Evidence map›Paper›PMID 34125400›Full record

ArticleAdvances in therapy2021

Pharmacokinetics and Safety of a Bilastine Once-Daily, Preservative-Free, Ophthalmic Formulation.

Dolores Ochoa, Manuel Román, Carmen Belmonte, Samuel Martín-Vilchez, Gina Mejía-Abril, Francisco Abad-Santos, Gonzalo Hernández, Paula Arranz, Lorena Elgezabal, Nieves Fernández

Open access · hybridAbstract read
In one paragraph

Article in Advances in therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.9field-weighted citation impact, top 28% 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

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. 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

10 authors at 3 institutions in 1 country.

Dolores OchoaClinical Trials Unit, Clinical Pharmacology Department, Hospital Universitario de La Princesa, Facultad de Medicina, Universidad Autónoma de Madrid (UAM), Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.
Manuel RománClinical Trials Unit, Clinical Pharmacology Department, Hospital Universitario de La Princesa, Facultad de Medicina, Universidad Autónoma de Madrid (UAM), Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.
Carmen BelmonteClinical Trials Unit, Clinical Pharmacology Department, Hospital Universitario de La Princesa, Facultad de Medicina, Universidad Autónoma de Madrid (UAM), Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.
Samuel Martín-VilchezClinical Trials Unit, Clinical Pharmacology Department, Hospital Universitario de La Princesa, Facultad de Medicina, Universidad Autónoma de Madrid (UAM), Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.
Gina Mejía-AbrilClinical Trials Unit, Clinical Pharmacology Department, Hospital Universitario de La Princesa, Facultad de Medicina, Universidad Autónoma de Madrid (UAM), Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.
Francisco Abad-SantosClinical Trials Unit, Clinical Pharmacology Department, Hospital Universitario de La Princesa, Facultad de Medicina, Universidad Autónoma de Madrid (UAM), Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.
Gonzalo HernándezDepartment of Research, Development, and Innovation, FAES FARMA, Av. Autonomía 10, 48940, Leioa, Spain.
Paula ArranzDepartment of Research, Development, and Innovation, FAES FARMA, Av. Autonomía 10, 48940, Leioa, Spain.
Lorena ElgezabalDepartment of Research, Development, and Innovation, FAES FARMA, Av. Autonomía 10, 48940, Leioa, Spain.
Nieves FernándezDepartment of Research, Development, and Innovation, FAES FARMA, Av. Autonomía 10, 48940, Leioa, Spain. nfernandez@faes.es.
Faes Farma (Spain) · ESHospital Universitario de La Princesa · ESUniversidad Autónoma de Madrid · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBilastine is a second-generation H

methodsThis was an open-label, single-centre, phase I, bioavailability clinical trial. One drop of the bilastine ophthalmic formulation was administered once daily in each eye of the subjects for 5 days. Bilastine plasma concentrations were measured by HPLC-MS/MS. Adverse drug reactions were recorded for each subject during drug administration and follow-up visits.

resultsTwelve healthy subjects (age 18-55 years) were included in the study. After multiple dose administration, bilastine reached a mean (± SD) maximum blood concentrations of 2682.26 ± 1615.88 pg/mL at a median time of 2.50 h (range 1.25-4.00 h). The half-life of bilastine in plasma was 7.88 ± 6.72 h. Steady state AUC was 19,512.51 ± 9248.76 h·pg/mL. Adverse events were mild and transient, consisting mainly of dysgeusia.

conclusionsBilastine once-daily ophthalmic formulation 6 mg/mL is absorbed into the bloodstream in low amounts by the ophthalmic route. The bilastine ophthalmic formulation showed a good safety profile after multiple dose administration.

Indexed as

Histamine H1 Antagonists, Non-SedatingUrticariaAdolescentAdultBenzimidazolesHumansMiddle AgedPiperidinesTandem Mass SpectrometryYoung AdultBenzimidazolesbilastineHistamine H1 Antagonists, Non-SedatingPiperidinesAllergic conjunctivitisBilastineH1 antihistamineOphthalmic formulationRhinoconjunctivitis

Identifiers

PMID34125400
PMCPMC8280016
OpenAlexW3171049925

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.