Docetexel Injection concentrate for nanodispersion
We have developed a self dispersing nano particle formulation of Docetaxel which avoids toxic solvents that are used in the conventional docetaxel formulation.
In animal studies, the formulation was found to be safe at doses upto 7.5 times the conventional formulation. Our formulation also achieved significantly higher concentration in tumors compared to the innovator brand.
In Phase I clinical trials in patients with solid tumors is completed., doses up to 150 mg/sq mt were found to be tolerated and effective. Compared to this, the usual dose that Docetaxel is administered is from 60- 100 mg/ sq. mt.
For DICN also, the patient does not need premedication of steroids and antihistamines. No inline filters and special infusion sets are required.
The extension of our Nanoparticle technology platform to this product is a validation that the platform technology works across numerous water- insoluble molecules.
For the US, this product will be filed as a 505 b(2).
For India, Phase I study in solid tumor patients has been completed. Phase II study in NSCLC patients is planned.