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Letrozole dispersing tablet dosage form

A technology of letrozole and dispersible tablets, applied in the field of medicine, can solve the problems of large gastrointestinal irritation, low bioavailability, inappropriateness and the like, and achieves the effects of low production and packaging cost, simple production process and convenient taking.

Inactive Publication Date: 2014-06-18
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Letrozole is of great significance to the vast number of breast cancer patients in my country. After clinical research, we found that the only common tablets and other dosage forms on the market are far from meeting the needs of the majority of patients, especially for those severe cancer patients who are difficult to take, For patients with decreased gastrointestinal absorption function after taking antineoplastic drugs for a long time, there is currently no approved drug delivery method
Ordinary tablets are inconvenient for patients to take, have low bioavailability, and cause severe gastrointestinal irritation, which reduces the compliance of long-term medication patients
Moreover, letrozole has poor water solubility and is not suitable for injection

Method used

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  • Letrozole dispersing tablet dosage form
  • Letrozole dispersing tablet dosage form
  • Letrozole dispersing tablet dosage form

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Embodiment 1 (prescription quantity is 1000 tablets)

[0018] Prescription A:

[0019] Letrozole 2.5g

[0020] Microcrystalline cellulose (disintegrant) 122.5g

[0021] Preparation process: The main drug is passed through a 100-mesh sieve, and the disintegrant is passed through a 80-mesh sieve. Weigh the prescribed amount of the disintegrant and mix evenly. , granulated, dried and pressed into tablets. Dispersible tablet dispersion time limit is 2.6min.

Embodiment 2

[0022] Embodiment 2 (prescription quantity is 1000 tablets)

[0023] Prescription B:

[0024] Letrozole 2.5g

[0025] Lactose (filler) 127g

[0026] Sodium carboxymethyl starch (disintegrant) 6g

[0027] 4%PVP K3Q Absolute ethanol solution (adhesive) 50g

[0028] Magnesium stearate (lubricant) 1g

[0029] Preparation process: the main drug is passed through a 100-mesh sieve, the filler and disintegrant are passed through a 80-mesh sieve, and the prescribed amount of filler and disintegrant is weighed and mixed evenly, and then the prescribed amount of the main drug is mixed with it by an equal amount of incremental method , add an appropriate amount of binder to granulate, add the prescribed amount of lubricant after drying, mix well, and press into tablets. Dispersible tablet dispersion time limit is 2.1min.

Embodiment 3

[0030] Embodiment 3 (prescription quantity is 1000 tablets)

[0031] Prescription C:

[0032] Letrozole 2.5g

[0033] Microcrystalline cellulose (filler) 200g

[0034] Cross-linked polyvinylpyrrolidone (disintegrant) 12g

[0035] 4%PVP K3Q Absolute ethanol solution (adhesive) 45g

[0036] Magnesium stearate (lubricant) 2g

[0037] The preparation process is the same as that of prescription B. The disintegration time limit of dispersible tablet is 1.6min.

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Abstract

The invention belongs to the technical field of medicine and relates to a letrozole dispersing tablet dosage form. A lot of clinical surveys prove that necessity of the letrozole dispersing tablet dosage form is confirmed and the letrozole dispersing tablet dosage form improves patient compliance and medicine bioavailability. The letrozole dispersing tablet dosage form can be used for treatment on breast cancer of postmenopausal women.

Description

technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a letrozole dispersible tablet dosage form, and also relates to a preparation method of the above-mentioned dispersible tablet. The above-mentioned letrozole dispersible tablet is used for patients who are ineffective after tamoxifen and other anti-estrogen therapy. Treatment of breast cancer in postmenopausal women. 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 developed by Swiss Novartis Pharmaceuticals. It was first launched in the UK in 1996 and in the US in 1997. Ch...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4196A61P35/00
Inventor 严洁李轩
Owner TIANJIN HANKANG PHARMA BIOTECH
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