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Novel capsule filled with alogliptin solid preparation and pioglitazone solid preparation

A technology of alogliptin and pioglitazone, which is applied in the field of oral hard capsules, can solve the problems of reducing effects, affecting qualitative and quantitative analysis results, increasing side effects, etc., and achieves the effects of improved stability, easy inspection and quality control, and enhanced compliance

Inactive Publication Date: 2013-10-23
HEILONGJIANG FUHE HUAXING PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If the active ingredients are in contact with each other, there are the following disadvantages: 1. Due to the influence of multi-component mixing uniformity, it is difficult to quantify each component accurately; 2. During product testing, it is difficult to determine the content of each component due to mutual interference, which affects the qualitative and quantitative analysis results; 3. . During long-term storage, due to possible chemical compatibility changes among the components, by-products are likely to be produced, reducing the effect or increasing side effects, and the product stability is not ideal.
Due to the existence of the above defects, although there are many advantages in the existing compound dosage form containing alogliptin, it may still cause adverse effects on product quality and human health

Method used

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  • Novel capsule filled with alogliptin solid preparation and pioglitazone solid preparation
  • Novel capsule filled with alogliptin solid preparation and pioglitazone solid preparation
  • Novel capsule filled with alogliptin solid preparation and pioglitazone solid preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Embodiment 1: see attached Figure 1-3 As shown, a tablet capsule filled with one pioglitazone tablet; one alogliptin tablet. The capsule specification is size 0. The capsule shell is composed of a lower capsule body 1 and an upper capsule body 2 set, which are equipped with the above two cylindrical tablets coated with different colors, namely alogliptin tablets (25mg alogliptin), pioglitazone tablets (containing pioglitazone 15mg ).

[0019] Pioglitazone tablets are yellow gastric-soluble film-coated, and alogliptin tablets are red film-coated. The capsules come in a transparent pp bottle packaging.

Embodiment 2

[0020] Example 2: The only difference from Example 1 is the dose, in which alogliptin tablets (alogliptin 12.5 mg) and pioglitazone tablets (containing pioglitazone 7.5 mg) are included.

[0021] The following will be explained in conjunction with the test example:

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Abstract

The invention relates to an oral-taking hard capsule, and in particular relates to a tablet capsule filled with an alogliptin tablet and a pioglitazone tablet. The tablet capsule comprises a capsule and tablets in the capsule, wherein the capsule contains an upper capsule body and a lower capsule body; at least one tablet taking alogliptin as an active component and at least one tablet taking pioglitazone as an active component are filled in the capsule. As the active components in the capsule are not in contact with each other, chemical compatibility among various components does not occur and a byproduct is not produced, so that the stability of the product is improved, especially a degradation product produced through the contact of alogliptin and pioglitazone is reduced, and related substances of the tablet capsule conform to the safety range of a human body.

Description

technical field [0001] The invention relates to an oral hard capsule, in particular to a tablet capsule filled with alogliptin tablets and pioglitazone tablets. Background technique [0002] Alogliptin pioglitazone tablets, English name: NESINA and ACTOS Tablets (LIOVEL), is a drug developed by Takeda for the treatment of diabetes. CN200880010374.4 discloses a multi-layer tablet of the above-mentioned compound preparation. In the prior art, the two active ingredients of alogliptin and pioglitazone exist in the same minimum preparation unit, and there is a possibility of contacting the two in vitro. If the active ingredients are in contact with each other, there are the following disadvantages: 1. Due to the influence of multi-component mixing uniformity, it is difficult to quantify each component accurately; 2. During product testing, it is difficult to determine the content of each component due to mutual interference, which affects the qualitative and quantitative analysi...

Claims

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Application Information

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IPC IPC(8): A61K31/513A61K31/4439A61K9/48A61P3/10
Inventor 吴光彦
Owner HEILONGJIANG FUHE HUAXING PHARMA GROUP
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