DDP-4 inhibitor drug orally disintegrating tablets and preparing method

A technology of DDP-4 and inhibitors, which is applied in drug combination, drug delivery, and pharmaceutical formulation, etc. It can solve problems such as uneven drug content and increased impurities in tablets, and achieve good taste, good uniformity, and smooth surface shape.

Inactive Publication Date: 2017-07-04
JIANGSU WANBANG BIOPHARMLS +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Aiming at the problem that the migration of soluble drug components among the wet granules of alogliptin orally disintegrating tablets leads to uneven drug content and the increase of impurities in the tablets during the acceleration process, an optimized DDP-4 inhibition method is disclosed. (Alogliptin) drug orally disintegrating tablet and preparation method thereof

Method used

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  • DDP-4 inhibitor drug orally disintegrating tablets and preparing method
  • DDP-4 inhibitor drug orally disintegrating tablets and preparing method
  • DDP-4 inhibitor drug orally disintegrating tablets and preparing method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Alogliptin Benzoate 34g

[0034] Lactose 48.5g

[0035] 30g pregelatinized starch

[0036] Microcrystalline Cellulose 18g

[0037] L-Hydroxypropylcellulose 15g

[0038] Cyclamate 1.5g

[0039] Magnesium Stearate 1.5g

[0040] Micronized silica gel 1.5 g

[0041] Makes 1000 pieces

[0042] Preparation process: mix the prescription amount of lactose, pregelatinized starch, microcrystalline cellulose, L-hydroxypropyl cellulose, cyclamate and micropowder silica gel in equal increments, and then add the prescription amount of agrelide benzoate Alogliptin and the above-mentioned mixed powder are mixed uniformly in equal increments, and finally the prescribed amount of magnesium stearate is added and mixed uniformly, the weight and hardness of the tablet are determined, and the tablets are directly compressed to obtain alogliptin orally disintegrating tablets.

[0043] Appearance: The orally disintegrating tablets of alogliptin prepared by this method are off-white with...

Embodiment 2

[0049] Alogliptin Benzoate 17g

[0050] Lactose 65.5g

[0051] 30g pregelatinized starch

[0052] Microcrystalline Cellulose 18g

[0053] L-Hydroxypropylcellulose 15g

[0054] Cyclamate 1.5g

[0055] Magnesium Stearate 1.5g

[0056] Micronized silica gel 1.5 g

[0057] Makes 1000 pieces

[0058] Preparation process: mix the prescription amount of lactose, pregelatinized starch, microcrystalline cellulose, L-hydroxypropyl cellulose, cyclamate and micropowder silica gel in equal increments, and then add the prescription amount of agrelide benzoate Alogliptin and the above-mentioned mixed powder are mixed uniformly in equal increments, and finally the prescribed amount of magnesium stearate is added and mixed uniformly, the weight and hardness of the tablet are determined, and the tablets are directly compressed to obtain alogliptin orally disintegrating tablets.

[0059] Appearance: The orally disintegrating tablets of alogliptin prepared by this method are off-white with...

Embodiment 3

[0065] Alogliptin Benzoate 8.5g

[0066] Lactose 74g

[0067] 30g pregelatinized starch

[0068] Microcrystalline Cellulose 18g

[0069] L-Hydroxypropylcellulose 15g

[0070] Cyclamate 1.5g

[0071] Magnesium Stearate 1.5g

[0072] Micronized silica gel 1.5 g

[0073] Makes 1000 pieces

[0074] Preparation process: mix the prescription amount of lactose, pregelatinized starch, microcrystalline cellulose, L-hydroxypropyl cellulose, cyclamate and micropowder silica gel in equal increments, and then add the prescription amount of agrelide benzoate Alogliptin and the above-mentioned mixed powder are mixed uniformly in equal increments, and finally the prescribed amount of magnesium stearate is added and mixed uniformly, the weight and hardness of the tablet are determined, and the tablets are directly compressed to obtain alogliptin orally disintegrating tablets.

[0075] Appearance: The orally disintegrating tablets of alogliptin prepared by this method are off-white with ...

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Abstract

The invention relates to DDP-4 inhibitor drug orally disintegrating tablets and a preparing method. The DDP-4 inhibitor drug orally disintegrating tablets comprise a DDP-4 inhibitor and pharmaceutic adjuvants. The pharmaceutic adjuvants include a diluent, a disintegrant, a corrigent, a lubricant and a glidant, but do not include a binder. By the adoption of the technical scheme, the problems of drugs like Alogliptin prepared through wet granulation that drug content is not uniform and more impurities are generated during long-term storage due to migration of soluble medicine composition particles during drying of wet particles are effectively solved, and an idea is provided for drugs with similar properties.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparation research, and in particular relates to orally disintegrating tablets of DDP-4 inhibitors and a preparation method thereof. Background technique [0002] Diabetes is an endocrine and metabolic disease characterized by elevated blood sugar. It is a chronic disease that plagues the world. At present, there are about 230 million patients in the world. It is estimated that the number of diabetic patients will increase to 300 million by 2025. Type Ⅱ Diabetes usually occurs after the age of 35 to 40, accounting for more than 90% of diabetic patients. With the improvement of living standards, the incidence rate among children also has a rising trend in recent years. Type Ⅱ diabetes has become a common frequently-occurring disease after tumors and cardiovascular and cerebrovascular diseases, and its drug market is expanding year by year. [0003] DPP-4 is a transmembrane protein molecule widely p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/513A61K47/38A61K47/36A61P3/10
CPCA61K9/0056A61K9/2054A61K9/2059A61K31/513
Inventor 胡小艳乔德水高雪芹
Owner JIANGSU WANBANG BIOPHARMLS
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