Development and Characterization of Glutathione Lyophilized Injection

The main objective of present research work was to design, development and characterization of glutathione lyophilized injection. Component excipients were selected based on the preliminary studies. Solubility trials were done to determine the solubility of Glutathione in water with different concentration of sodium bicarbonate. Then glutathione injection was formulated and lyophilized by setting the lyophilization cycle parameters. But, when glutathione was lyophilized alone the cake collapse was observed. So, in order to overcome this problem lyoprotectants (mannitol, lactose, trehalose and sucrose) were added in different concentration i.e. 5% and 10%. The lyophilization cycle was developed for these formulations by changing the process parameter. After formulation development, lyophilization cycle was optimized by reducing the total cycle time. Cycle time reduced at the initial stage of primary drying till the formulation remained stable. First stage of primary drying was reduced to 2520 minutes where the cake remains elegant. The batch L1 developed by FD cycle 11 with 5% trehalose having total lyophilization cycle time 59.75 hours was considered as optimized formulation because it exhibited a good cake formation and pH, moisture content, reconstitution time and assay was found within the range of desired product profile. Short term stability studies were conducted for the optimized formulation as per ICH guidelines for a period of 30 days which revealed that the formulation is stable. It was conclude that the lyophilization technique proves to be an advantage for development of stable injectable dosage form of Glutathione. Keywords: Glutathione, Lyophilized Injection, Injectable Dosage Form.