تصميم و تقييم مغوطات مص تادالافيل

الملخص EN

The aim of this study was to design, prepare and evaluate compressed lozenges of Tadalafil, because the existing market product of Tadalafil is not available in the form of lozenge.

these tablets dissolve slowly in the mouth and release their ingredients for buccal cavity membrane absorption of part of it, due to the abundance of blood vessels lining the oral cavity and tongue.

the saliva facilitates the melting of active substances and releasing them from the pharmaceutical form.

Tadalafil is metabolised in the liver by CYP3A4 to the catechol metabolite.

this dosage form gives a quick start of the effect, by avoiding the first hepatic effect on the absorbed ratio of the active substance on this path, thus increasing bioavailability.

- Tadalafil has decreases in blood pressure, and relaxation of pulmonary vascular smooth muscle cell, and vasodilatation of the pulmonary vascular bed, increasing blood flow in the cavernous tissues of the penis and producing an erection.

Tadalafil used for the treatment of erectile dysfunction.

the compressed lozenges were prepared by wet granulation using sucrose, manitol, sorbitol, lactose, dextrose PVP, HPMC.

In this study, the prepared compressed lozenges were controlled according to USP 39-NF34: hardness, disintegration, assay, content uniformity, and dissolution rate.

the optimized Tadalafil formulation were subjected to stability studies, according to ICH Q1A guidelines.

it found that most of prepared formulations conform to the pharmacopeia requirements: stable during storage, acceptable by the volunteers and preferred