Dr. Hetal Thakkar and her PhD student, Dr.Rahul Dhande have been granted Indian Patent for their invention on spherulites based targeted drug delivery systems for lung cancer. The title of the patent is “PEGlyted spherulites of anti-cancer active ingredients” bearing the patent number 344646.
The research work was carried out at Faculty of Pharmacy, The Maharaja Sayajirao University of Baroda by Dr. Rahul Dhande under the guidance of Dr. Hetal Thakkar.
The project work was planned taking into consideration the need of a better formulation for treatment of lung cancer, which is 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 treatment of cancer is the non-specific distribution of the drugs leading to serious side effects like anaemia, thrombocytopenia, cardiac arrhythmia, alopecia etc. Targeted delivery of anti-cancer drugs to the affected site leads to 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.
However, 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 Tartarate have been formulated.
Spherulites are concentric multilamellar vesicles obtained by shearing lamellar phase of lipids and surfactants. They consists of concentric bilayers of amphiphiles alternating with layers of aqueous medium in which hydrophilic drugs can be sequestered with high yield.
Spherulites are having the 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 offer a safer alternative to the conventional treatment of lung cancer.