Evidence map›Paper›PMID 27194003›Full record

ArticlePharmaceutical research2016

Rapid Absorption of Dry-Powder Intranasal Oxytocin.

Mikolaj Milewski, Adrian Goodey, Dinah Lee, Eric Rimmer, Robert Saklatvala, Shuzo Koyama, Mic Iwashima, Shunji Haruta

Abstract read
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Article in Pharmaceutical research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
3.0field-weighted citation impact, top 10% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Review
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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

8 authors at 2 institutions in 2 countries.

Mikolaj MilewskiMerck Research Laboratories, Merck & Co., Inc., Kenilworth, New Jersey, USA. mikolaj.milewski@merck.com.
Adrian GoodeyMerck Research Laboratories, Merck & Co., Inc., Kenilworth, New Jersey, USA.
Dinah LeeMerck Research Laboratories, Merck & Co., Inc., Kenilworth, New Jersey, USA.
Eric RimmerMerck Research Laboratories, Merck & Co., Inc., Kenilworth, New Jersey, USA.
Robert SaklatvalaMerck Research Laboratories, Merck & Co., Inc., Kenilworth, New Jersey, USA.
Shuzo KoyamaTR Division, Shin Nippon Biomedical Laboratories, Ltd., Kagoshima, Japan.
Mic IwashimaTR Division, Shin Nippon Biomedical Laboratories, Ltd., Kagoshima, Japan.
Shunji HarutaTR Division, Shin Nippon Biomedical Laboratories, Ltd., Kagoshima, Japan.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USShin Nippon Biomedical Laboratories (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo probe the suitability of a dry-powder oxytocin formulation containing a carrier (μco™; SNBL, Ltd.) for intranasal (IN) administration to treat post-partum hemorrhage in the developing world. Specifically, to investigate (1) whether IN administration can achieve rapid systemic absorption in cynomolgus monkeys, and (2) whether the formulation exhibits sufficient physical and chemical stability. This study was conducted to support Merck for Mothers, Merck's 10-year global initiative to end preventable maternal deaths.

methodsA partial-crossover pharmacokinetic (PK) study in cynomolgus monkeys (n = 6) was utilized to compare in vivo absorption of dry-powder IN oxytocin at three dose levels against an IM injection of an aqueous oxytocin formulation. Particle size distribution, delivered dose and chemical assay were monitored over a 12 month stability study.

resultsIN administration of oxytocin resulted in short (5 min) Tmax and good dose linearity in AUC and Cmax over the dose range tested (10-80 IU per animal). The relative bioavailability (BA) of IN oxytocin to IM injection was approximately 12%. The 80 IU formulation exhibited good physical stability and consistent dosing. After 12 months at 30°C/65%RH, pouched samples retained 86.0% of their original assay value.

conclusionsThe PK and stability data suggests that IN administration of oxytocin formulated in the μco™ carrier may represent a viable option for rapid systemic absorption in humans and a product compatible with resource-scarce regions.

Indexed as

Administration, IntranasalAnimalsCross-Over StudiesDrug Delivery SystemsMacaca fascicularisMaleNasal AbsorptionOxytocicsOxytocinTime FactorsOxytocicsOxytocinintranasal absorptionpeptidepharmacokineticspreclinicalstability

Identifiers

PMID27194003
OpenAlexW2397987517

What OpenQuestion holds

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Registered trials

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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.