Formulation of buprenorphine for sublingual use in neonates.

Authors

Ellena A Anagnostis, Thomas Jefferson University HospitalFollow
Rania E Sadaka, Thomas Jefferson University HospitalFollow
Linda A Sailor, Thomas Jefferson University HospitalFollow
David E Moody, University of UtahFollow
Kevin C Dysart, The Children’s Hospital of PhiladelphiaFollow
Walter k. Kraft, Thomas Jefferson UniversityFollow

Document Type

Article

Publication Date

10-1-2011

Comments

This article has been peer reviewed. It is the authors' final version prior to publication in The Journal of Pediatric Pharmacology and Therapeutics.

Volume 16, Issue 4, October 2011, Pages 281-284.

The published version is available at PMCID: PMC3385042 . Copyright © Pediatric Pharmacy Advocacy Group and Allen Press Publishing Services

Abstract

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 Additional samples were withdrawn at baseline from each batch and placed in oral dispensing syringes for 3 and 7 days.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.

Recommended Citation

Anagnostis, Ellena A; Sadaka, Rania E; Sailor, Linda A; Moody, David E; Dysart, Kevin C; and Kraft, Walter k., "Formulation of buprenorphine for sublingual use in neonates." (2011). Department of Pharmacology and Experimental Therapeutics Faculty Papers. Paper 38.
https://jdc.jefferson.edu/petfp/38

PubMed ID

22768012