Hydrochlorothiazide Nanocrystals Stabilization by Silk Sericin

Abstract

Abstract: Aim: The aim of present study deals with preparation and stabilization of Hydrochlorothiazide nanocrystals using silk sericin. Materials and Methods: Nanocrystals of BCS class II drugs were primed by antisolvent precipitation method in ratio of HCTZ: Sericin (1:0.5, 1:1, 1:1.5, 1:2). Further Nanocrystals were investigated by particle size, zeta potential, drug content, ATR- FTIR, XRD, DSC, SEM, in vitro dissolution study and stability study. Zeta potential (1:0.5) shows higher value -18.8 than other batches which means optimized P1 batch have more stability than other batches. Low loss of drug content in lyophilized P1 batch resulted in excellent revival of nanocrystals. In FTIR, principle peaks of pure drug HCTZ were retained in (1:0.5) P1 batch which are almost identical. Further XRD proved that HCTZ existed in crystalline state in the HCTZ nanocrystals. DSC of HCTZ and HCTZ nanocrystals peaks were found to be nearly indistinguishable. Nanocrystals were found to be sharp needle in shape. Results: Nanocrystals of P1 batch displayed enhanced dissolution performance than other batches as its % drug dissolution was found to be 89.39. % crystallinity of nanocrystals was somewhat increased but not any noteworthy difference after 3 months storage as % crystainity of P1 batch after storage for 3 months was found to be 44.01 to 45.07 hence it was increased to some extent, but difference was not noteworthy. Conclusion: Result verified that, sericin improves solubility and stability of nanocrystals. Thus, sericin play important role in stabilization of nanocrystals of poorly soluble drugs. Key words: Sericin, Stabilization, Lyophilization, Solubility, Antisolvent, Nanocrystals.