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Sustained-release pomalidomide tablet and preparation method thereof

A technology for pomalidomide and sustained-release tablets, which is applied in the field of pomalidomide sustained-release tablets and its preparation, can solve problems such as glycerol monostearate that has not been seen yet, and achieve expanded production, simple process, and good sustained-release. release effect

Inactive Publication Date: 2018-05-04
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

[0037] Embodiment 1: the preparation of pomalidomide sustained-release tablet

[0038]Take by weighing 0.5g pomalidomide, 2.5g glyceryl palmitostearate, 5g microcrystalline cellulose, cross 80 mesh sieves after mixing uniformly according to the equivalent incremental method, the waxy melt 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) added to the mixture of the main drug, microcrystalline cellulose and glyceryl palmitate stearate, with ethanol solution of PVPK30 (concentration: 5%wt.) As a soft material made of binder (solution dosage: 10g), granulate with a 30-mesh sieve, dry at 60°C for 1 hour, granulate with a 30-mesh sieve, add 0.2g magnesium stearate and 0.3g silicon dioxide, mix well, and press into tablets .

Embodiment 2

[0039] Embodiment 2: Preparation of Pomalidomide Sustained Release Tablets

[0040] Take by weighing 0.5g pomalidomide, 5g glyceryl palmitate stearate, 2.5g microcrystalline cellulose, cross 80 mesh sieves after mixing uniformly according to the equivalent 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) added to the mixture of the main drug, microcrystalline cellulose and glyceryl palmitate stearate, with ethanol solution of PVPK30 (concentration: 5%wt.) As a soft material made of binder (solution dosage: 10g), granulate with a 30-mesh sieve, dry at 60°C for 1 hour, granulate with a 30-mesh sieve, add 0.2g magnesium stearate and 0.3g silicon dioxide, mix well, and press into tablets .

Embodiment 3

[0041] Embodiment 3: the preparation of pomalidomide sustained-release tablet

[0042] Take by weighing 0.1g pomalidomide, 0.5g glyceryl monostearate, 2.5g microcrystalline cellulose, cross 80 mesh sieves after mixing uniformly according to the equivalent incremental method, 2g of waxy molten liquid (1.5g white beeswax and 0.5g PEG2000 plus ethanol (melted at 85°C and then dried to remove ethanol) was added to the mixture of the main drug, microcrystalline cellulose and glyceryl palmitate stearate, and the ethanol solution of PVPK30 (concentration: 2%wt.) was used as a binder (The amount of solution is 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 of 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 pharmaceutical preparations, and discloses a sustained-release pomalidomide tablet and a preparation method thereof. The sustained-release tablet is prepared fromthe following materials in percentage by mass: 1%-10% of pomalidomide, 50%-90% of a hydrophobic framework material, 1%-5% of a binder, and 0.5%-5% of a lubricant, wherein the hydrophobic framework material is a mixture of microcrystalline cellulose, glyceride wax, and a melting accelerating agent; glyceride is selected from one or two of glyceryl monostearate and glyceryl palmitostearate; the waxis selected from one or two of white beeswax and palm wax. The sustained-release tablet is prepared from the hydrophobic framework material and the like, which can well control the release of drugs;a process is simple, and the expanding production is facilitated.

Description

technical field [0001] The invention relates to a pharmaceutical preparation and a preparation method thereof, in particular to a pomalidomide sustained-release tablet and a preparation method thereof. Background technique [0002] On January 8, 2013, the US FDA approved Pomalyst (pomalidomide, pomalidomide) to treat patients with multiple myeloma whose disease has progressed after treatment with other anticancer drugs. [0003] Multiple myeloma is a blood cancer that primarily affects the elderly and originates in the plasma cells of the bone marrow. The National Cancer Institute estimates that about 21,700 Americans are diagnosed with multiple myeloma each year and 10,710 die from the disease. [0004] Pomalyst is a pill that regulates the body's immune system to destroy cancer cells and inhibit their growth. It is indicated for patients who have received at least two prior treatments, including lenalidomide and bortezomib, who have not responded to treatment (failure to...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/454A61K47/38A61K47/14A61K47/44A61P35/00
CPCA61K31/454A61K9/2013A61K9/2054
Inventor 雷林芳
Owner 佛山市弘泰药物研发有限公司
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