Comprehensive Evaluation of In-Vitro and In-Vivo Bioequivalence of Paclitaxel Injectable Suspension Compared to ABRAXANE 100 mg

Abstract

This study investigates the bioequivalence of PACLINAB® 100 mg Injectable Suspension (Nano Daru) compared to the reference drug ABRAXANE® 100 mg Injectable Suspension (Celgene UK). The in-vitro studies evaluated assay, content uniformity, and dissolution profile using USP 41/NF 36 standards. Key pharmacokinetic parameters, including Cmax, Tmax, T1/2, AUC0–t, AUC0–inf, and elimination rate constant (Ke), were assessed in in-vivo studies conducted with healthy volunteers. Analytical methods were validated following ICH M10 guidelines and EMEA recommendations, employing LC-MS/MS for bioanalytical analysis. Results demonstrated comparable in-vitro drug release profiles with f2 similarity factors exceeding 80. Pharmacokinetic analyses revealed PACLINAB® fell within the 80-125% confidence interval for AUC and Cmax, meeting bioequivalence criteria. Stability tests for stock and working solutions, processed samples, and freeze-thaw cycles confirmed analytical robustness. Validation studies, including accuracy, precision, linearity, and matrix effects, confirmed the reliability of the LC-MS/MS method. Key findings highlight PACLINAB® as an effective alternative to ABRAXANE®, offering comparable bioavailability and dissolution performance. These results support PACLINAB® as a cost-effective bioequivalent formulation, underscoring its clinical and pharmacological interchangeability. This work contributes to the ongoing effort to improve accessible cancer therapies.