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Saxagliptin medicinal preparation

A technology of pharmaceutical preparations and fillers, which is applied in the field of saxagliptin pharmaceutical preparations, can solve the problems of uniform dispersion, difficulty in controlling content uniformity, and inability to accurately control content uniformity, so as to reduce degradation, reduce types of excipients, and ensure drug effective effect

Active Publication Date: 2016-04-20
BEIJING WINSUNNY PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The existing specifications of saxagliptin are 5 mg and 2.5 mg. Due to the small amount of active ingredients, it is difficult to evenly disperse it in a large number of excipients, and it is impossible to accurately control the content uniformity. The saxagliptin pharmaceutical preparation developed by the present invention solves the problem of It is difficult to control the content uniformity of small-scale pharmaceutical preparations

Method used

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  • Saxagliptin medicinal preparation
  • Saxagliptin medicinal preparation
  • Saxagliptin medicinal preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036]

[0037] Preparation:

[0038] (1) Mix microcrystalline cellulose and calcium hydrogen phosphate, add hydrochloric acid solution to granulate, dry, granulate, the measured particle size is 0.60mm; the particle pH is 4.2;

[0039] (2) Mix the above granules with magnesium stearate, micronized silica gel and saxagliptin evenly;

[0040] (3) Press into tablets, and coat with Opadry II.

Embodiment 2

[0042]

[0043] Preparation:

[0044] (1) Mix starch and calcium carbonate, add succinic acid solution to granulate, dry, granulate, the measured particle size is 0.64mm; the pH of the granules is 5.3;

[0045] (2) Mix the above granules with micronized silica gel and saxagliptin evenly;

[0046] (3) Press into tablets, and coat with Opadry II.

Embodiment 3

[0048]

[0049] Preparation:

[0050] (1) Mix microcrystalline cellulose and sucrose, add fumaric acid solution to granulate, dry, granulate, the measured particle size is 0.4mm; the particle pH is 4.8;

[0051] (2) Mix the above granules with magnesium stearate, talcum powder and saxagliptin evenly;

[0052] (3) Press into tablets, and coat with Opadry II.

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Abstract

The invention discloses a novel saxagliptin medicinal preparation. The novel saxagliptin medicinal preparation comprises saxagliptin, acidic granules and lubricants. The acidic granules are made of fillers and acid. The novel saxagliptin medicinal preparation has the advantages that the shortcoming of instable properties of the saxagliptin can be effectively overcome by the aid of the novel saxagliptin medicinal preparation, degradation of the saxagliptin which is an active constituent can be reduced, and accordingly curative effects can be guaranteed.

Description

technical field [0001] The invention relates to a pharmaceutical preparation of a dipeptidyl peptidase-4 (DPP-4) inhibitor, in particular to a pharmaceutical preparation of saxagliptin. Background technique [0002] Saxagliptin is a hypoglycemic drug jointly developed by Bristol-Myers Squibb and AstraZeneca. Saxagliptin is a highly effective dipeptidyl peptidase-4 (DPP-4) inhibitor that selectively inhibits DPP-4 can increase the levels of endogenous glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), thereby regulating blood sugar. Saxagliptin can effectively reduce glycosylated hemoglobin and postprandial blood sugar without affecting body weight, and has no obvious risk of hypoglycemia. It can be used as a monotherapy or in combination with metformin, sulfonylureas, and thiazolidinediones. The chemical name of saxagliptin is (1S,3S,5S)-2-[(2S)-2-amino-2-(3-hydroxy-l-adamantyl)-l-carbonylethyl]-2- Azabicyclo[3.1.0]hexane-3-carbonitrile...

Claims

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Application Information

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IPC IPC(8): A61K31/403A61K47/04A61K47/38A61P3/10
Inventor 产运霞黄玉锋张英杰彭小玲王帅耿玉先白小玉侯艳艳
Owner BEIJING WINSUNNY PHARMA CO LTD
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