Formulation Development and Evaluation of Paclitaxel Loaded Solid Lipid Nanoparticles Using Glyceryl Monostearate.

ABSTRACT

Solid Lipid Nanoparticles (SLNs) are important because of their size and stability. SLNs have been reported as an alternative drug delivery device to traditional polymeric nanoparticles. SLNs are in submicron range (50- 1000nm) and are composed of physiologically tolerated lipid components. At room temperature the particles are in solid state. They are made up of bio-compatible and bio-degradable materials capable of incorporating lipophilic and hydrophilic drugs. Paclitaxel is a Di-terpenoid Pseudo-alkaloid having anti-neoplastic activity particularly against primary epithelial, ovarian carcinoma, Breast cancer, Colon Cancer, Brain Cancer, Lungs cancer and AIDs Related Kaposi’s Sarcoma. Paclitaxel is an effective drug against Aggressive Cancer’s because it adversely affect the process of cell division by preventing restructuring. The present study is to investigate the probability of incorporating paclitaxel in SLNs using Glyceryl Mono-stearate (GMS) as a lipid matrix, poly-oxy ethylene (Brij 97) as a surfactant, soya-lecithin as a co-emulsifier. Paclitaxel loaded SLNs are prepared by Solvent emulsification and evaporation method using ultra sonication and optimization of critical process variables were carried out to develop stable SLNs. The average particle size of SLNs was found to be 63nm ± 5.77 with Poly dispersity index (PDI) 0.272 ± 0.02 and entrapment efficiency was found 94.58%. The stability studies and zeta potential were performed at refrigerated temperature (2-8 OC) indicating no significant increase in particle size after one month storage. In-vitro release studies showed initial burst release followed by controlled release for 48hrs (about 73%). The release profile was fitted into Higuchi’s model (r2=0.9774). The drug diffuses from SLNs at a comparatively slower rate as the distance for diffusion increases.