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Tablet splitting: How accurate does the dose get?

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. Objective.

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Tablet splitting: How accurate does the dose get?

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

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

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

  4. 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

  5. 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

  6. NPPG, Belfast 29th Oct 2005

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

  8. 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

  9. 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

  10. 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

  11. 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

  12. Alvedon (Paracetamol) NPPG, Belfast 29th Oct 2005

  13. Catapresan (clonidine) NPPG, Belfast 29th Oct 2005

  14. Hydrocortone (hydrocortisone) NPPG, Belfast 29th Oct 2005

  15. Prednisolone (prednisolone) NPPG, Belfast 29th Oct 2005

  16. Tavegyl (clemastine) NPPG, Belfast 29th Oct 2005

  17. NPPG, Belfast 29th Oct 2005

  18. 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

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