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Lurasidone hydrochloride orally-disintegrating tablet preparation and preparation method thereof

A technique for lurasidone hydrochloride orally disintegrating tablets and lurasidone hydrochloride, applied in the field of pharmaceutical preparations

Inactive Publication Date: 2013-04-24
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] At present, the clinical preparations of lurasidone hydrochloride mainly include capsules and ordinary tablets, and there are no relevant reports on orally disintegrating tablet preparations.

Method used

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  • Lurasidone hydrochloride orally-disintegrating tablet preparation and preparation method thereof
  • Lurasidone hydrochloride orally-disintegrating tablet preparation and preparation method thereof
  • Lurasidone hydrochloride orally-disintegrating tablet preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

specific Embodiment 1

[0029] Specific Example 1 Lurasidone Hydrochloride Orally Disintegrating Tablets (1000 Tablets)

[0030]

[0031]

[0032] Preparation method:

[0033] 1. Pass the raw and auxiliary materials through a 100-mesh sieve.

[0034] 2. Mix the prescribed amount of lurasidone with mannitol, microcrystalline cellulose, and low-substituted hydroxypropyl cellulose in a mixer.

[0035] 3. Add 60% alcohol solution of 2% hypromellose to the above mixture to make soft material and granulate.

[0036] 4. Dry until moisture L.O.D (90°C, 5min) < 3%, granulate, add the dosage of low-substituted hydroxypropyl cellulose, acesulfame potassium, mint flavor and magnesium stearate, and mix with the above-mentioned granules with medicine.

[0037] 5. Measure the particle content, calculate the weight of the tablet, and press the tablet to make a total of 1000 tablets, and control the hardness to 20-40N.

specific Embodiment 2

[0038] Specific Example 2 Lurasidone Hydrochloride Orally Disintegrating Tablets (1000 Tablets)

[0039]

[0040] Preparation method:

[0041] 1. Pass the raw and auxiliary materials through a 100-mesh sieve.

[0042] 2. Mix the prescribed amount of lurasidone with lactose, microcrystalline cellulose, and croscarmellose sodium in a mixer.

[0043] 3. Add 60% hypromellose solution to the above mixture to make soft material and granulate.

[0044] 4. Dry until moisture L.O.D (90°C, 5min) < 3%, granulate, convert the amount of croscarmellose sodium, acesulfame potassium, mint essence and magnesium stearate, and mix with the above-mentioned granules with medicine uniform.

[0045] 5. Measure the particle content, calculate the weight of the tablet, and press the tablet to make a total of 1000 tablets, and control the hardness to 20-40N.

specific Embodiment 3

[0046] Specific Example 3 Lurasidone Hydrochloride Orally Disintegrating Tablets (1000 Tablets)

[0047]

[0048] Preparation method:

[0049] 1. Pass the raw and auxiliary materials through a 100-mesh sieve.

[0050] 2. Mix the prescribed amount of lurasidone with lactose, microcrystalline cellulose, and cross-linked polyvinylpyrrolidone in a mixer.

[0051] 3. Add 40% alcohol aqueous solution to the above mixture to make soft material and granulate.

[0052] 4. Dry until moisture L.O.D (90°C, 5min) < 3%, granulate, convert the amount of cross-linked polyvinylpyrrolidone, acesulfame potassium, mint flavor and magnesium stearate, and mix with the above-mentioned granules with medicine.

[0053] 5. Measure the particle content, calculate the weight of the tablet, and press the tablet to make a total of 1000 tablets, and control the hardness to 20-40N.

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Abstract

The invention belongs to the technical field of medicine, and relates to a lurasidone hydrochloride orally-disintegrating tablet preparation and a preparation method thereof. The orally-disintegrating tablet comprises the following components in mass percent: 5-60 percent of lurasidone hydrochloride, 25-80 percent of filling material, 5-20 percent of disintegrating agent, 0.02-0.15 percent of wetting agent, 0.2-5 percent of flavoring agent and 0.5-2 percent of lubricating agent. The invention aims to provide a lurasidone hydrochloride orally-disintegrating tablet with simple preparation process, low cost, convenience in use and quick action to the indications; and compared with the conventional preparation for oral use, the lurasidone hydrochloride orally-disintegrating tablet preparation can reduce the difficulty in swallowing, improve the compliance, is suitable for special populations such as the elderly, children, patients with difficulty in swallowing and mental patients, can be fully disintegrated within 60 s, can be disintegrated into extremely fine powder, is higher in drug dissolution rate and quick in absorption, and can improve the bioavailability of insoluble drugs, for example, lurasidone hydrochloride.

Description

Technical field: [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a lurasidone hydrochloride orally disintegrating tablet and a preparation method of the orally disintegrating tablet. Background technique: [0002] Schizophrenia is a common mental illness. According to estimates by the World Health Organization, the lifetime prevalence rate of schizophrenia in the world is about 3.8‰-8.4‰. According to research in the United States, the lifetime prevalence rate is as high as 13‰; my country 1994 According to the annual survey data, the prevalence rate in urban areas is 7.11‰, and that in rural areas is 4.26‰, and it shows an increasing trend year by year. The etiology of schizophrenia is complex and has not yet been fully elucidated. It mostly occurs in young and middle-aged people, manifested as obstacles in perception, thinking, emotion, will, and other aspects. Mental activities are not coordinated with the surrounding...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/496A61P25/18
Inventor 付珊珊郭夏宋雪梅
Owner BEIJING VENTUREPHARM BIOTECH
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