Formulation and Evaluation of Protein Bound Paclitaxel Nanoparticles for Injectable Suspension

Abstract

Aims: The aim of present study is to develop Paclitaxel nanoparticles for injectable suspension, an anti-neoplastic drug formulation.
 Study design: Mention the design of the study here.
 Place and Duration of Study: Sagar Institute of Research & Technology- Pharmacy, Ayodhya Bypass Road, Bhopal, between June 2017 and June2018.
 Methodology: The Human serum albumin (HSA) is the most abundant plasma protein in the human blood with a half-life of 19 days. It can reversibly bind hydrophobic drug substances, transport them in the body and release drugs at cell surface. The formulation is prepared by homogenization at high-pressure of paclitaxel in the presence of human serum albumin into a nanoparticle colloidal suspension. Paclitaxel nano particles have been stabilized by human albumin and maintain the average size of 100 nm
 Results: The particle size of the reconstituted solution is checked using the laser diffraction Technique the particle is White to yellow lyophilized after reconstitution the particle become homogeneous milky suspension without visible particulates. Reconstitution time NMT 25 minutes 20.45 sec. The assay was performed by HPLC and found to be 90.0% to 110.0% of label. The retention time of Paclitaxel peak obtained in sample corresponds to the respective standards obtained from standards the pH NLT 6.00 to NMT 8.00 Particle size NLT 100 nm – NMT 200 nm. Sterility test was comply as per USP <71>
 Conclusion: The nano-delivery systems could have the potential to be free of Cremophor EL and ethanol, enhance Paclitaxel solubility, improve Paclitaxel pharmacokinetic profiles in vivo, decrease its side effects, passively or actively target to tumor sites due to the EPR (Enhanced Permeability and Retention) effect and the use of targeting ligands, respectively, nanotechnology is a very active research area in both academic and industrial settings.
 Keywords: paclitaxel, Anti-cancer, nanotechnology, Injectable, Suspension