THE LYOPHILIZATION PROCESS FOR THE DEVELOPMENT OF UNSTABLE DOXORUBICIN INJECTABLE FORMULATION

This technology is developed for individual pharmaceutical products to improve its stability and preservation during its storage condition. This technique is applicable for thermolabile substances. The aim was to develop a stable anthracycline antibiotic lyophilized product as parentral preparation whose performance in treating disease is similar or nearby with that of marketed dosage form, so that a dosage forms having same therapeutic efficacy at a low cost can be available in the market. As drug has poor stability and impurity problem,therefore stability was improved and impurities also get minimizes by using lyophilization process. Excipients are also used as a cryoprotectant in the formulation. Three Lyophilization cycle was developed and the trial batch is manufactured by all three developed cycles out of which the best cycle by which the product manufactured is of best quality is selected and the formulation is manufactured. Key words: Lyophilization, Desiccation , Desorption, Stability