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Olaparib capsule and preparation method thereof

A technology of olaparib and capsules, which is applied in the field of medicine, can solve the problems of easy stickiness of olaparib raw materials, unstable quality of finished products, and slow dissolution rate, etc., to meet the needs of clinical use, simple production process, and stable quality Effect

Inactive Publication Date: 2017-04-05
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Olaparib raw materials tend to become sticky after absorbing moisture, resulting in increased hardness, difficulty in disintegration, and slower dissolution rate
Therefore, if the selection of auxiliary materials is not good, it is easy to absorb moisture, which will lead to unstable quality of the finished product during storage

Method used

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  • Olaparib capsule and preparation method thereof
  • Olaparib capsule and preparation method thereof
  • Olaparib capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～3

[0028] The weight percent of each component of embodiment 1~3

[0029]

[0030] The preparation method of olaparib capsules:

[0031] 1) Pass olaparib through a 200-mesh sieve, filler and hydroxypropyl cellulose through a 80-mesh sieve, and mix evenly to obtain olaparib premixed powder;

[0032] 2) Prepare an ethanol solution with a concentration of 60%, and its dosage is 55% of the total weight of olaparib, hydroxypropyl cellulose, filler, cosolvent and lubricant; dissolve the cosolvent with half the weight of ethanol solution to obtain Ethanol solution of co-solvent;

[0033] 3) Put the olaparib premixed powder in the wet granulator, add the ethanol solution of the co-solvent, add the remaining ethanol solution and purified water according to the granulation of the material, and stir to obtain the wet granulator passing through a 14-mesh sieve. particles;

[0034] 4) Dry the wet granules; granulate;

[0035] 5) Mix the granules with the lubricant passed through a 80-m...

experiment example 1

[0036] Experimental example 1 In order to investigate the quality stability of the above-mentioned different formula products under different conditions, they were placed under the conditions of high temperature (60°C±2°C), high humidity (92.5%±5%), and light (4500LX±500LX) for 10 days. Day, to investigate the influencing factors.

[0037]

[0038] From the above test results, the products produced under the process conditions are less affected by temperature, humidity and light, and have good quality stability.

experiment example 2

[0039] Experimental example 2 In order to investigate the quality stability of the product during the long-term storage process, we selected the product of Example 1 and placed it under the condition of 40°C and 75% humidity for 6 months, and placed 24 samples under the condition of 25°C and 60% humidity. Month, inspect the stability of product quality.

[0040]

[0041] From the results of product stability investigation in the following examples, the product produced under the process conditions has good quality stability.

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Abstract

The invention relates to an olaparib capsule and a preparation method thereof. The olaparib capsule comprises olaparib which is an active ingredient, and hydroxypropyl cellulose serving as a disintegrating agent and a bonding agent. The olaparib capsule can be rapidly disintegrated and resolved out, the process is simple, and quality is stable.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a medicinal preparation and a preparation method thereof, in particular to an olaparib capsule and a preparation method thereof. Background technique [0002] Olaparib (AZD2281, Ku-0059436) is a selective PARP1 / 2 inhibitor with IC50 of 5 nM / 1 nM, 300 times more potent than Tankyrase-1, released on December 19, 2014 Approved for the treatment of patients with advanced ovarian cancer associated with BRCA gene defects. [0003] Olaparib is a drug that is insoluble in water and acid, and the conventional preparation method has poor dissolution effect and poor quality stability. In pharmacy, in order to speed up the dissolution, the particle size of the raw material is usually reduced and a suitable disintegrant is added to obtain the effect of rapid disintegration and rapid dissolution. [0004] Olaparib raw materials tend to become sticky after absorbing moisture, resulting in incre...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/502A61K47/38A61P35/00
CPCA61K9/1652A61K31/502A61K47/38
Inventor 严洁李轩
Owner TIANJIN HANKANG PHARMA BIOTECH
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