Formulation & Evaluation of Gemcitabine Hydrochloride Loaded Solid Lipid Nanoparticles

INTRODUCTION Gemcitabine hydrochloride is an antimetabolite (pyrimidine analog) with poor oral bioavailability (9%) due to the first pass metabolism. GEM is a water soluble drug (log p = -1.4) with a short half-life of 42 to 94 minutes (short infusions) and 245 to 638 minutes (long infusions) respectively. Extensive first pass metabolism, low bioavailability, high dosing frequency and less halflife of GEM are evident through formulations of tablets and injections. These problems can be overcome by incorporating drug in a suitable delivery system such as SLN’s. Solid Lipid Nanoparticles are a new generation of submicron-sized lipid emulsions where the liquid lipid (oil) has been substituted by a solid lipid. Solid lipid nanoparticles are typically spherical with an average diameter between 1 nm to 1000 nm. SLNs have been proposed as an alternative drug carrier system to other novel delivery approaches such as emulsions, liposomes, and polymeric nanoparticles due to various advantages, including feasibility of incorporation of lipophilic and hydrophilic drugs, improved physical stability, low cost, ease of scale-up, and manufacturing. The objective of this work is to formulate and evaluate solid lipid nanoparticles loaded with Gemcitabine hydrochloride by double emulsion method using stearic acid & GMS as lipid core, with a view to protect the drug from rapid metabolism & sustain the drug release.