Tablet splitting: How accurate does the dose get? Åsa Andersson Karolinska Pharmacy, Stockholm, Sweden

Reasons for tablet splitting Swallowing difficulties Financial reasons Adjust dosage for paediatric patients NPPG, Belfast 29th Oct 2005

Objective To study the dosing accuracy with splitted tablets in the paediatric setting NPPG, Belfast 29th Oct 2005

Objective To study the dosing accuracy with splitted tablets in the paediatric setting To compare tablet halves splitted manually and by using a tablet splitter NPPG, Belfast 29th Oct 2005

Objective To study the dosing accuracy with splitted tablets in the paediatric setting To compare tablet halves splitted manually and by using a tablet splitter (Assuming that the active substance is uniformly distributed in the tablet) NPPG, Belfast 29th Oct 2005

NPPG, Belfast 29th Oct 2005

Method Survey to nurses at the local Children’s Hospital NPPG, Belfast 29th Oct 2005

Method Survey to nurses at the local Children’s Hospital Five different tablets were splitted, both manually and by using a tablet splitter NPPG, Belfast 29th Oct 2005

Method Survey to nurses at the local Children’s Hospital Five different tablets were splitted, both manually and by using a tablet splitter The resulting halves and quarters were weighed and the difference between the expected weight and the actual was calculated NPPG, Belfast 29th Oct 2005

The European Pharmacopoeia (suppl. 4.4) Criteria for variability of weight No more than 2 out of 20 tablets may deviate from the mean value by more than: Tablets weighing < 80 mg 10% Tablets weighing 80 - 250 mg 7,5% Tablets weighing > 250 mg 5% We based our results on the criteria set in the European Pharmacopoiea. We could see no reason to use other criteria for splitted tablets. NPPG, Belfast 29th Oct 2005

Tablet characteristics Mean weight s.d C.V. Size Scored/Crossed mg mm Alvedon (paracetamol), 500 mg 0.548 0.007 1.294 16.2*7.7*5.8 Scored Hydrocortone (hydrocortisone)10 mg 0.244 0.003 1.272 10.8*6.9 Crossed Catapresan (clonidine), 75 mcg 0.096 0.001 1.075 6.0*2.3 Scored Tavegyl (clemastine), 1 mg 0.131 0.001 0.932 7.0*2.4 Scored Prednisolon (prednisolon), 5 mg 0.178 0.002 0.896 8.0*2.7 Scored NPPG, Belfast 29th Oct 2005

Alvedon (Paracetamol) NPPG, Belfast 29th Oct 2005

Catapresan (clonidine) NPPG, Belfast 29th Oct 2005

Hydrocortone (hydrocortisone) NPPG, Belfast 29th Oct 2005

Prednisolone (prednisolone) NPPG, Belfast 29th Oct 2005

Tavegyl (clemastine) NPPG, Belfast 29th Oct 2005

NPPG, Belfast 29th Oct 2005

Conclusion Splitting of tablets for paediatric dosing should be avoided due to lack of dosing accuracy If splitting is necessary - use a device Do not split tablets into quarters NPPG, Belfast 29th Oct 2005