title: Repackaged sodium valproate tablets--Meeting quality and adherence to ensure seizure control.
abstract: OBJECTIVE
  Sodium valproate, which is commonly repacked to assist with adherence to ensure seizure control, is hygroscopic and therefore sensitive to moisture. The aim of this study was thus to determine the stability implications of removing the enteric coated tablets from their original packaging and repackaging into a Dose Administration Aid (DAA) with storage under various environmental conditions.
  
  
  METHODS
  Physicochemical stability of enteric coated sodium valproate tablets repackaged into a DAA and stored at controlled room temperature, accelerated and refrigerated conditions was evaluated for 28 days. A validated high performance liquid chromatography method was used for the quantitation of the drug content.
  
  
  RESULTS
  Although the chemical stability (sodium valproate between 95 and 105% of labelled content) was maintained for 28 days for all storage conditions, for those tablets stored under accelerated conditions the integrity of the enteric coat was compromised after only 8 days.
  
  
  CONCLUSIONS
  Repackaging of enteric coated sodium valproate should be undertaken with caution and be informed by storage climate. This is particularly relevant for those patients living in hot, humid environments where they should be advised to store their DAA in a refrigerator.
authors.affiliation: Department of Pharmacy, King's College, London, United Kingdom.
authors.forename: Nichola
authors.initials: N
authors.lastname: Redmayne
authors.affiliation: Pharmacy, College of Medicine and Dentistry, James Cook University, Townsville, QLD 4811, Australia.
authors.forename: Sherryl
authors.initials: S
authors.lastname: Robertson
authors.affiliation: Pharmacy, College of Medicine and Dentistry, James Cook University, Townsville, QLD 4811, Australia.
authors.forename: Jutta
authors.initials: J
authors.lastname: Kockler
authors.affiliation: Pharmacy, College of Medicine and Dentistry, James Cook University, Townsville, QLD 4811, Australia.
authors.forename: Victoria
authors.initials: V
authors.lastname: Llewelyn
authors.affiliation: School of Pharmacy, Griffith University, Gold Coast, QLD 4222, Australia.
authors.forename: Alison
authors.initials: A
authors.lastname: Haywood
authors.affiliation: Pharmacy, College of Medicine and Dentistry, James Cook University, Townsville, QLD 4811, Australia. Electronic address: Beverley.Glass@jcu.edu.au.
authors.forename: Beverley
authors.initials: B
authors.lastname: Glass
mesh_terms: D000927:Anticonvulsants / Q000008:administration & dosage* / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid; D004349:Drug Packaging / Q000379:methods / Q000592:standards; D004355:Drug Stability; D004356:Drug Storage / Q000379:methods; D006801:Humans; D010349:Patient Compliance / Q000523:psychology; D012640:Seizures / Q000188:drug therapy* / Q000523:psychology; D013607:Tablets; D013696:Temperature; D014635:Valproic Acid / Q000008:administration & dosage* / Q000737:chemistry
chemical_list: D000927:Anticonvulsants; D013607:Tablets; D014635:Valproic Acid
keywords: Adherence; Dose Administration Aids; Enteric coating; Epilepsy; Packaging; Stability