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Compound composition of vildagliptin and melbine and preparation method thereof

A technology for metformin and a composition is applied to the compound tablet composition containing vildagliptin and metformin and the field of preparation thereof, and can solve the problems of difficult mixing of main drugs, poor compressibility of vildagliptin, large dose of metformin and the like , to achieve the effect of being suitable for clinical application, with small batch-to-batch variability and small content variability

Inactive Publication Date: 2014-06-11
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Both metformin and vildagliptin have poor compressibility, and the dose of metformin is large, while the dose of vildagliptin is small, and it is difficult to mix the two evenly. They are mainly granulated by wet method or melting method, although it can Improve the compressibility to a certain extent, but still have the defects of poor compressibility and difficulty in mixing the main ingredients evenly

Method used

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  • Compound composition of vildagliptin and melbine and preparation method thereof
  • Compound composition of vildagliptin and melbine and preparation method thereof
  • Compound composition of vildagliptin and melbine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0078] Example 1 wet granulation

[0079] Table 1 Example 1 prescription summary

[0080]

[0081] * Removed during processing.

[0082] Specific process: Grind metformin needle crystals and pass through a 100-mesh sieve for later use; pass hydroxypropyl cellulose through a 60-mesh sieve for later use. Pass metformin and hydroxypropyl cellulose through a 60-mesh sieve 10 times, mix evenly, add an appropriate amount of ethanol to prepare the soft material, and then use a 30-mesh sieve to granulate. The prepared granules were dried in an oven at 60°C. Pass the dried granules through a 36-mesh sieve for granulation. Mix the sized granules with the prescribed amount of vildagliptin and magnesium stearate for 15 minutes, and mix well. According to the prescription quantity, the mixed material was weighed, and a special-shaped punch of 20mm×10mm was used for tableting, keeping the hardness of the short diameter at 150N.

[0083]

Embodiment 2

[0084] Example 2 dry granulation

[0085] Table 2 Example 2 prescription summary

[0086]

[0087] * Removed during processing.

[0088] Specific process: Grind metformin needle crystals and pass through a 100-mesh sieve for later use; pass hydroxypropyl cellulose through a 60-mesh sieve for later use. The magnesium stearate of metformin, hydroxypropyl cellulose, and 50% prescription amount is passed through a 60-mesh sieve 10 times, and mixed uniformly. The mixed materials are punched into special-shaped tablets of 20 mm × 10 mm, and then the compressed tablets are crushed to a certain particle size with a mortar. Pass the pulverized particles through a 30-mesh sieve to ensure that the particle size of the dry granulation does not exceed 560 μm (30-mesh sieve). Mix the sized granules with the prescribed amount of vildagliptin and magnesium stearate for 15 minutes, and mix well. According to the prescription quantity, the mixed material was weighed, and a special-shap...

Embodiment 3

[0091] Table 3 Example 3 prescription summary

[0092]

[0093] * Removed during processing.

[0094] Specific process: Dissolve the prescribed amount of metformin and hydroxypropyl cellulose in 90% ethanol solution, and remove the solvent by rotating the solution at 60°C and 40 rpm. The resulting solid was scraped off and dried at 60°C. The dried material is crushed to a certain particle size with a mortar. Pass the pulverized particles through a 30-mesh sieve to ensure that the particle size does not exceed 560 μm (30-mesh sieve). Mix the sized granules with the prescribed amount of vildagliptin and magnesium stearate for 15 minutes, and mix well. According to the prescription quantity, the mixed material was weighed, and a special-shaped punch of 20mm×10mm was used for tableting, keeping the hardness of the short diameter at 150N.

[0095]

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Abstract

The invention belongs to the field of pharmaceutical preparations, and provides a compound tablet composition of vildagliptin and melbine and a preparation method thereof. The composition comprises an adhesive which accounts for 20-30% of the composition based on dry weight and has apparent viscosity of 2-4 mpas in 1% water solution. According to the provided composition, the compressibility of the melbine is improved and the compressibility of the vildagliptin is improved at the same time, the compressibility and the mobility of the powder are good, the between-run content difference of the prepared compound tablets is small, the tablets are qualified in friability and rapid in digestion, and the technological feasibility is high.

Description

[0001] technical field [0002] The invention belongs to the field of pharmaceutical preparations, in particular to a compound tablet composition containing vildagliptin and metformin and a preparation method thereof. [0003] Background technique [0004] Diabetes has become the third major disease that seriously endangers human health after cardiovascular and cerebrovascular diseases and malignant tumors. According to pathological characteristics, diabetes can be divided into type Ⅰ diabetes and type Ⅱ diabetes. Type Ⅱ diabetes is non-insulin-dependent diabetes, which seriously threatens human health. Type 2 diabetes is characterized by insulin resistance, manifested by progressive failure of pancreatic β-cells, resulting in insufficient insulin secretion after a glucose load and impaired incretin response to glucose. Chronic hyperglycemia will lead to serious microvascular and macrovascular complications. Effective glycemic control can significantly reduce the morbidi...

Claims

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Application Information

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IPC IPC(8): A61K31/40A61K9/20A61P3/10A61K31/155
Inventor 陈庆财赵俊赵小伟黄海琴金雪锋
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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