title: Formulation of buprenorphine for sublingual use in neonates.
abstract: OBJECTIVE
  The only medication used sublingually in the neonate is buprenorphine for the treatment of neonatal abstinence syndrome (NAS). Compared with morphine, buprenorphine reduces the length of treatment and length of hospitalization in neonates treated for NAS. The objective of this study was to characterize the stability of ethanolic buprenorphine for sublingual administration.
  
  
  METHODS
  Buprenorphine solution was prepared and stored in amber glass source bottles at either 68°F to 77°F (20°C-25°C) or 36°F to 46°F (2.2°C-7.8°C). Samples were collected from each of these batches on days 0, 3, 7, 14, and 30. Additional samples were withdrawn at baseline from each batch and placed in oral dispensing syringes for 3 and 7 days. Buprenorphine concentration was assessed by liquid chromatography-electrospray ionization-tandem mass spectrometry.
  
  
  RESULTS
  Neither storage temperature (p=0.65) nor storage time (p=0.24) significantly affected buprenorphine concentrations. All of the mean concentrations, regardless of storage temperature, were above 95% of the labeled concentration, and the potency was maintained for samples stored either in the original amber glass source bottles or in oral syringes.
  
  
  CONCLUSIONS
  An ethanolic buprenorphine solution is stable at room temperature for 30 days.
authors: Ellena A
authors: EA
authors: Anagnostis
authors: Rania E
authors: RE
authors: Sadaka
authors: Linda A
authors: LA
authors: Sailor
authors: David E
authors: DE
authors: Moody
authors: Kevin C
authors: KC
authors: Dysart
authors: Walter K
authors: WK
authors: Kraft