PHARMACEUTICAL TABLET COMPOSITION COMPRISING EDOXABAN

The invention relates to a pharmaceutical composition in the form of a tablet, comprising a) edoxaban, or a salt thereof or a hydrate of said edoxaban or edoxaban salt, as an active ingredient, b) lactose as a water-soluble filler, and c) crospovidone and sodium starch glycolate as disintegrants. Th...

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Hauptverfasser: SCHLEHAHN, HENDRIK, RALLABANDI, BALA RAMESHA CHARY, PATTIPATI, SRIKANTH, JOSHI, ABHAY RAMAKANT, STAVER, RUSLAN, BANDLA, SRIMANNARAYANA, REDDY, SIVA REDDY MARAM, CHAMARTHI, PHANIKISHORE RAVI
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creator SCHLEHAHN, HENDRIK
RALLABANDI, BALA RAMESHA CHARY
PATTIPATI, SRIKANTH
JOSHI, ABHAY RAMAKANT
STAVER, RUSLAN
BANDLA, SRIMANNARAYANA
REDDY, SIVA REDDY MARAM
CHAMARTHI, PHANIKISHORE RAVI
description The invention relates to a pharmaceutical composition in the form of a tablet, comprising a) edoxaban, or a salt thereof or a hydrate of said edoxaban or edoxaban salt, as an active ingredient, b) lactose as a water-soluble filler, and c) crospovidone and sodium starch glycolate as disintegrants. The invention further relates to the pharmaceutical composition for use as a medicament in the treatment and/or prevention of a medical condition associated with unwanted blood clots, and to methods for preparing the pharmaceutical composition using wet granulation methods. L'invention concerne une composition pharmaceutique sous la forme d'un comprimé, qui comprend a) de l'edoxaban ou un sel de celui-ci ou un hydrate dudit edoxaban ou sel d'edoxaban, en tant que principe actif, b) du lactose en tant que charge soluble dans l'eau, et c) de la crospovidone et du glycolate d'amidon sodique en tant que délitants. L'invention concerne en outre la composition pharmaceutique destinée à être utilisée en tant que médicament dans le traitement et/ou la prévention d'un état médical associé à des caillots sanguins indésirables, et des procédés de préparation de la composition pharmaceutique à l'aide de procédés de granulation par voie humide.
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subjects HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS
title PHARMACEUTICAL TABLET COMPOSITION COMPRISING EDOXABAN
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