European Journal of Biomedical and Pharmaceutical Sciences

FORMULATION DEVELOPMENT AND EVALUATION OF COLON TARGETED ORAL DRUG DELIVERY SYSTEM OF AZILSARTAN MEDOXAMIL

Sivakumar Kalidoss*, Kailasam Koumaravelou and Arumugam Kottaimuthu

ABSTRACT

The aim of the present work was to develop and evaluate colon specific sustained release tablet using Azilsartan Medoxamil, coating material and matrix forming polymers. Colon targeted tablets were prepared in two steps. Initially core tablets Azilsartan Medoxamil were prepared by wet granulation method using different concentration of, microcrystalline cellulose as filler, mannitol as diluents, crosscarmellose sodium as disintegrating agents, hydroxyl propyl cellulos as sustained release polymer, magnesium stearate was used as a glidant and lubricant respectively. And then the tablets were coated by using different polymers. Eudragit L100 and S100 were used as enteric coating polymers. The precompression blend of all formulations was subjected to various flow property tests and all the formulations were passed the tests. The tablets were coated by using polymers and the coated tablets were subjected to various evaluation techniques. Drug and physical mixture were evaluated for incompatibility study by Fourier transform infrared spectroscopy (FTIR). The prepared tablets were evaluated for hardness, weight variation, friability and drug content uniformity and it was found that the results comply with official standards. All the batches of matrix tablet (AM1-AM5) were subjected for in-vitro dissolution in various simulated gastric fluids for suitability for colon specific drug delivery system. The amount of Azilsartan Medoxamil released from tablets at different time intervals was estimated by RP-HPLC methods. Among all the formulations AM5 formulation was found to be optimized as it was retarded the drug release up to 24 hours and showed maximum of 99.79 cumulative percentage drug release. The studies confirmed that, the designed formulation could be used potentially for colon delivery by controlling drug release in stomach and the small intestine.

Keywords: Azilsartan Medoxamil, wet granulation, hydroxyl propyl cellulose, Eudragit L100 and S100.