Dutasteride preparation used for increasing bioavailability and preparation method
A technology of dutasteride and steramine, which is applied in the field of pharmaceutical compositions, can solve the problems of low dissolution rate of dutasteride, etc., and achieve the effect of improving bioavailability and in vitro dissolution rate
Active Publication Date: 2013-06-26
CHONGQING HUAPONT PHARMA
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AI Technical Summary
Problems solved by technology
[0005] The purpose of the present invention is to solve the problem of low dissolution rate of dutasteride and provide a dutasteride composition with improved bioavailability
Method used
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Experimental program
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Effect test
Embodiment 1～5
[0027] The preparation of embodiment 1~5 degree tasteride soft capsule
[0028] 1. Formula: see Table 1;
[0029] Table 1 Example 1~5 prepares the formula of dutasteride soft capsule
[0030]
[0031] 2. Preparation method: Mix all components, heat to dissolve, stir until uniform, and obtain a liquid medicine; take another appropriate amount of gelatin and water, heat in a container to obtain a rubber liquid; take the above liquid medicine and rubber liquid, and use RGY6X15F soft Capsule machine compression molding, drying, 1000 dutasteride soft capsules.
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The invention provides a pharmaceutical composition containing dutasteride used for increasing bioavailability and a preparation method, the pharmaceutical composition containing dutasteride comprises 0.02-0.5% (W / W) of dutasteride, 30-70% (W / W) of oily medium and 25-66% (W / W) of surfactant; wherein the surfactant is one or more selected from span, tween, lecithin, soyabean lecithin or cholesterin. Compared with the prior art, the preparation prepared by the composition can obviously increase the dissolution in vitro of dutasteride, and the bioavailability can reach 144%.
Description
technical field [0001] The invention relates to a pharmaceutical composition, in particular to a dutasteride preparation with improved dissolution rate and bioavailability, and also relates to a preparation method of the pharmaceutical composition. Background technique [0002] Dutasteride is a drug used to treat enlarged prostate. [0003] Dutasteride is poorly soluble in water and therefore has low bioavailability. AVODART, a dutasteride formulation manufactured by Glaxo The main drug, dutasteride, is dissolved with caprylic / capric glyceride to form a liquid and encapsulated in soft capsules to prepare soft capsules, hoping to improve its bioavailability. But the bioavailability of this product is still not high, only about 60% (see FDA's AVODART described in the manual). [0004] Therefore, it is necessary to conduct research to develop a new formulation to improve the solubility of dutasteride and obtain a dutasteride preparation with further improved bioavailabili...
Claims
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Login to View More IPC IPC(8): A61K31/58A61K47/44A61K47/34A61K47/28A61K9/48A61P13/08A61K47/10
Inventor 虞忠鲁定国杨春维
Owner CHONGQING HUAPONT PHARMA
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