A drug/polymer complex, preferably ciprofloxacin/hpmc, its...

A - Human Necessities – 61 – K

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Details

A61K 9/19 (2006.01) A61K 9/44 (2006.01) A61K 31/496 (2006.01) A61K 47/48 (2006.01)

Patent

CA 2571554

The present invention is directed to a drug /polymer complex, preferably ciprofloxacin/HPMC, its method of manufacturing using lyophilization and its use in an osmotic device. This invention pertains to the enhanced delivery of orally administered pharmaceutical agents and methods, dosage forms and devices thereof. In particular, the invention is directed to methods including providing a low solubility drug having a pKa between about 6 and about 9; dissolving the low solubility drug in an aqueous solution, wherein a pH of the aqueous solution is less than about 6.0; dissolving a hydrophilic polymer in the aqueous solution, wherein the weight ratio of the hydrophilic polymer to the low solubility drug is less than or equal to about 0.15; lyophilizing the aqueous solution to obtain a lyophilized power. Also disclosed are drug formulation made according to the method, and dosage forms that include the drug formulation.

L'invention concerne l'administration améliorée d'agents pharmaceutiques administrés par voie orale agents ainsi que des méthodes, des formes posologiques et des dispositifs associés. D'une manière plus spécifique, l'invention concerne des méthodes consistant à produire un médicament à faible solubilité ayant un pKa compris entre environ 6 et environ 9 ; à dissoudre le médicament à faible solubilité dans une solution aqueuse, le pH de la solution aqueuse étant inférieur à environ 6,0 ; à dissoudre un polymère hydrophile dans la solution aqueuse, le rapport pondéral entre le polymère hydrophile et le médicament à faible solubilité étant inférieur ou égal à environ 0,15 ; à lyophiliser la solution aqueuse afin d'obtenir une poudre lyophilisée. L'invention concerne également des formulations pharmaceutiques élaborées conformément à ladite méthode et des formes posologiques qui comprennent ces formulations pharmaceutiques.

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