A combination preparation of dapagliflozin and metformin hydrochloride and a preparation method thereof

CN122163595APending Publication Date: 2026-06-09QINGDAO HUANGHAI PHARM CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
QINGDAO HUANGHAI PHARM CO LTD
Filing Date
2024-12-09
Publication Date
2026-06-09

AI Technical Summary

Technical Problem

In existing technologies, the dosage of dapagliflozin in combination preparations of dapagliflozin and metformin hydrochloride varies greatly, resulting in poor content uniformity, low melting point and poor solubility, making it difficult to achieve rapid dissolution. Furthermore, the production process is complex and costly, making it difficult to guarantee product quality.

Method used

Dapagliflozin and metformin hydrochloride were granulated separately, and the particle size D(90) of dapagliflozin was controlled to be no greater than 50 μm. β-cyclodextrin was added, along with disintegrants and binders, to prepare bilayer tablets. β-cyclodextrin promotes the dissolution of dapagliflozin, thus solving the problem of content uniformity.

Benefits of technology

The content uniformity and dissolution of dapagliflozin and metformin hydrochloride combination preparations are consistent with the original product, simplifying the production process, reducing production costs, and making it suitable for large-scale industrial production.

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Abstract

This invention belongs to the field of pharmaceutical preparation technology, specifically relating to a compound preparation of dapagliflozin and metformin hydrochloride and its preparation method. The compound preparation includes dapagliflozin granules and metformin hydrochloride granules; the dapagliflozin granules include dapagliflozin technical, β-cyclodextrin, filler, disintegrant, and lubricant; the metformin hydrochloride granules include metformin hydrochloride technical, sustained-release material, filler, binder, and lubricant; wherein the particle size D of the dapagliflozin raw material is... (90) The concentration ranges from 5μm to 50μm. This invention addresses the problem of inconsistent dosages of dapagliflozin and metformin hydrochloride, making it difficult to control content uniformity. Simultaneously, it effectively overcomes the low melting point and poor solubility of dapagliflozin, achieving dissolution curves for both dapagliflozin and metformin hydrochloride consistent with the original marketed products.
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