• Lenkalapally Matsyagiri1
• Dr. Bontha Vijaya Kumar2

The aim of the research work was mainly focused on the formulation & evaluation of gastro retentive floating microballoons of Alendronate sodium using different polymers. It is used in the treatment of Osteoporosis and paget’s disease, belongs to class II as per BBCS and hence it exhibits low aqueous solubility and high permeability and it undergo high first pass metabolism, which affects in low dissolution rate and in turn affect the bioavailability. Floating microballons were prepared by non-aqueous solvent evaporation method by using polymers like Eudragit S 100, Eudragit RS 100, HPMCK4M, Ethyl cellulose, solvents like Ethanol, Dichloromethane. Preliminary Solubility, acid stability studies were conducted for a drug. Drug-Excipient compatibility study was done by using DSC & FTIR and found that the drug was compatible with all the excipients. Floating microballons were evaluated for physicochemical properties by measuring the angle of repose, Carr’s index, mean particle size and floating properties like drug entrapment efficiency, % yield, floating buoyancy, Drug content and in vitro drug release studies, conducted drug release kinetics, stability studies further conducted in vivo studies for optimized batch. Results shown that the in vitro evaluation studies demonstrated that microballoons prepared by using Eudragit S 100 and Eudragit RS 100 in 1:1 ratio (ASF10) shown maximum drug release. Hence it is selected as the optimized formulation and it followed zero order kinetics. The in vivo Radiographic images showed buoyant for up to 5.5 h. The mean area under plasma time curve AUC 0-t and AUC 0-total of reference formulation was 1023.01ng/ml×h and 1548.60 ng/ml×h and while AUC 0-t and AUC 0-total of test formulation was 1652.21ng/ml×h and 2939.76 ng/ml×h, This indicates that the overall absorption of Alendronate sodium was more in the test formulation with respect to the reference product at the same dose. It was observed from the results that the oral bioavailability of optimized formulation (ASF10) was increased significantly when compared to marketed formulation. Relative bioavailability with respect to marketed formulation was found to be 189.8 which is due to prolonged gastric residence time of Alendronate sodium floating microballoons. Microballoons were found to be stable at storage conditions for three months.

Alendronate sodium, Floating microballoons, Gastro retentive drug delivery system, in vitro and in vivo Evaluation.

"FORMULATION AND EVALUATION OF GASTRO RETENTIVE FLOATING MICROBALLOONS OF ALENDRONATE SODIUM", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.6, Issue 2, page no.622-636, February-2019, Available :http://www.jetir.org/papers/JETIR1902F51.pdf

"FORMULATION AND EVALUATION OF GASTRO RETENTIVE FLOATING MICROBALLOONS OF ALENDRONATE SODIUM", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.6, Issue 2, page no. pp622-636, February-2019, Available at : http://www.jetir.org/papers/JETIR1902F51.pdf