Vinay Kumar Katakam, Sunil Reddy, Jagan Mohan Somagoni, Pavan Kumar Panakanti, and Madhusudan Rao Yamsani
A biphasic gastroretentive floating drug delivery system with multiple-unit pellets prepared by extrusion–spheronization process based on gas formation technique was developed for Alfuzosin Hydrochloride to maintain constant plasma level of a drug concentration within the therapeutic window. The system consists of a multiple - unit pellets to be filled into a hard gelatine capsule. The effect of the preparative parameters, e.g., Amount of PR coating on core units, amount of the effervescent agent layered onto the PR coated pellets, and type and coating level of the gas-entrapped polymeric membrane, on the floating ability and drug release properties of the multiple-unit FDDS were evaluated. The system using Eudragit RL30D, Eudragit RS30D and combination of them as polymeric layer could float within acceptable time. The drug release was linear with the square root of time. The rapid floating and the controlled release properties were achieved in this present study. The stability studies of samples showed no significant change in dissolution profiles. In vivo gastric residence time was examined by radiograms, and it was observed that the units remained in the stomach for about 6 h in fed state and stable for 6 months at 40°C/75% RH.
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