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Self micro emulsifying composition of tretinoin medicines and its preparing method

A technology of self-microemulsification and composition, which is applied in the direction of drug combination, non-active ingredients of polymer compounds, active ingredients of anhydride/acid/halide, etc. It can solve the problem of affecting drug bioavailability, low solubility, and low drug dissolution rate, etc. problems, to achieve the effects of easy industrial production, simple process, and improved dissolution and absorption

Inactive Publication Date: 2007-04-11
EAST CHINA UNIV OF SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this type of drug is highly fat-soluble and has low solubility in water or body fluids, so the dissolution rate of the drug after oral administration is low, thereby affecting the bioavailability of the drug.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] The components and weight percentages of the self-microemulsifying composition in this example are: 1% drug, 30% emulsifier, 40% co-emulsifier, 28.98% oil phase and 0.02% stabilizer.

[0017] Described medicine is tretinoin.

[0018] The emulsifier is polyoxyethylene hydrogenated castor oil EL.

[0019] Described auxiliary emulsifier is dimethyl isosorbide.

[0020] The oily phase is caprylic acid glyceride.

[0021] The stabilizer is tert-butyl p-hydroxyanisole.

[0022] The preparation method of the self-microemulsifying composition in this example is: disperse tretinoin and tert-butyl p-hydroxyanisole in polyoxyethylene hydrogenated castor oil EL, dimethyl isosorbide, glyceryl caprylate In the mixture, heat at 40°C to melt and mix the components evenly, so that the retinoic acid is completely dissolved to obtain a self-microemulsified composition, which can be filled in a soft capsule containing a sunscreen.

[0023] The beneficial effects of this embodiment are:...

Embodiment 2

[0025] The components and weight percentages of the self-microemulsifying composition in this embodiment are: 3% drug, 70% emulsifier, 16.99% co-emulsifier, 10% oil phase and 0.01% stabilizer.

[0026] Described medicine is tretinoin.

[0027] The emulsifier is a mixture of polyoxyethylene hydrogenated castor oil RH and Tween 20.

[0028] Described co-emulsifier is propylene glycol.

[0029] The oil phase is a mixture of isopropyl palmitate and glyceryl caprylate.

[0030] The stabilizer is a mixture of edetate disodium and butylcresol.

[0031] The preparation method of the self-microemulsifying composition in this embodiment is: the mixture of tretinoin, edetate disodium and butylcresol is dispersed in the mixture of polyoxyethylene hydrogenated castor oil RH and Tween 20, propylene glycol, A mixture of isopropyl palmitate and glyceryl caprylate, heated at 70°C to melt and mix the components to dissolve tretinoin completely to obtain a self-microemulsifying composition, w...

Embodiment 3

[0034] The components and weight percentages of the self-microemulsifying composition of this embodiment are: 1% drug, 50% emulsifier, 20% co-emulsifier, 28% oil phase and 1% stabilizer.

[0035] Described medicine is tretinoin.

[0036] The emulsifier is a mixture of caprylic / capric macrogol glyceride and Tween 80.

[0037] Described co-emulsifier is polyethylene glycol 200.

[0038] The oil phase is polyethylene glycol olein.

[0039] The stabilizer is a mixture of edetate disodium and vitamin E.

[0040] The preparation method of the self-microemulsifying composition in this example is: disperse the mixture of tretinoin, disodium edetate and vitamin E in the mixture of caprylic acid / capric macrogol glyceride and Tween 80, poly In the mixture of ethylene glycol 200 and polyethylene glycol olein, heat at 50°C to melt and mix the components evenly, so that the retinoic acid is completely dissolved to obtain a self-microemulsified composition, which can be filled in a sunscr...

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Abstract

A compound of vitamin A acid medicine and self micro emulsifying and its preparation method belongs to technical field of medicine. In said invention, components of compound and percent weight are : medicine 0.5%-3%, emulsifying agent 30%-70%, emulsifying agent assistant 5%-40 %, oil phase 10%-50% and stabilizer 0%-2%. Preparation method of said compound is : dispersing medicine and stabilizer into one or random multi-components described hereinabove, heating slightly and making components soluble evenly and completely to obtain self micro emulsifying compound , said compound can be contained into soft capsule with opacifier.

Description

technical field [0001] The invention relates to a composition and a preparation method thereof, which belong to the technical field of pharmaceutical preparations, in particular to a retinoic acid drug self-microemulsifying composition and a preparation method thereof. Background technique [0002] The self-microemulsifying composition is a uniform and transparent drug-containing composition composed of an oil phase, a surfactant (i.e. an emulsifier) ​​and a co-emulsifier. Emulsifier, the composition can be prepared as a microemulsion under slight agitation after adding water. The self-microemulsifying composition is easy to prepare, convenient to take, can spontaneously form a microemulsion under physiological conditions in vivo, has good stability, and is convenient for industrial production. The immunosuppressant cyclosporine A self-microemulsifying composition soft capsule has been successfully used in clinical practice The self-microemulsifying composition becomes a re...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/19A61K9/107A61K9/48A61K47/44A61K47/34A61K47/22A61K47/14A61P17/06A61P17/10A61P35/00A61K47/10A61K47/26A61K47/42
Inventor 景秋芳任福正唐燕辉沈永嘉
Owner EAST CHINA UNIV OF SCI & TECH
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