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

A - Human Necessities – 61 – K

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Details

A61K 31/575 (2006.01) A61K 9/00 (2006.01) A61K 9/08 (2006.01) A61K 31/198 (2006.01) A61K 33/24 (2006.01) A61K 45/06 (2006.01) A61K 47/12 (2006.01) A61K 47/36 (2006.01) A61P 1/04 (2006.01) A61P 1/16 (2006.01) A61P 3/06 (2006.01) A61P 35/00 (2006.01) A61Q 11/00 (2006.01) A61K 35/413 (2006.01)

Patent

CA 2406930

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. 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 either or both an aqueous soluble starch conversion product and a aqueous soluble non-starch polysaccharide. The composition remains in solution without forming a precipitate over a range of pH values and, according to one embodiment, remains in solution for 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. Non-limiting examples of pharmaceutical compounds include insulin, heparin, bismuth compounds, amantadine and rimantadine.

L'invention concerne des compositions à usage pharmaceutique ou autres, qui comprennent des solutions aqueuses claires d'acides biliaires ne formant pas de précipités détectables dans de larges plages de valeurs de pH de la solution aqueuse, ainsi que les procédés de préparation desdites solutions. Les compositions selon l'invention renferment de l'eau ; un acide biliaire se présentant 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 de l'amidon soluble dans l'eau et/ou un polysaccharide soluble dans l'eau ne contenant pas d'amidon. Ladite composition reste dans la solution, sans former de précipité dans toute une plage de valeurs de pH, et dans un mode de réalisation, la composition reste dans la solution pour toutes les valeurs de pH susceptibles d'être obtenues dans un système aqueux. La composition, dans certains modes de réalisation, peut contenir, en outre, un composé pharmaceutique en quantités pharmaceutiquement efficaces. Parmi les exemples, non exhaustifs, de ces composés pharmaceutiques figurent l'insuline, l'héparine, les composés du bismuth, l'amantadine et la rimantadine.

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