Global Patent Index - EP 4045048 A4

EP 4045048 A4 20230524 - 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

EP 4045048 A4 20230524 (EN)

Application

EP 19949416 A 20191014

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 9/20 (2006.01); A61K 31/155 (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)

C-Set (source: EP)

  1. A61K 31/4985 + A61K 2300/00
  2. A61K 31/155 + A61K 2300/00

Citation (search report)

  • [XI] EP 2691083 B1 20170802 - KRKA TOVARNA ZDRAVIL D D NOVO MESTO [SI]
  • [XI] WO 2015114152 A1 20150806 - GALENICUM HEALTH SL [ES]
  • [XI] "Antidiabetic drug formulations ED - Darl Kuhn", IP.COM, IP.COM INC., WEST HENRIETTA, NY, US, 5 July 2018 (2018-07-05), XP013179268, ISSN: 1533-0001
  • See also references of WO 2021076066A1

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

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