Tadalafil containing orally-dissolved film agent and preparation method thereof
2016
The invention relates to a tadalafil containing orally-dissolved film agent and a preparation method thereof. The tadalafil containing orally-dissolved film agent starts to be absorbed in the oral cavity, takes effect quickly and is good in treatment effect and convenient to take, and water drinking is not needed. The tadalafil containing orally-dissolved film agent comprises the active ingredient tadalafil, a high-polymer film-forming material, a skin penetration enhancer and pharmaceutically-acceptable other auxiliary materials, wherein the weight percentage of tadalafil in the orally-dissolved film agent is 10-50%, preferably 20-50%; the D90 partical size of tadalafil is smaller than or equal to 25 microns, preferably smaller than or equal to 20 microns and more preferably smaller than or equal to 15 microns. The skin penetration enhancer is added into the prescription, meanwhile, the particle size of the bulk pharmaceutical chemical is controlled, tadalafil is micronized, it is ensured that the medicine is partially absorbed at the oral mucosa, the active ingredient is absorbed in the oral cavity more rapidly, and the film agent takes effect faster than tablets and other common film agents.
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