FORMULATION AND CHARACTERIZATION OF ODT USING DIFFERENT CO-PROCESS CONTAINING DACLATSVIR: IN VITRO AND IN VIVO PHARMACOKINETICS STUDY ON HEALTHY VOLUNTEERS FOR HEPATITIS C TREATMENT

Objective: This study aimed to prepare and evaluate oral disintegrating tablets (ODTs) of Daclatasvir dihydrochloride (DCV) using different co-processed excipients enhance drug dissolution improve bioavailability for the treatment hepatitis C infection. Methods: Ten Daclatasvir-ODTs formulae were prepared via direct compression. The evaluated according taste masking, weight variation, thickness, friability, hardness, content, wetting time. In vitro disintegration time, in vivo tests also taken as parameters selection best formula. selected formula was subjected an on volunteers compared a marketed product. Results: All DCV-ODTs had acceptable physical properties accordance with pharmacopeial standards. Pharmaburst® (F10) recorded shortest time (14±0.08s), fastest (46±0.16s), (27±0.16s), attained onset (94.3±0.03 %) at 5 min all other has been identified pharmacokinetic showed that Pharmaburst-based significant Cmax increase (2.17±0.28 μg/ml) (1.42±0.59) product decrease Tmax 60 instead 110 Conclusion: humans ODTs found be appropriate delivery faster absorption rate when products applicable related nature dosage form.