METHOD OF PRODUCING DOSAGE UNITS OF A SOLID DRUG FORM CONTAINING WARFARIN SODIUM SALT AS ACTIVE COMPONENT

Title:

METHOD OF PRODUCING DOSAGE UNITS OF A SOLID DRUG FORM CONTAINING WARFARIN SODIUM SALT AS ACTIVE COMPONENT

Document Type and Number:

WIPO Patent Application WO2005034919

Kind Code:

B1

Abstract:

The invention relates to a method of producing dosage units of a solid drug form containing as the active substance warfarin sodium salt in an amount of 1 to 10 mg and having high degree of content uniformity satisfying the Bergum criterion, characterized in that an aqueous solution of warfarin sodium salt and /or its clathrate which optionally contains in the dissolved state one of the pharmaceutically acceptable excipients co-forming the solid drug form to be prepared but not all the pharmaceutically acceptable excipients co-forming the solid drug form to be prepared, is brought into contact with solid particles of at least one pharmaceutically acceptable excipient co-forming the solid drug form to be prepared, whereupon optionally the particles are dried and optionally mixed with a required amount of solid particles of the remaining pharmaceutically acceptable excipients co-forming the solid drug form to be prepared, and the thus-obtained particulate mixture is formulated into dosage units of the solid drug form.

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Inventors:

FRANC ALES (CZ)
ZALUDEK BOREK (CZ)
GONEC ROMAN (CZ)
MALECEK MIROSLAV (CZ)
TKADLECKOVA HANA (CZ)
PETROVICOVA ANNA (CZ)

Application Number:

PCT/CZ2004/000067

Publication Date:

August 04, 2005

Filing Date:

October 14, 2004

Export Citation:

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Assignee:

PLIVA LACHEMA AS (CZ)
FRANC ALES (CZ)
ZALUDEK BOREK (CZ)
GONEC ROMAN (CZ)
MALECEK MIROSLAV (CZ)
TKADLECKOVA HANA (CZ)
PETROVICOVA ANNA (CZ)

International Classes:

A61K31/37; A61K9/16; A61K9/20; A61K31/00; (IPC1-7): A61K9/20; A61K9/16; A61K31/00

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