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Oral cavity instant film containing risperidone and preparation method for oral cavity instant film

An oral instant film and risperidone technology, which is applied in the field of medicine, can solve the problems of complex production process, many components and complex process of film preparation, and achieve the effects of improving medication compliance, simple production process and convenient use.

Inactive Publication Date: 2015-04-29
AVENTIS PHARMA HAINAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There are some defects in this drug taste masking method: (1) The raw materials need to be micronized, and the particles need to be wetted with an alcohol solution containing coating materials after drying, and then sieved after being slightly dried. The process is complicated and the "slightly dry" process It is not easy to grasp; (2) the selection of excipients is limited to water-insoluble fillers; (3) after drying the granules between the No. 3 drug sieve and the No. 6 drug sieve, the coating will produce obvious gritty feeling when the patient takes it, reducing the compliance
[0007] CN101632651B discloses a fast-dissolving oral film containing risperidone and a preparation method thereof. The film composition additives include flavoring agents, coloring agents, preservatives, pH regulators, disintegrants, etc., and the ingredients are many and complex, and cannot be effective Improve taste
However, the film production process is complicated and the cost is high
[0008] Risperidone tastes bitter, and it is technically difficult to completely cover this bitter taste. The oral preparations currently on the market include tablets, capsules, and orally disintegrating tablets, and the taste is not ideal. The majority of patients, especially children, urgently need a good taste. Preparations that can effectively mask the bad taste of drugs

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Each tablet contains risperidone 2mg, and the composition of each 1000 tablets of risperidone oral instant film is as follows:

[0022] Risperidone 2.0g

[0023] Hypromellose 24.0g

[0024] Sodium Carboxymethyl Cellulose 6.0g

[0025] Glycerin 6.0g

[0026] Sucralose 0.1g

[0027] Pure water 200ml

[0028] Specific operation process:

[0029] Weigh 24g of hypromellose and add 200ml of pure water, stir at room temperature, dissolve for about 1 hour, add 6g of glycerin and mix well, add 6g of sodium carboxymethylcellulose under stirring at room temperature, mix well and then add 2.0g of risperidone , stir and mix well, add 0.1g of sucralose and stir well. After degassing by ultrasonication for 0.5 hours, scrape it evenly onto a flat plate, dry it at 60°C, demold it, cut it into a certain size, and seal it to get the risperidone oral instant film.

[0030] Evaluation: The film is white and translucent in appearance, poor in flexibility, slow to dissolve in the oral ...

Embodiment 2

[0032] Each tablet contains risperidone 2mg, and the composition of each 1000 tablets of risperidone oral instant film is as follows:

[0033] Risperidone 2.0g

[0034] Hypromellose 24.0g

[0035] Sodium Carboxymethyl Cellulose 6.0g

[0036] Propylene glycol 6.0g

[0037] Sucralose 0.1g

[0038] Pure water 200ml

[0039] Specific operation process:

[0040]Weigh 24g of hypromellose and add 200ml of pure water, stir at room temperature, dissolve for about 1 hour, add 6g of propylene glycol and mix well, add 6g of sodium carboxymethylcellulose under stirring at room temperature, mix well and then add 2.0g of risperidone , stir and mix well, add 0.1g of sucralose and stir well. After degassing by ultrasonication for 0.5 hours, scrape it evenly onto a flat plate, dry it at 60°C, demold it, cut it into a certain size, and seal it to get the risperidone oral instant film.

[0041] Evaluation: The appearance of the film is white and translucent, the flexibility is average, the...

Embodiment 3

[0043] Each tablet contains risperidone 2mg, and the composition of each 1000 tablets of risperidone oral instant film is as follows:

[0044] Risperidone 2.0g

[0045] Polyvinyl alcohol 24.0g

[0046] Sodium Carboxymethyl Cellulose 6.0g

[0047] Propylene glycol 6.0g

[0048] Sucralose 0.1g

[0049] Pure water 200ml

[0050] Specific operation process:

[0051] Weigh 24g of polyvinyl alcohol and add 200ml of pure water, dissolve in a water bath at 65°C, add 6g of propylene glycol and mix well, add 6g of sodium carboxymethylcellulose under stirring at room temperature, mix well, add 2.0g of risperidone, stir and mix well, Add 0.1g of sucralose and stir well. After degassing by ultrasonication for 0.5 hours, scrape it evenly onto a flat plate, dry it at 60°C, demold it, cut it into a certain size, and seal it to get the risperidone oral instant film.

[0052] Evaluation: The appearance of the film is white and translucent, slightly viscous, relatively soft, the dissoluti...

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Abstract

The invention provides a risperidone oral cavity instant film capable of shielding bad taste of medicine and a preparation method for the instant film. The oral cavity instant film mainly comprises medicine active components shielding taste and auxiliary materials applicable in pharmacology; the medicine active ingredients comprise risperidone; the auxiliary materials applicable in pharmacology comprise a film forming material, a plasticizer, a sweetener, a filling agent and the like. The oral cavity instant film has the advantages that the oral cavity instant film is favorable in taste, can be dissolved quickly in oral cavity without drinking water, and is high in bioavailability and convenient to use; the preparation technology is simple, convenient and feasible; the related auxiliary materials are easy to purchase; the oral cavity instant film has favorable social and economic benefits.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to an oral preparation for treating psychosis, in particular to an oral instant film containing risperidone and a preparation method thereof. The obtained film has good taste, does not need to drink water, can quickly dissolve in the oral cavity, is especially suitable for patients with swallowing difficulties, has the advantages of high bioavailability, convenient use, and simple and easy preparation process. Background technique [0002] Risperidone is a derivative of Benzisoxazole, which is an atypical new antipsychotic with dual antagonism of dopamine D2 receptors and 5-HT2 receptors of serotonin effect. A large number of clinical trials and clinical application studies have shown that risperidone is an effective antipsychotic drug for the treatment of acute and chronic schizophrenia and other obvious positive symptoms of various psychotic states (such as hallucinations, halluci...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/519A61K47/48A61P25/18
Inventor 浦洁刁媛媛马苏峰
Owner AVENTIS PHARMA HAINAN
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