alexa Bioequivalence Study of Pegylated Doxorubicin Hydrochloride Liposome (PEGADRIA) and DOXIL® in Ovarian Cancer Patients: Physicochemical Characterization and Pre-clinical Studies
ISSN: 2157-7439

Journal of Nanomedicine & Nanotechnology
Open Access

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Research Article

Bioequivalence Study of Pegylated Doxorubicin Hydrochloride Liposome (PEGADRIA) and DOXIL® in Ovarian Cancer Patients: Physicochemical Characterization and Pre-clinical Studies

Ali SM1, Sheikh S1, Ahmad A1, Ahmad MU1, Chen P2, Paithankar M3, Choudhury K4, Makadia RD5, Kumar A6, Velavan K7, Satheesh CT8, Singh JK9, Mamillapalli G10, Saptarishi D3, Kale P11, Patel R11, Barkate HV3 and Ahmad I1*

1Jina Pharmaceuticals Inc., 28100 Ashley Circle, Suite 103, Libertyville, IL 60048, USA

2Nia Life Sciences Inc., 28100 Ashley Circle, Suite 102, Libertyville, IL 60048, USA

3Intas Pharmaceuticals, Ahmedabad, Gujarat, India

4Health Point Multispeciality Hospital, Kolkata, West Bengal, India

5Shree Giriraj Multispeciality Hospital, Rajkot, Gujarat, India

6Sapthagiri Institute of Medical Science and Research Centre, Bengaluru, Karnataka, India

7Erode Cancer Centre, Erode, Tamilnadu, India

8Sri Venkateshwara Hospital, Bengaluru, Karnataka, India

9S. S Hospital and Research Centre, Patna, Bihar, India

10City Cancer Centre, Vijayawada, Andhra Pradesh, India

11Lambda Therapeutic Research Ltd. Ahmedabad, Gujarat, India

*Corresponding Author:
Imran Ahmad
Jina Pharmaceuticals Inc 28100
Ashley Circle, Suite 103
Libertyville, IL 60048, USA
Tel: 8475730700
E-mail: [email protected]

Received Date: March 02, 2016; Accepted Date: March 16, 2016; Published Date: March 23, 2016

Citation: Ali SM, Sheikh S, Ahmad A, Ahmad MU, Chen P, et al. (2016) Bioequivalence Study of Pegylated Doxorubicin Hydrochloride Liposome (PEGADRIA) and DOXIL® in Ovarian Cancer Patients: Physicochemical Characterization and Pre-clinical studies. J Nanomed Nanotechnol 7: 361. doi:10.4172/2157-7439.1000361

Copyright: © 2016 Ali SM, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

 

Abstract

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 chemotherapy under fasting conditions. The pharmacokinetic parameters were determined based on the concentration-time profiles of doxorubicin, whereas the concentration was determines using LC-MS/MS methods.
Results: PEGADRIA was similar to Doxil® in terms of general morphology, lamellarity, size, shape, drug loading, lipid bilayer and Peg layer thickness. PEGADRIA and Doxil® showed comparable survival benefit in leukemic mice. The toxicity profiles of PEGADRIA in both mice and rats were comparable to those of Doxil®. Plasma concentrations of doxorubicin from cancer patients were measured to determine the pharmacokinetics profile. The geometric mean ratios (90% confidence intervals) of PEGADRIA /Doxil® for free doxorubicin and encapsulated doxorubicin were similar.
Conclusion: PEGADRIA was found to have similar physicochemical profile compared to Doxil®. In addition, it was safe and bioequivalent to Doxil® in ovarian cancer patients.

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