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Explore tablet splitting for pediatric dosing accuracy, reasons for splitting, methods of comparison, and conclusions based on a study. Avoid tablet splitting for pediatric dosing if possible.
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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
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% 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
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