FORMULATION & DEVELOPMENT OF SOLID LIPID NANOPARTICLES LOADED WITH ATORVASTATINCALCIUM
Mukesh Sharma1, Atindra Shukla1, Dinesh O Shah1, B. N. Suhagia2
1 Shah-Schulman Center for Surface Science & nanotechnology, Dharmsinh Desai University, Nadiad
2 Faculty of Pharmacy, Dharmsinh Desai University, Nadiad
Solid Lipid Nanoparticles (SLNs) are a colloidal carrier system for controlled drug delivery. A solvent injection technique was adopted to prepare lipophilic atorvastatin calcium (ATC) loaded glyceryl monostearate (GMS) nanodispersion with narrow size distribution. The mean particle size and size distribution, zeta potential, drug loading and stability study of the SLNs were investigated in detail. The entrapment of ATC in the oily nanocompartment, was formed by ATC inclusion into the solid matrix of the nanoparticles. It was verified by its high entrapment efficiency and the absence of endothermic or crystalline peaks when analyzed by DSC and PXRD, respectively. SEM image showed
spherical particle confirming the particle size measured by light scattering techniques. The stability of ATC was substantially improved by incorporation in SLN powder. After 1 months of storage, >97% ATC remained intact. A pharmacokinetic study was conducted in wistar rats after oral administration of 10mg kg-1 ATC in different formulations. It was found that the relative bioavailability of ATC in SLNs was significantly increased compared with that of the ATC solution. These results also demonstrate the principle suitability of SLN as a prolonged release formulation for lipophilic drugs. SLNs offer a new approach to improve the oral bioavailability of poorly soluble drugs.
Keywords: Atorvastatin calcium, Solid lipid nanoparticles, Stability studies, Entrapment efficacy, In-Vitro drug release, Bioavailability.