Oral drug preparation of tadalafil

Abstract

The invention relates to an oral drug preparation of tadalafil and an application of the oral drug preparation in treatment of male erectil dysfunction. The oral drug preparation is characterized in that a main drug is tadalafil or a salt thereof; a specific dosage form is a preparation capable of be quickly releasing in an oral cavity, such as an orally disintegrating tablet, a chewable tablet or an oral film; since tadalafil is an insoluble drug and is poor in the bioavailability, the infective dose of tadalafil is relatively high, a plurality of adverse reactions are generated, and visual impairment or loss can be caused by an unreasonable prescription. The research on a tadalafil drug preparation in terms of improvement of the bioavailability of the medicine and reduction of the adverse reactions is particularly important for wide clinic application of tadalafil in treatment of the male sexual dysfunction; in addition, improvement of the compliance of the tadalafil drug preparation when the tadalafil drug preparation is taken by a patient, particularly taken in a non-swallowing manner without water is a great good news for lots of ED patients. The oral drug preparation is patient-oriented and prepared on the basis of a lot of researches.

Description

technical field [0001] The invention relates to an oral pharmaceutical preparation of tadalafil and its application in treating male erectile dysfunction. Background technique [0002] Tadalafil, trade name Cialis, is a reversible, selective phosphodiesterase-5 inhibitor (PDE5), developed by Eli Lilly and Company for the treatment of male erectile dysfunction (ED), 2003 It was approved by the FDA on November 23, and it is also the third new drug approved by the FDA for ED. The specific mechanism of action of tadalafil is as follows: nitric oxide (NO) is the main mediator that causes relaxation and erection of cavernous smooth muscle. Tadalafil is a selective inhibitor of phosphodiesterase (PDE) V, which can enhance the physiological response of penile erection caused by NO release under sexual stimulation. NO is released from nerve endings and endothelial cells and binds to receptors on the smooth muscle of the cavernous body, activating intracellular soluble guanylate cyc...

AI Technical Summary

Problems solved by technology

[0004] Tadalafil is a poorly soluble drug with relatively low bioavailability, so the ineffective dose taken is relatively large, which will produce a variety of adverse reactions, and unreasonable drug use can cause vision damage or loss