Journal of Nanomedicine & Nanotechnology

Patel R

Publications

• Research Article
  Bioequivalence Study of Pegylated Doxorubicin Hydrochloride Liposome (PEGADRIA) and DOXIL^® in Ovarian Cancer Patients: Physicochemical Characterization and Pre-clinical studies.
  Author(s): Ali SM, Sheikh S, Ahmad A, Ahmad MU, Chen P, Paithankar M, Choudhury K, Makadia RD, Kumar A, Velavan K, Satheesh CT, Singh JK, Mamillapalli G, Saptarishi D, Kale P, Patel R, Barkate HV and Ahmad I Ali SM, Sheikh S, Ahmad A, Ahmad MU, Chen P, Paithankar M, Choudhury K, Makadia RD, Kumar A, Velavan K, Satheesh CT, Singh JK, Mamillapalli G, Saptarishi D, Kale P, Patel R, Barkate HV and Ahmad I
  
  Objective:To develop Pegylated Doxorubicin Hydrochloride Liposome (PEGADRIA) and compare its physicochemical properties, preclinical safety and efficacy, clinical pharmacokinetic and safety profiles with those of the reference product, Doxil®. Methods: PEGADRIA was prepared and the structure morphology, lamellarity, size, shape, drug loading, lipid bilayer and Peg layer thickness were determined. Safety studies were conducted in mice and rats and efficacy study was conducted in a P-388 leukemia mouse model. To evaluate the pharmacokinetic profile of PEGADRIA, a multicenter, open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose cross-over bioequivalence study was conducted with Doxil® in ovarian cancer patients whose disease had progressed or reoccurred after platinum based chemot.. View More»
  DOI: 10.4172/2157-7439.1000361

  Abstract PDF