Long-term stability of 0.1% rapamycin hydrophilic gel in the treatment of facial angiofibromas
Stabilité à long terme du gel hydrophile à 0,1 % de rapamycine dans le traitement des angiofibromes faciaux
Résumé
Objectives : In recent years, various formulations containing rapamycin were tested, mainly with petrolatum to treat facial angiofibromas in tuberous sclerosis, especially in children. Nevertheless, a weak tolerance was found due to irritations and bleeding. Moreover, efficacy was insufficient in young adults. The aims of this study were to develop and characterize a hydro-alcoholic gel containing solubilized rapamycin, to realize the stability study at 4°C up to one year. Methods : Two different gels at 0.1% rapamycin were performed with or without α-tocopherol and urea. Different methods were used to characterize the gels: HPLC, gas chromatography, pH, visual observation and optical microscopy. A physicochemical and microbiological stability study was also conducted during 1 year at 4°C. Results : Whatever the formulation, gels were physicochemically and microbiologically stable up to 1 year at 4°C: Organoleptic characteristics and pH were unchanged, no significant decrease was found in rapamycin concentration, tocopherol droplets size was constant and the rheological comportment unmodified. Conclusions : The present study provides, for the first time, extended stability data concerning a hydro-alcoholic gel of rapamycin.
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