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

Title:

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

Document Type and Number:

WIPO Patent Application WO2006007354

Kind Code:

A3

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.

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Inventors:

DONG LIANG CHANG (US)
HAN JASMINE E (US)
POLLOCK-DOVE CRYSTAL (US)
WONG PATRICK S L (US)

Application Number:

PCT/US2005/020356

Publication Date:

April 27, 2006

Filing Date:

June 08, 2005

Export Citation:

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Assignee:

ALZA CORP (US)
DONG LIANG CHANG (US)
HAN JASMINE E (US)
POLLOCK-DOVE CRYSTAL (US)
WONG PATRICK S L (US)

International Classes:

A61K9/19; A61K9/14; A61K9/20; A61K9/24; A61K9/44; A61K9/48; A61K31/496; A61K47/48; A61K9/00; A61K47/10; A61K47/38

Domestic Patent References:

WO2002039993A2	2002-05-23
WO2004032980A1	2004-04-22
WO1998002148A2	1998-01-22
WO1999021586A2	1999-05-06

Foreign References:

EP0506979A1	1992-10-07
US5543155A	1996-08-06

Other References:

SEITAKARI R L ET AL: "Effect of different surface active agents on the crystallinity of lyophilized diltiazem hydrochloride", S.T.P. PHARMA SCIENCES 1999 FRANCE, vol. 9, no. 4, 1999, pages 365 - 369, XP009062124, ISSN: 1157-1489

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