Infacort®, Oral Hydrocortisone Granules with Taste Masking for the Treatment of Neonates and Infants with Adrenal Insufficiency
Results: The pharmacokinetic results for 10mg Infacort® vs 10mg hydrocortisone immediate release were: Cmax LSmean 566 vs 598 nmol/l, ratio Infacort® to hydrocortisone (90% CI), 95 (84-107); AUC0-inf LSmean 1602 vs 1576 hr*nmol/l, ratio Infacort® to hydrocortisone (90% CI), 101 (96-107); Tmax LSmean 0.75 vs 1.00 hr, mean difference Infacort® to hydrocortisone (95% CI), 0.0 (-0.5-0.3). Infacort® & hydrocortisone at a dose of 10 mg were bioequivalent, as reflected by geometric LSmean 90 % CI for ratios of Cmax, AUC0-t and AUC0-inf within 0.8 – 1.25. Infacort® was tested for dose-proportionality between 0.5 mg – 10 mg; Cmax, AUC0-t and AUC0-inf were shown to increase in a linear fashion and were dose-proportional when adjusted for protein binding. The majority of subjects described Infacort® as, “not good or bad”, for smell (81.3% to 87.5 % of subjects), feel in the mouth (68.8 % of subjects) and taste (68.8 % to 81.3 % of subjects).
Conclusions: Infacort® was safe, well tolerated and of neutral taste when administered as a single oral dose of 10 mg. Infacort® granules and hydrocortisone tablets were bioequivalent with respect to Cmax, AUC and tmax and demonstrated dose-proportionality. Infacort® provides a new formulation specifically designed for the treatment of infants and neonates with adrenal insufficiency.
Disclosure: MW: Management Position, Diurnal. DD: Employee, Diurnal. HH: Employee, Diurnal. DE: Employee, Diurnal. GT: Employee, Diurnal. RJR: Other activities, please specify:, Asterion Ltd, Director, Diurnal Ltd. Nothing to Disclose: SS, TJ, OB, HK
Source: Martin Whitaker1, Dena Digweed2, Sarah Spielmann3, Hiep Huatan2, David Eckland2, Trevor Johnson4, Geoff Tucker4, Oliver Blankenstein5, Heiko Krude, MD6 and Richard J. Ross, MBBS, MD, FRCP7, 1University of Sheffield, 2Diurnal Limited, 3Charity Universitatsmedizen Berlin, Germany, Berlin, Germany, 4Simcyp, United Kingdom, 5Charity Universitatsmedizen, Berlin, Germany, 6Charity – Universitatsmedizin Berlin Campus Virchow, Berlin, Germany, 7Univ of Sheffield, Sheffield, United Kingdom, Infacort, Oral Hydrocortisone Granules with Taste Masking for the Treatment of Neonates and Infants with Adrenal Insufficiency