Evidence map›Paper›PMID 35460023›Full record

ArticlePharmaceutical research2023

Osmolality of Excipients for Parenteral Formulation Measured by Freezing Point Depression and Vapor Pressure - A Comparative Analysis.

Mariana Hugo Silva, Sarah P Hudson, Lidia Tajber, Matthieu Garin, Wenyu Dong, Tatsiana Khamiakova, René Holm

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Article in Pharmaceutical research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.0field-weighted citation impact, top 29% 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

3 citing papers in PubMed, 14 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

7 authors at 3 institutions in 5 countries.

Mariana Hugo SilvaPharmaceutical Product Development and Supply, Janssen Research and Development, Johnson & Johnson, Beerse, Belgium.
Sarah P HudsonDepartment of Chemical Sciences, SSPC the Science Foundation Ireland Research Centre for Pharmaceuticals, Bernal Institute, University of Limerick, Castletroy, Co. Limerick, Ireland.
Lidia TajberSchool of Pharmacy and Pharmaceutical Sciences, SSPC the Science Foundation Ireland Research Centre for Pharmaceuticals, Trinity College Dublin, Dublin 2, College Green, Ireland.
Matthieu GarinPharmaceutical Product Development and Supply, Janssen Research and Development, Johnson & Johnson, Beerse, Belgium.
Wenyu DongPharmaceutical Product Development and Supply, Janssen Research and Development, Johnson & Johnson, Beerse, Belgium.
Tatsiana KhamiakovaPharmaceutical Product Development and Supply, Janssen Research and Development, Johnson & Johnson, Beerse, Belgium.
René HolmPharmaceutical Product Development and Supply, Janssen Research and Development, Johnson & Johnson, Beerse, Belgium. reho@sdu.dk.ORCID http://orcid.org/0000-0003-4894-7765
Janssen (Belgium) · BEScience Foundation Ireland · IEJohnson & Johnson (United States) · US

Funding

H2020 Marie Skłodowska-Curie Actions 861278
6 · The paper itself

Abstract

purposeTo investigate the difference in methods to determine the osmolality in solutions of stabilizers used for long-acting injectable suspensions.

methodsThe osmolality was measured by freezing point depression and vapor pressure for 11 different polymers and surfactants (PEG 3350, 4000, 6000, 8000, 20,000, PVP K12, K17 and K30, poloxamer 188, 388 and 407, HPMC E5, Na-CMC, polysorbate 20 and 80, vitamin E-TPGS, phospholipid, DOSS and SDS) in different concentrations.

resultsIndependently of the measuring method, an increase in osmolality with increasing concentration was observed for all polymers and surfactants, as would be expected due to the physicochemical origin of the osmolality. No correlation was found between the molecular weight of the polymers and the measured osmolality. The osmolality values were different for PVPs, PEGs, and Na-CMC using the two different measurement methods. The values obtained by the freezing point depression method tended to be similar or higher than the ones provided by vapor pressure, overall showing a significant difference in the osmolality measured by the two investigated methods.

conclusionsFor lower osmolality values (e.g. surfactants), the choice of the measuring method was not critical, both the freezing point depression and vapor pressure could be used. However, when the formulations contained higher concentrations of excipients and/or thermosensitive excipients, the data suggests that the vapor pressure method would be more suited.

Indexed as

DepressionExcipientsFreezingOsmolar ConcentrationPolymersSurface-Active AgentsVapor PressureExcipientsPolymersSurface-Active Agentsfreezing point depressionosmolalityparenteral vehiclessuspensionvapor pressure

Identifiers

PMID35460023
OpenAlexW4224212846

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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.