Content uniformity of quartered hydrocortisone tablets in comparison with mini-tablets for paediatric dosing.

ABSTRACT:

Objectives

Children requiring cortisol replacement therapy are often prescribed hydrocortisone doses of 2.5 mg, but as this is commercially unavailable 10 mg tablets, with functional break lines, are split commonly in an attempt to deliver the correct dose. This study aimed to determine the dose variation obtained from quartered hydrocortisone tablets when different operators performed the splitting procedure and to ascertain whether better uniformity could be attained from mini-tablets as an alternative formulation.

Methods

Hydrocortisone 10 mg tablets were quartered by four different operators using a standard pill splitter. Hydrocortisone 2.5 mg mini-tablets (3 mm diameter) were formulated using a wet granulation method and manufactured using a high-speed rotary press sim

SUBMITTER: Madathilethu J 

PROVIDER: S-EPMC5843003 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature