Stability of corticosteroid patch test preparations.
This study investigated the stability of tixocortol pivalate, budesonide, and hydrocortisone-17-butyrate (Hc-17-B) when present in a mix with petrolatum and when the corticosteroids were kept separately in petrolatum. The concentrations chosen for the corticosteroids were the same as those used in a study within the European Environmental Contact Dermatitis Research Group (EECDRG), in which 2 corticosteroid mixes (1 with a high concentration and 1 with a low concentration) and the 3 individual constituents, each at 2 concentrations, were patch tested. Ethanolic solutions of each corticosteroid, as well as 2 mixtures of these 3 corticosteroids, were also made up at corresponding concentrations. The preparations were kept at room temperature, refrigerated, and deep frozen, and repeatedly for 1 year, investigations to check stability by high performance liquid chromatography were carried out. A decrease of < or =20% of the initial value at time 0 was used as the threshold for stability. The petrolatum preparations and the ethanolic solutions of budesonide and tixocortol pivalate were stable for at least the whole investigative period, irrespective of storage conditions, while Hc-17-B 1.0% in ethanol kept deep frozen was stable at least during the same period. The latter corticosteroid when kept at room temperature was stable for 3 months only.
Isaksson
M
M
Department of Occupational and Environmental Dermatology, Malmö University Hospital, Sweden.
Gruvberger
B
B
Persson
L
L
Bruze
M
M
D000287:Administration, Topical; D000305:Adrenal Cortex Hormones; D000893:Anti-Inflammatory Agents; D019819:Budesonide; D017449:Dermatitis, Allergic Contact / Q000175:diagnosis*; D004355:Drug Stability; D006854:Hydrocortisone / Q000031:analogs & derivatives*; D010328:Patch Tests
D000305:Adrenal Cortex Hormones; D000893:Anti-Inflammatory Agents; C007975:hydrocortisone-17-butyrate; D019819:Budesonide; C019112:tixocortol pivalate; D006854:Hydrocortisone