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Formulations for the preparation of immediate-release tablets for oral use containing low-dose mifepristone for the treatment of endometriosis, tablets thus obtained and their preparation process

An endometriosis and tablet technology, which can be used in medical preparations containing active ingredients, pill delivery, pharmaceutical formulations, etc., can solve problems such as slow removal

Inactive Publication Date: 2015-04-22
VALPHARMA INT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It has a long half-life of about 20 hours (much longer than many glucocorticoid agonists), which makes its elimination from the body very slow

Method used

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  • Formulations for the preparation of immediate-release tablets for oral use containing low-dose mifepristone for the treatment of endometriosis, tablets thus obtained and their preparation process
  • Formulations for the preparation of immediate-release tablets for oral use containing low-dose mifepristone for the treatment of endometriosis, tablets thus obtained and their preparation process
  • Formulations for the preparation of immediate-release tablets for oral use containing low-dose mifepristone for the treatment of endometriosis, tablets thus obtained and their preparation process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0027] A low-dose mifepristone immediate-release tablet formulation with good content uniformity.

[0028] For a batch of 1,000,000 tablets, use 5kg of raw material, 71.417kg of microcrystalline cellulose, 3.333kg of polyvinylpyrrolidone, 2.5kg of croscarmellose sodium, 0.833kg of magnesium stearate and 0.250kg of anhydrous colloidal dioxide silicon.

[0029] a) Preparation of premix

[0030] The mifepristone and microcrystalline cellulose are mixed together, and the mixture is sieved.

[0031] b) Mixing of excipients

[0032] The remaining microcrystalline cellulose, polyvinylpyrrolidone and croscarmellose sodium are mixed together.

[0033] c) Mixing of ingredients and active premix

[0034] The premix containing the active ingredients was added to the excipient mixture and mixed in BIN at 8 rpm for 10 minutes.

[0035] d) Add lubricants and glidants

[0036] Magnesium stearate and microcrystalline silica (microcrystalline silica) are sieved and then added to BIN and mixed with the remai...

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Abstract

Formulations for the preparation of immediate-release tablets for oral use containing low-dose mifepristone for the treatment of endometriosis, tablets thus obtained and their preparation process, are described.

Description

Invention field [0001] The present invention relates to the field of pharmaceutical compositions for the treatment of endometriosis. Background of the invention [0002] As we all know, endometriosis is a chronic and complex disease. It often causes people to suffer to the extent of disability. It originates from the tissue covering the inner wall of the uterus, that is, the excessive existence or covering of the endometrium (endometrium). Excessive presence of tissue on the lining of other organs such as the ovaries, fallopian tubes, peritoneum, vagina, and intestines. [0003] It is estimated that about 10% of women in Europe are affected by endometriosis, and 30%-40% of female infertility cases are attributable to endometriosis; in Italy, at least 3 million women have been diagnosed with Endometriosis. [0004] So far, there is no known treatment method that can permanently solve endometriosis, and it has not been discovered so far. [0005] It is also known that mifepristone, al...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/567
CPCA61K31/567A61K9/2095A61K9/2054A61K31/575A61P15/08A61P15/02A61K9/2013A61K9/2027A61K9/2009
Inventor 罗伯托·瓦尔杜斯塞若茨·阿万尼塞因
Owner VALPHARMA INT
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