EP 1986529 A2 20081105 - STORAGE-STABLE ORAL DOSAGE FORM OF AMOXICILLIN AND CLAVULANIC ACID
Title (en)
STORAGE-STABLE ORAL DOSAGE FORM OF AMOXICILLIN AND CLAVULANIC ACID
Title (de)
LAGERSTABILE ORALE DARREICHUNGSFORM VON AMOXICILLIN UND CLAVULANSÄURE
Title (fr)
FORME D'ADMINISTRATION PAR VOIE ORALE STABLE AU STOCKAGE D'AMOXICILLINE ET D'ACIDE CLAVULANIQUE
Publication
Application
Priority
- EP 2007001335 W 20070215
- DE 102006007830 A 20060217
Abstract (en)
[origin: WO2007093425A2] The present invention relates to an airtight-packaged system comprising 1. a combination of two independently prepared pharmaceutical drug forms consisting of a drug form in aqueous formulation comprising amoxicillin trihydrate as active pharmaceutical ingredient and of a drug form prepared separately therefrom and comprising potassium clavulanate as active pharmaceutical ingredient, where the active ingredients in the combination of the two drug forms are present in a nominal ratio by weight of amoxicillin to clavulanic acid of from 20:1 to 1:1, and 1. a preparation comprising at least one desiccant in amounts such that when the packaged system is stored under stress conditions at 40°C/75% relative humidity for up to 3 months the dimerization of amoxicillin trihydrate does not exceed 1.5% by weight, and the degradation of clavulanic acid does not exceed 10% by weight.
IPC 8 full level
A47G 21/18 (2006.01); A61J 7/00 (2006.01); A61J 15/00 (2006.01); A61K 9/16 (2006.01); A61K 9/50 (2006.01); A61K 9/58 (2006.01); A61K 31/424 (2006.01); A61K 31/43 (2006.01); B01J 20/00 (2006.01); B65D 81/00 (2006.01); C08J 9/00 (2006.01); C08L 23/00 (2006.01); C08L 29/00 (2006.01); C08L 69/00 (2006.01); C08L 77/00 (2006.01)
CPC (source: EP US)
A47G 21/183 (2013.01 - EP US); A61J 7/0038 (2013.01 - EP US); A61K 9/0095 (2013.01 - EP US); A61K 9/1611 (2013.01 - EP US); A61K 9/1623 (2013.01 - EP US); A61K 9/5026 (2013.01 - EP US); A61K 9/5084 (2013.01 - EP US); A61K 31/00 (2013.01 - EP US); A61K 31/424 (2013.01 - EP US); A61K 31/43 (2013.01 - EP US); A61K 45/06 (2013.01 - EP US); A61P 31/00 (2017.12 - EP)
Citation (search report)
See references of WO 2007093425A2
Designated contracting state (EPC)
AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI SK TR
DOCDB simple family (publication)
WO 2007093425 A2 20070823; WO 2007093425 A3 20071018; DE 102006007830 A1 20070830; EP 1986529 A2 20081105; US 2008300569 A1 20081204
DOCDB simple family (application)
EP 2007001335 W 20070215; DE 102006007830 A 20060217; EP 07722835 A 20070215; US 19278408 A 20080815