Evidence map›Paper›PMID 34697049›Full record

ArticleEuropean journal of hospital pharmacy : science and practice2021

Development of a sterile morphine hydrogel for the local treatment of painful skin ulcers.

Mark M P M Jansen, Viviënne P H van Waas, Jacques M Verzijl, David Burger

Open access · greenAbstract read
In one paragraph

Article in European journal of hospital pharmacy : science and practice, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 94% 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

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Article
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

4 authors at 2 institutions in 1 country.

Mark M P M JansenHospital Pharmacy, Elisabeth-TweeSteden Ziekenhuis, Tilburg, The Netherlands mmpm.jansen@etz.nl.ORCID 0000-0003-4390-9911
Viviënne P H van WaasHospital Pharmacy, Elisabeth-TweeSteden Ziekenhuis, Tilburg, The Netherlands.
Jacques M VerzijlHospital Pharmacy, Elisabeth-TweeSteden Ziekenhuis, Tilburg, The Netherlands.
David BurgerPharmacy, Radboudumc, Nijmegen, The Netherlands.
Elisabeth-TweeSteden Ziekenhuis · NLRadboud University Nijmegen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesIt is often difficult to relieve the pain from skin ulcers. In several patients, topical morphine, applied as a hydrogel, has been described as useful. There is no such product commercially available. We present a solution for compounding, packaging, sterilisation and chemical stability of a morphine containing hydrogel.

methodsWe developed a morphine containing poloxamer 407 thermoreversible hydrogel with a concentration of 5 mg/g (0.5% w/w) morphine hydrochloride. The hydrogel was packaged into a plastic prefillable syringe system: BD Sterifill SCF. This syringe can be steam sterilised after it has been filled.

resultsSterility tests according to the European Pharmacopoeia showed the product to be sterile directly after production and sterilisation and after 20 months of storage. The stability of the morphine hydrochloride was assessed by monthly analysis of the concentration with a stability indicating HPLC-UV method. Morphine hydrochloride concentrations remained between 90% and 110% of the theoretical concentration for a period of 36 months, when stored at room temperature outside the influence of light.

conclusionWith the described formulation, packaging, sterilisation and stability data, together with the previously reported biopharmaceutical dissolution profile, we present a complete solution for a morphine containing poloxamer 407 hydrogel that can be compounded in any pharmacy with a steam or hot water steriliser at their disposal. This might improve the availability of a sterile morphine hydrogel for the treatment of painful skin ulcers.

Indexed as

InfertilitySkin UlcerHumansHydrogelsMorphinePainHydrogelsMorphinedevelopmentmorphinepainful skin ulcerspoloxamer 407sterile hydrogeltopical

Identifiers

PMID34697049
PMCPMC8552166
OpenAlexW2966057325

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.