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US 2026/0137624 A1Published application
Pharmaceutical composition and uses thereof
AssigneeBoehringer Ingelheim International GmbH
InventorsMasanori ITO, Kenji EGUSA, Kyle KLEINBECK, Roman Christian MESSERSCHMID, Peter SCHNEIDER, Venkata VOLETI
Life of this patent
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Abstract
The present invention relates to pharmaceutical compositions comprising fixed dose combinations of a DPP-4 inhibitor drug and/or a SGLT-2 inhibitor drug, and metformin XR, processes for the preparation thereof, and their use to treat certain diseases.
Claims16
A pharmaceutical composition comprising:
- a) an inner extended release tablet core consisting of metformin hydrochloride, poly(ethylene oxide) as swelling and/or extended release polymer, low molecular weight hydroxypropyl methylcellulose as binder, and magnesium stearate as lubricant, wherein the metformin hydrochloride is present in a unit dosage strength of 1000 mg,
- wherein the inner extended release tablet core is coated with a barrier coating;
- b) an immediate release coating comprising 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene and one or more excipients, wherein the 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene is present in a unit dosage strength of 5, 10, 12.5 or 25 mg;
- wherein the immediate release coating comprises:
- 8-20% w/w of polyethylene glycol of molecular weight of about 6000,
- 5-35% w/w of 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene,
- 40-70% w/w of hydroxypropyl methylcellulose,
- 0-5% w/w of polyethylene glycol of molecular weight of about 8000,
- 5-20% w/w of talc,
- wherein % w/w relate to the weight of the immediate release coating;
- and
- c) the barrier coating is present between said inner extended release tablet core and said immediate release coating, wherein the barrier coating separates the inner extended release tablet core from the immediate release coating, wherein
- the barrier coating has a weight in the range from 50 to 100 mg, or
- the barrier coating has a weight of 68 mg or 85 mg,
- wherein said pharmaceutical composition is a tablet for oral administration,
- wherein the barrier coating is a film coat formulation consisting of:
- one or more film-coating agents selected from a mixture of hydroxypropyl methylcellulose (HPMC) and polydextrose;
- polyethylene glycol;
- and titanium dioxide.
16 more elements
Dependencies are inferred from the claim text.