TY - JOUR AU - ABOUHUSSEIN, DALIA AU - TEAIMA, MAHMOUD H. AU - AL-NUSEIRAT, ADI AU - BADARY, OSAMA AU - EL-NABARAWI, MOHAMED A. AU - EL-MONEM, REHAB ABD PY - 2022/09/07 Y2 - 2024/03/29 TI - 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 JF - International Journal of Applied Pharmaceutics JA - Int J App Pharm VL - 14 IS - 5 SE - Original Article(s) DO - 10.22159/ijap.2022v14i5.44289 UR - https://journals.innovareacademics.in/index.php/ijap/article/view/44289 SP - 105-112 AB - <p><strong>Objective: </strong>This study aimed to prepare and evaluate oral disintegrating tablets (ODTs) of Daclatasvir dihydrochloride (DCV) using different co-processed excipients to enhance drug dissolution and improve oral bioavailability for the treatment of hepatitis C infection.</p><p><strong>Methods: </strong>Ten Daclatasvir-ODTs formulae were prepared using co-processed excipients via direct compression. The prepared formulae were evaluated according to taste masking, weight variation, thickness, friability, hardness, drug content, and wetting time. <em>In vitro</em> disintegration time, <em>in vivo</em> disintegration time, and <em>in vitro</em> dissolution tests were also evaluated and taken as parameters for the selection of the best formula. The selected best formula was subjected to an <em>in vivo</em> study on volunteers and compared to a marketed product.</p><p><strong>Results: </strong>All DCV-ODTs had acceptable physical properties in accordance with pharmacopeial standards. DCV-ODTs prepared with Pharmaburst® (F10) recorded the shortest wetting time (14±0.08s), fastest <em>in vitro</em> disintegration time (46±0.16s), shortest <em>in vivo</em> disintegration time (27±0.16s), and attained the fastest onset of dissolution (94.3±0.03 %) at 5 min to all other excipients and has been identified as the best formula. The <em>in vivo</em> pharmacokinetic study showed that the Pharmaburst-based formula has a significant Cmax increase of (2.17±0.28 μg/ml) compared to (1.42±0.59) for the marketed product and a significant decrease of Tmax to 60 min instead of 110 min for the marketed product.</p><p><strong>Conclusion: </strong>The <em>in vivo</em> pharmacokinetic study in humans showed that the ODTs was found to be appropriate for delivery of Daclatasvir with a faster drug absorption rate when compared to the marketed products with applicable taste related to the nature of dosage form.</p> ER -