Evidence map›Paper›PMID 33768475›Full record

ArticleDrug delivery and translational research2021

Inhaled antibodies: formulations require specific development to overcome instability due to nebulization.

Alexie Mayor, Béatrice Thibert, Sylvain Huille, Renaud Respaud, Héloïse Audat, Nathalie Heuzé-Vourc'h

Open access · bronzeAbstract read
In one paragraph

Article in Drug delivery and translational research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
4.4field-weighted citation impact, top 5% 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

22 citing papers in PubMed, 40 citations in OpenAlex.

  1. Review
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  9. Inhalable Nanofitin demonstrates high neutralization of SARS-CoV-2 virus via direct application in respiratory tract.Molecular therapy : the journal of the American Society of Gene Therapy · 2023
    Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Review
  15. Review
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  18. Monoclonal antibody therapies against SARS-CoV-2.The Lancet. Infectious diseases · 2022
    Review
  19. Article
  20. 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 at 2 institutions in 1 country.

Alexie MayorINSERM, Centre D'Etude Des Pathologies Respiratoires, Universite François Rabelais de Tours, 10 Boulevard Tonnellé, U1100F-37032, Tours, France.ORCID 0000-0001-5700-6196
Béatrice ThibertSanofi, Formulation and Process Development, Impasse Des Ateliers, 94400, Vitry-sur-Seine, France.
Sylvain HuilleSanofi, Formulation and Process Development, Impasse Des Ateliers, 94400, Vitry-sur-Seine, France.
Renaud Respaud
Héloïse Audat *Sanofi, Formulation and Process Development, Impasse Des Ateliers, 94400, Vitry-sur-Seine, France.
Nathalie Heuzé-Vourc'h *INSERM, Centre D'Etude Des Pathologies Respiratoires, Universite François Rabelais de Tours, 10 Boulevard Tonnellé, U1100F-37032, Tours, France. nathalie.vourch@med.univ-tours.ORCID 0000-0003-4929-5068
Sanofi (France) · FRUniversité de Tours · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Respiratory infections are life-threatening and therapeutic antibodies (Ab) have a tremendous opportunity to benefit to patients with pneumonia due to multidrug resistance bacteria or emergent virus, before a vaccine is manufactured. In respiratory infections, inhalation of anti-infectious Ab may be more relevant than intravenous (IV) injection-the standard route-to target the site of infection and improve Ab therapeutic index. One major challenge associated to Ab inhalation is to prevent protein instability during the aerosolization process. Ab drug development for IV injection aims to design a high-quality product, stable to different environment stress. In this study, we evaluated the suitability of Ab formulations developed for IV injection to be extended for inhalation delivery. We studied the aerosol characteristics and the aggregation profile of three Ab formulations developed for IV injection after nebulization, with two mesh nebulizers. Although the formulations for IV injection were compatible with mesh nebulization and deposition into the respiratory tract, the Ab were more unstable during nebulization than exposition to a vigorous shaking. Overall, our findings indicate that Ab formulations developed for IV delivery may not easily be repurposed for inhalation delivery and point to the requirement of a specific formulation development for inhaled Ab.

Indexed as

Drug Delivery SystemsNebulizers and VaporizersAdministration, InhalationAerosolsHumansAerosolsFormulation developmentInhalationMesh nebulizationMonoclonal antibodyRespiratory tract infections

Identifiers

PMID33768475
PMCPMC7993445
OpenAlexW3138789532

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.