FORMULATION DEVELOPMENT & EVALUATION OF EFFERVESCENT TABLET OF ALENDRONATE SODIUM WITH VITAMIN D3

Abstract

Alendronate sodium is a bisphosphonates which has antiresorptive effect which is implicated in the prophylaxis and treatment of osteoporosis. The objective of this study was to formulate effervescent tablet of Alendronate sodium with Vitamin D₃ against osteoporosis thereby improving patient compliance.                                                                                                                          As per revised definition proposed to US FDA, Effervescent tablet is a tablet intended to be dissolved or dispersed in water before administration.         Effervescent tablets were formulated using citric acid and sodium bicarbonate as effervescent composition by wet granulation. The drug-excipient compatibility study done by DSC & FTIR analysis and it reveals absence of interaction between the drug and excipients. The flowability study of precompression blend shows good flow properties. Formulation was evaluated for weight variation, thickness, hardness, solution time, pH of solution & content uniformity. All the evaluation parameters were within the limit and complies specifications as per U.S.P. & B.P. From the Stability analysis may be inferred that there was no degradation and change in the formulation.                                                                                                                                                  The Effervescent tablet of Sodium Alendronate and Vitamin D₃ is a new pharmaceutical formulation to be taken orally and offering a considerable advantage: avoidance of gastro-intestinal disorders, to the limits of the possible. As compared to the pure drug and marketed tablet, this formulation displayed significantly effective in the oral osteoporosis treatment in post menopausal women.