title: Extemporaneous benznidazole oral suspension prepared from commercially available tablets for treatment of Chagas disease in paediatric patients.
abstract: OBJECTIVE
  To develop an extemporaneous 1% benznidazole (BNZ) suspension, with masked taste and adequate stability starting from available commercial tablets. The quality of compounding was evaluated through content uniformity measurement and physical and microbiological stability evaluation, under different storage conditions during 90 days.
  
  
  METHODS
  Six batches of 1% BNZ suspension were prepared using safe excipients currently available in a galenic area of Hospital Pharmacy and then stored at 5 and 25 °C for 90 days. The BNZ content was determined by UV spectrophotometry. Physical stability was defined as the absence of colour, odour and/or flavour changes and the re-suspension of solid phase by a reasonable amount of simple 15-s shaking. The compliance with microbiological attributes of non-sterile pharmaceutical products was also evaluated.
  
  
  RESULTS
  An oral liquid suspension, containing 1% of BNZ, was developed from commercially available BNZ tablets. The formulations stored for 90 days were easily re-dispersed after a simple 15-s shaking, ensuring the pouring of a liquid volume containing the desired dose of BNZ. All samples were within the acceptable range of BNZ concentration with minimal standard deviations. There were no detectable changes in colour, odour, viscosity, pH and microbial growth, complying with official quality requirements. The quality attributes were not affected by storage, room or refrigeration conditions or by the frequent opening or closing of the multidose containers.
  
  
  CONCLUSIONS
  Paediatric oral liquid suspension containing 1.0% of BNZ was easily prepared starting from commercial tablets, being an interesting alternative for optimising the paediatric treatment of Chagas disease.
authors.affiliation: Department of Pharmacy, National University of Cordoba, Cordoba, Argentina.
authors.forename: Mónica C
authors.initials: MC
authors.lastname: García
authors.affiliation: Department of Pharmacy, National University of Cordoba, Cordoba, Argentina.
authors.forename: Ruben H
authors.initials: RH
authors.lastname: Manzo
authors.affiliation: Department of Pharmacy, National University of Cordoba, Cordoba, Argentina.
authors.forename: Alvaro F
authors.initials: AF
authors.lastname: Jimenez-Kairuz
mesh_terms: D000284:Administration, Oral; D014355:Chagas Disease / Q000188:drug therapy*; D002648:Child; D004339:Drug Compounding / Q000379:methods; D004355:Drug Stability; D004356:Drug Storage; D006801:Humans; D009593:Nitroimidazoles / Q000008:administration & dosage* / Q000627:therapeutic use; D010372:Pediatrics; D013056:Spectrophotometry, Ultraviolet; D013535:Suspensions; D013607:Tablets; D013649:Taste
chemical_list: D009593:Nitroimidazoles; D013535:Suspensions; D013607:Tablets; C009999:benzonidazole
keywords: Benznidazol; Fórmula magistral; benznidazole; chagas disease; composition; compounding; enfermedad de Chagas; maladie de Chagas; oral paediatric suspension; suspension orale pédiatrique; suspensión pediátrica oral