NON-PULSATILE PROLONGED-RELEASE BETAHISTINE ORAL SOLID COMPOSITIONS

The present invention relates to an oral solid non-pulsatile 24 hours prolonged-release composition comprising an amount of betahistine, or of a pharmaceutically acceptable salt thereof, equivalent to 48 mg of betahistine dihydrochloride, together with one or more pharmaceutically acceptable excipie...

Ausführliche Beschreibung

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Bibliographische Detailangaben
Hauptverfasser:	DUBE, VINOD PURUSHOTTAM, NAIDU, VENKATA RAMANA, PATEL, HIMANSHUKUMAR DASHARATHLAL, BORUDE, SUNIL SHANTWAN
Format:	Patent
Sprache:	eng ; pol
Schlagworte:	HUMAN NECESSITIES HYGIENE MEDICAL OR VETERINARY SCIENCE PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
Online-Zugang:	Volltext bestellen
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Beschreibung
Zusammenfassung:	The present invention relates to an oral solid non-pulsatile 24 hours prolonged-release composition comprising an amount of betahistine, or of a pharmaceutically acceptable salt thereof, equivalent to 48 mg of betahistine dihydrochloride, together with one or more pharmaceutically acceptable excipients or carriers, wherein the composition exhibits a dissolution profile according to which: up to 30% by weight of betahistine is dissolved in 1 hour; from 35% to 45% by weight of betahistine is dissolved in 2 hours; from 46% to 60% by weight of betahistine is dissolved in 4 hours; from 61 % to 80% by weight of betahistine is dissolved in 8 hours; from 81% to 97% by weight of betahistine is dissolved in 16 hours; and from 98% to 100% by weight of betahistine is dissolved in 24 hours. It also relates to its use in therapy, particularly in the treatment of a vestibular disease or condition, more particularly in the treatment of Ménière's disease.