Preparation of aqueous clear solution dosage forms with bile...

A - Human Necessities – 61 – K

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A61K 9/00 (2006.01) A61K 31/575 (2006.01) A61K 47/28 (2006.01) A61K 47/36 (2006.01)

Patent

CA 2338457

Compositions for pharmaceutical and other uses for preparing clear aqueous solutions containing bile acids which do not form precipitates over selected ranges of pH values of the aqueous solution and methods of making such solutions. The compositions of the invention comprise water; a bile acid in the form of a bile acid, bile acid salt, or a bile acid conjugated with an amine by an amide linkage; and a high molecular weight aqueous soluble starch conversion product. The composition remains in solution without forming a precipitate over a range of pH values and, according to one embodiment, remains in solution all pH values obtainable in an aqueous system. The composition, according to some embodiments, may further contain a pharmaceutical compound in a pharmaceutically effective amount.

La présente invention concerne des compositions à usage pharmaceutique et autres qui permettent de préparer des solutions aqueuses claires renfermant des acides biliaires qui ne forment pas de précipités sur certaines plages de pH de la solution aqueuse, et des procédés de réalisation de telles solutions. Les compositions selon l'invention renferment de l'eau, un acide biliaire sous forme d'acide biliaire proprement dit, de sel d'acide biliaire ou d'acide biliaire mélangé à un amine par une liaison amide; et un produit de transformation de l'amidon aqueux soluble à poids moléculaire élevé. Cette composition reste en solution sans former de précipité sur une plage déterminée de valeurs de pH et, selon un mode de réalisation, reste en solution pour toutes les valeurs de pH pouvant être obtenues dans un système aqueux. Selon d'autres modes de réalisation, cette composition peut en outre renfermer un composé pharmaceutique en dose pharmaceutiquement efficace.

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