EP 4045048 A1 20220824 - ORAL FORMULATIONS COMPRISING SITAGLIPTIN HCI MONOHYDRATE WITH IMPROVED PHARMACEUTICAL CHARACTERISTICS
Title (en)
ORAL FORMULATIONS COMPRISING SITAGLIPTIN HCI MONOHYDRATE WITH IMPROVED PHARMACEUTICAL CHARACTERISTICS
Title (de)
ORALE FORMULIERUNGEN MIT SITAGLIPTIN-HCI-MONOHYDRAT MIT VERBESSERTEN PHARMAZEUTISCHEN EIGENSCHAFTEN
Title (fr)
FORMULATIONS ORALES COMPRENANT DU MONOHYDRATE DE HCI DE SITAGLIPTINE PRÉSENTANT DES CARACTÉRISTIQUES PHARMACEUTIQUES AMÉLIORÉES
Publication
Application
Priority
TR 2019050865 W 20191014
Abstract (en)
[origin: WO2021076066A1] An oral pharmaceutical formulation in the form of an immediate release tablet comprising sitagliptin hydrochloride, preferably monohydrate manufactured by using wet granulation method wherein croscarmellose sodium and dibasic calcium phosphate are used both in intragranular and extragranular phases. The total amount ratio of croscarmellose sodium used in intragranular and extragranular phases to the total amount of composition is between 1:5 and 5:1, preferably between 1:2 and 2:1, more preferably 1:2.5 and, the amount of ratio of dibasic calcium phosphate in intragranular to the amount of ratio of dibasic calcium phosphate in extragranular phases is 1:5, preferably 1:2, more preferably 1:1.
IPC 8 full level
A61K 9/22 (2006.01); A61K 31/4985 (2006.01)
CPC (source: EP)
A61K 9/2009 (2013.01); A61K 9/2054 (2013.01); A61K 31/155 (2013.01); A61K 31/4985 (2013.01)
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)
WO 2021076066 A1 20210422; EP 4045048 A1 20220824; EP 4045048 A4 20230524
DOCDB simple family (application)
TR 2019050865 W 20191014; EP 19949416 A 20191014