Quickly dissolved film and preparation method thereof

A thin-film and fast technology, which can be applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, pharmaceutical formulas, etc., can solve the problems of poor absorption, delayed peak time, etc., and achieve a simple preparation method and low cost. , the effect of simple process

Inactive Publication Date: 2011-05-11
TIANJIN PACIFIC PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Oral absorption of frovatriptan is slightly poor. After a single oral administration of 2.5 mg of this product, the peak time is about 2 to 4 hours, and the absolute bioavailability is about 20% to 30%. Food has no obvious effect on its bioavailability. But peak time can be delayed

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Frotriptan 3.2g, 2.5g HPC, 6.0g polyvinylpyrrolidone, 0.02g stevia, 0.3g glycerin, dissolved in 16ml 95% ethanol to form a suspension, this solution is smeared on silicone rubber paper with a squeegee , The formed 350-micron film is dried at 35°C for 30 minutes, and then dried at 65°C for 30 minutes. The flat weight is 80g / m 2 Next, form a film with a thickness of 90 microns, carefully remove it from the silicone rubber paper, and cut it into 2×3 cm pieces to obtain the drug film.

Embodiment 2

[0045] Frotriptan 3.2g, methylcellulose 2.0g, vinylpyrrolidone-vinyl acetate-copolymer 5.0g, 0.02g aspartose, 0.1g xanthan gum, 0.3g propylene glycol, dissolved in 12ml of 50% ethanol, A suspension is formed. This solution is smeared on silicone rubber paper with a squeegee. The formed 300-micron film is dried at 30°C for 30 minutes and then dried at 60°C for 60 minutes. The flat weight is 100g / m 2 Next, form a film with a thickness of 80 microns, carefully remove it from the silicone rubber paper, and cut it into 2×3 cm pieces to obtain the drug film.

Embodiment 3

[0047] Frotriptan 3.2g, 7.5g vinylpyrrolidone-vinyl acetate-copolymer, 0.02g sodium saccharin, 0.3gPEG400, dissolved in 12ml of 75% ethanol to form a suspension, this solution is smeared on silicone rubber paper with a squeegee Above, the formed 250-micron film was dried at 30°C for 30 minutes, and then dried at 60°C for 60 minutes. The flat weight was 80g / m 2 Next, form a film with a thickness of 75 microns, carefully remove it from the silicone rubber paper, and cut it into 2×3 cm pieces to obtain the drug film.

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PUM

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Abstract

The invention relates to a quickly dissolved film. The film is characterized by consisting of 0.01 to 90 percent of frovatripan serving as an active ingredient and the balance of film forming material and medicinal auxiliary materials. A preparation method comprises the following steps of: dissolving frovatripan and polymer in water or organic solvent or suspending other auxiliary materials, coating the solution on silicon rubber paper or a proper carrier, and drying for 0.5 to 4 hours at the temperature of between 35 and 65 DEG C; and performing shearing or film pressure separation on the dried semi-finished product to obtain the film of the specified size.

Description

Technical field [0001] The invention relates to the field of pharmaceutical preparations, and more specifically, is a new dosage form of a film that dissolves quickly in the oral cavity and a preparation method thereof. Background technique [0002] Migraine. The most common causes of headaches in young women are many. The most common is migraine. Others include tension headaches, diffuse headaches caused by facial diseases, headaches caused by toxic or metabolic diseases, and some serious organic Headache caused by illness. Migraine is a headache with periodic nerve-vascular dysfunction and is the most common type of chronic recurrent headache. It is manifested as pulsating or piercing pain on one or both sides of the head, often accompanied by symptoms such as nausea, vomiting, anorexia, photophobia, and fatigue. It usually starts in adolescence and is most common in women. It is often related to the menstrual cycle and often has a family history. The pathogenic mechanism of...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/403A61K47/36A61K47/42A61K47/38A61P25/06
Inventor 宋德成
Owner TIANJIN PACIFIC PHARMA
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