title: The accuracy, precision and sustainability of different techniques for tablet subdivision: breaking by hand and the use of tablet splitters or a kitchen knife.
abstract: BACKGROUND
  Tablets are frequently subdivided to lower the dose, to facilitate swallowing by e.g. children or older people or to save costs. Splitting devices are commonly used when hand breaking is difficult or painful.
  
  
  METHODS
  Three techniques for tablet subdivision were investigated: hand breaking, tablet splitter, kitchen knife. A best case drug (paracetamol), tablet (round, flat, uncoated, 500 mg) and operator (24-year student) were applied. Hundred tablets were subdivided by hand and by three devices of each of the following types: Fit & Healthy, Health Care Logistics, Lifetime, PillAid, PillTool, Pilomat tablet splitter; Blokker kitchen knife. The intra and inter device accuracy, precision and sustainability were investigated. The compliance to (adapted) regulatory requirements was investigated also.
  
  
  RESULTS
  The accuracy and precision of hand broken tablets was 104/97% resp. 2.8/3.2% (one part per tablet considered; parts right/left side operator). The right/left accuracies of the splitting devices varied between 60 and 133%; the precisions 4.0 and 29.6%. The devices did not deteriorate over 100-fold use. Only hand broken tablets complied with all regulatory requirements.
  
  
  CONCLUSIONS
  Health care professionals should realize that tablet splitting may result in inaccurate dosing. Authorities should undertake appropriate measures to assure good function of tablet splitters and, where feasible, to reduce the need for their use.
authors.affiliation: Medicines Evaluation Board, Department of chemical pharmaceutical assessment (DAR/AN/MD) resp. Pharmacotherapeutic Group 3 (ST) resp. Scientific Board (YH), Utrecht, The Netherlands. Electronic address: da.v.riet@cbg-meb.nl.
authors.forename: Diana A
authors.initials: DA
authors.lastname: van Riet-Nales
authors.affiliation: Medicines Evaluation Board, Department of chemical pharmaceutical assessment (DAR/AN/MD) resp. Pharmacotherapeutic Group 3 (ST) resp. Scientific Board (YH), Utrecht, The Netherlands.
authors.forename: Myrthe E
authors.initials: ME
authors.lastname: Doeve
authors.affiliation: Medicines Evaluation Board, Department of chemical pharmaceutical assessment (DAR/AN/MD) resp. Pharmacotherapeutic Group 3 (ST) resp. Scientific Board (YH), Utrecht, The Netherlands.
authors.forename: Agnes E
authors.initials: AE
authors.lastname: Nicia
authors.affiliation: Medicines Evaluation Board, Department of chemical pharmaceutical assessment (DAR/AN/MD) resp. Pharmacotherapeutic Group 3 (ST) resp. Scientific Board (YH), Utrecht, The Netherlands; Radboud University Medical Centre, Department of Health Evidence (ST) resp. department of clinical pharmacy (YH, BB), Nijmegen, The Netherlands.
authors.forename: Steven
authors.initials: S
authors.lastname: Teerenstra
authors.affiliation: National Institute for Public Health and the Environment (RIVM), Centre for Health Protection (GZB), Department of Public Health Effects, Bilthoven, The Netherlands.
authors.forename: Kim
authors.initials: K
authors.lastname: Notenboom
authors.affiliation: Medicines Evaluation Board, Department of chemical pharmaceutical assessment (DAR/AN/MD) resp. Pharmacotherapeutic Group 3 (ST) resp. Scientific Board (YH), Utrecht, The Netherlands; Radboud University Medical Centre, Department of Health Evidence (ST) resp. department of clinical pharmacy (YH, BB), Nijmegen, The Netherlands.
authors.forename: Yechiel A
authors.initials: YA
authors.lastname: Hekster
authors.affiliation: Radboud University Medical Centre, Department of Health Evidence (ST) resp. department of clinical pharmacy (YH, BB), Nijmegen, The Netherlands; Sint Maartenskliniek, Department of pharmacy, Nijmegen, The Netherlands.
authors.forename: Bart J F
authors.initials: BJ
authors.lastname: van den Bemt
mesh_terms: D000082:Acetaminophen; D000328:Adult; D003297:Cooking and Eating Utensils; D005260:Female; D006801:Humans; D007880:Legislation, Drug; D013607:Tablets / Q000592:standards; D055815:Young Adult
chemical_list: D013607:Tablets; D000082:Acetaminophen
keywords: Break mark; Medication; Pharmaceutical development; Tablet splitting; Weight uniformity