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Pharmaceutical composition of linagliptin and salt, ester and derivative thereof as well as preparation method of pharmaceutical composition

A technology of composition and derivatives, which is applied in the direction of drug combination, pharmaceutical formula, and active ingredients of heterocyclic compounds, etc., can solve the problems of cumbersome process and uncertain amount of adhesive, and solve the problem of cumbersome process and adhesive The effect of adding indefinite amount

Active Publication Date: 2017-09-19
SICHUAN KELUN PHARMA RES INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Aiming at the defects existing in the prior art, the present invention avoids the use of pregelatinized starch and copolyvinylpyrrolidone, and at the same time solves the problems of the original granulation method such as cumbersome procedures and uncertain amount of binder added.

Method used

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  • Pharmaceutical composition of linagliptin and salt, ester and derivative thereof as well as preparation method of pharmaceutical composition
  • Pharmaceutical composition of linagliptin and salt, ester and derivative thereof as well as preparation method of pharmaceutical composition
  • Pharmaceutical composition of linagliptin and salt, ester and derivative thereof as well as preparation method of pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0092] Embodiment 1 Preparation of the pharmaceutical composition of the present invention

[0093]

[0094] [Preparation Process]

[0095] a, mixing linagliptin, mannitol, and hydroxypropyl cellulose to prepare a premix;

[0096] B, adding magnesium stearate to the above mixed powder for final mixing;

[0097] c, compressing the final mixture into tablet cores;

[0098] d, prepare coating suspension;

[0099] e. Coat the tablet core with the coating suspension to a weight gain of about 2-4% to produce a film-coated tablet.

Embodiment 2

[0100] Embodiment 2 Preparation of the pharmaceutical composition of the present invention

[0101]

[0102] [Preparation Process]

[0103] a, mixing linagliptin, mannitol, hydroxypropyl methylcellulose and starch to prepare a premix;

[0104] b. Wetting the premix prepared in step a by adding a wetting agent, and granulating;

[0105] c, sieving: sieve the granules prepared in step b through a 20-mesh sieve, and dry the granules below about 60°C until the required weight loss on drying reaches the range of 0.5-2%. Sieve through a 20-mesh sieve;

[0106] d, adding magnesium stearate to the granules for final mixing;

[0107] e, compressing the final mixture into tablet cores;

[0108] f. Prepare a coating suspension and coat the tablet core with the coating suspension to a weight gain of about 2-4% to produce a film-coated tablet.

Embodiment 3

[0109] Embodiment 3 Preparation of the pharmaceutical composition of the present invention

[0110]

[0111] [Preparation Process]

[0112] a, mixing linagliptin, mannitol, hydroxypropyl methylcellulose and starch to prepare a premix;

[0113] b. Wetting the premix prepared in step a by adding a wetting agent, and granulating;

[0114] c, sieving: sieve the granules prepared in step b through a 20-mesh sieve, and dry the granules below about 60°C until the required weight loss on drying reaches the range of 0.5-2%. Sieve through a 20-mesh sieve;

[0115] d, adding magnesium stearate to the granules for final mixing;

[0116] e, compressing the final mixture into tablet cores;

[0117] f. Prepare a coating suspension and coat the tablet core with the coating suspension to a weight gain of about 2-4% to produce a film-coated tablet.

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PUM

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Abstract

The invention relates to a linagliptin pharmaceutical composition. The linagliptin pharmaceutical composition is prepared from linagliptin or a salt, an ester and a derivative thereof, a diluting agent, an adhesive, a disintegrating agent and a lubricant, wherein the diluting agent contains one diluting agent so that the cost of auxiliary materials is remarkably reduced. The invention further provides a preparation process of the linagliptin pharmaceutical composition; a traditional preparation procedure is simplified and the production efficiency is improved.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing linagliptin and its salts, esters and derivatives and a preparation method thereof, belonging to the field of medicines. Background technique [0002] Incretin (GLP-1) is considered to be one of the promising new drugs for the treatment of diabetes because of its multiple functions such as promoting β-cell differentiation and inhibiting gastric emptying. Peptidase 4) can rapidly inactivate GLP-1, so its application is limited. In recent years, studies have found that DPP Ⅳ inhibitors can successfully inhibit the activity of DPP Ⅳ, promote β-cell regeneration, and inhibit β-cell apoptosis. Therefore, DPP Ⅳ has become a new target for the treatment of type Ⅱ diabetes, and DPP Ⅳ inhibitors have become a new target for the treatment of diabetes. of new drugs. [0003] Linagliptin is a selective DPP IV inhibitor developed by Boehringer Ingelheim. Compared with other DPP IV inhibitors on the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K47/38A61K47/36A61K47/26A61K31/522A61P3/10
CPCA61K9/2018A61K9/2054A61K9/2059A61K9/28A61K31/522
Inventor 沈利梁力吴媛赵栋王利春王晶翼
Owner SICHUAN KELUN PHARMA RES INST CO LTD
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