Design, Development and Characterization Of Nano-Crystal Nicardipine HCL Tablet by Spherical Crystallization Technique 20mg

Abstract

Nicardipine belongs to BCS class-II drug having low solubility and orally bioavailability of about 10-40%. The objective of the present study is to develop a nano-crystal based Nicardipine Hcl tablet by spherical crystallization technique. The nano crystals were prepared with adding the bridging solvent bad solvent with stabilizing solvents in ration of 1:0.3 of Drug, dichloromethane, PVP K-30 showing highest solubility of drug.  The optimized nano-crystals (F8 batch) shown good entrapment efficiency, particle size, poly disparity and zeta potential value. By using the nano-crystal Nicardipine hydrochloride is prepared by using the fast dissolving tablets. The above results indicated crospovidone containing (f20) shown good dissolution and drug content. The Nicardipine Hydrochloride tablets were shown good stability in the studies. The bioavailability studies of Nicardipine nano crystal based tablets in the rabbit and compared with the pure drug.  Nicardipine Nano tablets were shown C_max57.24 ng/ml, T max at 10 Hr, AUC(0-∞) at 624.4 ng.min/ml and t1/2 at 6.49 hr. AUC and maximum plasma concentration of Nicardipine Hcl Nano crystal tablet is higher than pure nicardipine drug it indicates Nicardipine Nano tablet  produce more bioavailability than the nicardipine hydrochloride. Hence there is no significant difference between the pharmacokinetic parameters of Nicardipine hydrochloride obtained with pure drug and optimized formulation. Thus the prepared Nicardipine Nano tablet proved to be a potential technology for enhancing the transfer of poorly water soluble lipophilic compounds to the aqueous phase, thus enhancing the bioavailability.