Bavouma Charles Sombie, B. Gerard Josias Yameogo, Rasmane Semde, Viviane Henschel, Karim Amighi and Jonathan Goole
This work evaluated under accelerated conditions the stability of the biodegradable gentamicin-glyceryl monooleate water based-gel used in the treatment of chronic osteomyelitis. Three batches of 600.0 g of gentamicin -glyceryl monooleate -water based-gel (5/80/15% w/w) were manufactured. The samples were stored in a climatic test chamber for stability evaluation according to the standards published by the International Conference on Harmonisation and the World Health Oganization (25 ± 2°C / 60 ± 5%RH) for 6 months. Samples were evaluated at pre-determinate times 0, 3 and 6 months with regard to their physicochemical properties and In Vitro drug release characteristics. Gentamicin sulfate present in the freshly prepared gels was the same after three and six months of storage at 25°C / 60% RH. However the relative amount of gentamicin sulfate in the freshly prepared gel that was about 110% decreased by about 11% after six months of storage. The release profiles of the gels remained similar despite a partial hydrolysis of glyceryl monooleate and an increase in the residual amount of water and in the viscosity.
