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Pharmaceutical composition containing risperidone, oral dissolving film agent and preparation method

An oral instant film, risperidone technology, which is applied in the directions of drug combinations, medical preparations containing active ingredients, and medical preparations without active ingredients, etc. The problem of low degree of automation, to achieve the effect of preventing the phenomenon of vomiting, excellent stability and easy acceptance

Pending Publication Date: 2021-12-28
QILU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This kind of preparation process is cumbersome, low in efficiency, not high in automation, and not easy for industrial production, and the invention does not clearly control the inclusion rate and has no steps to remove free drugs. If the inclusion rate is low, there will be unincluded Lipe Ketones, the prepared oral instant film will still taste bitter

Method used

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  • Pharmaceutical composition containing risperidone, oral dissolving film agent and preparation method
  • Pharmaceutical composition containing risperidone, oral dissolving film agent and preparation method
  • Pharmaceutical composition containing risperidone, oral dissolving film agent and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Example 1 Eudragit Eudragit E100 coating prepared oral instant film

[0043] The first step: risperidone coating - preparation of coating intermediate II (risperidone content 9.3%)

[0044] prescription:

[0045]

[0046] Process:

[0047] 1) Preparation of coating solution: Add 95% ethanol weighed into a 2000ml beaker, stir at high speed with an overhead mechanical stirrer, slowly add Eudragit E100 and continue stirring until it dissolves into a clear and transparent coating solution (solid content 5%). Take out 540 g of the dissolved coating solution, add the prescribed amount of risperidone, shear and disperse for 10 minutes, and rotate at 4000 rpm to form a uniform suspension of risperidone, which is used as coating solution I for later use; the remaining 180 g of coating solution is used as coating Liquid II spare;

[0048] 2) Fluidized coating: Install GPCG 2LabSystem fluidized bed (top spray coating) as required, wait for the empty machine to preheat to ab...

Embodiment 2

[0053] Example 2 Eudragit Eudragit E100 coating prepared oral instant film

[0054] The first step: risperidone coating - preparation of coating intermediate II (risperidone content 20.5%)

[0055] prescription:

[0056]

[0057] Process:

[0058] 1) Preparation of coating solution: Add 95% ethanol weighed into a 2000ml beaker, stir at high speed with an overhead mechanical stirrer, slowly add Eudragit E100 and continue stirring until it dissolves into a clear and transparent coating solution (solid content 5%). Take out 226.8 g of the dissolved coating solution, add the prescribed amount of risperidone, shear and disperse for 10 minutes, and rotate at 4000 rpm to form a uniform suspension of risperidone, which is used as coating solution I for subsequent use; the remaining 56.7 g of coating solution is used as Coating solution II is standby;

[0059] 2) Fluidized coating: Install GPCG 2LabSystem fluidized bed (top spray coating) as required, wait for the empty machine ...

Embodiment 3

[0064] Example 3 Eudragit Eudragit E100 coating prepared oral instant film

[0065] The first step: risperidone coating - preparation of coating intermediate II (risperidone content 6.3%)

[0066] prescription:

[0067]

[0068] Process:

[0069] 1) Preparation of coating solution: Add 95% ethanol weighed into a 2000ml beaker, stir at high speed with an overhead mechanical stirrer, slowly add Eudragit E100 and continue stirring until it dissolves into a clear and transparent coating solution (solid content 5%). Take out 661.5 g of the dissolved coating solution, add the prescribed amount of risperidone, shear and disperse for 10 minutes, and rotate at 4000 rpm to form a uniform suspension of risperidone, which is used as coating solution I for later use; the remaining 661.5 g of coating solution is used as Coating solution II is standby;

[0070] 2) Fluidized coating: Install GPCG 2LabSystem fluidized bed (top spray coating) as required, wait for the empty machine to pr...

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Abstract

The invention discloses a pharmaceutical composition containing risperidone, an oral dissolving film agent and a preparation method, and belongs to the technical field of pharmaceutical preparations. The provided pharmaceutical composition containing risperidone comprises an active component risperidone, a coating substrate mannitol, a coating material and a solvent, and the weight percentage of risperidone in the pharmaceutical composition is 6.3-20.5%. The invention further provides an oral instant film agent. The film agent comprises the pharmaceutical composition containing risperidone, a film-forming material, a plasticizer, a filler, a metal ion complexing agent and a flavoring agent, and the film-forming material is selected from polyvinyl alcohol. The invention further provides preparation methods of the pharmaceutical composition and the oral dissolving film agent. The finally prepared oral instant film agent can completely cover the bitter taste of the raw material risperidone, and the process is mature and simple and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a pharmaceutical composition containing risperidone, a preparation method of the pharmaceutical composition, an oral instant film with the pharmaceutical composition as the main raw material, and the oral instant film Preparation. Background technique [0002] Risperidone is an atypical new antipsychotic drug, which can selectively inhibit the mesolimbic dopaminergic nervous system, and will not produce severe extrapyramidal reactions like traditional antischizophrenia drugs. It has few adverse reactions in clinical administration, high safety and low price, and is currently one of the first-selected drugs for anti-schizophrenia. [0003] The currently marketed risperidone preparations mainly include risperidone tablets, capsules, orally disintegrating tablets and oral liquids. Ordinary tablets and capsules need to be taken with water, especially for children ...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/519A61K47/32A61P25/18A61K9/50A61K47/10
CPCA61K31/519A61K9/006A61K47/32A61K47/10A61P25/18A61K9/7007A61K9/5026
Inventor 何花王栋海周志超杨清敏张明会
Owner QILU PHARMA
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