The development of lyophilized injection of zoledronic acid, mannitol used as lyophilisation aid, sodium citrate as buffering agent and water for injection as solvent. The filled vials were loaded into lyophilizer and lyophilized them as per standard cycle and for development of stability for reconstitution. The objective of the project is to formulate the reconstitution solvent for lyophilized zoledronic acid injection for same solvent used for intravenous bolos as well as intravenous infusion administration and better stability of formulation. Quality control tests like description, pH, related substances, moisture content, reconstitution time, assay and particle count were checked according to Pharmacopoeial method and present within the specified limits. The lyophilized product of all the formulations (F1-F6) prepared were an appearance of white to white crystalline powder. The pH of all the formulations is in the range of 3.5-6.99. These pH values of all the formulation are within the limit. The related substances in formulations not exceeded the limit of 0.5%. The assay values of formulations (F2-F6) were in the range of 93.6 % -101.43 %. The formulations (F 2-F6) show a water content range of 0.78 to 2.39 %. The formulation F4 was one of the best optimized compositions; it was used for reconstitution stability. The results concluded that the formulation F4 is the optimized and the best formulation.
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