Tadalafil orodispersible film and preparation method thereof

Abstract

The present disclosure relates to a composition for preparing an orodispersible film, which comprises tadalafil or a pharmaceutically acceptable salt thereof, a surfactant, a plasticizer and a sweetener; an orodispersible film; and a preparation method thereof . The orodispersible film of the present disclosure can improve the dissolution rate of tadalafil without a complicated process, and it has excellent stability compared with the previous Cialis because the generation of related compounds is suppressed regardless of the presence or absence of packaging. In addition, when polyethylene glycol 400 is included in a specific content as a plasticizer, excellent film properties can be maintained, including preventing film breakage, securing flexibility, and preventing oil leakage of film formulations.

Description

technical field [0001] The present disclosure relates to a composition for preparing an oral dispersible film, which comprises tadalafil (tadalafil) or a pharmaceutically acceptable salt thereof, a surfactant, a plasticizer and a sweetener; An oral dispersible film; and a preparation method thereof. Background technique [0002] There are various types of orodispersible formulations such as tablets, chewable tablets, sublingual tablets, capsules and liquid formulations for oral administration. Among these preparations, general tablets, capsules, etc. are disadvantageous for patients who have difficulty taking medicines, and liquid preparations are disadvantageous in terms of stability and inaccurate volume. Therefore, new and easy-to-administer formulations are needed. [0003] Recently, several formulations with different drug delivery systems have been released. ODT (Orodispersible Tablet), which is an orodispersible solid preparation, is one of these preparations. The...

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Problems solved by technology

[0012] Therefore, the dissolution rate of control drug is very important for the effective absorption of tadalafil with low water solubility, but the technical difficulty lies in applying tadalafil to orodispersible film preparation, because orodispersible film preparation has low dissolution rate. Spend

[0013] As explained above, in the preparation of recently appeared orodispersible films, especially the orodispersible films containing poorly water-soluble tadalafil as an active ingredient, there is a need for a formulation that is effective in improving the dissolution rate of the drug, and at the same time inhibits related compounds, but no such improved tadalafil orodispersible film exists to date

[0014] In addition, mass production is required for commercial utilization, but occasionally causes a reduction in product value due to membrane breakage, excessive flexibility, and leakage of the membrane's liquid additives to the membrane surface during distribution.

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