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Dispersible tablet containing letrozole

A technology for dispersible tablets and letrozole, which is applied in the field of dispersible tablets containing letrozole, can solve the problems of cumbersome patch production process, short effective time, difficulty in popularization, etc., and solve the problems of drug dissolution and low bioavailability, biological The effect of high utilization and simple production process

Active Publication Date: 2009-07-01
AVENTIS PHARMA HAINAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] CN1927190 discloses a letrozole transdermal patch and its preparation method, which solves the problems of short effective time, frequent administration and many adverse reactions in the treatment of advanced postmenopausal breast cancer in the existing letrozole dosage forms
However, the patch production process is cumbersome and requires high equipment and equipment. The level of domestic auxiliary materials is difficult to meet the requirements of good patch production. Therefore, it is difficult to popularize the production and use of domestic letrozole patches.
[0005] At present, the oral preparations in clinical use are only ordinary tablets, but because letrozole is insoluble in water, it is difficult to dissolve in solid preparations, which seriously affects its bioavailability, and then affects the therapeutic effect

Method used

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  • Dispersible tablet containing letrozole
  • Dispersible tablet containing letrozole
  • Dispersible tablet containing letrozole

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020]

[0021] Preparation process: Weigh letrozole, polyethylene glycol, and sorbitol according to the prescription amount to prepare a solid dispersion, crush and sieve for use; mix with the prescription amount of microcrystalline cellulose and sodium carboxymethyl starch, and make a soft material. Pass through a 20-mesh sieve to granulate, dry, and granulate with a 24-mesh sieve; add micronized silica gel and citric acid in the prescribed proportion, mix well, and press into tablets.

Embodiment 2

[0023]

[0024] Preparation process: Weigh letrozole, lactose, xylitol, and povidone according to the prescription quantity to prepare a solid dispersion; crush and sieve for later use, replace hydroxypropyl cellulose with a low prescription quantity, mix well, make a soft material, pass Granulate with a 20-mesh sieve, dry, and granulate with a 24-mesh sieve; add grape essence and magnesium stearate in the prescribed ratio, mix well, and compress into tablets.

Embodiment 3

[0026]

[0027] Preparation process: Weigh letrozole, polyethylene glycol and mannitol to prepare a solid dispersion according to the prescription, pulverize and sieve for later use, mix with the prescription quantity of croscarmellose sodium and sucrose, and make a soft material. Granulate with a 20-mesh sieve, dry, and granulate with a 24-mesh sieve; add the cantaloupe essence and magnesium stearate in the prescription ratio, mix well, and compress into tablets.

[0028] Embodiment 1~3 compares with comparative example 1, commercially available common tablet dissolution rate (n=6, X ± SD)

[0029]

[0030] The results show that the dissolution rate of the dispersible tablets of Examples 1 to 3 prepared by solid dispersion technology is significantly higher than that of ordinary dispersible tablets, and higher than that of commercially available ordinary tablets.

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Abstract

The invention discloses a dispersible tablet containing letrozole which has letrozole action ingredient and pharmaceutical accessories. The tablet is applied to the treatment of post-menopausal breast cancer.

Description

technical field [0001] The invention relates to a dispersible tablet containing letrozole, in particular to a dispersible tablet containing letrozole. Background technique [0002] Breast cancer is one of the main tumors that threaten women's health, its incidence rate accounts for about 30% of malignant tumor incidence, and its mortality rate accounts for about 15%. Clinical statistics show that the incidence of breast cancer tends to be younger and urban-rural integration, and the prevention and treatment work has a long way to go. [0003] Letrozole is a synthetic benzyltriazole derivative, which is a new type of highly selective aromatase inhibitor. By inhibiting aromatase, the level of estrogen is reduced, thereby eliminating the stimulating effect of estrogen on tumor growth. Letrozole is 150-250 times more potent in vivo than the first-generation aromatase inhibitor, aminoglutethimide. Clinical studies have proved that letrozole has strong antitumor effect, high spe...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4196A61P35/00
Inventor 尚丽霞
Owner AVENTIS PHARMA HAINAN
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