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Composition containing alogliptin and pioglitazone

A pioglitazone and chip-coated technology, which is applied in the field of chip-coated tablets containing alogliptin and pioglitazone, can solve the problems of high specificity of the drug-containing coating layer, failure to achieve blood sugar control, increase production costs, etc., and achieve inspection and quality control Easy, reduce the risk of by-product formation, the effect of safety assurance

Active Publication Date: 2015-11-11
杭州成邦医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The main features of type 2 diabetes are insulin resistance and pancreatic β-cell dysfunction. Therefore, any of the above drugs alone cannot achieve ideal blood sugar control
Analysis of its examples shows that the proportion of the drug-containing coating layer is very large, which is difficult to achieve in the production process, and the uneven coating will also cause problems such as drug flushing; Risk of impurities from active ingredient exposure
[0006] Patent CN201220120673.7 discloses the tablet capsule of the above-mentioned compound preparation, but the process is cumbersome, the energy consumption is large, and the production cost is increased

Method used

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  • Composition containing alogliptin and pioglitazone
  • Composition containing alogliptin and pioglitazone
  • Composition containing alogliptin and pioglitazone

Examples

Experimental program
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Effect test

preparation example Construction

[0029] The preparation method of the core-coated tablet of alogliptin and pioglitazone of the present invention comprises the following steps:

[0030] 1) Preparation of the chip: mix alogliptin (or pioglitazone) and auxiliary materials uniformly, press into tablets or make granules by conventional granulation means, and then press into tablets;

[0031] 2) Chip coating: the coating components can be applied to the chip by conventional coating techniques; such as using a film coating device and the like.

[0032] 3) Preparation of coated chips: mix pioglitazone (or alogliptin) with auxiliary materials uniformly or prepare granules by conventional granulation means, and then pressurize and wrap the prepared alogliptin in a core-coating tablet press. (or pioglitazone) coated chips.

[0033] The core-coated tablet of alogliptin and pioglitazone provided by the invention has rapid dissolution in vitro, and the dissolution rate of each active component does not interfere with each...

Embodiment 1-4

[0035] Table 1 embodiment 1-4 prepares the package chip of alogliptin and pioglitazone

[0036]

[0037]

[0038] According to the formula in Table 1, mix alogliptin with microcrystalline cellulose, cross-linked polyvinylpyrrolidone, 1 / 2 prescription amount of hydroxypropyl methylcellulose and silicon dioxide, dry granulate, and then add 1 / 2 prescription amount of hypromellose and magnesium stearate, mix well, and compress into tablets. The coating solution prepared according to the prescription is coated on the prepared alogliptin chip. According to the prescription, mix pioglitazone with starch, 1 / 2 prescription amount of sodium carboxymethyl starch, povidone and silicon dioxide, and then add 1 / 2 prescription amount of carboxymethyl starch sodium and stearic acid after dry granulation Magnesium, mixed evenly, and coated on the alogliptin coated chip by using a core-coated tablet press to obtain the coated chip of alogliptin and pioglitazone.

Embodiment 5-8

[0039] Table 2 embodiment 5-8 prepares the package chip of pioglitazone and alogliptin

[0040]

[0041]

[0042] According to the formula in Table 2, mix pioglitazone with starch, povidone, 1 / 2 prescription amount of sodium carboxymethyl starch and silicon dioxide, dry granulate, and then add 1 / 2 prescription amount of carboxymethyl starch Sodium and magnesium stearate, blended, compressed into tablets. The coating solution prepared according to the prescription is coated on the prepared pioglitazone chip. According to the prescription, mix alogliptin with microcrystalline cellulose, 1 / 2 prescription amount of hydroxypropyl methylcellulose, cross-linked polyvinylpyrrolidone and silicon dioxide, and then add 1 / 2 prescription amount Hypromellose and magnesium stearate are mixed evenly, and coated on the coated chips of pioglitazone by using a core-coated tablet press to obtain the coated chips of pioglitazone and alogliptin.

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Abstract

The invention provides a composition containing alogliptin and pioglitazone. The composition comprises 13-33wt% of tablet core, 0.4-10wt% of isolation coating layer and 60-85wt% of outer layer, wherein when the tablet core contains alogliptin, the outer layer contains pioglitazone; when the tablet core contains pioglitazone, the outer layer contains alogliptin; alogliptin accounts for 2.5-10wt% of the total tablet and pioglitazone accounts for 3-16wt% of the total tablet. The composition has the advantages of simple and reliable production process, low loss, good product stability and few by-products, so that the composition is beneficial to large-scale industrial production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a core-coated tablet containing alogliptin and pioglitazone. Background technique [0002] Alogliptin is a DPP-4 (dipeptidyl peptidase-4) inhibitor, which can promote postprandial insulin secretion and inhibit glucagon secretion, and is suitable for the treatment of type 2 diabetes. [0003] Pioglitazone is a thiazolidinedione hypoglycemic agent and an insulin activator for patients with type 2 diabetes. [0004] The main features of type 2 diabetes are insulin resistance and pancreatic β-cell dysfunction. Therefore, any one of the above drugs alone cannot achieve ideal blood sugar control. The effect of combining the two drugs is better, but there is a problem of poor stability. [0005] The compound tablet of alogliptin and pioglitazone (trade name: Oseni) was developed and launched in 2011 by Japan's Takeda Pharmaceutical Co., Ltd. Its patent information is disclo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/32A61K9/36A61K31/513A61K31/4439A61P3/10
Inventor 戈震
Owner 杭州成邦医药科技有限公司
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