In this study the nasal administration of carbamazepine has been studied using chitosan nanopartcles. The chitosan nanoparticles were prepared by ionic gelation of chitosan (100-300mg) with Tripolyphosphate sod (100-300mg in 100ml. Nine formulations were prepared, characterized and compared in terms of morphology (Transmission electron microscopy), drug content, particle size (zetasizer) and In-vitro drug release. In-vitro drug release studies were performed in Franz diffusion cell using phosphate buffer (buffer pH 5.5) as dissolution medium. The Chitosan nanoparticles had a mean size of 124.2±05 to 580±13nm, zeta potential were found to be +21 to 26.6 mV and the entrapment efficiency were found to be 65 to 72.7%. The in-vivo study was performed on Wistar rat, nanoparticles were administered through nasal route and compared with carbamazepine given by i.v. route, the results indicate that carbamazepine loaded chitosan nanoparticles enhances the drug absorption through nose. The results showed that the carbamazepine could be directly transported into the rat brain through nose and the possible side effects could be minimized.
Process validation is an essential component for the safety of drug product and also to maintain the quality of the product. Process validation is the fundamental component for assuring the quality system used by pharmaceutical industries. Process validation is the key element to assure the identity, purity, safety, efficacy and also maintaining the quality of final product. The Process validation precisely focused on the aim, method of analysis, and knowledge. The Process validation establishes the flexibilities and limitations which are faced during the manufacturing process; the variables are controlled for attaining the desired attributes, which assures a consistency in quality of product throughout the product life. In this article an overview is given on process validation with special reference to tablet.
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