Mometasone furoate cream and preparation method thereof

A technology of mometasone furoate cream and mometasone furoate, applied in ointment delivery, pharmaceutical formula, emulsion delivery, etc., can solve the problems of high skin irritation, easy hardening of cream, and disorder of menstrual cycle, and achieve appropriate The effect of retention in the skin, low skin penetration, and good stability

Active Publication Date: 2016-11-23
REGENEX PHARMA LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When too much mometasone furoate is in a suspended state, it is difficult to enter the skin to achieve the necessary effect. When mometasone furoate dissolves more or completely dissolves and absorbs through the skin, it is not only difficult to achieve the necessary effect, but also stimulates the skin Sexuality, long-term use may also cause side effects such as inhibition of the HAP axis, Cushing's syndrome, and menstrual cycle disorders caused by the cumulative absorption of glucocorticoids
The mometasone furoate cream sold in the market is generally poor in stability. After opening the mouth, the cream is easy to harden, the product quality changes, and the use effect is not good. Moreover, it also has a certain relationship with mometasone furoate absorbed through the skin. side effects

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] prescription:

[0017] Material composition Prescription ratio (g ） mometasone furoate 0.1 White Vaseline 400 Glyceryl mono and distearate 15 Span 80 15 Tween 80 5 Titanium dioxide 5 Anhydrous citric acid 0.1 Propylene Glycol 25 water 34.8 Production volume 500

[0018] Preparation method: 1) Weigh white petrolatum, glyceryl mono- and distearate, Span 80 and titanium dioxide according to the prescription amount, heat and melt at 60°C while stirring and mixing evenly to obtain the oil phase; Mix Wen 80 and anhydrous citric acid evenly, add mometasone furoate and heat to 35°C and mix evenly; 3) Weigh propylene glycol and water according to the prescription amount, mix and heat to 60°C, add the mixture prepared in step 2) Add to propylene glycol aqueous solution, stir and mix evenly at 60°C to obtain the water phase; 4) Slowly add the water phase to the...

Embodiment 2

[0020] prescription:

[0021] Material composition Prescription ratio (g ） mometasone furoate 2 White Vaseline 50 Glyceryl mono and distearate 20 Span 80 3 Tween 80 5 Titanium dioxide 5 Anhydrous citric acid 3 Propylene Glycol 7 water 5 Production volume 100

[0022] Preparation method: 1) Weigh white petrolatum, glyceryl mono- and distearate, Span 80 and titanium dioxide according to the prescription amount, heat and melt at 75°C while stirring and mixing evenly to obtain the oil phase; Mix Wen 80 and anhydrous citric acid evenly, add mometasone furoate and heat to 50°C and mix evenly; 3) Weigh propylene glycol and water according to the prescription amount, mix and heat to 75°C, add the mixture prepared in step 2) Add to propylene glycol aqueous solution, stir and mix evenly at 75°C to obtain the water phase; 4) Slowly add the water phase to the oil phase...

Embodiment 3

[0024] prescription:

[0025] Material composition Prescription ratio (g ） mometasone furoate 0.5 White Vaseline 720 Glyceryl mono and distearate 40 Span 80 60 Tween 80 15 Titanium dioxide 15 Anhydrous citric acid 9.5 Propylene Glycol 80 water 60 Production volume 1000

[0026] Preparation method: 1) Weigh white petrolatum, glyceryl mono- and distearate, Span 80 and titanium dioxide according to the prescription amount, heat and melt at 65°C while stirring and mixing evenly to obtain the oil phase; Mix Wen 80 and anhydrous citric acid evenly, add mometasone furoate and heat to 45°C and mix evenly; 3) Weigh propylene glycol and water according to the prescription amount, mix and heat to 65°C, add the mixture prepared in step 2) Add to propylene glycol aqueous solution, stir and mix evenly at 70°C to obtain the water phase; 4) Slowly add the water phase to th...

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PUM

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Abstract

The invention discloses mometasone furoate cream and a preparation method thereof. The mometasone furoate cream is prepared through the technology method comprising the steps that mometasone furoate is mixed with a mixture of Tween-80 and anhydrous citric acid, and then the obtained mixture is added into an aqueous propylene glycol solution. The mometasone furoate cream has the better stability, the appropriate retention amount in the skin and the lower skin penetration amount.

Description

technical field [0001] The invention relates to a cream of mometasone furoate and a preparation method thereof. Background technique [0002] Mometasone furoate is a synthetic glucocorticoid drug, which has the characteristics of strong curative effect and low inhibition of adrenal cortex function. Mometasone furoate cream, which has the effect of reducing inflammation and itching, is very suitable for skin diseases that respond to glucocorticoids. [0003] The extremely poor solubility of mometasone furoate brings certain difficulties to the preparation of its topical cream preparation, mometasone furoate is insoluble in water, and has poor solubility in commonly used solvents for topical administration, such as propylene glycol and hexylene glycol, Currently, different solvents have been used for the development of topical compositions containing mometasone furoate, in which mometasone furoate is present in a partially dissolved and partially suspended state, or in a comp...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/58A61K9/06A61K47/44A61P17/00A61P17/04
Inventor 张欣彭贵子徐华黄志骢黎文健袁永玲左联卢智俊
Owner REGENEX PHARMA LTD
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