Decitabine is a class II drug used in treatment of myeloid leukemia. Generally it is an unstable drug and requires\r\nstringent storage conditions. The objective of the study was to formulate a stable injectable dosage form containing decitabine\r\nand evaluating the injectable dosage form. For this purpose preformulation study of the drug was carried out using lactose,\r\nmannitol, dihydrogen potassium phosphate and other key excipients. Lyophilization technique was employed for the\r\nformulation of the injection, initially the drug was formulated as such with water for injection without any excipients and it was\r\nobserved that the cake characteristics of the lyophilized product were not good due to the less solute content, in order to\r\nincrease the bulk of the formulation the drug was formulated by using various excipients such as anhydrous lactose, lactose\r\nmonohydrate, mannitol. These lyophilized formulations were subjected to various evaluation parameters such as reconstitution\r\ntime, pH and percentage of water content, drug content and short term stability studies. It was observed that the selected\r\nformulation containing mannitol as bulking agent showed the promising results with 99.1 percentage of drug content even after\r\n3 months of stability studies passing all the vital evaluation parameters by maintaining integral cake appearance. From the\r\nresults it was concluded that the lyophilization technique proves to be an advantage for development of stable injectable dosage\r\nform and the identified formula F3 as the best for the treatment of myeloid leukemia.
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