Lurasidone hydrochloride sustained release tablet and preparing method thereof

A technology for lurasidone hydrochloride and sustained-release tablets, which is applied in the fields of pharmaceutical formulations, pill delivery, and nervous system diseases, and can solve problems such as glycerol monostearate that has not yet been seen, and achieve expanded production and good sustained-release effects , The effect of simple process

Inactive Publication Date: 2018-05-08
佛山市弘泰药物研发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the matrix materials of sustained-release tablets, there are no reports on glyceryl monostearate and glyceryl palmitate stearate

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Embodiment 1: Preparation of Lurasidone Hydrochloride Sustained Release Tablets

[0043] Take by weighing 0.8g lurasidone hydrochloride, 2.5g glyceryl palmitate stearate, 5g microcrystalline cellulose, cross 80 mesh sieves after mixing uniformly according to the equal amount incremental method, the waxy molten liquid of 2.5g (0.5g white Beeswax, 1g of palm wax and 1g of PEG6000 plus ethanol (melted at 85°C and then dried to remove ethanol) were added to the mixture of the main drug, microcrystalline cellulose and glyceryl palmitate stearate, and the ethanol solution of PVPK30 (concentration: 5%wt. ) as a binder (solution dosage: 10g) to make soft materials, granulate with a 30-mesh sieve, dry at 60°C for 1 hour, and granulate with a 30-mesh sieve, add 0.2g magnesium stearate and 0.3g silicon dioxide, mix well, and press piece.

Embodiment 2

[0044] Embodiment 2: Preparation of Lurasidone Hydrochloride Sustained Release Tablets

[0045] Take by weighing 1.0g lurasidone hydrochloride, 5g glyceryl palmitate stearate, 2.5g microcrystalline cellulose, cross 80 mesh sieves after mixing uniformly according to the equal addition method, 2.5g waxy molten liquid (0.5g white Beeswax, 1g of palm wax and 1g of PEG6000 plus ethanol (melted at 85°C and then dried to remove ethanol) were added to the mixture of the main drug, microcrystalline cellulose and glyceryl palmitate stearate, and the ethanol solution of PVPK30 (concentration: 5%wt. ) as a binder (solution dosage: 10g) to make soft materials, granulate with a 30-mesh sieve, dry at 60°C for 1 hour, and granulate with a 30-mesh sieve, add 0.2g magnesium stearate and 0.3g silicon dioxide, mix well, and press piece.

Embodiment 3

[0046] Embodiment 3: Preparation of Lurasidone Hydrochloride Sustained-release Tablets

[0047] Take by weighing 1.2g lurasidone hydrochloride, 0.5g glyceryl monostearate, and 2.5g microcrystalline cellulose, pass through an 80 mesh sieve after mixing uniformly according to the equal amount incremental method, and 2g of waxy molten liquid (1.5g white beeswax and 0.5g PEG2000 plus ethanol, melted at 85°C and dried to remove ethanol) added to the mixture of the main drug, microcrystalline cellulose and glyceryl palmitate stearate, and the ethanol solution of PVPK30 (concentration: 2%wt.) as the binding agent (solution dosage: 10g) to make soft material, granulate with 30-mesh sieve, dry at 60°C for 1 hour, after granulation with 30-mesh sieve, add 0.1g magnesium stearate, mix well, and press into tablets.

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PUM

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Abstract

The invention belongs to the field of pharmaceutic preparation, and discloses a lurasidone hydrochloride sustained release tablet and a preparing method thereof. The release tablet is prepared from, by mass, 5-15% of lurasidone hydrochloride, 50-90% of hydrophobic skeleton material, 1-5% of adhesive and 0.5-5% of lubricant. The lurasidone hydrochloride sustained release tablet comprises the hydrophobic skeleton material and the like, medicine release can be regulated well, the lurasidone hydrochloride sustained release tablet can be used for treating osteoarthritis, the process is simple, andexpanded production is facilitated.

Description

technical field [0001] The invention relates to a pharmaceutical preparation and a preparation method thereof, in particular to a lurasidone hydrochloride sustained-release tablet and a preparation method thereof. Background technique [0002] 1. Drug overview [0003] Four 6-week controlled studies of lurasidone hydrochloride in adults with schizophrenia confirmed the efficacy and safety of lurasidone hydrochloride. In these studies, lurasidone hydrochloride showed significantly greater improvements relative to placebo in the primary efficacy measures, which included the Positive and Negative Syndrome Scale (PANSS) total score and the Brief Psychiatric Rating Scale (from the PANSS Scale derived), a total of 5 trials confirmed the tolerability and safety of lurasidone hydrochloride. The most prominent symptoms include hallucinations, delusions, disorganized thinking and behavior, and suspiciousness. Hearing voices that other people cannot hear is the most common type of h...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K47/14A61K47/38A61K31/496A61P25/18
CPCA61K9/2013A61K9/2054A61K31/496
Inventor 雷林芳
Owner 佛山市弘泰药物研发有限公司
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