Investigation of self-microemulsifying and microemulsion systems for protection of prednisolone from gamma radiation.

Radiation is efficient for terminal sterilization. Unfortunately, its use for liquid pharmaceuticals is difficult. This work investigated the potential radioprotective effect of self-microemulsifying (SMEDDS), microemulsions and their phase transition systems which were reported to enhance ocular drug delivery. Prednisolone solutions were prepared in SMEDDS, W/O microemulsions containing, 5% w/w (ME 5%) or 10% w/w (ME 10%) water, liquid crystalline system with 25% water (LC) and coarse emulsion containing 80% water (EM). These were subjected to gamma irradiation with aqueous solution and suspension being used as control. The physical properties of the formulations were monitored and the chemical potency of the drug was determined using a stability indicating HPLC method. The phase behavior of the formulations was not affected by irradiation but the viscosity of LC was significantly reduced. The SMEDDS, ME 5% and ME 10% showed excellent radiation protection as indicated by no change in the chemical potency. The LC retained 84% and the EM retained 39.8% of the chemical potency after exposure to 20 KGy. The aqueous solution was extensively degraded with the suspension retaining only 73.5% of the potency at 20 KGy. SMEDDS and W/O microemulsion can thus protect prednisolone from degradation by ionizing radiation.