METHOD OF PRODUCING DOSAGE UNITS OF A SOLID DRUG FORM CONTAINING WARFARIN SODIUM SALT AS ACTIVE COMPONENT
摘要
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.
申请公布号
WO2005034919(B1)
申请公布日期
2005.08.04
申请号
WO2004CZ00067
申请日期
2004.10.14
申请人
PLIVA-LACHEMA A.S.;FRANC, ALES;ZALUDEK, BOREK;GONEC, ROMAN;MALECEK, MIROSLAV;TKADLECKOVA, HANA;PETROVICOVA, ANNA
发明人
FRANC, ALES;ZALUDEK, BOREK;GONEC, ROMAN;MALECEK, MIROSLAV;TKADLECKOVA, HANA;PETROVICOVA, ANNA