Stable formulations of fingolimod

Sugar alcohol-free formulations of fingolimod. Compositions of fingolimod, salts thereof, or esters thereof that lack sugar alcohols are disclosed. The composition may include a water- soluble filler and a water-insoluble filler, in addition to other common excipients. In some examples, the water-so...

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Bibliographische Detailangaben
Hauptverfasser: Kirsch, John D, Liu, Zhi, Chattaraj, Sarat C
Format: Patent
Sprache:eng
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Beschreibung
Zusammenfassung:Sugar alcohol-free formulations of fingolimod. Compositions of fingolimod, salts thereof, or esters thereof that lack sugar alcohols are disclosed. The composition may include a water- soluble filler and a water-insoluble filler, in addition to other common excipients. In some examples, the water-soluble filler is glycine and the water-insoluble filler is dibasic calcium phosphate dihydrate as fillers. In some examples, the water-soluble filler and water-insoluble filler are present in equal concentrations. The compositions disclosed here may be used to make immediate release dosage forms containing fingolimod hydrochloride.