Preparation and evaluation of carbamazepine-superdisintegrants agglomerates by spherical crystallization technique

Abstract

Objective: The purpose of this study was to prepare and evaluate carbamazepine (CBZ)-superdisintegrants agglomerates by spherical crystallization technique. Methods: The process involved recrystallization of CBZ and its simultaneous agglomeration with disintegrants: sodium starch glycolate (SSG) or croscarmellose sodium (CCS). An ethanol, isopropyl acetate, water system was used, where they acted as solvent, bridging liquid and non-solvent respectively. The agglomerates were characterized by differential scanning calorimetry (DSC), powder X-ray diffraction (XRPD), FTIR and Scanning electron microscopy and were evaluated for micromeritic properties, disintegration time and drug release. Results: In comparison to conventional drug crystals, the agglomerates depicted significantly improved micromeritic properties and their dissolution rates were enhanced. Although CBZ-CCS agglomerates showed better disintegration time than CBZ-SSG agglomerates, CCS had lower effect on dissolution rate, probably due to possible charge interactions with drug. Conclusion: Spherical crystallization is an efficient and simple technique, which is useful for preparing drug-superdisintegrants agglomerates to improve the micromeritic properties and the dissolution rates.