Research on formulation and development of amoxicillin microspheres by using spray drying technique

Abstract

The aim of the current investigation is to design oral once daily modified release dosage forms of amoxicillin trihydrate for treatment of H. Pylori infection, which release the drug for 24 hours and match with theoretical drug release profile. The tablets and capsules were prepared by the different method using different polymers in different concentrations. The interference of the polymers was ruled out by FT-IR spectroscopy studies. The powder-blends of tablets and drug were evaluated for their physical properties like angle of repose, bulk density, compressibility index, and Hausner ratio and found to be satisfactory. The manufactured tablets were evaluated for in process and finished product quality control tests
including appearance, Swelling study, Drug entrapment efficiency, mucoadhesive of microsphere, Particle size analysis, drug content, and in vitro drug release. All formulations showed appearance, thickness, weight variation, hardness, friability and drug content in specified limit. All formulat ions showed acceptable pharmacotechnical properties and complied with in-house specifications for tested parameters. The formulated amoxicillin trihydrate tablets followed zero order release kinetics and Higuchi diffusion was the dominant mechanism of drug release, resulting in regulated and complete release within 24 hours. Formulations were subjected to short term stability studies as per ICH guidelines and were found stable. Microsphere formulations 8 were evaluated for weight uniformity, drug content and in vitro drug release.