Long-term stability of 0.1% rapamycin hydrophilic gel in the treatment of facial angiofibromas - Archive ouverte HAL Accéder directement au contenu
Article Dans Une Revue European Journal of Hospital Pharmacy Année : 2020

Long-term stability of 0.1% rapamycin hydrophilic gel in the treatment of facial angiofibromas

Résumé

Objectives: In recent years, various formulations containing rapamycin, mainly petrolatum-based, have been tested on facial angiofibromas in tuberous sclerosis. They are often poorly tolerated due to irritation and bleeding. In addition, their effectiveness was insufficient in young adults. The objective of this study was to develop and characterise a hydro-alcoholic gel containing solubilised rapamycin. The stability of the product stored at 4°C was evaluated over 1 year. Methods: Two different 0.1% rapamycin gels were formulated with or without α-tocopherol and urea. Different methods were used to characterise the gels: HPLC, gas chromatography, pH, visual observation and optical microscopy. A physico-chemical and microbiological stability study was also conducted for 1 year at 4°C. Results: Gels were physically and microbiologically stable after 1 year at 4°C: organoleptic characteristics and pH unchanged, no significant decrease in rapamycin was observed, tocopherol droplet size was constant and rheological behaviour was not altered. Conclusions: This study describes a new gel formulation to improve skin penetration using various excipients to promote skin tolerance. This study provides, for the first time, detailed stability data for a hydro-alcoholic rapamycin gel.

Dates et versions

hal-04119747 , version 1 (06-06-2023)

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Citer

Guillaume Le Guyader, Victoire Vieillard, Karine Andrieux, Mylène Rollo, Olivier Thirion, et al.. Long-term stability of 0.1% rapamycin hydrophilic gel in the treatment of facial angiofibromas. European Journal of Hospital Pharmacy, 2020, 27 (e1), pp.e48-e52. ⟨10.1136/ejhpharm-2018-001695⟩. ⟨hal-04119747⟩
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