Comprehensive Evaluation of In-Vitro and In-Vivo Bioequivalence of Paclitaxel Injectable Suspension Compared to ABRAXANE ۱۰۰ mg

This study investigates the bioequivalence of PACLINAB® ۱۰۰ mg Injectable Suspension (Nano Daru) compared to the reference drug ABRAXANE® ۱۰۰ mg Injectable Suspension (Celgene UK). The in-vitro studies evaluated assay, content uniformity, and dissolution profile using USP ۴۱/NF ۳۶ standards. Key pharmacokinetic parameters, including Cmax, Tmax, T۱/۲, AUCO-t, AUC۰-inf, and elimination rate constant (Ke), were assessed in in-vivo studies conducted with healthy volunteers. Analytical methods were validated following ICH M۱۰ guidelines and EMEA recommendations, employing LC-MS/MS for bioanalytical analysis. Results demonstrated comparable in-vitro drug release profiles with f۲ similarity factors exceeding ۸۰. Pharmacokinetic analyses revealed PACLINABⓇ fell within the ۸۰-۱۲۵% 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.

کلیدواژه ها:

Paclitaxel ، Injectable Suspension ، Bioequivalence ، Pharmacokinetics ، ABRAXANE® ، LC-MS/MS ، In-Vitro Dissolution ، Stability Testing ، Analytical Validation ، PACLINAB®