Dried forms of aqueous solubilized bile acid dosage...

A - Human Necessities – 61 – K

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A61K 9/16 (2006.01)

Patent

CA 2588168

Compositions for pharmaceutical and other uses comprising clear aqueous solutions of bile acids which do not form any detectable precipitates over selected ranges of pH values of the aqueous solution and methods of making such solutions are disclosed. Compositions of the disclosure may comprise water; a bile acid in the form of a bile acid, bile acid salt, or bile acid conjugated with an amine by an amide linkage; and either or both an aqueous soluble starch conversion product and an aqueous soluble non-starch polysaccharide. The composition remains in solution without forming a precipitate over a range of 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. The disclosure further provides dried forms of primary aqueous solubilized bile acid formulations and methods of preparing such dried forms.

L'invention concerne des compositions à usages pharmaceutiques et autres, contenant des solutions aqueuses claires d'acides biliaires qui ne forment pas de précipités détectables sur des plages de valeurs pH choisies de la solution aqueuse, ainsi que des procédés de fabrication de ces solutions. Les compositions selon l'invention peuvent contenir de l'eau, un acide biliaire sous la forme d'un acide biliaire, d'un sel d'acide biliaire ou d'un acide biliaire conjugué à une amine par une liaison amide, et un produit de conversion d'amidon soluble aqueux ou un polysaccharide non amidon soluble aqueux, ou les deux à la fois. Cette composition reste en solution, sans former de précipité sur la plage de toutes les valeurs pH pouvant être obtenues dans un système aqueux. Dans certains modes de réalisation, cette composition peut également contenir un composé pharmaceutique dans une quantité pharmaceutiquement efficace. L'invention concerne encore des formes séchées de préparations d'acide biliaire solubilisé aqueux primaire, ainsi que des procédés de préparation de ces formes séchées.

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