Dividing the Tablets for Children ? Good or Bad?

Abstract

Author(s): Asa C Andersson, Synnöve Lindemalm, and Staffan Eksborg

Introduction: To investigate the dosing accuracy using split tablets in paediatric patients.Methods:Five brands of tablets (Alvedon® (paracetamol), Catapresan® (clonidine), Hydrocortone® (hydrocortisone), Prednisolon® (prednisolon) and Tavegyl® (clemastine) were split into halves and quarters by hand or by using a tablet splitter. The resulting halves and quarters were weighed. Results: Three out of the five tablet brands passed the test in the Ph. Eur. (European Pharmacopoeia) for subdivision of tablets when split once and when split twice to yield quarters only one of the tablets passed the test. When also applying the limit for relative standard deviation (RSD) from the US Pharmacopoeia only one of the tablet halves passed and the other two was just outside the limit. None of the tablet quarters passed the RSD limit. Conclusion: Our results indicate that tablets larger than 8 mm might be split once. Tablets should not be split more than once, due to uncertainty in dose accuracy. There is a need for more commercially available age-appropriate formulations. Extemporaneously prepared formulations should be considered as an alternative to the use of split tablets.Key words: Dosing accuracy, Manipulation of drugs, Paediatric patients, Subdivision of tablets, Tablet splitting 

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