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 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

11. Tablet characteristics
Mean weight s.d C.V Size Scored/Crossed
mg mm
Alvedon (paracetamol), 500 mg *7.7* Scored
Hydrocortone (hydrocortisone)10 mg * Crossed
Catapresan (clonidine), 75 mcg * Scored
Tavegyl (clemastine), 1 mg * Scored
Prednisolon (prednisolon), 5 mg * 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