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Lenalidomide composition tablets and preparation method thereof

A technology for lenalidomide and composition, which is applied in the field of lenalidomide composition tablet and preparation thereof, can solve the problem that the granulation porosity reproducibility is affected by many factors, the drug dissolution stability is greatly affected, and the The problems of granulation and drying take a long time, and the preparation process is simple and easy to operate, the content of moisture and impurities is low, and the crystal form is stable.

Active Publication Date: 2016-05-04
DEYANG HUAKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, these methods have long operation steps, long time-consuming granulation and drying, high energy consumption, more equipment required, low preparation efficiency, and high production costs; Dissolution slows down; the reproducibility of granulation porosity, specific surface area and other properties are affected by many factors, which have a greater impact on the stability of drug dissolution

Method used

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  • Lenalidomide composition tablets and preparation method thereof
  • Lenalidomide composition tablets and preparation method thereof
  • Lenalidomide composition tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] A lenalidomide composition tablet, the composition of which comprises by weight percentage: 10% of lenalidomide crystals, 40% of lactose, 30% of microcrystalline cellulose, 2% of konjac glucomannan, β-cyclodextrin 10%, sodium carboxymethyl starch 6%, sodium stearyl fumarate 0.5%, powdered cellulose 1.5%.

[0037] A preparation method of the above-mentioned lenalidomide composition tablet, comprising the following steps:

[0038] Step 1, mixing lenalidomide crystals with lactose, microcrystalline cellulose, and sodium carboxymethyl starch at a rotating speed of 500 r / min, pulverizing, and passing through a 100-mesh sieve to obtain 100-mesh mixture particles;

[0039] Step 2. Add konjac glucomannan and β-cyclodextrin to purified water and ethanol with a volume ratio of 1:2, stir evenly to obtain a granulation liquid, add the granulation liquid to the mixture particles, stir evenly, filter, Granulate to obtain wet granules, dry the wet granules at 60°C to obtain dry granu...

Embodiment 2

[0043] A lenalidomide composition tablet, the composition of which comprises by weight percentage: 15% of lenalidomide crystals, 34% of lactose, 28% of microcrystalline cellulose, 3% of konjac glucomannan, β-cyclodextrin 12%, sodium carboxymethyl starch 6%, sodium stearyl fumarate 0.6%, powdered cellulose 1.4%.

[0044] A preparation method of the above-mentioned lenalidomide composition tablet, comprising the following steps:

[0045] Step 1, mixing lenalidomide crystals with lactose, microcrystalline cellulose, and sodium carboxymethyl starch at a rotating speed of 300 r / min, pulverizing, and passing through a 200-mesh sieve to obtain 200-mesh mixture particles;

[0046] Step 2. Add konjac glucomannan and β-cyclodextrin to purified water and ethanol with a volume ratio of 1:4, stir evenly to obtain a granulation liquid, and input the granulation liquid into a stainless steel nozzle with voltage applied, Apply high-voltage static electricity on the stainless steel nozzle thr...

Embodiment 3

[0050] A lenalidomide composition tablet, the composition of which comprises by weight percentage: 16% of lenalidomide crystals, 31% of lactose, 28% of microcrystalline cellulose, 3.7% of konjac glucomannan, β-cyclodextrin 12%, sodium carboxymethyl starch 8%, sodium stearyl fumarate 0.8%, powdered cellulose 0.5%.

[0051] A preparation method of the above-mentioned lenalidomide composition tablet, comprising the following steps:

[0052] Step 1. Add crude lenalidomide and polymethyl methacrylate with a weight ratio of 1:4 to the dimethyl sulfoxide solution, stir until completely dissolved to obtain a mixture solution, and input the mixture solution to a voltage-applied In the stainless steel nozzle, apply high-voltage static electricity on the stainless steel nozzle through a high-voltage power supply, spray the mixture solution from the stainless steel nozzle and spray it into the receiving device containing isopropanol and water with a volume ratio of 1:1 at 60 ° C, and the ...

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Abstract

The invention discloses lenalidomide composition tablets and a preparation method thereof. The tablets comprise components in percentage by weight as follows: 10%-18% of lenalidomide crystals, 28%-40% of lactose, 28%-40% of microcrystalline cellulose, 1%-5% of konjac glucomannan, 10%-15% of beta-cyclodextrin, 5%-10% of sodium carboxymethyl starch, 0.5%-1.5% of sodium stearyl fumarate and 0.5%-1.5% of powdered cellulose. The preparation technology of the lenalidomide composition tablets is stable, simple and easy to operate, technological parameters are reliable, and the production cycle is shorter; experimental research shows that the lenalidomide raw material is stable in crystal form, higher in purity and capable of meeting the quality requirement of final products; the synthesis technology is concise, stable, feasible and applicable to mass production; the quality is controllable, the stability is better, and the lenalidomide raw material is unchanged under conditions of affecting factors such as the high temperature, high humidity and 10 days of illumination and is stable after being stored for 6 months under the acceleration condition.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a lenalidomide composition tablet and a preparation method thereof. Background technique [0002] Myelodysplastic syndrome (MDS), also known as preleukemia, is a group of acquired clonal diseases originating from hematopoietic stem cells, and its characteristic pathophysiological changes are abnormal development of clonal hematopoietic stem / progenitor cells and ineffective hematopoiesis. The basic clinical features are abnormal morphology of hematopoietic cells in the bone marrow and peripheral blood cytopenias, and a high risk of transformation into dosage forms of myeloid leukemia. The etiology of MDS may be related to heredity, environment or certain factors such as viral hepatitis, tumor radiotherapy and chemotherapy, and some cytotoxic drugs. MDS is mainly seen in the elderly, and 90% of patients are >60 years old. According to statistics...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/454A61K9/28A61P7/00C07D401/04
CPCA61K9/2054A61K9/28A61K31/454C07D401/04
Inventor 李维李开均黄晓平邓强
Owner DEYANG HUAKANG PHARMA
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