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Pharmaceutical composition containing vildagliptin and metformin and preparation method of pharmaceutical composition

A composition and drug technology, applied in the field of pharmaceutical preparations, can solve the problems of unfavorable scale-up production, complicated process, expensive price, etc., and achieve the effects of easy operation, simple process and stable product quality

Active Publication Date: 2017-01-04
QILU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation process of this formulation requires a special production equipment, a hot-melt extruder, which is expensive, high in cost, complex in process, low in efficiency, and low in yield, which is not conducive to large-scale production

Method used

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  • Pharmaceutical composition containing vildagliptin and metformin and preparation method of pharmaceutical composition
  • Pharmaceutical composition containing vildagliptin and metformin and preparation method of pharmaceutical composition
  • Pharmaceutical composition containing vildagliptin and metformin and preparation method of pharmaceutical composition

Examples

Experimental program
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Effect test

preparation example Construction

[0032] In the preparation method of the embodiment, the name, model and purchaser of the main instrument need to be used, as shown in the following table:

[0033] device name model Manufacturer Granulating Coating Machine DP-II Chongqing Jinggong Pharmaceutical Machinery Co., Ltd. Down drive crushing and granulating machine U5 Canada QUADRO Machinery Company Hopper mixer JGSD-15 Chongqing Jinggong Pharmaceutical Machinery Co., Ltd. Laboratory dry press granulator LGY-120 Beijing Sinopharm Longli Automation Technology Co., Ltd. Rotary Tablet Press ZP8S Shanghai Tianxiang Jiantai Pharmaceutical Machinery Co., Ltd. Coating machine Labcoat M O'HARA Technologies Inc

Embodiment 1

[0034] Embodiment 1: Metformin Vildagliptin Tablet Oral Preparation Prescription and Process

[0035] prescription:

[0036]

[0037] Note: * will be removed during processing.

[0038] Preparation Process:

[0039] (1) Preparation of metformin hydrochloride granules:

[0040] Preparation of binder aqueous solution: prepare a certain concentration of binder and stir until the solution is clear;

[0041] Fluidized bed granulation: put the material metformin hydrochloride in the fluidized bed, set the inlet air temperature at 50°C, start spraying the binder solution when the material temperature reaches 35-45°C, and then dry the obtained granules in the fluidized bed , control particle moisture below 2.0%;

[0042] Dry granulation: Use a 1.0mm sieve for granulation.

[0043] (2) Non-lubricating mixing: add about 1 / 2 metformin hydrochloride granules, vildagliptin, lactose and the remaining 1 / 2 metformin hydrochloride granules to the hopper mixer in sequence, set the param...

Embodiment 2

[0048] Example 2: Metformin Vildagliptin Tablet Oral Preparation Prescription and Process

[0049] prescription:

[0050]

[0051] Note: * will be removed during processing.

[0052] Preparation Process:

[0053] (1) Preparation of metformin hydrochloride granules:

[0054] Preparation of binder aqueous solution: prepare a certain concentration of binder and stir until the solution is clear;

[0055] Fluidized bed granulation: put the material metformin hydrochloride in the fluidized bed, set the inlet air temperature at 50°C, start spraying the binder solution when the material temperature reaches 35-45°C, and then dry the obtained granules in the fluidized bed , control particle moisture below 2.0%;

[0056] Grain sizing: Use a 1.0mm sieve for sizing.

[0057] (2) Non-lubricating mixing: add about 1 / 2 metformin hydrochloride granules, vildagliptin, lactose and the remaining 1 / 2 metformin hydrochloride granules into the hopper mixer in sequence, set the parameters at 15...

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Abstract

The invention provides a pharmaceutical composition containing vildagliptin and metformin. In the pharmaceutical composition, vildagliptin is good in content uniformity, high in dissolution rate and stable in product. A preparation method of the pharmaceutical composition comprises the steps that metformin hydrochloride and an adhesive are prepared into granules through a fluidized bed granulation technology; the granules, vildagliptin and a filler are mixed to be uniform, and then dry granulation is conducted; the mixture is mixed with a lubricant, and tablets are prepared. By means of the fluidized bed granulation technology, the fluidity and compressibility of metformin hydrochloride are greatly improved, the granularity of vildagliptin is controlled to be within a certain range, direction contact of metformin hydrochloride and vildagliptin is reduced, and degradation of vildagliptin is reduced; by means of dry granulation, the content uniformity, a tablet weight difference and the like of the granules all meet the requirements. By means of the preparation process, compound preparations with small differences between batches can be obtained, the friability, content uniformity and stability of the tablets all meet the requirements, and the pharmaceutical composition can be subjected to scale-up production in a workshop.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a compound tablet composition containing vildagliptin and metformin, and a preparation method of the composition. Background technique [0002] Diabetes has become the third major disease that seriously endangers human health after cardiovascular and cerebrovascular diseases and malignant tumors. According to pathological characteristics, diabetes is divided into type I diabetes and type II diabetes, and about 90% to 95% of diabetic patients belong to type II diabetes. [0003] Vildagliptin, its chemical name is: (2S)-1-[2-(3-hydroxy-adamantyl-1-amino)-acetyl]-pyrrolidine-2-carbonitrile. Molecular formula is C 17 h 15 N 3 o 2 , the relative molecular mass is 303.4, and the structural formula is as follows: [0004] [0005] Vildagliptin is a dipeptidyl peptidase IV (DPP-IV) inhibitor, also known as an incretin enhancer, which reduces the activity of...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/40A61K9/20A61P3/10A61K31/155
CPCA61K9/2054A61K9/2095A61K31/155A61K31/40A61K2300/00
Inventor 于艳玲何平董倩张明会
Owner QILU PHARMA CO LTD
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