Tadalafil solid dispersion and its tablet

A technology of solid dispersion and tadalafil, which is applied in the directions of non-active ingredients medical preparations, pill delivery, organic active ingredients, etc. problems, to achieve the effect of improving poor oral absorption, simple preparation process and reducing dosage
CN104188912BInactive Publication Date: 2017-12-22SHANDONG UNIV
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
SHANDONG UNIV
Publication Date
2017-12-22
Estimated Expiration
Not applicable · inactive patent

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Abstract

The invention discloses a preparation method of tadalafil solid dispersion: dissolving tadalafil and a carrier material in absolute ethanol, and evaporating under reduced pressure at 50-90°C to obtain it; the tadalafil and The mass ratio of the carrier material is 1:0.5-1:13; the carrier material is selected from one or both of polyvinylpyrrolidone K30 and poloxamer. The present invention also provides a tadalafil solid dispersion tablet: made of tadalafil solid dispersion, filler, disintegrant, lubricant, wherein, the amount of filler accounts for 40% of the total weight of the tablet % to 70%; the amount of disintegrant accounts for 0.5% to 10% of the total weight of the tablet; the amount of lubricant accounts for 0.1% to 5% of the total weight of the tablet. The tadalafil solid dispersion and the tablet of the invention improve the in vitro dissolution rate of the tadalafil, and improve the disadvantages of poor oral absorption and low bioavailability.
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Description

technical field

[0001] The invention relates to a tadalafil solid dispersion, a tablet thereof, and a preparation method thereof. Background technique

[0002] Erectile dysfunction (ED) is the inability to consistently obtain or maintain an erection sufficient for sexual intercourse. ED is one of the common diseases of andrology, its incidence rate accounts for about 10% of adult males, and its prevalence rate increases gradually with age. With the in-depth study of the pathogenesis of ED, the treatment of ED has also made a breakthrough. Sildenafil is the first approved selective phosphodiesterase inhibitor type 5 (PED-5) and is considered to be the first oral drug that can effectively treat ED. The currently marketed PED-5 inhibitor There are three kinds, namely sildenafil, vardenafil, and tadalafil, among which tadalafil is the only ED drug that is not affected by diet, and has a long half-life (17.5h) and good tolerance Etc.

[0003] The chemical name of tadalafil is...

Claims

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