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Ultra-micronized megestrol acetate and pharmaceutical composition containing same

A megestrol acetate, ultra-micronized technology, applied in the field of pharmacy, to achieve the effect of improving appetite and cachexia

Active Publication Date: 2010-03-17
青岛国海生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, the above-mentioned problems have not been solved in the country

Method used

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  • Ultra-micronized megestrol acetate and pharmaceutical composition containing same
  • Ultra-micronized megestrol acetate and pharmaceutical composition containing same
  • Ultra-micronized megestrol acetate and pharmaceutical composition containing same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Embodiment 1: the preparation of ultramicronized megestrol acetate dispersible tablet

[0019] Formula: ultra-micronized megestrol acetate 1.6kg

[0020] Microcrystalline cellulose 0.5kg

[0021] Polyvinylpyrrolidone 1.0kg

[0022] Magnesium stearate 0.02kg

[0023] Appropriate amount of starch slurry

[0024] Made into 10000 pieces

[0025] Preparation method: Megestrol acetate, microcrystalline cellulose, and polyvinylpyrrolidone are respectively pulverized and mixed with a jet mill classifier, wherein 100% of the megestrol acetate particle size is less than or equal to 10 μm. Then add an appropriate amount of starch slurry to the mixture, stir and granulate, dry and granulate, finally add magnesium stearate, mix well, and compress with a tablet machine to obtain 10,000 megestrol acetate dispersible tablets.

Embodiment 2

[0026] Embodiment 2: the preparation of ultramicronized megestrol acetate sheet

[0027] Formula: ultra-micronized megestrol acetate 1.6kg

[0028] Microcrystalline Cellulose 1.2kg

[0029] Polyvinylpyrrolidone 0.3kg

[0030] Magnesium stearate 0.02kg

[0031] Appropriate amount of starch slurry

[0032] Made into 10000 pieces

[0033] Preparation method: Megestrol acetate, microcrystalline cellulose, and polyvinylpyrrolidone are respectively pulverized and mixed with a jet mill classifier, wherein 100% of the megestrol acetate particle size is less than or equal to 10 μm. Then add an appropriate amount of starch slurry to the mixture, stir and granulate, dry and granulate, finally add magnesium stearate, mix well, and compress with a tablet machine to obtain 10,000 megestrol acetate tablets.

Embodiment 3

[0034] Embodiment 3: the preparation of ultramicronized megestrol acetate capsule

[0035] Formula: ultra-micronized megestrol acetate 1.6kg

[0036] Microcrystalline Cellulose 1.2kg

[0037] Polyvinylpyrrolidone 0.3kg

[0038] Magnesium stearate 0.02kg

[0039] Appropriate amount of starch slurry

[0040] Make 10000 capsules

[0041] Preparation method: Megestrol acetate, microcrystalline cellulose, and polyvinylpyrrolidone are respectively pulverized and mixed with a jet mill classifier, wherein 100% of the megestrol acetate particle size is less than or equal to 10 μm. Then add an appropriate amount of starch slurry to the mixture, stir and granulate, dry and granulate, finally add magnesium stearate, mix well, and fill with a full-automatic capsule filling machine to obtain 10,000 megestrol acetate capsules.

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Abstract

The invention relates to an ultra-micronized megestrol acetate in which 100% of particle sizes are smaller than or equal to 10 mu m. The invention also relates to a pharmaceutical composition containing the ultra-micronized megestrol acetate, which comprises an effective quantity of ultra-micronized megestrol acetate and medically acceptable excipient, wherein the effective quantity is 80-160 mg of ultra-micronized megestrol acetate. The pharmaceutical composition can be prepared into dispersing tablets, common tablets and capsules and used for treating advanced breast cancer, advanced endometrial carcinoma, renal carcinoma, prostatic cancer and oophoroma, and can improve the appetite and the cachexia of patients with advanced tumors.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to ultramicronized megestrol acetate and a pharmaceutical composition containing ultramicronized megestrol acetate. Background technique [0002] Megestrol acetate is a kind of progestin, which is mainly used in the treatment of advanced breast cancer and advanced endometrial cancer, and also has certain curative effect on kidney cancer, prostate cancer and ovarian cancer. It can also improve appetite and cachexia in patients with advanced tumors. [0003] Since megestrol acetate is insoluble in water and is often administered as an oral preparation, its crystal form and particle size are important factors affecting the bioavailability of the drug and directly affect the efficacy of the drug. At present, the megestrol acetate preparations on the market in China mainly include ordinary tablets, dispersible tablets and capsules, etc. The particle size of the megestrol acetate raw ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07J7/00A61K31/57A61P35/00
Inventor 孙雪燕赵协民
Owner 青岛国海生物制药有限公司
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