Formulation and optimization of oral drug used for erectile dysfunction / Khaled Ibrahim Elrefaai ; Supervised Mohamed Ahmed Elnabarawi , Mahmoud Hassan Teaima

Thesis (Ph.D.) - Cairo University - Faculty of Pharmacy - Department of Pharmaceutics

Vardenafil Hydrochloride (VH) oral disintegrating tablets (ODTs) and Fast Dissolving Films (FDFS) have been prepared. Dapoxetine Hydrochloride (DH) and Caffeine was added to the best selected formula of the prepared SC ODTs to treat premature ejaculation and maintain normal blood pressure and prevent its decrease caused by administration of VH. The physicopharmaceutical properties as well as the dissolution behavior of the all the prepared (ODTs) and (FDFS) formulae were evaluated. Moreover, VH, DH and Caffeine bioavailability in human volunteers from the prepared (ODTs) and (FDFS) was compared to that of the market product oral tablet (Levitra® and Priligy®). The effect of addition of caffeine to the best selected formula of VH ODTs and unmedicated FDFs on the blood pressure of human volunteers was also monitored. Preparation of ODTs and FDFs enhanced the dissolution rate and extent of VH, DH and Caffeine with 100 % of drug being dissolved after 15 minutes. Moreover, the in vivo study showed that the bioavailability of VH in ODTs FDFs was higher than that of commercial oral product (Levitra®), with relative bioavailability values of 100.9 % and 116% respectively compared to the commercial oral product (Levitra®). Addition of caffeine to the best selected formula of VH ODTs and unmedicated FDFs inhibit severe decrease in the blood pressure which caused by administration of the best selected formula of VH ODTs, FDFs and commercial oral product (Levitra®)

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