Pharmaceutical dosage forms of biguanide-sulfonylurea combinations

A pharmaceutical dosage form, sulfonylurea technology, applied in the direction of sulfonylurea active ingredients, drug combination, pill delivery, etc.

Inactive Publication Date: 2006-02-01
RANBAXY LAB LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] Although the combination of these two antidiabetic drugs is known in the art and can be conveniently formulated, it is difficult to achieve a simple and cost-effective method that provides sustained release of the water-soluble active ingredient, the biguanide, and water-insoluble or sparingly soluble drugs. Immediate release combination of active ingredients, namely sulfonylureas

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 4

[0109] program:

[0110] 1. Grind metformin hydrochloride mixed with microcrystalline cellulose and sodium carboxymethyl cellulose. Sift the mixture.

[0111] 2. Separately sieve the hydroxypropyl methylcellulose and mix with the mixture from step 1 in a low shear mixer. The mixture is then blended with magnesium stearate, passed through a roller compactor, and ground to form granules.

[0112] 3. Mix glimepiride, lactose, microcrystalline cellulose and sodium starch glycolate, and granulate with polyvinylpyrrolidone solution in pure water.

[0113] 4. Granulate the wet mass from step 3, dry and sieve.

[0114] 5. Compress the lubricated granules of metformin and glimepiride into bilayer tablets with a rotary tablet press.

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PUM

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Abstract

The present invention relates to orally administered pharmaceutical compositions that include a combination of antidiabetic agents wherein one agent is present in an extended release form and the other agent is present in an immediate release form. For example, in one embodiment the dosage form includes an extended release layer that includes a biguanide; and an immediate release layer that includes a sulfonylurea.

Description

field of invention [0001] The present invention relates to a pharmaceutical composition for oral administration comprising a combination of antidiabetic drugs, wherein one antidiabetic drug is present in sustained release form and the other antidiabetic drug is in immediate release form. Background of the invention [0002] The term diabetes is commonly used to refer to various pathological conditions characterized by hyperglycemia and abnormal lipid, carbohydrate and protein metabolism. These states are also often associated with other co-morbidities, such as obesity, and are associated with an increased risk of cardiovascular disease. [0003] Diabetes mellitus can generally be classified as insulin-dependent diabetes mellitus (IDDM, type I diabetes) or insulin-independent diabetes mellitus (NIDDM, type II diabetes). [0004] Essentially all forms of diabetes are due to decreased circulating concentrations of insulin (insulin deficiency) and / or decreased response of perip...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/64A61K9/20A61K9/24
CPCA61K31/64A61K9/209A61P3/10
Inventor A·特里汉S·马丹V·K·阿罗拉R·马利克
Owner RANBAXY LAB LTD
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