ORAL IMMEDIATE RELEASE FORMULATION OF A POORLY WATERSOLUBLE ACTIVE SUBSTANCE

The invention is related to an oral immediate release formulation of Benzazepin -1- acetic acid derivatives comprising: a) said active substance in an amount of up to 65% of the total weight of the formulation; b) at least 10% w/w an alkaline compound or a mixture of alkaline compounds; c) between 0...

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Bibliographische Detailangaben
Hauptverfasser: DE WINTER, MARIUS L, SINGH, SUKHJEET, JAIN, RAJESH, KUMAR, ROHIT
Format: Patent
Sprache:eng ; spa
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Zusammenfassung:The invention is related to an oral immediate release formulation of Benzazepin -1- acetic acid derivatives comprising: a) said active substance in an amount of up to 65% of the total weight of the formulation; b) at least 10% w/w an alkaline compound or a mixture of alkaline compounds; c) between 0.1 and 10% of one or more surfactants, and d) optionally comprises auxiliary materials an amount of between 1% and 45% of the total weight of the formulation. La invencion se refiere a una formulacion oral de liberacion inmediata de derivados del acido benzazepin-1-acetico que comprende a) dicha sustancia activa en una cantidad de hasta 65% del peso total de la formulacion; b) al menos 10% p/p de un compuesto alcalino o una mezcla de compuestos alcalinos; c) entre 0.1 y 10% p/p de uno o mas agentes tensioactivos, y d) opcionalmente materiales auxiliares en una cantidad comprendida entre 1% y 45% del peso total de la formulacion.