Research work was carried out at the Faculty of Pharmacy in the Maharaja Sayajirao University of Baroda by Ph.D. student Dr. Rahul Dhande under the guidance of Dr. Hetal Thakkar. The title of the patent is “PEGlyted spherulites of anti-cancer active ingredients” bearing the patent number 344646.
The project work was planned to take into consideration the need for a better formulation of lung cancer treatment, characterized by uncontrolled cell growth in tissues of the lung and if untreated, becomes metastatic and spreads to other parts of the body.
The main problem of cancer is its non-specific distribution of drugs which leads to serious side effects like anemia, thrombocytopenia, cardiac arrhythmia, alopecia, etc. Targeted delivery of the anticancer drug to the affected site will lead to the achievement of better therapeutic action with reduced dose and side-effects. Various nanocarrier based formulations of anti-cancer drugs for targeted drug delivery are available in the market and also reported.
There are certain limitations of the nanocarriers such as low drug entrapment efficiency, poor stability, etc. In the present invention, the spherulites of two anti-cancer drugs, Gemcitabine Hydrochloride and Vinorelbine Tartrate have been formulated. Spherulites are concentric multilamellar vesicles obtained by shearing the lamellar phase of lipids and surfactants. They consist of concentric bilayers of amphiphiles alternating with layers of the aqueous medium in which hydrophilic drugs can be sequestered with high yield. Spherulites are having possible applications such as encapsulation of hydrophilic as well as lipophilic drugs, encapsulation of large molecular weight molecules, and also have possible theranostic applications.
The developed formulations were evaluated using various in-vitro and in-vivo studies. The in-vivo studies conducted on rats using gamma scintigraphy indicated the preferential accumulation of the formulation in the lungs and negligible distribution to the other organs. This proves that the developed spherulite formulation of the anti-cancer drugs offers a safer alternative to the conventional treatment of lung cancer.
