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Exemestane tablet and technique for preparing the same

A technology of exemestane and preparation process, applied in the field of pharmaceutical preparations, can solve the problems of unsmooth surface and pitting of film-coated tablets and the like

Active Publication Date: 2009-07-01
SHANGHAI FOSUN PHARMA DEV CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] When conducting a comprehensive inspection of Exemestane Tablets, it was found that the dissolution rate was only between 65% and 75% (lower than the legal standard of 75%), and the surface of the film-coated tablets after coating was not smooth and clean, and there were problems such as pitting

Method used

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  • Exemestane tablet and technique for preparing the same
  • Exemestane tablet and technique for preparing the same
  • Exemestane tablet and technique for preparing the same

Examples

Experimental program
Comparison scheme
Effect test

example 1-3

[0059] Example of Exemestane Tablets (1000 Tablets)

[0060]

[0061] Operation process:

[0062] 1. Mix exemestane micronized (10-25um) and lactose evenly and pass through an 80-mesh sieve; sodium starch glycolate, hydroxypropyl cellulose, microcrystalline cellulose, and magnesium stearate pass through a 100-mesh sieve respectively.

[0063] 2. Put exemestane, lactose, carboxymethyl starch sodium, hydroxypropyl cellulose, and microcrystalline cellulose in the formula amount into a high-speed wet granulator and stir at low speed (120 rpm) for 3 minutes, then at high speed (180 rpm) ) and stirred for 2 min, added about 40 g of 8% PVP ethanol solution to granulate, stirred at low speed (120 rpm) for 2 min, and granulated at low speed (1200 rpm) for 1 min.

[0064] 3. Ventilate and dry at 60-70°C for 1.5-2.5 hours, and sieve with a 16-mesh sieve.

[0065] 4. Add the prescription amount of magnesium stearate, mix after 50 revolutions (3 revolutions / minute), take a sample to d...

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Abstract

The invention relates to aromasin tablet and preparation method of same. The invention reduces the dosage of carboxyrnethyl starch sodium and hyprolose, and increases the dosage of microcrystalline cellulose. The aromasin is micronized which overcomes the shortage of the current technical process. The invention provides products of better quality and dissolution rate, and capable being used in industrial production.

Description

Technical field: [0001] The present invention relates to pharmaceutical preparations. It specifically relates to exemestane tablets and a preparation process thereof. Background technique: [0002] Breast cancer is one of the most common malignant tumors among women in the world. The incidence rate is increasing year by year. In today's elderly population, women over 65 years old, about 26% suffer from breast cancer, and about 1 / 3 of the tumor growth requires high estrogen levels to maintain, that is, estrogen dependence Characteristics. Estrogen-dependent breast cancer occurs more frequently in postmenopausal women. Antiestrogens are commonly used in patients with estrogen-dependent breast cancer. Tamoxifen has been used as the first-line treatment drug, but the effect of tamoxifen is better when it is first used, and long-term use is prone to drug resistance, leading to disease recurrence. Another class of aromatase inhibitors whose mechanism of action is different fro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/5685A61K9/20A61K47/38A61P35/00A61P35/04A61P15/14
Inventor 熊洁蔡胜包玉林
Owner SHANGHAI FOSUN PHARMA DEV CO LTD
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