Formulation and characterization of cyclophosphamide injections using lyophilization technique

Introduction: The parenteral route of administration is generally adopted for rapid onset of action and 100% bioavailability especially for the drugs which have poor bioavailability through peroral route. Newly developed drugs often show poor solubility and require novel dosage forms such as liposomes, nanoparticles to minimize solubility problems and side effects due to toxicity. These dosage forms are often inherently labile due to agglomeration, sedimentation etc., and can be stabilized and manufactured by freeze drying. Lyophilization is the most common method for manufacturing solid pharmaceuticals products and is central to the preservation of materials which must be dried thoroughly in order to ensure stability and require a gentle, easily sterilizable process. Materials and Methods: The current research work involves the formulation of cyclophosphamide injections using lyophilization technique by using different concentrations of cyclophosphamide. The formulated cyclophosphamide injections are further subjected to different evaluation tests such as melting point, differential scanning calorimetry, dissolution rate study, solution stability, pH stability, rubber stopper compatibility and photostability. Results: The moisture content of the formulation is greatly reduced to as low as 0.9% (w/w) thus enhancing the stability of the product. Conclusion: The lyophilized technique proved to be an advantage for the development of stable injectable dosage form of Cyclophosphamide.