Iloperidone oral disintegrating tablet and its preparation method

A technology of iloperidone and orally disintegrating tablets is applied in the field of orally disintegrating tablets of antipsychotic pharmaceutical preparations and its preparation field, which can solve the problems of affecting oral taste, toxicity and the like, and achieves good taste, rapid disintegration and suitable for large The effect of mass production

Active Publication Date: 2012-08-01
浙江四维医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

General oral tablets are added with sodium lauryl sulfate, and some also add Tween to increase the release of th

Method used

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  • Iloperidone oral disintegrating tablet and its preparation method
  • Iloperidone oral disintegrating tablet and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0052] Example 1:

[0053] According to the prescription ratio of this example (Imperidone: Mannitol is 12:20), weigh 24g of Imperidone and 40g of mannitol and mix uniformly. Airflow pulverization will control the particle size range to 99% less than 45 microns and 90% less than 20 microns, spare. Weigh 32g of crushed spare materials, prepare 20 mesh particles with 5% hypromellose aqueous solution as a viscosing agent, and dry them for later use; then weigh 20g of microcrystalline cellulose and 30g of xylitol, mix well, use 5 % Hypromellose aqueous solution is used as a viscosing agent to prepare 20 mesh particles, which are dried for later use; finally, the two spare particles are added to aspartame 2g, orange flavor 1g, cross-linked pvp8g, magnesium stearate 1g, micronized powder 1g of silica gel, mixed uniformly, controlled pressure 45N, tablet weight 95mg tablet, theoretical amount is 1000 tablets.

[0054] Appearance: good

[0055] Taste: excellent

Example Embodiment

[0056] Example 2:

[0057] According to the prescription ratio of this example (Imperidone: Xylitol is 12:30), weigh 24 g of Imperidone and 60 g of mannitol and mix them uniformly. Airflow pulverization will control the particle size range of 99% to less than 45 microns, 90% Less than 20 microns, spare. Weigh 42g of crushed spare materials, use 5% hypromellose aqueous solution as a viscous agent to prepare 24 mesh particles, and dry them for later use; then weigh 20g microcrystalline cellulose and 30g mannitol, mix well, use 5% The hypromellose aqueous solution is used as a viscous agent to prepare 24 mesh particles, which are dried for later use; finally, add 2g of AK sugar, 1g of orange flavor, cross-linked pvp8g, 2g of talcum powder, and 1g of micro-powdered silica gel. , Controlled pressure 37N, tablet weight 106mg, the theoretical amount is 1000 tablets.

[0058] Appearance: good

[0059] Taste: excellent

Example Embodiment

[0060] Example 3:

[0061] According to the prescription ratio of this example (Imperidone:Sorbitol is 12:40), weigh 24 g of Imperidone and 80 g of mannitol and mix uniformly. Airflow pulverization will control the particle size range to 99% less than 45 microns and 90% less than 20 microns, spare. Weigh 52g of crushed spare materials, use 5% hypromellose aqueous solution as a viscosing agent to prepare 24 mesh granules, and dry them for use; then weigh 20g of microcrystalline cellulose, 10g of lactose, and 30g of mannitol and mix well. Use 5% hypromellose aqueous solution as a viscous agent to prepare 24 mesh granules, dry them for later use; finally add 2 g of AK sugar, 1 g of peppermint flavor, 15 g of sodium carboxymethyl starch, and magnesium stearate. 3g, 1g of micro-powdered silica gel, mixed uniformly, controlled pressure 42N, tablet weight 134mg, and the theoretical amount is 1000 tablets.

[0062] Appearance: good

[0063] Taste: excellent

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Abstract

The invention relates to a medicinal preparation, concretely relates to an Iloperidone oral disintegrating tablet preparation. The oral disintegrating tablet preparation takes Iloperidone or its medicinal active salt as active components, the prescription ingredients and the weight ratio are as follows: 2-30% of Iloperidone, 40-80% of filler, 1-15% of disintegrating agent, 0-3% of lubricant, 0-3% of flow aid, 0-10% of flavoring agent and 0-20% of adhesive. The invention also provides a preparation method of the oral disintegrating tablet preparation, which comprises the following steps: uniformly mixing the active component raw materials and partial auxiliary materials in the preparation process in advanced, air-flow crushing by controlling the 99% particle size less than 45 micrometers and 90% particle size less than 20 micrometers. The Iloperidone oral disintegrating tablet has the advantages of fast disintegration, rapid dissolution with disintegration time of 2-40 seconds, good mouthfeel, no gritty mouthfeel and high biological availability, and enables compliance of administration requirement of schizophrenia patients, the preparation process is simple, and is suitable for large scale production.

Description

Technical field: [0001] The invention relates to a pharmaceutical preparation, in particular to an orally disintegrating tablet of an antipsychotic drug preparation and a preparation method thereof. Background technique [0002] According to statistics, there are currently about 400 million people in the world suffering from mental illnesses of varying severity, and it has become the top ten types of diseases in the world. Mental diseases have become one of the most frequently occurring diseases in my country, just like cardiovascular and cerebrovascular diseases, respiratory diseases and malignant tumors. According to the survey, there are about 16 million mental patients in my country, and the incidence of mental diseases is on the rise in China, and about 250,000 people die by suicide every year. Schizophrenia is one of the highest prevalence rates among mental diseases, and the incidence rate in cities is significantly higher than that in rural areas. According to stati...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/454A61P25/18
Inventor 阮建山车大庆
Owner 浙江四维医药科技有限公司
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