Preparation method of alogliptin benzoate tablet high in bioavailability

A technology of alogliptin tablets and benzoic acid, which is applied in the field of preparation of alogliptin benzoate tablets, can solve the problems of affecting human absorption, slow disintegration, and lowering the level of hemoglobin Alc, so as to speed up the disintegration speed and speed up Absorption, bioavailability enhancement effect

Inactive Publication Date: 2017-07-04

CISEN PHARMA

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AI-Extracted Technical Summary

Problems solved by technology

The efficacy of alogliptin combined with sulfonylureas, metformin, thiazolidinediones and insulin and other current clinical standard hypoglycemic drugs shows that this product can significantly reduce the level of hemoglobin Alc, and all of them ...

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Abstract

The invention belongs to the technical field of drug preparation, and more specifically relates to a preparation method of alogliptin benzoate tablet high in bioavailability. The preparation method comprises following steps: alogliptin benzoate raw material is subjected to micronization treatment; prescription dosages of alogliptin benzoate, a filling material, and a disintegrating agent are weighed, and are uniformly mixed, a prescription dosage of an adhesive solution is added so as to obtain a soft material, the soft material is sieved using a sieve of 20 meshes, and is subjected to drying and size stabilization, and a prescription dosage of a lubricant is added for uniform mixing so as to obtain mixed particles; the mixed particles are subjected to tabletting using a tablet machine; and coating is carried out so as to obtain finished products. Compared with the prior art, the preparation method comprises following advantages: raw material micronization is adopted so as to increase disintegrating speed; and the particle size is reduced, so that absorption by human body is accelerated, and the bioavailability of alogliptin benzoate is increased.

Application Domain

Organic active ingredientsMetabolism disorder +3

Technology Topic

Drugs preparationsSieve +10

Image

Examples

Experimental program(4)
Effect test(1)

Example Embodiment

[0025] Example 1

[0026] Alogliptin Benzoate Tablets (Specification: 12.5mg (calculated as alogliptin), 10,000 tablets in total)

[0027]

[0028] Preparation method:

[0029] (1) Weigh the raw material of alogliptin benzoate through micronization and pass through a 120 mesh sieve, mannitol, microcrystalline cellulose, hypromellose, cross-linked carmellose sodium pass through a 80 mesh sieve, stearin Magnesium acid is passed through a 40-mesh sieve for subsequent use.

[0030] (2) Take alogliptin benzoate, mannitol, microcrystalline cellulose, and croscarmellose sodium in the prescribed amount by weighing and mix them evenly, then add the adhesive soft material in the prescribed amount, and pass through a 20-mesh sieve. grain. The prepared wet granules are air-dried at 50-60°C.

[0031] (3) The dry granules are passed through an 18-mesh sieve for granulation, and the prescription amount of magnesium stearate is added and mixed evenly to obtain mixed granules.

[0032] (4) Determining the content of alogliptin benzoate in the granules, and determining the tablet weight according to the content. The mixed granules are placed on a tablet machine and compressed into tablets.

[0033] (5) Coating: 10% Opadry coating solution Configuration: Weigh the prescribed amount of Opadry coating powder and slowly add it into the stirring purified water, mix well, continue stirring for 45 minutes, and set aside. Put the tablet cores in the coating pot, adjust the rotating speed of the coating pot to about 6-8r/min, the atomization pressure to 400kpa, and control the tablet bed temperature at 40-45°C. The weight gain of the coating is about 2.0% to 3.0%. After the surface is dry, control the temperature of the tablet bed at 35 to 40°C and stop after 10 minutes. 10000 pieces can be made

Example Embodiment

[0034] Example 2

[0035] Alogliptin Benzoate Tablets (Specification: 12.5mg (calculated as alogliptin), 10,000 tablets in total)

[0036]

[0037] The preparation method is the same as in Example 1, and 10,000 alogliptin benzoate tablets can be obtained.

Example Embodiment

[0038] Example 3

[0039] Alogliptin Benzoate Tablets (Specification: 12.5mg (calculated as alogliptin), 10,000 tablets in total)

[0040]

[0041] The croscarmellose sodium was premixed with the new glucoside P1, and the other preparation methods were the same as in Example 1, and 10,000 alogliptin benzoate tablets could be prepared.

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PUM

Property	Measurement	Unit
Particle size	110.0 ~ 120.0	µm
tensile		MPa
Particle size		Pa
strength	10

Description & Claims & Application Information

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Classification and recommendation of technical efficacy words

Fast disintegration
Promote absorption

Traditional Chinese medicine preparation for treating dizziness, palpitation, insomnia and forgetfulness and preparation method of traditional Chinese medicine preparation

InactiveCN107320564AFast disintegrationImprove curative effectNervous disorderDigestive systemHydroxypropylmethyl celluloseGlucan

Owner:广西大海阳光药业有限公司

Preparation method of alogliptin benzoate tablet high in bioavailability

AI-Extracted Technical Summary

Problems solved by technology

Abstract

Image

Examples

Example Embodiment

Example Embodiment

Example Embodiment

PUM

Description & Claims & Application Information

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