title: Design of pediatric oral formulations with a low proportion of methadone or phenobarbital for the treatment of neonatal abstinence syndrome.
abstract: BACKGROUND
  Elaboration of oral liquid formulations is the best alternative when no marketed forms are available for pediatrics.
  
  
  OBJECTIVE
  The development, characterization and stability evaluation of methadone (MI, MII, MIII) and phenobarbital (PI, PII) can be used for the treatment of neonatal abstinence syndrome (NAS).
  
  
  METHODS
  A standard operating procedure was established and parameters such as appearance, pH, rheological behavior and drug content were evaluated at three temperatures for 90 days.
  
  
  CONCLUSIONS
  Changes in color of phenobarbital made necessary the storage below 25 °C. pH did not change in methadone solutions and was able to maintain phenobarbital solubilized. Degradation data at 4 °C fitted to Plateau equation followed by one phase decay. MI was stable for 60 days at the three temperatures; MII for 90 days at 4 and 25 °C and 60 days at 40 °C; MIII for 60 days at 4 °C, 15 days at 25 °C and 7 days at 4 °C. PI was stable for 60 days at 4 °C and 30 days at 25 °C. PII was stable for 7 days at 4 and 25 °C. All solutions met microbial specifications.
  
  
  CONCLUSIONS
  A correct dosage for the treatment of NAS was guaranteed.
authors.affiliation: a Pharmacokinetics and Biopharmaceutics Unit , School of Pharmacy, University of Barcelona , Barcelona , Spain and.
authors.forename: Nora
authors.initials: N
authors.lastname: Provenza
authors.affiliation: a Pharmacokinetics and Biopharmaceutics Unit , School of Pharmacy, University of Barcelona , Barcelona , Spain and.
authors.forename: Ana C
authors.initials: AC
authors.lastname: Calpena
authors.affiliation: a Pharmacokinetics and Biopharmaceutics Unit , School of Pharmacy, University of Barcelona , Barcelona , Spain and.
authors.forename: Mireia
authors.initials: M
authors.lastname: Mallandrich
authors.affiliation: a Pharmacokinetics and Biopharmaceutics Unit , School of Pharmacy, University of Barcelona , Barcelona , Spain and.
authors.forename: Blanca
authors.initials: B
authors.lastname: Pueyo
authors.affiliation: b Department of Pharmacy and Pharmaceutical Technology , School of Pharmacy, University of Granada , Granada , Spain.
authors.forename: Beatriz
authors.initials: B
authors.lastname: Clares
mesh_terms: D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical / Q000379:methods* / Q000592:standards; D015195:Drug Design; D004349:Drug Packaging; D004355:Drug Stability; D006801:Humans; D007231:Infant, Newborn; D008691:Methadone / Q000008:administration & dosage / Q000138:chemical synthesis*; D009357:Neonatal Abstinence Syndrome / Q000188:drug therapy; D010634:Phenobarbital / Q000008:administration & dosage / Q000138:chemical synthesis*; D012212:Rheology / Q000379:methods / Q000592:standards; D016896:Treatment Outcome
chemical_list: D008691:Methadone; D010634:Phenobarbital
keywords: Methadone; neonatal abstinence syndrome; pediatric formulations; phenobarbital