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Anastrozole dispersible tablet and preparation method thereof

A technology for anastrozole and dispersible tablets, which is applied in the field of anastrozole dispersible tablets and its preparation, and can solve the problems of high overall toxicity, poor selectivity, and limitations in wide application

Inactive Publication Date: 2013-03-27
BEIJING YILING BIOENG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Despite its proven efficacy in this setting, anglutimide's widespread use has been limited both by its overall toxicity and by its lack of selectivity for aromatase
Because of its poor selectivity, corticosteroids need to be supplemented at the same time, so people began to study to find new, more selective and less toxic aromatase inhibitors

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Weight ratio of raw and auxiliary materials: Anastrozole 10g, cross-linked polyvinylpyrrolidone 75g, lactose 500g, microcrystalline cellulose 400g, povidone 1.5g, sodium saccharin 1.5g, silicon dioxide 1g, magnesium stearate 1.5g.

[0058] Preparation method: (a) Pretreatment: Anastrozole, cross-linked polyvinylpyrrolidone, microcrystalline cellulose, lactose, silicon dioxide, sodium saccharin, magnesium stearate, dried, crushed through a 100-mesh sieve, and weighed 1.5 grams The povidone is dissolved in 30ml50% ethanol;

[0059] (b) Ingredients: 10 grams of anastrozole, 500 grams of lactose, 1.5 grams of sodium saccharin, 37.5 grams of cross-linked polyvinylpyrrolidone, and 200 grams of microcrystalline cellulose were weighed and mixed uniformly;

[0060] (c) Granulation: Use the povidone ethanol solution described in step (a) and 60ml of 50% ethanol to make the mixed material obtained in step (b) into a suitable soft material, granulate with a 24 mesh sieve, and dry t...

Embodiment 2

[0064] Weight ratio of raw and auxiliary materials: Anastrozole 15 grams, low-substituted hydroxypropyl cellulose 150 grams, mannitol 100 grams, microcrystalline cellulose 750 grams, povidone 3 grams, aspartame 0.5 grams, magnesium stearate 2 grams, talcum powder 0.5 grams;

[0065] Preparation method: (a) Pretreatment: Anastrozole, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, mannitol, magnesium stearate, aspartame, talcum powder, drying, pulverizing through a 100-mesh sieve, weighing Get 3 grams of povidone and dissolve in 50ml60% ethanol;

[0066] (b) Ingredients: Weigh 15 grams of anastrozole, 100 grams of mannitol, 0.5 grams of aspartame, 75 grams of low-substituted hydroxypropyl cellulose, and 500 grams of microcrystalline cellulose and mix well;

[0067] (c) Granulation: Use the povidone ethanol solution described in step (a) and 50ml of 60% ethanol to make the mixed material obtained in step (b) into a suitable soft material, granulate with an 1...

Embodiment 3

[0071] Weight ratio of raw and auxiliary materials: 5 grams of anastrozole, 15 grams of cross-linked polyvinylpyrrolidone, 750 grams of lactose, 150 grams of microcrystalline cellulose, 0.5 grams of povidone, 5 grams of sodium saccharin, 3 grams of silicon dioxide, and 1 gram of talcum powder;

[0072] Preparation method: (a) Pretreatment: Anastrozole, cross-linked polyvinylpyrrolidone, microcrystalline cellulose, lactose, silicon dioxide, sodium saccharin, talcum powder, drying, pulverizing and passing through a 100-mesh sieve, weighing 0.5 g of polyvinylpyrrolidone The ketone was dissolved in 30ml30% ethanol;

[0073] (b) Ingredients: 5 grams of anastrozole, 750 grams of lactose, 5 grams of sodium saccharin, 7.5 grams of cross-linked polyvinylpyrrolidone, and 100 grams of microcrystalline cellulose were weighed and mixed uniformly;

[0074] (c) Granulation: Use the povidone ethanol solution described in step (a) and 50ml of 30% ethanol to make the mixed material obtained in ...

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Abstract

The invention provides an anastrozole dispersible tablet and a preparation method thereof. The anastrozole dispersible tablet comprises a primary component which is anastrozole, and auxiliary components comprising a disintegrating agent, a filler, a flavoring agent and the like. The anastrozole dispersible tablet rapidly forms a uniform suspension after meeting water, has the characteristics of convenient administration, fast absorption, high biological availability and the like, can improve the compliances of patients, and can increase the clinical medication selection of doctors and the patients.

Description

technical field [0001] The invention relates to an anastrozole dispersible tablet and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Dispersible tablets are new types of tablets that have attracted increasing attention. The preparation process of the dispersible tablet is simple, and the tablet can be quickly disintegrated into a uniform suspension when put into water. The finished product can be dispersed in water and taken orally, or swallowed, chewed or sucked. Dispersible tablets are the dosage forms recommended in the "Guidelines for the Development of New National Pharmaceutical Preparations". Dispersible tablets are also included in the 2005 edition of Chinese Pharmacopoeia. [0003] Anastrozole is a potent non-steroidal aromatase inhibitor. It can reduce the level of plasma estrogen and produce the effect of inhibiting the growth of breast tumors. It is clinically used in the treatment ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4196A61K47/38A61P35/00A61P15/14
Inventor 王超王永秦拢
Owner BEIJING YILING BIOENG
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