Evidence map›Paper›PMID 29700898›Full record

ArticleJournal of peptide science : an official publication of the European Peptide Society2018

Development and stability of a heat-stable formulation of carbetocin for the prevention of postpartum haemorrhage for use in low and middle-income countries.

Mattias Malm, Ingbritt Madsen, Johan Kjellström

Registry-linked trialOpen access · bronzeAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of peptide science : an official publication of the European Peptide Society, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04482959 (Intraoperative Carbetocin to Decrease Blood Loss During Hysteroscopic Myomectomy), which is not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
12.0field-weighted citation impact, top 1% 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.

NCT04482959 phase4completednot on this mapstarted 2020, after this paper: background citation

Intraoperative Carbetocin to Decrease Blood Loss During Hysteroscopic Myomectomy: a Randomized Controlled Trial

TypeinterventionalSponsorMansoura University HospitalRan2020 to 2022Enrolled40ConditionsMyoma, UterusArmsCarbetocin, Sodium chloride 0.9%
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 79 citations in OpenAlex.

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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

3 authors at 1 institution in 1 country.

Mattias MalmFerring Pharmaceuticals A/S, Kay Fiskers Plads 11, 2300, Copenhagen S, Denmark.
Ingbritt MadsenFerring Pharmaceuticals A/S, Kay Fiskers Plads 11, 2300, Copenhagen S, Denmark.ORCID http://orcid.org/0000-0003-4984-4151
Johan KjellströmFerring Pharmaceuticals A/S, Kay Fiskers Plads 11, 2300, Copenhagen S, Denmark.
Ferring Pharmaceuticals (Denmark) · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Postpartum haemorrhage is a leading cause of maternal death worldwide. Oxytocin, currently the drug of choice for prevention of PPH, requires constant refrigeration. In pursuit of an alternative medicine, Ferring Pharmaceuticals have developed a heat-stable formulation of carbetocin, an oxytocin analogue. This study aimed to define that formulation, and to investigate its stability under ICH climate zone IV conditions (30°C/75% relative humidity) for at least 3 years and at extreme temperatures, such as 60°C, for shorter periods of time. The development resulted in a heat-stable carbetocin formulation consisting of 0.1 mg/mL carbetocin in sodium succinate buffer, mannitol, and methionine. The optimum pH was determined to be pH 5.45 (5.25-5.65). The generated stability data of this formulation show that ≥95% purity of the peptide was maintained for a minimum of 3 years at 30°C, 6 months at 40°C, 3 months at 50°C and 1 month at 60°C. In addition, the heat-stable carbetocin formulation was not sensitive to freezing or light. The reported highly stable peptide formulation facilitates the distribution in low and middle-income countries, where maintaining cold chain distribution is difficult. Ferring Pharmaceuticals, the World Health Organization, and MSD for Mothers have established a collaboration to develop this heat-stable formulation of carbetocin for the prevention of post-partum hemorrhage in women after vaginal childbirth, with the aim of making the medicine available in the public sector of developing countries that have a high burden of maternal mortality.

Indexed as

Drug CompoundingAdultDrug StorageFemaleHot TemperatureHumansHydrogen-Ion ConcentrationOxytocinPostpartum HemorrhagePregnancycarbetocinOxytocincarbetocinheat stabilityoxytocinpostpartum haemorrhageuterotonic

Identifiers

PMID29700898
PMCPMC6001700
OpenAlexW2801213679

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.