Evidence map›Paper›PMID 39470941›Full record

ArticlePharmaceutical research2024

Pharmacokinetic Study of Fingolimod Nasal Films Administered via Nose-to-Brain Route in C57BL/6 J Mice as Potential Treatment for Multiple Sclerosis.

Paraskevi Papakyriakopoulou, Evangelos Balafas, Nikolaos Kostomitsopoulos, Dimitrios M Rekkas, Kumlesh K Dev, Georgia Valsami

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Article in Pharmaceutical research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Article
  2. 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.

Paraskevi PapakyriakopoulouDepartment of Pharmacy, School of Health Sciences Sector of Pharmaceutical Technology, National and Kapodistrian University of Athens, Athens, 15784, Greece.
Evangelos BalafasLaboratory Animal Facility, Centre of Clinical, Experimental Surgery and Translational Research, Biomedical Research Foundation of the Academy of Athens, Athens, 11527, Greece.
Nikolaos KostomitsopoulosLaboratory Animal Facility, Centre of Clinical, Experimental Surgery and Translational Research, Biomedical Research Foundation of the Academy of Athens, Athens, 11527, Greece.
Dimitrios M RekkasDepartment of Pharmacy, School of Health Sciences Sector of Pharmaceutical Technology, National and Kapodistrian University of Athens, Athens, 15784, Greece.
Kumlesh K DevDepartment of Physiology, Drug Development Research Group, School of Medicine, Trinity College Dublin, Dublin, D18 DH50, Ireland. devk@tcd.ie.
Georgia ValsamiDepartment of Pharmacy, School of Health Sciences Sector of Pharmaceutical Technology, National and Kapodistrian University of Athens, Athens, 15784, Greece. valsami@pharm.uoa.gr.ORCID http://orcid.org/0000-0002-2395-6844

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFingolimod hydrochloride (FH) has emerged as a vital medication for managing Multiple Sclerosis (MS). Despite its high oral bioavailability of 93%, it is plagued by slow oral absorption (T

objectiveThis study aims to develop and evaluate FH nasal films for enhanced drug delivery.

methodsA Design of Experiments approach was employed to formulate FH nasal films, utilizing HPMC E50 as a film-forming polymer, PEG 400 as a plasticizer, and Me-β-CD as a permeation enhancer. Two formulations with superior in vitro and ex vivo performance were selected for in vivo evaluation. A comparative pharmacokinetic study was conducted in C57BL/6 J mice in the brain and serum after administration of nasal films and oral FH solution, respectively. Sparse sampling and non-compartmental analysis were used.

resultsFH nasal films efficiently delivered the drug to both serum (C

conclusionsThe rapid nose-to-brain delivery within 30 min, in contrast to 10-h Tmax of the oral solution, indicates the potential of a combined IN and oral treatment regimen. This approach could expedite the attainment of steady-state concentrations, offering a promising method for managing multiple sclerosis (MS).

Indexed as

Administration, IntranasalBrainFingolimod HydrochlorideMice, Inbred C57BLMultiple SclerosisAdministration, OralAnimalsBiological AvailabilityDrug Delivery SystemsFemaleImmunosuppressive AgentsMaleMiceNasal MucosaFingolimod HydrochlorideImmunosuppressive Agentsfingolimodmultiple sclerosisnasal filmnose-to-brainpharmacokinetic study

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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.