COMPARISON OF HYDROCORTISONE 10MG TABLETS: TABLET HARDNESS OPTIMISED FOR ADULT USE HAS NEGATIVE CONSEQUENCES FOR PAEDIATRIC USE

BackgroundChildren's medicines are not always readily available as an age appropriate product and manipulation of adult products is often required. Recently the commercial manufacturing process for 10mg hydrocortisone tablets has changed and the compression force increased due to tablets fracturing on removal from the blister pack. However, this change led to parents of children requiring hydrocortisone reporting that the tablets were more difficult to manipulate.This study evaluated 10mg hydrocortisone tablets for their suitability for manipulation in order to deliver an appropriate dose to children (2mg dose). The physical properties of tablets with the old and new compression force were compared as well as the accuracy of obtaining the paediatric dose.MethodsThe tablets compared were hydrocortisone Auden 10mg tablets (Brand A, PL16876/002)-these are the newer, harder tablets- and hydrocortisone 10mg tablets (Brand B, PL17507/0097). Tablet physical properties including friability (Copley FRV200) and tablet hardness (Copley TBF1000) were compared. The accuracy of split doses (halve and quarter tablets) were recorded on a Sartorius analytical balance. The accuracy of the 2mg paediatric dosing was assessed by crushing the tablet, adding 10mL of water and extracting 2mL. The concentration was measured using UV analysis (Jenway Genova Plus) according to a calibration curve (wavelength=246nm). Two devices were used to crush the tablets: a spoon onto a plate and a commercially available crushing device (Apothecary Ezy Crush Pill Crusher With Ergo Grip).ResultsAs anticipated Brand A tablets were harder (51.85 plus or minus 5.1N) compared to Brand B (30.99 plus or minus 4.1N). Brand A tablets passed the friability testing with