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Preparation method of glipizide osmotic pump controlled release tablet

A glipizide tablet and osmotic pump controlled-release technology, which is applied in the field of preparation of glipizide osmotic pump controlled-release tablets, can solve the problems of difficult drying, large amount of excipients, and long time consumption, and achieve easy-to-accept therapeutic effects, The effect of improving the dissolution rate and simple process

Active Publication Date: 2011-07-27
SHANDONG XINHUA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation method provided by the CN 01128292.4 patent is to adopt the primary osmotic pump technology to prepare a single-layer osmotic pump preparation. The advantage of this method is that although it does not need to use a double-layer tablet press, the disadvantage is that the weight of the prepared tablets is relatively large (about 700 mg per tablet) ), the amount of excipients is large, the cost is high, and it is difficult for patients to take
At the same time, the process of preparing cyclodextrin inclusion compound is complex, time-consuming and difficult to dry
[0008] Although the process of CN 200610114125.2 has been improved, it is still relatively complicated, and the process of CN 01128292.4 has been greatly improved, but the prepared tablets are too large, the cost is high, and it is difficult for patients to accept

Method used

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  • Preparation method of glipizide osmotic pump controlled release tablet
  • Preparation method of glipizide osmotic pump controlled release tablet
  • Preparation method of glipizide osmotic pump controlled release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] A preparation method of glipizide osmotic pump controlled-release tablet:

[0041] A: Preparation of solid dispersion

[0042] prescription:

[0043]

[0044] Get acetone (China Petroleum and Chemical Corporation, the same below) and put it in a container, add povidone K30 (US ISP company, the same below) and sodium lauryl sulfate (Germany Congis company, the same below) to make it dissolve or Evenly disperse, heat the acetone solution at 35°C, add glipizide (Weihai Diso Pharmaceutical Co., Ltd., the same below) while stirring, keep stirring to make it disperse evenly, dry, make the loss on drying within 2%, and pass 24 Mesh sieve.

[0045] B: Preparation of tablet core

[0046] prescription:

[0047]

[0048] Get glipizide solid dispersion, meglumine (Shanghai Pharmaceutical Group Co., Ltd., the same below), povidone K30, hypromellose E50 (U.S. Dow company, the same below), sodium chloride (Tianjin Haiguang Pharmaceutical Co., Ltd. Industry Co., Ltd., the sa...

Embodiment 2

[0057] A preparation method of glipizide osmotic pump controlled-release tablet:

[0058] A: Preparation of solid dispersion

[0059] prescription:

[0060]

[0061] Take isopropanol and put it in a container, add Tween 80 (Shanghai Shengyu Chemical Co., Ltd., the same below), lactose (Shanghai Huamao Pharmaceutical Co., Ltd., the same below) and hypromellose E3 (U.S. Dow Company, The same below) to make it dissolve or disperse evenly, keep the isopropanol solution at 35°C, add glipizide while stirring, keep stirring to make it disperse evenly, dry, make the loss on drying within 2%, pass through a 24 mesh sieve .

[0062] B: Preparation of tablet core

[0063] prescription:

[0064]

[0065] Take glipizide solid dispersion, meglumine, povidone K30, polyethylene glycol-8000 (Xi'an Hui'an Cellulose Chemical Co., Ltd.), sodium chloride and mix evenly, then add magnesium stearate and mix evenly. Tablet, the hardness is controlled at 100N.

[0066] C: Coating of semi-p...

Embodiment 3

[0074] A preparation method of glipizide osmotic pump controlled-release tablet:

[0075] A: Preparation of solid dispersion

[0076] prescription:

[0077]

[0078] Take water and put it in a container, add meglumine, hypromellose E15 (Dow Company of the United States, the same below) and mannitol (Roquette Company of France) to dissolve or disperse evenly, and use it as the water phase for future use. Take 95% ethanol and put it in another container, add glipizide to make it disperse, as the ethanol phase. With continuous stirring, the aqueous phase was slowly added to the ethanol phase. Continue to stir for about 30 minutes after the addition, dry to make the loss on drying within 2%, and pass through a 24-mesh sieve.

[0079] B: Preparation of tablet core

[0080] prescription:

[0081]

[0082] Take the above glipizide solid dispersion, poloxamer (Germany BASF company), hyprolose E50, polyoxyethylene N80 (U.S. Dow company), sodium chloride and magnesium stearat...

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Abstract

The invention relates to a preparation method of a glipizide osmotic pump controlled release tablet. A glipizide tablet core is prepared by the following steps of semipermeable membrane wrapping, laser boring and damp-proof layer wrapping. The preparation method is characterized in that the preparation of the glipizide tablet core comprises preparation of solid dispersoid and preparation of the tablet core. In the preparation method, a solid dispersion technology is utilized, so that the dissolving speed of medicines is improved; the solubility of the glipizide is improved through the fluxing auxiliary materials; and a proper amount of penetration promoter is added to adjust the osmotic pressure so as to achieve constant-speed or approximately-constant-speed release. The invention has the advantages that the process is simple, the cost is low, the release tablet is easy to accept by patients and the treating effect is good.

Description

technical field [0001] The invention relates to a preparation method of a glipizide osmotic pump controlled-release tablet, in particular to a preparation method of a glipizide osmotic pump controlled-release tablet by adopting solid dispersion technology and primary osmotic pump technology. Background technique [0002] Diabetes has become the third major disease that seriously endangers human health after cardiovascular and cerebrovascular diseases and malignant tumors. Glipizide is a lipophilic weak acid with a pKa value of 5.9 and is a second-generation sulfonylurea oral hypoglycemic agent. It was used clinically in the early 1980s. Glipizide is absorbed quickly and completely after oral administration without first-pass effect. Insulin sensitivity significantly enhances the ability of peripheral tissues to uptake glucose. At the same time, glipizide also has the characteristics of reducing serum cholesterol and triglycerides, increasing high-density lipoprotein, and i...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K9/28A61K9/44A61K31/64A61K47/38A61P3/10
Inventor 汪洋潘西海孙艳华郑忠辉
Owner SHANDONG XINHUA PHARMA CO LTD
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