Pharmaceutical composition containing lenalidomide, and preparation method and medical application thereof

A technology of lenalidomide and composition, applied in the field of pharmaceutical preparations, can solve the problems of high production cost, slow drug dissolution, low preparation efficiency and the like, and achieve the effect of quality, safety and controllability

Inactive Publication Date: 2017-01-11
JIANGSU HANSOH PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] 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 cost...

Method used

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  • Pharmaceutical composition containing lenalidomide, and preparation method and medical application thereof
  • Pharmaceutical composition containing lenalidomide, and preparation method and medical application thereof
  • Pharmaceutical composition containing lenalidomide, and preparation method and medical application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0085] Composition and dosage of capsule contents containing 5 mg of active ingredient (200 capsules)

[0086] components Dosage Lenalidomide 1.000g anhydrous lactose 29.400g microcrystalline cellulose 8.000g Croscarmellose Sodium 1.200g Magnesium stearate 0.400g

[0087] Preparation Process:

[0088] 1) Pretreatment of raw and auxiliary materials: lenalidomide is micronized and passed through a 60-mesh sieve, and microcrystalline cellulose and croscarmellose sodium are passed through a 60-mesh sieve for treatment.

[0089] 2) Add the prescribed amount of microcrystalline cellulose into the laboratory hopper mixer, set the speed at 15 rpm, and mix for 3 minutes;

[0090] 3) Add the prescription amount of lenalidomide and croscarmellose sodium into the laboratory hopper mixer, add anhydrous lactose in equal increments, set the speed at 15 rpm, and mix for 20 minutes;

[0091] 4) Magnesium stearate is added to the laboratory hopper...

Embodiment 2

[0094] Composition and dosage of capsule contents containing 5 mg of active ingredient (200 capsules)

[0095] components Dosage Lenalidomide 1.000g corn starch 29.400g microcrystalline cellulose 8.000g Croscarmellose Sodium 1.200g Magnesium stearate 0.400g

[0096] The preparation process refers to Example 1.

Embodiment 3

[0098] Composition and dosage of capsules containing 10 mg of active ingredient (200 capsules)

[0099] components Dosage Lenalidomide 2.00g anhydrous lactose 54.80g microcrystalline cellulose 20.00g Crospovidone 2.40g Magnesium stearate 0.8g

[0100] The preparation process refers to Example 1.

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Abstract

The invention relates to a pharmaceutical composition containing lenalidomide, and a preparation method thereof. The pharmaceutical composition is prepared from the lenalidomide, a thinning agent, a disintegrating agent, a lubricating agent and an optional pharmaceutically acceptable carrier. The pharmaceutical composition containing the lenalidomide provided by the invention has favorable stability and drug dissolution rate, the product quality can be controlled, and the preparation method is simple in process, high in operability and suitable for industrialized mass production.

Description

technical field [0001] The invention belongs to pharmaceutical preparations, in particular to a pharmaceutical preparation of lenalidomide and a preparation method thereof. Background technique [0002] Lenalidomide (Revlimid), the chemical name is 3-(4-amino-1,3-dihydro-1-oxo-2H-isoindol-2-yl)-2,6-piperidine di Ketone, formula C 13 h 13 N 3 o 3 , and its molecular weight is 259.2606. Lenalidomide is an antineoplastic drug developed by Celgene Biopharmaceutical Company of the United States. It is an analogue of thalidomide, but it has fewer side effects than thalidomide and does not cause neonatal deformities. Clinically, it is mainly used for the treatment of myelodysplastic syndrome (MDS), multiple myeloma (MM), leukemia and mantle cell lymphoma, and was approved by the FDA in 2005. Lenalidomide is a representative drug of a new generation of immunomodulators, which has a dual mechanism of action. [0003] The patent No. US7119106 provides a pharmaceutical compositi...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K47/26A61K47/38A61K47/12A61K47/36A61K47/32A61K31/454A61P35/00A61P35/02
CPCA61K9/4858A61K9/4866A61K31/454
Inventor 孙长安陈刚胜陈中亚周炳城
Owner JIANGSU HANSOH PHARMA CO LTD
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