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Maeen Abdulaziz Almodhwahi, Speaker at Pharma Research Conferences 2022
King Abdulaziz University, Saudi Arabia
Title : Preparation and Optimization of Oral Lyophilized Flash Tablets Loaded with Sildenafil Citrate Self Nanoemulsifying System


Sildenafil citrate (SLC) is a drug used worldwide mainly to treat erectile dysfunction. Several barriers are facing the conventional product, which decreased its efficacy as; limited solubility, delayed onset of action, low bioavailability with large variability in the absorption profile. The study aimed to develop an optimized SLC self-nanoemulsifying lyophilized tablet (SNELTs) in order to overcome the previously mentioned barriers. The solubility of SLC in various oils, surfactants, and cosurfactants was estimated. Extreme vertices mixture design a special cubic model was used to develop an optimized SLC-loaded self nanoemulsion with minimum droplet size. Sixteen formulations were prepared and characterized for droplet size. The results of solubility studies indicated that clove oil\oleic acid mixture, Tween 20, and Propylene glycol were selected as oil, surfactant, and cosurfactant, respectively. The optimum SLC-loaded SNEDDS formula showed a droplet size of 65 nm. This formulation is composed of a 10 % oil mixture, 60 % surfactant, and 30 % cosurfactant. For preparation of SNELTs, 0.4% fumed silica, 0.1% HPMC and 0.4% Explotab were the optimum ratio of SNELTs components. This formula is showing satisfactory results in both disintegration and dissolution studies. In vivo pharmacokinetic studies indicated higher bioavailability (1.44 times) for SNELTs compared to conventional tablets. In conclusion, highly bioavailable oral lyophilized flash tablets of SLC was successfully prepared, which will be a good alternative for the conventional solid dosage form.