STATISTIC ESTIMATION OF BREAKING TABLETS OF ENALAPRIL 20 MG
Keywords:
enalapril, breaking tablets, pediatric formulations, score lineAbstract
Objective: The aim of this study was to evaluate the accuracy of breaking into half and quarter-tablets Enalapril 20 mg sold in the Albanian market, in dosages suitable for use in children.
Methods: 100 whole tablets of Enalapril 20 mg were chosen at random from each of three different manufacturers based on scoring characteristic: scored on one side, scored on both sides and not scored. Whole tablets from each of the three product types were weighed and the mean weight calculated. The pills were then split in half and quarter by using a pill-splitter. The resulting half-tablets and quarter-tablets were weighed and the mean weights were calculated.
Results: All the whole tablets were found to conform to the set criteria. Only halves from those tablets scored on both sides passed the weight uniformity test, with no individual half outside the 85-115 % range. Quarter-tablets failed the weight uniformity test. A higher relative standard deviation was observed for half and quarter-tablets of the not-scored tablet.
Conclusion: The study shows that deviations in weight were observed in half tablets and quarter tablets of Enalapril 20 mg. These deviations were related to the presence or not of the score line. Such inadequate breaking of the tablets may result in dose variability and complicate therapeutic outcome.
Keywords: Enalapril, Breaking tablets, Pediatric formulations, Score line
Downloads
References
Brion F, Nunn AJ, Rieutord A. Extemporaneous (magistral) preparation of oral medicines for children in European hospitals. Acta Paediatr 2003;92:486-90.
Ceci A, Reggiardo G. Utilizzo di prodotti pharmaceutics non documentati nella pratica pediatrica in Italia. Ital J Pediatr 1997;23:959-66.
Conroy S, McIntyre J, Choonara I, Stephenson T. Drug trials in children: problems and the way forward. Br J Clin Pharmacol 2000;49:93-7.
Cohen CI, Cohen SI. Potential savings from splitting newer antidepressant medications. CNS Drugs 2002;16:353-8.
Stimpel M, Vetter H, Küffer B, Groth H, Greminger P, Vetter W. The scored tablet--a source of error in drug dosing? J Hypertens 1985;3:97-9.
Gupta P, Gupta K. Broken tablets: does the sum of the parts equal the whole? Am J Hosp Pharm 1988;45:1498.
Myriam S, Philippe A, Fontan JE, Brion F. Splitting tablets in half. Am J Hosp Pharm 1994;15:548-50.
Van Vooren L, De Spiegeleer B, Thonissen T, Joye P, Van Durme J, Slegers G. Statistical analysis of tablet breakability methods. J Pharm Pharm Sci 2002;5:190-8.
Teng J, Song CK, Williams RL, Polli JE. Lack of medication dose uniformity in commonly split tablets. J Am Pharm Assoc 2002;42:195-9.
McDevitt JT, Gurst AH, Chen Y. Accuracy of tablet splitting. Pharmacotherapy 1998;18:193-7.
Cook TJ, Edwards S, Gyemah C, Shah M, Shah I, Fox T. Variability in tablet fragment weights when splitting unscored cyclobenzaprine 10 mg tablets. J Am Pharm Assoc 2004;44:583-6.
Rosenberg JM, Nathan JP, Plakogiannis F. Weight variability of pharmacist-dispensed split tablets. J Am Pharm Assoc 2002;42:200-5.
Boggie DT, Delattre ML, Schaefer MG, Morreale AP, Plowman BK. Accuracy of splitting unscored valdecoxib tablets. Am J Health-Syst Pharm 2004;61:1482-3.
Uniformity of dosage units. United States pharmacopeia 24/national formulary 19:Rockville, MD: United States Pharmacopeial Convention; 1999. p. 2000-3.
European Pharmacopoeia. European Directorate for the Quality of Medicines within the Council of Europe, Strasbourg; 1997.
Rashed SM, Nolly RJ, Robinson L, Thoma L. Weight variability of scored and unscored split psychotropic drug tablets. Hosp Pharm 2003;38:930-4.
Robinson RF, Nahata MC, Batisky DL, Mahan JD. Pharmacologic treatment of chronic pediatric hypertension. Paediatr Drugs 2005;7:27-40.
Edeki T, Johnson A, Li Kam Wa E. Enalapril pharmakokinetics and ACE inhibition, following single and chronik oral dosing. Int J Clin Pharmacol Ther 1994;32:142-4.
Tahaineh LM, Gharaibeh SF. Tablet splitting and weight uniformity of half-tablets of 4 medications in pharmacy practice. J Pharm Pract 2012;25:471-6.
Grissinger M. Tablet splitting-only if you ‘‘half’’ to. PT 2010;35:69-70.
Polli JE, Kim S, Martin BR. Weight uniformity of split tablets required by a veterans affairs policy. J Managed Care Pharm 2003;9:401-7.
Zaid AN, Ghosh AA. Compliance of scored tablet halves produced by Palestinian pharmaceutical companies with the new European pharmacopoeia requirements. Arch Pharm Res 2011;34:1183-9.
Hill SW, Varker AS, Karlage K, Myrdal PB. Analysis of drug content and weight uniformity for half-tablets of 6 commonly split medications. J Managed Care Pharm 2009;15:253-61.