Imran Ahmad
Jina Pharmaceuticals, Inc.,
28100 N. Ashley Ct., Suite 103, Libertyville, IL 60048
Tanzania
Research Article
Development of Aqueous Based Formulation of Docetaxel: Safety and
Pharmacokinetics in Patients with Advanced Solid Tumors
Author(s): Ateeq Ahmad, Saifuddin Sheikh, Shoukath M Ali, Moghis U Ahmad, Mahesh Paithankar, Dipak Saptarishi, Kirti Maheshwari, Kirushna Kumar, Jeba Singh, GN Patel, Jayanti Patel, Ashish Mukhopadhay, Ritwik Pandey, Chinmoy Bose, Singh JK, Manisha Singh, Rahul Chowdhary, Prashant Kale and Imran Ahmad
Ateeq Ahmad, Saifuddin Sheikh, Shoukath M Ali, Moghis U Ahmad, Mahesh Paithankar, Dipak Saptarishi, Kirti Maheshwari, Kirushna Kumar, Jeba Singh, GN Patel, Jayanti Patel, Ashish Mukhopadhay, Ritwik Pandey, Chinmoy Bose, Singh JK, Manisha Singh, Rahul Chowdhary, Prashant Kale and Imran Ahmad
A well characterized Nanosomal Docetaxel Lipid Suspension (NDLS) formulation was developed without using any detergent or toxic organic solvents to avoid hypersensitivity reactions caused by the marketed Taxotere® product. The lyophilized NDLS formulation was easily resuspended in water and found to be physically and chemically stable for 48 hours. Physico-chemical characterization of NDLS confirmed a homogeneous formulation with an average particle size of less than 100 nm. Percent Docetaxel association with lipids in NDLS formulation was found to be greater than 95%. The in-vitro release assay showed a sustained release of 25% Docetaxel after 4 hours and 100% Docetaxel release after 42 hours of incubation. Sub-chronic toxicity in mice and rats showed comparable safety to Taxotere®. However, a pharmacokinetics study in rats revealed greater systemi.. View More»
DOI:
10.4172/2157-7439.1000295