination
105077Informations de copyright
Copyright © 2023. Published by Elsevier B.V.
Déclaration de conflit d'intérêts
Declaration of Competing Interest Catherine Wainwright, Steve Fuller, Victoria Dickinson and Wendy Greenwood are employees of Cycle Pharmaceuticals, a global, privately-owned biotechnology company headquartered in Cambridge (UK). Cycle Pharmaceuticals manufactures Tascenso ODT® and markets the product in the United States of America.