SYSTEMATIC DESIGN AND CHARACTERIZATION OF MODIFIED MULTICOATED MULTIPARTICULATE SYSTEM (3MPS)

The current research aimed to develop a patient-friendly modified multicoated multi-particulate system (3MPS) of Telmisartan (TEL) and Hydrochlorothiazide (HCTZ), integrating advanced analytical and statistical tools to overcome the limitations of the single-unit dosage form. The secondary aim was to develop a robust method for simultaneously determining TEL and HCTZ. The new robust, precise, and accurate first-order derivative UV spectrophotometric method was developed. The 3MPS were designed using a fluidized bed processor (FBP). Initially, microcrystalline cellulose core pellets were coated with HCTZ, then with Eudragit L100 (EL100) and Eudragit S100 (ES100), and finally with TEL. The amount of EL100 and ES100 were screened as independent variables, whereas %CDR of TEL and HCTZ was chosen as a response from the risk assessment study. A crucial relationship between amount of EL100 and ES100 with % drug release, accomplishing the central composite design. 3MPS showed excellent flowability, desired size, spherical shape, and acceptable physicochemical properties. The optimized 3MPS was able to release HCTZ for up to 24 h. The influence of hydroalcoholic media revealed a significant dose-dumping effect due to the solubility of EL100 and ES100 in alcohol. The patient- industry-friendly 3MPS was developed using advanced technology and upgraded statistical tools. The amount of EL100 and ES100 was considered significant to achieve the desired properties of the 3MPS. TEL IR release and HCTZ control release for 24 h were obtained in a 3MPS. The newer 3MPS should be developed at an industrial scale and have better patient compliance.