Cycle Pharmaceuticals Ltd, The Broers Building, 21JJ Thomson Avenue, Cambridge CB3 0FA, UK.
Cycle Pharmaceuticals Ltd, The Broers Building, 21JJ Thomson Avenue, Cambridge CB3 0FA, UK.
Mult Scler Relat Disord. 2023 Dec;80:105077. doi: 10.1016/j.msard.2023.105077. Epub 2023 Oct 14.
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.
免疫调节剂芬戈莫德是一种用于治疗多发性硬化症（MS）的鞘氨醇-1-磷酸受体调节剂。我们分析了三种已获 FDA 批准的芬戈莫德 0.5 毫克通用胶囊产品的芬戈莫德含量。分析结果表明，不同制造商生产的芬戈莫德含量差异很大，其中一种产品的芬戈莫德含量为批准剂量的 76.8%。这明显低于 FDA 接受标准的 90.0-110.0%的标签声称。
