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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 the drug and improve the bioavailability, but they have varying degrees of toxicity and also affect the oral taste

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

Embodiment 1

[0053] According to the prescription ratio of this embodiment (iloperidone: mannitol is 12: 20), take iloperidone 24g and mannitol 40g and mix evenly, and jet milling will control the particle size range at 99% less than 45 microns, and 90% less than 45 microns. 20 microns, spare. Take by weighing 32g of pulverized standby materials, prepare 20 mesh granules with 5% hypromellose aqueous solution as a binder, and dry for subsequent use; then weigh 20g of microcrystalline cellulose and 30g of xylitol and mix evenly, and mix them with 5% hypromellose % hypromellose aqueous solution is prepared into 20 mesh granules as a binder, and is dried for subsequent use; finally, 2 g of aspartame, 1 g of orange essence, 8 g of cross-linked pvp, 1 g of magnesium stearate, and micropowder are added to the two spare granules. 1g of silica gel, mixed evenly, controlled pressure 45N, tablet weight 95mg, the theoretical amount is 1000 tablets.

[0054] Appearance: Good

[0055] Taste: excellent...

Embodiment 2

[0057] According to the prescription ratio of this embodiment (iloperidone: xylitol is 12:30), take iloperidone 24g and mannitol 60g and mix evenly, jet milling will control the particle size range at 99% less than 45 microns, 90% Less than 20 microns, spare. Weigh 42g of crushed spare material, prepare 24 mesh granules with 5% hypromellose aqueous solution as a binder, and dry for standby; then weigh 20g of microcrystalline cellulose and 30g of mannitol and mix evenly with 5% hypromellose The hypromellose aqueous solution is used as a binder to prepare 24-mesh granules, which are dried for later use; finally, add 2g of AK sugar, 1g of orange essence, 8g of cross-linked pvp, 2g of talcum powder, and 1g of micronized silica gel to the two spare granules, and mix well , the control pressure is 37N, the tablet weight is 106mg, and the theoretical amount is 1000 tablets.

[0058] Appearance: good

[0059] Taste: Excellent

Embodiment 3

[0061] According to the prescription ratio of this embodiment (iloperidone: sorbitol is 12:40), take iloperidone 24g and mannitol 80g and mix evenly, jet milling will control the particle size range at 99% less than 45 microns, and 90% less than 45 microns. 20 microns, spare. Weigh 52g of the pulverized spare material, prepare 24 mesh particles with 5% hypromellose aqueous solution as a binder, and dry for standby; then weigh 20g of microcrystalline cellulose, 10g of lactose, and 30g of mannitol and mix evenly. Use 5% hypromellose aqueous solution as a binder to prepare 24-mesh granules, dry them for later use; finally add 2 g of AK sugar, 1 g of mint flavor, 15 g of sodium carboxymethyl starch, and magnesium stearate to the two spare granules 3g, 1g of micro-powdered silica gel, mixed evenly, controlled pressure 42N, tablet weight 134mg tablet, 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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