A tablet comprising empagliflozin and metformin hydrochloride

EP4531829A4Pending Publication Date: 2026-06-03SANOVEL ILAC SANAYI & TICARET ANONIM SIRKETI
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Patent Information

Authority / Receiving Office
EP · EP
Patent Type
Applications
Current Assignee / Owner
SANOVEL ILAC SANAYI & TICARET ANONIM SIRKETI
Filing Date
2023-05-25
Publication Date
2026-06-03

AI Technical Summary

Technical Problem

Existing formulations of empagliflozin and metformin hydrochloride face challenges due to low solubility and poor compressibility of empagliflozin, and metformin's high amounts causing issues with homogeneity, flowability, and dissolution profile, leading to ineffective tablet formulations.

Method used

A film-coated tablet using hydroxypropyl methyl cellulose or hydroxypropyl cellulose as a binder, combined with diluents like corn starch and glidants/lubricants such as anhydrous colloidal silicon dioxide and magnesium stearate, to enhance dissolution profile, flowability, and compressibility, with a wet granulation process for preparation.

Benefits of technology

The solution provides a tablet with improved pharmacotechnical properties, high bioavailability, long-term stability, and a simple, cost-effective production method, overcoming the limitations of previous formulations.

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Abstract

The present invention relates to a film coated tablet comprising empagliflozin and metformin hydrochloride, wherein comprising at least one binder which is hydroxypropyl methyl cellulose or hydroxypropyl cellulose or mixtures thereof, the tablet provides pharmacotechnical properties and the desired dissolution profile. The present invention also relates to a simple, rapid, cost effective, time-saving and industrially convenient method of preparing the tablet.
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