EP 3886817 A1 20211006 - PHARMACEUTICAL COMPOSITION COMPRISING RAMIPRIL AND INDAPAMIDE
Title (en)
PHARMACEUTICAL COMPOSITION COMPRISING RAMIPRIL AND INDAPAMIDE
Title (de)
PHARMAZEUTISCHE ZUSAMMENSETZUNG MIT RAMIPRIL UND INDAPAMID
Title (fr)
COMPOSITION PHARMACEUTIQUE COMPRENANT DU RAMIPRIL ET DE L'INDAPAMIDE
Publication
Application
Priority
- EP 18460069 A 20181127
- EP 2019082610 W 20191126
Abstract (en)
[origin: WO2020109319A1] It relates to an oral multilayer tablet comprising (a) a first layer comprising an indapamide compound, and one or more pharmaceutically acceptable excipients, and (b) a second layer comprising a ramipril compound, and a stabilizing agent; and wherein the second layer has an impurity level of (2S,3aS,6aS)-1-[(S)-2-[[(S)-1- carboxy-3-phenylpropyl]amino]propanoyl]octahydrocyclopenta-[b]pyrrole2-carboxylic acid (impurity E) equal to or lower than 1.0% after 6 months at 40°C/75% RH as measured by ultra performance liquid chromatography (UPLC). It also relates to a process for the preparation of the multilayer tablet.
IPC 8 full level
A61K 9/24 (2006.01); A61K 31/403 (2006.01); A61K 31/404 (2006.01); A61P 9/12 (2006.01)
CPC (source: EP)
A61K 9/209 (2013.01); A61K 31/403 (2013.01); A61K 31/404 (2013.01); A61P 9/12 (2017.12)
Citation (search report)
See references of WO 2020109319A1
Designated contracting state (EPC)
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
Designated extension state (EPC)
BA ME
DOCDB simple family (publication)
DOCDB simple family (application)
EP 2019082610 W 20191126; EP 19806009 A 20191126