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Glipizide oral instant film and preparation method thereof

A technology of oral instant film and oral instant film agent, applied in the field of glipizide oral instant film and preparation thereof, can solve the problems of difficulty in dispersion, affecting the content uniformity of the main drug, easy to float above the solution, etc., and achieves portability. Effect

Active Publication Date: 2015-06-03
HEFEI HUAFANG PHARMA SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But generally speaking, oral instant films are prepared from hydrophilic matrix materials, while glipizide is almost insoluble in water, and easily floats above the solution, and is difficult to disperse in hydrophilic glue. During the scraping and drying process, due to the hydrophobicity of glipizide, the main ingredient of glipizide will agglomerate during the drying process, which will affect the content uniformity of the main ingredient

Method used

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  • Glipizide oral instant film and preparation method thereof
  • Glipizide oral instant film and preparation method thereof
  • Glipizide oral instant film and preparation method thereof

Examples

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Effect test

example 1

[0034] Each tablet contains 5mg of glipizide, and the composition of 1000 tablets of glipizide oral instant film is:

[0035]

[0036] The specific operation process is as follows:

[0037] The glipizide is pulverized by jet milling, the polyethylene glycol 4000 and the glipizide are uniformly combined, hot-melt extruded to make a solid dispersion, pulverized, and sieved. Weigh hydroxypropyl methylcellulose, add water and stir to swell and dissolve to obtain solution A; then weigh the pulverized solid dispersion and sucralose, add water and stir to dissolve to obtain solution B; add the above solution B to solution A, stir After uniformity, add calcium carbonate, stir and mix evenly, remove air bubbles, apply film, dry, cut into 3cm×2cm, and obtain glipizide oral instant film.

[0038] The film has a rough appearance, high hardness, obvious graininess to the touch, poor flexibility, slow dissolution at the entrance, low viscosity, and a melting time limit of 50 seconds.

example 2

[0040] Each tablet contains 5mg of glipizide, and the composition of 1000 tablets of glipizide oral instant film is:

[0041]

[0042] The specific operation process is as follows:

[0043] The glipizide is pulverized by jet milling, the polyethylene glycol 4000 and the glipizide are uniformly combined, hot-melt extruded to make a solid dispersion, pulverized, and sieved. Weigh hydroxypropyl methylcellulose, xanthan gum, add water, stir and dissolve to obtain solution A; then weigh the pulverized solid dispersion, sucralose, add water and stir to dissolve to obtain solution B; add the above solution B to the solution In A, stir evenly, add calcium carbonate, mix evenly, remove air bubbles, apply a film, dry, cut into 3cm×2cm, and obtain glipizide oral instant film.

[0044] The film has a good appearance, translucent, grainy to the touch, moderate flexibility, improved dissolution rate at the entrance, increased viscosity, and a melting time limit of 35s.

example 3

[0046] Each tablet contains 5mg of glipizide, and the composition of 1000 tablets of glipizide oral instant film is:

[0047]

[0048]

[0049] The specific operation process is as follows:

[0050] The glipizide is pulverized by jet milling, the polyethylene glycol 4000 and the glipizide are uniformly combined, hot-melt extruded to make a solid dispersion, pulverized, and sieved. Weigh hydroxypropyl methylcellulose, xanthan gum, add water, stir, swell and dissolve to obtain solution A; then weigh the pulverized solid dispersion, sucralose, add water and stir to dissolve to obtain solution B; add the above solution B to solution A After stirring evenly, add calcium carbonate and colloidal silicon dioxide, mix evenly, remove air bubbles, apply a film, dry, cut into 3cm×2cm, and obtain the glipizide oral instant film.

[0051] The film has a good appearance, translucent, no grainy feeling, moderate flexibility, good dissolution at the entrance, moderate viscosity, and a m...

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Abstract

The invention belongs to the field of pharmaceutical preparations, and particularly relates to a prescription of a glipizide oral instant film and a preparation method thereof. The oral instant film comprises medical active ingredients and pharmaceutically adaptable auxiliary materials. The film comprises the following components in percentage by weight: 1-30% of glipizide, 40-80% of a macromolecular film-forming material, 0-30% of a plasticizer, 0-20% of a corrigent and 0-20% of other auxiliary materials. The film prepared by the glipizide film can be taken without water. The film placed in the oval cavity can be quickly dispersed and dissolved (equivalent to an oral solution) and is swallowed into stomach with saliva. After the film is orally taken, no disintegration process is available, so that the film has the advantages of being quick to absorb, quick to response and high in bioavailability. The product is accurate in dosage, and dust explosion in the production process is nearly avoided, so that the problem on labor protection and environmental pollution can be solved.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a glipizide oral instant film and a preparation method thereof. technical background [0002] Diabetes has become the third major disease that seriously endangers human health after cardiovascular and cerebrovascular diseases and malignant tumors. Glipizide is a second-generation sulfonylurea oral hypoglycemic agent. Glipizide mainly promotes insulin secretion from pancreatic β cells, especially glucose-stimulated insulin secretion, and enhances the effect of insulin on target tissues, thereby effectively reducing blood sugar concentration and glycosylated hemoglobin; it can also improve hyperlipidemia It can reduce triglyceride and cholesterol levels, increase the ratio of high-density lipoprotein cholesterol in total cholesterol, inhibit platelet aggregation and promote fibrinolysis, so it may have a certain preventive effect on vascular lesions, and is the treatment...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/64A61P3/10
Inventor 杨贤龙何勇吴宗好
Owner HEFEI HUAFANG PHARMA SCI & TECH
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