Evidence mapPaperPMID 42598403Full record

ReviewACS omega2026

Advances in Formulation and Technological Strategies for Montelukast Pulmonary Delivery.

Carla Giordani Testa, Millena de Sousa Afonso, João Vitor Vicente-da-Silva, Érika Yoko Suzuki, Renata Ribeiro de Castro, Luiz Cláudio Rodrigues Pereira da Silva, Lucio Mendes Cabral, Alice Simon, Flávia Almada Do Carmo

Abstract readReview
In one paragraph

Review in ACS omega, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

9 authors.

Carla Giordani TestaDepartment of Drugs and Pharmaceutics, Faculty of Pharmacy, Universidade Federal Do Rio de Janeiro, 21941-902 Rio de Janeiro, Brazil.
Millena de Sousa AfonsoDepartment of Drugs and Pharmaceutics, Faculty of Pharmacy, Universidade Federal Do Rio de Janeiro, 21941-902 Rio de Janeiro, Brazil.ORCID https://orcid.org/0009-0003-3583-4996
João Vitor Vicente-da-SilvaDepartment of Drugs and Pharmaceutics, Faculty of Pharmacy, Universidade Federal Do Rio de Janeiro, 21941-902 Rio de Janeiro, Brazil.ORCID https://orcid.org/0000-0001-6321-2914
Érika Yoko SuzukiDepartment of Pharmaceutical Sciences, Universidade Federal Rural Do Rio de Janeiro, 23897-090 Seropédica, Brazil.
Renata Ribeiro de CastroInstituto de Tecnologia Em Fármacos, Fundação Oswaldo Cruz, 21041-250 Rio de Janeiro, Brazil.
Luiz Cláudio Rodrigues Pereira da SilvaDepartment of Drugs and Pharmaceutics, Faculty of Pharmacy, Universidade Federal Do Rio de Janeiro, 21941-902 Rio de Janeiro, Brazil.
Lucio Mendes CabralDepartment of Drugs and Pharmaceutics, Faculty of Pharmacy, Universidade Federal Do Rio de Janeiro, 21941-902 Rio de Janeiro, Brazil.ORCID https://orcid.org/0000-0002-4550-5729
Alice SimonDepartment of Drugs and Pharmaceutics, Faculty of Pharmacy, Universidade Federal Do Rio de Janeiro, 21941-902 Rio de Janeiro, Brazil.
Flávia Almada Do CarmoDepartment of Drugs and Pharmaceutics, Faculty of Pharmacy, Universidade Federal Do Rio de Janeiro, 21941-902 Rio de Janeiro, Brazil.ORCID https://orcid.org/0000-0003-0474-9070

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Montelukast is a leukotriene receptor antagonist used in the management of asthma by modulating airway inflammation. Conventional oral formulations exhibit considerable variation in bioavailability due to extensive first-pass metabolism, short half-life, and wide distribution into peripheral compartments. These limitations, along with systemic adverse effects, challenge consistent therapeutic outcomes. Pulmonary drug delivery has been proposed as a promising alternative by targeting the drug directly to the lungs, potentially bypassing first-pass metabolism and reducing systemic exposure. However, despite extensive research on inhalable montelukast formulations, no product has yet been commercialized. This review discusses the main challenges involved in formulating montelukast for pulmonary administration and highlights recent advances in particle engineering, nanocarriers, and formulation strategies to overcome these limitations. Considering the potential advantages of pulmonary delivery for montelukast, a literature search was conducted to identify inhalable formulations of the drug. Twenty articles were identified, including sixteen on DPIs, one on nebulized montelukast, one on pMDIs and two articles reporting results related to clinical studies of inhaled montelukast. Overall, three clinical studies specifically evaluated inhaled montelukast. No patents evaluating inhaled montelukast were found, although three patents mention inhalation as a possible route without disclosing actual inhaled formulations or device strategies. The available studies were analyzed according to formulation strategies, particle engineering approaches, inhalation devices, and reported outcomes. For DPI formulations, particle aerodynamic diameter plays a critical role in lung deposition, and a mass median aerodynamic diameter (MMAD) in the range of 1-5 μm is generally considered optimal for lung deposition. After deposition, formulation performance depends on an initial burst release followed by sustained drug release, low epithelial permeability, and prolonged pulmonary retention, which are expected to minimize systemic exposure. Overall, the limited number of research highlights a translational gap and important opportunities for the development of inhalable montelukast therapies.

Identifiers

PMID42598403
PMCPMC13470731

What Socratic 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 Socratic graph.