DRUG/POLYMER COMPLEX, PREFERABLY CIPROFLOXACIN/HPMC, ITS METHOD OF MANUFACTURING USING LYOPHILIZATION AND ITS USE IN AN OSMOTIC DEVICE

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DRUG/POLYMER COMPLEX, PREFERABLY CIPROFLOXACIN/HPMC, ITS METHOD OF MANUFACTURING USING LYOPHILIZATION AND ITS USE IN AN OSMOTIC DEVICE
Publication Number: WO/2006/007354 International Application No.: PCT/US2005/020356
Publication Date: 19.01.2006 International Filing Date: 08.06.2005

Int. Class.: A61K 9/19 (2006.01), A61K 31/496 (2006.01), A61K 47/48 (2006.01), A61K 9/44 (2006.01)
Applicants: ALZA CORPORATION [US/US]; 1900 Charleston Road, P.O. Box 7210, Mountain View CA 94039-7210 (US) (All Except US).
DONG, Liang, Chang [US/US]; 181 Leota Avenue, Sunnyvale, CA 94086 (US) (US Only).
HAN, Jasmine, E. [GB/US]; 305 Elan Village Lane #301, San Jose, CA 95134 (US) (US Only).
POLLOCK-DOVE, Crystal [US/US]; 2334 Carol Avenue, Mountain View, CA 94040 (US) (US Only).
WONG, Patrick, S., L. [US/US]; 1533 Burlingame Avenue, Burlingame, CA 94010 (US) (US Only).
Inventors: DONG, Liang, Chang [US/US]; 181 Leota Avenue, Sunnyvale, CA 94086 (US).
HAN, Jasmine, E. [GB/US]; 305 Elan Village Lane #301, San Jose, CA 95134 (US).
POLLOCK-DOVE, Crystal [US/US]; 2334 Carol Avenue, Mountain View, CA 94040 (US).
WONG, Patrick, S., L. [US/US]; 1533 Burlingame Avenue, Burlingame, CA 94010 (US).
Agent: ABRAHAM, David; Alza Corporation, c/o Johnson & Johnson, One Johnson & Johnson Plaza WH3221, New Brunswick, NJ 08933 (US).
Priority Data: 60/583,816 28.06.2004 US
Abstract:
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