Endocrine Abstracts

Introduction: In paediatric practice hydrocortisone (HC) is frequently prescribed in doses of ≤2.5 mg. HC tablets are only available in 10 mg strengths or as 2.5 mg Corlan pellets, a formulation designed for oro-mucosal delivery. Thus, tablets are segmented to obtain an appropriate dose. This study examines the accuracy of obtaining 2.5 mg HC doses from quartered tablets.

Materials and methods: Of 10 mg Hydrocortone tablets were studied. Weight uniformity of whole and quartered tablets was assessed. Tablets were quartered using a tablet cutter to mimic the manipulations undertaken prior to drug administration. HC content of each quarter was determined by HPLC.

Results: The mean intact tablet weight was 245.9±2.5 mg (n=10) with a coefficient of variation (CV) of 1.0%. The mean quartered weight was 56.7±7.6 mg (n=144 quarters), CV 13.4%. The ranges of these values were 38–68 mg. The anticipated quarter weight was 61.5 mg indicating an average loss of 4.8 mg. The mean HC content for the 144 quarters was 1.85±0.55 mg, CV 29.7%.

Discussion: Hydrocortone tablets were oval in shape with a central score line. Limited disintegration occurred during halving but accurate quartering proved impossible. Tablet brittleness resulted in quarters being gathered from tablet debris; increasing the risk of under- or over-dosing. The USP limits of weight variation (85–115%) were met by the intact tablets but by only 67% of the quarters against the target 61.5 mg weight.

Conclusions: Splitting Hydrocortone tablets into quarters produced unacceptable variation in weight uniformity and HC content. Oral dosing with Corlan (2.5 mg) would be more reproducible but its pharmacokinetics taken orally are unknown. The data highlight the need for appropriate paediatric strengths and formulations of HC.