Evidence map›Paper›PMID 22768012›Full record

ArticleThe journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG2011

Formulation of buprenorphine for sublingual use in neonates.

Ellena A Anagnostis, Rania E Sadaka, Linda A Sailor, David E Moody, Kevin C Dysart, Walter K Kraft

Registry-linked trialAbstract read
In one paragraph

Article in The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04455802 (Prospective Randomized Blinded Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
0.6field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04455802 phase3withdrawnnot on this mapstarted 2020, after this paper: background citation

Prospective Randomized Blinded Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)

TypeinterventionalSponsorWomen and Infants Hospital of Rhode IslandRan2020 to 2021Enrolled0ConditionsNeonatal Opioid Withdrawal SyndromeArmsBuprenorphine or Placebo, Morphine or Placebo
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. Stability Study of a Compounded Sublingual Buprenorphine Solution for Neonatal Opioid Withdrawal Syndrome.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2023
    Article
  3. Neonatal opioid withdrawal syndrome: a review of the science and a look toward the use of buprenorphine for affected infants.Journal of perinatology : official journal of the California Perinatal Association · 2022
    Review
  4. Review
  5. Using buprenorphine to treat neonatal abstinence syndrome: a quality improvement study.Journal of perinatology : official journal of the California Perinatal Association · 2021
    Article
  6. Article
  7. Review
  8. Buprenorphine in Neonatal Abstinence Syndrome.Clinical pharmacology and therapeutics · 2018
    Review
  9. Article
  10. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 1 country.

Ellena A Anagnostis
Rania E Sadaka
Linda A Sailor
David E Moody
Kevin C Dysart
Walter K Kraft
Thomas Jefferson University Hospital · USChildren's Hospital of Philadelphia · USThomas Jefferson University · USUniversity of Utah · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe 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.

methodsBuprenorphine 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.

resultsNeither 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.

conclusionsAn ethanolic buprenorphine solution is stable at room temperature for 30 days.

Indexed as

buprenorphinedrug stabilitynewborn infantpharmaceutical chemistrysublingual administration

Identifiers

PMID22768012
PMCPMC3385042
OpenAlexW2159281741

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.