OBJECTIVES: 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 Additional samples were withdrawn at baseline from each batch and placed in oral dispensing syringes for 3 and 7 days.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.
OBJECTIVES: 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 Additional samples were withdrawn at baseline from each batch and placed in oral dispensing syringes for 3 and 7 days.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.
Entities:
Keywords:
buprenorphine; drug stability; newborn infant; pharmaceutical chemistry; sublingual administration
Authors: Neil S Seligman; Nicole Salva; Edward J Hayes; Kevin C Dysart; Edward C Pequignot; Jason K Baxter Journal: Am J Obstet Gynecol Date: 2008-10 Impact factor: 8.661
Authors: Walter K Kraft; Eric Gibson; Kevin Dysart; Vidula S Damle; Jennifer L Larusso; Jay S Greenspan; David E Moody; Karol Kaltenbach; Michelle E Ehrlich Journal: Pediatrics Date: 2008-08-11 Impact factor: 7.124
Authors: David E Moody; Matthew H Slawson; Eric C Strain; John D Laycock; Alan C Spanbauer; Rodger L Foltz Journal: Anal Biochem Date: 2002-07-01 Impact factor: 3.365
Authors: Walter K Kraft; Susan C Adeniyi-Jones; Inna Chervoneva; Jay S Greenspan; Diane Abatemarco; Karol Kaltenbach; Michelle E Ehrlich Journal: N Engl J Med Date: 2017-05-04 Impact factor: 91.245
Authors: Lori A Devlin; Leslie W Young; Walter K Kraft; Elisha M Wachman; Adam Czynski; Stephanie L Merhar; T Winhusen; Hendrée E Jones; Brenda B Poindexter; Lauren S Wakschlag; Amy L Salisbury; Abigail G Matthews; Jonathan M Davis Journal: J Perinatol Date: 2021-09-23 Impact factor: 3.225