Oral quick-dissolving film preparation and preparation method thereof

An oral instant film agent, water-soluble film-forming technology, applied in the direction of pharmaceutical formula, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., can solve the problem of no oral instant film and achieve shortening Disintegration time, solve the effect of longer disintegration time, and improve drug compliance

Inactive Publication Date: 2012-12-19
SUZHOU UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In the prior art, there are reports of orally disintegrating tablets of the above-mentioned drugs, but no reports of oral instant films

Method used

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  • Oral quick-dissolving film preparation and preparation method thereof
  • Oral quick-dissolving film preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Polyvinyl alcohol 1788 1000mg

[0035] Macrogol 4000 250mg

[0036] Sodium Alginate 100mg

[0037] Purified water 20mL

[0038] First add the above amount of polyvinyl alcohol into purified water under stirring, and dissolve in a water bath to obtain a gel solution, then add polyethylene glycol 4000 and sodium alginate, and stir to dissolve. Allow the prepared solution to stand or sonicate to remove air bubbles. Spread the solution evenly on 15×15cm 2 Stainless steel plate, 40-60 ℃ blast heating and drying for 2 hours. Remove the film and cut it to get the film agent, which is white, has poor release performance, poor toughness and is brittle.

Embodiment 2

[0040] Polyvinyl alcohol 1788 1000mg

[0041] Macrogol 1000 250mg

[0042] Sodium Alginate 100mg

[0043] Purified water 20mL

[0044] First add the above amount of polyvinyl alcohol into purified water under stirring, and dissolve in a water bath to obtain a gel solution, then add polyethylene glycol 1000 and sodium alginate, and stir to dissolve. Allow the prepared solution to stand or sonicate to remove air bubbles. Spread the solution evenly on 15×15cm 2 Stainless steel plate, 40-60 ℃ blast heating and drying for 2 hours. Remove the film and cut it to get the film agent, which is transparent and has poor release performance.

Embodiment 3

[0046] Polyvinyl alcohol 1788 1000mg

[0047] Glycerin 250mg

[0048] Sodium Alginate 100mg

[0049] Purified water 20mL

[0050] First add the above-mentioned amount of polyvinyl alcohol into purified water under stirring, and dissolve in a water bath to obtain a gel solution, then add glycerin and sodium alginate, and stir to dissolve. Allow the prepared solution to stand or sonicate to remove air bubbles. Spread the solution evenly on 15×15cm 2 Stainless steel plate, 40-60 ℃ blast heating and drying for 2 hours. Remove the film and cut it to get the film agent. The film is transparent, good release performance, flexible and sticky on the surface.

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Abstract

The invention discloses an oral quick-dissolving film preparation and a preparation method thereof. The oral quick-dissolving film comprises the following components in percentage by weight: 20 to 40 percent of medicinal active component, 40 to 75 percent of water-soluble film forming material, 10 to 25 percent of plasticizer, 0 to 25 percent of disintegrating agent, and 0.1 to 8 percent of water, wherein the medicinal active component is one of sildenafil, tadalafil, vardenafil or salts thereof. According to the oral quick-dissolving film preparation, the disintegration time limited of the film preparation can be remarkably accelerated, the problem that most oral solid preparations should be taken with water can be solved, medicine taking time cannot be delayed under a condition without water, and the taking compliance of a patient can be improved.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to an oral instant film and a preparation method thereof, in particular to an oral instant film for treating erectile dysfunction. Background technique [0002] Oral solid immediate-release preparations generally refer to solid preparations that can disintegrate or dissolve quickly after oral administration, and are rapidly released and absorbed through the oral cavity or gastrointestinal mucosa. Because of its convenient administration, high bioavailability, fast absorption, and small adverse reactions, it has always been concerned by pharmaceutical workers and favored by people. Oral solid immediate-release preparations combine the advantages of oral solid preparations and liquid preparations, while avoiding the disadvantages of ordinary solid preparations such as long dissolution time and low dissolution rate after taking, and oral liquid preparations that are inconvenient to carry...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/4985A61K31/519A61K31/53A61K47/32A61K47/34A61K47/36A61K47/38A61P15/10A61K47/10
Inventor 曹青日施丽丽徐卫娟崔京浩
Owner SUZHOU UNIV
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