Journal of Chemical and Pharmaceutical Research (ISSN : 0975-7384)

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Original Articles: 2014 Vol: 6 Issue: 8

Formulation development and compatibility study of ibandronate sodium injection 3mg/3mL

Abstract

Intravenous bisphosphonates have been shown to be highly effective in preventing and treating postmenopausal Osteoporosis and the associated risk fracture. Ibandronate is a highly potent amino-bisphosphonate proven to significantly increase vertebral and non-vertebral bone mineral density when administered as I.V. injection. The main objective of present study was to develop a stable formulation and manufacturing process of Ibandronate sodium injection 3mg/3mL. As a part of preformulation study the compatibility study was performed. The excipients selected were the same as mentioned in PIL of reference listed drug. Compatibility study with regard to product contact materials such as Platinum cured silicone tube, SS316L (Metal), PVDF membrane filter, and stopper was performed and found compatible. Thermal cycling and Photostability study were also performed and indicates that drug product was thermal and photo stable. Ibandronate sodium injection was prepared by dissolving all the ingredients in Water for injection under continuous stirring and solution was filtered through Sterilized Optiseal Durapore PVDF cartridge filter 0.45 micron, followed by sterilized Optiseal Durapore PVDF cartridge filter 0.22 micron. Filling, stoppering and sealing was done in aseptic manufacturing and filling area. Terminal sterilization was done at 1210C. Formulations were visually inspected and results were found well within specified limits. Accelerated stability study at different time interval was performed and justified by relevant stability results.