Formulation and evaluation of mouth dissolving film of tadalafil
Abstract
This research work was aimed to enhance the oral bioavailability and provide faster onset of action of Tadalafil (used for the treatment of the erectile dysfunction (ED) and pulmonary arterial hypertension) by formulating its mouth dissolving film (MDF).Tadalafil belongs to BCS class II and the oral bioavailability of it's about 28%.The MDF of Tadalafil was prepared by solvent casting method using HPMC-E5 (film forming agent), Methyl cellulose (thickening agent), Propylene glycol (plasticizer), Tween-80 (solubilizing agent), Microcrystalline cellulose (disintegrating agent), Citric acid (saliva stimulating agent), Sucrose (sweetening agent), Vanillin (flavoring agent), EDTA disodium (preservative).The formulation was optimized by two factors, three level (2 3 ) full factorial design using concentration of Plasticizer (X1) and concentration of film forming agent (X2) as independent variables and formulation was evaluated for uniformity of mass, thickness, folding endurance, drug content uniformity, in-vitro disintegration, invitro drug dissolution study and stability study.Based on results it was concluded that MDF (F5) showed enhanced bioavailability and faster onset of action as compared to available tablet dosage form.
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