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Dividing the Tablets for Children–Good or Bad?

Submitted by webadmin on Tue, 10/18/2016 - 12:25
Pharmaceutical Methods,2016,7,1,23-27.
Published:January 2016
Type:Original Article

Dividing the Tablets for Children–Good or Bad?

Åsa C Andersson1*, Synnöve Lindemalm1,2, Staffan Eksborg1,3

1Division of Paediatrics, Karolinska University Hospital, Astrid Lindgrens Children’s Hospital, Stockholm, Sweden, EUROPE.

2Department of Clinical Sciences, Karolinska Institutet, Intervention and Technology (CLINTEC), Stockholm, Sweden, EUROPE.

3Department of Women’s and Children’s Health, Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden, EUROPE.

Abstract:

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.

Tablet splitter from LGS Corp (USA).