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Lelrozol orally-disintegrating tablet and its preparation method

A technology for oral disintegrating tablets and letrozole, which is applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, and pill delivery, etc., can solve the problems of affecting the therapeutic effect, difficult and difficult dissolution of letrozole, etc.

Active Publication Date: 2013-03-27
BEIJING YILING BIOENG
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  • Summary
  • Abstract
  • Description
  • Claims
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AI Technical Summary

Problems solved by technology

[0004]Current clinically used oral preparations are only ordinary tablets, but because letrozole is insoluble in water, it is difficult to dissolve in solid preparations, which seriously affects its bioavailability degree, thereby affecting the treatment effect
[0005] CN 101467971A discloses a dispersible tablet of letrozole, which uses solid dispersion technology to overcome the slow dissolution rate of the main drug

Method used

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  • Lelrozol orally-disintegrating tablet and its preparation method
  • Lelrozol orally-disintegrating tablet and its preparation method
  • Lelrozol orally-disintegrating tablet and its preparation method

Examples

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Embodiment 1

[0051] Weight ratio of raw and auxiliary materials:

[0052] Letrozole 250g, polyethylene glycol 6000 8750g, maltodextrin 1000g, hydrolyzed gelatin 20g.

[0053] Preparation Process:

[0054] (a) Preparation of dispersion: Weigh polyethylene glycol 6000 and letrozole in proportion, heat and melt polyethylene glycol 6000 and add letrozole, stir well, fully cool, and pulverize through a 100-mesh sieve to obtain Dorozole dispersion is ready for use;

[0055] (b) Ingredients: dissolving the hydrolyzed gelatin into a 0.5% aqueous solution, adding the letrozole dispersion and maltodextrin obtained in step (a) in proportion, and fully stirring to obtain a mixed material;

[0056] (c) Freeze-drying: put the mixed material obtained in step (b) into a suitable mold, and after pre-freezing at -40°C for 12 hours, enter the sublimation stage, the vacuum degree is 1.03mba, and the partition temperature is 5°C; in the analysis stage, the vacuum degree 0.77mba, the partition temperature is...

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Abstract

The invention provides a Lelrozol orally-disintegrating tablet and its preparation method. The Lelrozol orally-disintegrating tablet contains a primary component which is Lelrozol, and auxiliary components comprising a disintegrating agent, a filler, a flavoring agent and the like. The Lelrozol orally-disintegrating tablet has the advantages of rapid disintegration in the oral cavity, and entrance to the digestive tract along with swallowing, 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 drug choices of doctors and the patients.

Description

technical field [0001] The invention relates to a letrozole orally disintegrating tablet and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Breast cancer is one of the most common malignant tumors in women. According to statistics, the incidence rate accounts for 7-10% of all kinds of malignant tumors in the whole body. Its incidence is often related to heredity, and the incidence rate is higher in women between the ages of 40 and 60 and before and after menopause. Malignant tumors usually occurring in the glandular epithelium of the breast. It is one of the most common malignant tumors that seriously affects women's physical and mental health and even threatens their lives. [0003] Letrozole (Lelrozol) is a new generation aromatase inhibitor, which is a synthetic benzylic triazole derivative. Letrozole reduces the level of estrogen by inhibiting aromatase, thereby eliminating the effect of estr...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4196A61K47/42A61P35/00
Inventor 王永王超秦拢
Owner BEIJING YILING BIOENG
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