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Microporous spongy film preparation and preparation method thereof

A microporous sponge and sponge-like technology, which is applied in the direction of pharmaceutical formulations, making medicines into special physical or ingestible devices, sheet-like delivery, etc., can solve problems such as poor hand feeling, and is beneficial to emergency applications, membranes, etc. Uniform dosing and high bioavailability

Active Publication Date: 2012-08-29
SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In order to increase the dissolution rate of the film, its thickness is usually reduced as much as possible; however, the prepared film is too thin, and the hand feel is not good

Method used

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  • Microporous spongy film preparation and preparation method thereof
  • Microporous spongy film preparation and preparation method thereof
  • Microporous spongy film preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] Preparation method of film for drug film preparation:

[0065] (1) 100g pore forming agent is added to 100g HPMC water slurry, and the weight concentration of HPMC water slurry is 25%;

[0066] The components of the pore-forming agent include microcrystalline cellulose with a particle size of 1 μm and ethanol adsorbed thereon, and the parts by weight of the microcrystalline cellulose and the parts by weight of the solvent are:

[0067] Microcrystalline cellulose 100 parts

[0068] 300 parts of ethanol

[0069] (2) Then adopt the method reported in the literature of the research on nitroglycerin membrane (Chinese Journal of Pharmaceutical Industry, 1977, 12 (5)), apply and form a membrane, and obtain a thin film precursor;

[0070] (3) Dry the thin film precursor obtained in step (2) at 80° C. to obtain the thin film for drug film preparation, with a thickness of 0.06 mm and a micropore diameter of 50 nm. Its electron microscope photo see figure 1 .

[0071] From f...

Embodiment 2

[0073] Preparation method of film for drug film preparation:

[0074] (1) 50g pore forming agent, 1g antioxidant are added to the water slurry of 100g PVA, and the weight concentration of PVA water slurry is 20%;

[0075] The components of the pore-forming agent include chitin with a particle size of 0.5 μm and acetone adsorbed thereon, and the parts by weight of chitin and the parts by weight of the solvent are:

[0076] Chitosan 100 parts

[0077] Acetone 400 parts

[0078] (2) Then adopt the method reported in the literature of the research on nitroglycerin membrane (Chinese Journal of Pharmaceutical Industry, 1977, 12 (5)), apply and form a membrane, and obtain a thin film precursor;

[0079] (3) Dry the thin film precursor obtained in step (2) at 60° C. to obtain the thin film for drug film preparation, with a thickness of 0.1 mm and a micropore diameter of 80 nm. Its electron microscope photo see figure 2 .

Embodiment 3

[0081] Voglibose Microporous Sponge Film:

[0082] Add 100g of pore-forming agent, 2g of voglibose, and 2g of Tween-80 into 100g of HPMC water slurry, and the weight concentration of HPMC water slurry is 25%.

[0083] Others are the same as embodiment 1.

[0084] Get 6 film preparations, clamp them with paper clips respectively, adopt the apparatus for dissolution determination (the third method of appendix XC of the Chinese Pharmacopoeia version in 2010), take phosphate buffer (pH5.8) 100ml as the dissolution medium, and the rotating speed is Minute 30 revolutions, since the test product contacts the dissolution medium, time it immediately, after 10, 20, 30 seconds, 1, 2 minutes respectively, take 1ml of the solution, filter, take the continued filtrate, adopt post-column fluorescence derivatization method, illuminate High performance liquid chromatography (Chinese Pharmacopoeia 2010 edition two appendix VD) is measured and calculated the dissolution amount of each tablet. ...

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Abstract

The invention discloses a microporous spongy film preparation and a preparation method thereof. The microporous spongy film preparation comprises active ingredients in a treatment effective amount, which are supported on a microporous spongy film for the film preparation. A basic net structure is made of polymer materials, medicines can be dissolved or mixed in the materials, and a large number of micropores are formed in the film preparation through a pore forming agent; the microporous spongy film preparation has an in-vivo pharmacokinetics mode similar to that of corresponding orally disintegrating tablets and solution tablets in the market, can be used for quickly taking effect, has the biological effects equivalent to corresponding preparations in the market, can be quickly disintegrated in the oral cavity, is high in bioavailability and favorable for clinical emergency treatment, and is thicker and better in handfeel than the common film preparation; the preparation process is simplified, and the production time is shortened; and the prepared film preparation is uniform, attractive and elegant.

Description

technical field [0001] The invention relates to a medicine film preparation. Background technique [0002] Drug film preparations promptly had many studies as early as the seventies in the 20th century, such as stable drug film (Chinese Journal of Pharmaceutical Industry, 1976, 12 (19)), phenethylpiperidine drug film (Chinese Journal of Pharmaceutical Industry, 1976, 12 (22)), external contraceptive film (Chinese Journal of Pharmaceutical Industry, 1977, 4-5 (45)), nitroglycerin film (Chinese Journal of Pharmaceutical Industry, 1977, 12 (5)), evergreen glycoside film (Chinese Pharmaceutical Industry Journal, 1980, 4 (18)), clonidine slow-release film (Chinese Journal of Pharmaceutical Industry, 1981, 3 (141)) and so on. The Chinese Pharmacopoeia also records the film as a statutory preparation (1995 edition, 2000 edition, 2005 edition, 2010 edition of the Pharmacopoeia of the People's Republic of China). Due to various reasons in China, this dosage form has not developed r...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/70A61K47/38A61K47/32A61K47/34A61K47/36A61K47/04A61K31/133A61K31/4196A61K31/437A61K31/4178A61K31/485A61K31/5415A61K39/00A61K38/00A61J3/00C08J9/28C08J5/18A61K47/26
Inventor 陈芳傅民侯惠民夏怡然张晓红王坚
Owner SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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