Risperidone fast-dissolving and/or fast-release solid oral film for gastrointestinal administration and preparation method thereof

A technology of risperidone and oral film, which is applied in the field of medicine, can solve the problems such as the technical solution of the preparation method, and achieve the effects of short disintegration time limit, fast dissolution rate and good reproducibility

Inactive Publication Date: 2020-07-17
武汉华夏理工学院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Disadvantages: suitable for small doses of raw materials
[0009] In general, there is no technical solution related to the preparation method of risperidone instant and / or immediate release solid oral film and the dosage form in the prior art

Method used

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  • Risperidone fast-dissolving and/or fast-release solid oral film for gastrointestinal administration and preparation method thereof
  • Risperidone fast-dissolving and/or fast-release solid oral film for gastrointestinal administration and preparation method thereof
  • Risperidone fast-dissolving and/or fast-release solid oral film for gastrointestinal administration and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043]

[0044] *95% ethanol and purified water are removed after the membrane is dried.

[0045] Preparation method: all auxiliary materials such as risperidone raw material medicine, microcrystalline cellulose, maltodextrin, sucralose, etc. are passed through an 80-mesh sieve for use.

[0046] Weigh risperidone raw materials, microcrystalline cellulose, maltodextrin, titanium dioxide, sucralose, citric acid, hydroxypropyl methylcellulose (E-15), menthol, and glycerin according to the prescription ratio, and add 95% Use proper amount of ethanol and purified water, grind and stir to make the mixture evenly, set aside to defoam and set aside.

[0047] Adjust the running speed and height of the coating screw, the thickness of the coating film is about 100μm, so that the coating is continuous. Dry at 70°C for 1 hour to obtain.

Embodiment 2

[0049]

[0050] *95% ethanol and purified water are removed after the membrane is dried.

[0051] Preparation method: all auxiliary materials such as risperidone crude drug, microcrystalline cellulose, maltodextrin, sucralose, aspartame, etc. are passed through an 80-mesh sieve for use.

[0052] Weigh risperidone raw materials, microcrystalline cellulose, maltodextrin, titanium dioxide, sucralose, aspartame, sodium citrate, hydroxypropyl methylcellulose (E-15), and hydroxypropyl according to the prescription ratio Methyl cellulose E-6, menthol, glycerin, add 95% ethanol and an appropriate amount of purified water, grind and stir to make the mixture uniform, stand for defoaming, and set aside.

[0053] Adjust the running speed and height of the coating screw, the thickness of the coating film is about 90μm, so that the coating is continuous. The drying temperature is 80°C and the drying time is 0.7 hours.

Embodiment 3

[0055]

[0056]

[0057] *95% ethanol and purified water are removed after the membrane is dried.

[0058] Preparation method: all auxiliary materials such as risperidone raw material medicine, microcrystalline cellulose, maltodextrin, aspartame, etc. are passed through an 80-mesh sieve for use.

[0059] Weigh risperidone raw materials, microcrystalline cellulose, maltodextrin, titanium dioxide, aspartame, citric acid, hydroxypropyl methylcellulose E-50, menthol, glycerin according to the prescription ratio, and add 95% ethanol And an appropriate amount of purified water, grind and stir to mix evenly, stand still to defoam, and set aside.

[0060] Adjust the running speed and height of the coating screw, the thickness of the coating film is about 100μm, so that the coating is continuous. Dry at 85°C for 0.5 hours to get.

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Abstract

The invention belongs to the technical field of medicines, and in particular relates to a risperidone instant and / or rapid-release solid oral membrane for gastrointestinal administration and a preparation method of the oral membrane. In terms of each dose unit, the oral membrane consists of 1-3mg of risperidone, 5.0-40.0wt% of a filler, 20.0-45.0wt% of a film-forming material, 1.0-5.0wt% of a stabilizer, 10.0-25.0wt% of a plasticizer, 0-5.0wt% of a flavoring agent and 0-1.0wt% of an opacifying agent. The preparation method comprises the following steps: grinding and uniformly stirring and mixing the risperidone, the stabilizer, the plasticizer, the opacifying agent, the film-forming material, the filler, the flavoring agent and a solvent, conducting standing by and defoaming, adding an obtained mixture to a continuous coating machine, conducing continuous coating, and conducting drying and cutting so as to obtain the oral membrane. The oral membrane provided by the invention is quite short in disintegration time limited and rpaid in dissolution rate. The preparation method is simple to operate and good in repeatability; and the prepared medicine in the dosage form of the oral membrane is short in disintegration time limited and rapid in dissolution rate.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and particularly relates to a fast-dissolving and / or fast-release solid oral film of risperidone administered through the gastrointestinal tract and a preparation method thereof. Background technique [0002] Risperidon (Risperidon) is a serotonin / dopamine antagonist with a unique balance mechanism. It is effective for both positive and negative symptoms of schizophrenia. It can also improve cognitive function and help patients return to society. At present, the domestic clinical application of risperidone preparations mainly include tablets (1mg, 2mg and 3mg), dispersible tablets (1mg), capsules (1mg), oral liquid (30mL: 30mg), orally disintegrating tablets (0.5mg, 1mg) And 2mg) and microsphere injection (25mg, 37.5mg and 50mg) and so on. The risperidone tablet produced by Xi'an Janssen Pharmaceutical Co., Ltd. under the trade name "Vista" is the first domestic marketed variety and was approved for...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/70A61K31/519A61K47/38A61P25/18
CPCA61K9/0056A61K9/7007A61K31/519A61K47/38
Inventor 吴小玉常娱
Owner 武汉华夏理工学院
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