Pharmaceutical compositions comprising metformine and glibenclamide for the treatment of type II diabetes mellitus

A technology of metformin and glibenclamide, applied in the field of pharmaceutical compositions containing metformin and glibenclamide for the treatment of type II diabetes, capable of solving problems such as decreased bioavailability

Inactive Publication Date: 2005-03-16
MENARINI INT OPERATIN S LUXEMBORG SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0024] As the advantages of coadministering metformin and glyburide or its salts are now evident, the need to address the reduced bioavailability of glibenclamide when mixed with metformin is felt

Method used

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  • Pharmaceutical compositions comprising metformine and glibenclamide for the treatment of type II diabetes mellitus

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] Embodiment 1 (comparison)

[0062] Preparation of 5mg glibenclamide tablet

[0063] Composition of each tablet, in mg:

[0064] Glibenclamide 5

[0065] Pregelatinized corn starch 58.3

[0066] Hydrated colloidal silica 0.5

[0067] Lactose monohydrate 96.2

[0068] Sodium Lauryl Sulfate 1

[0069] Talc powder 0.5

[0070] Magnesium stearate 0.5

[0071] preparation:

[0072] The mixture of active ingredient and excipients was granulated and the granules obtained were dried and then compressed until tablets were obtained, each containing 5 mg of glibenclamide and having the composition reported above.

Embodiment 2

[0073] Embodiment 2 (comparison)

[0074] Preparation of 400mg Metformin Tablets

[0075] Composition of each tablet, in mg:

[0076] Metformin Hydrochloride 400

[0077] Microcrystalline Cellulose 65

[0078] cornstarch 60

[0079] Anhydrous Colloidal Silica 20

[0080] Gelatin 40

[0081] Glycerin 17.5

[0082] Talc 17.5

[0083] Magnesium Stearate 7.5

[0084] Cellulose acetate phthalate 2

[0085] The mixture of active ingredient and excipients was granulated and the prepared granules were dried and then compressed to obtain tablets, each containing 400 mg of metformin and having the composition reported above.

Embodiment 3

[0086] Embodiment 3 (comparison)

[0087] Preparation of tablets containing a mixture of glibenclamide + metformin (5 + 400 mg)

[0088] Composition of each tablet, in mg:

[0089] Metformin Hydrochloride 400

[0090] Glibenclamide 5

[0091] Microcrystalline Cellulose 65

[0092] cornstarch 55

[0093] Pregelatinized corn starch 58.3

[0094] Anhydrous Colloidal Silica 20

[0095] Hydrated colloidal silica 0.5

[0096] Lactose monohydrate 96.2

[0097] Gelatin 40

[0098] Glycerin 17.5

[0099] Talc 18

[0100] Magnesium Stearate 8

[0101] Cellulose acetate phthalate 2

[0102] Sodium Lauryl Sulfate 1

[0103] Diethyl phthalate 0.5

[0104] The two active ingredients are granulated together with excipients. The granules thus obtained are dried and sized immediately after drying is complete. Magnesium stearate is added to the sized granules and mixed. The obtained mixture was finely granulated to obtain tablets, each having the composition reported above....

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PUM

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Abstract

Orally administrable pharmaceutical compositions in the form of tablets, comprising glibenclamide and metformin, or pharmaceutically acceptable salts thereof, as active ingredients, maintained separate from one another within the same composition, are described for the treatment of type-II diabetes mellitus.

Description

field of invention [0001] The present invention relates to a new pharmaceutical composition comprising glibenclamide and metformin, effective for the treatment of type II diabetes, wherein the two active ingredients are kept separate from each other although in the same composition. Background technique [0002] Non-insulin-dependent type II diabetes is a metabolic disease characterized by hyperglycemia, which is related to insulin deficiency, peripheral tissue resistance to insulin itself, increased liver production of glucose, and decreased glucose tolerance. [0003] There are two main classes of antidiabetic drugs: the sulfonylureas, of which we refer to glibenclamide, chlorpropamide, gliclazide, tolazamide, gliquidone, glipizide, tosylate butylurea; and the biguanides, of which we refer to phenformin and metformin. Sulfonylureas work by stimulating the pancreas to produce insulin, so residual activity of this organ is necessary for these drugs to work, whereas biguanid...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/24A61K9/28A61K31/155A61K31/64A61K47/04A61K47/10A61K47/12A61K47/20A61K47/26A61K47/34A61K47/36A61K47/38A61K47/42A61P3/10A61P43/00
CPCA61K31/155A61K9/209A61K31/64A61P3/10A61P3/08A61P43/00A61K2300/00A61K9/20
Inventor A·托塞蒂M·圭杜奇G·维蒂
Owner MENARINI INT OPERATIN S LUXEMBORG SA
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