Evidence map›Paper›PMID 40011324›Full record

ArticleAAPS PharmSciTech2025

Innovative Drug Development Approach to Address the Transition to Low Global Warming Potential Propellant Using Hydrofluoroalkane-152a, for Triple Combination Pressurized Metered-Dose Inhaler Products Targeting Small Airways.

A Matturro, E Zambelli, E Cuoghi, D Copelli, F Usberti, A Fioni, L Labadini

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In one paragraph

Article in AAPS PharmSciTech, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

7 authors.

A MatturroGlobal Technical Development, R&D, Chiesi Farmaceutici S.P.A, L.Go Belloli 11/A, 43122, Parma, Italy. ab.matturro@chiesi.com.ORCID http://orcid.org/0009-0002-0502-3001
E ZambelliGlobal Technical Development, R&D, Chiesi Farmaceutici S.P.A, L.Go Belloli 11/A, 43122, Parma, Italy.
E CuoghiGlobal Technical Development, R&D, Chiesi Farmaceutici S.P.A, L.Go Belloli 11/A, 43122, Parma, Italy.
D CopelliGlobal Technical Development, R&D, Chiesi Farmaceutici S.P.A, L.Go Belloli 11/A, 43122, Parma, Italy.
F UsbertiGlobal Technical Development, R&D, Chiesi Farmaceutici S.P.A, L.Go Belloli 11/A, 43122, Parma, Italy.
A FioniDepartment of Pharmacokinetics, Biochemistry and Metabolism, R&D, Chiesi Farmaceutici S.P.A, Parma, Italy.
L LabadiniAIR Pipeline Development, Chiesi Farmaceutici S.P.A, Parma, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Recent and emerging environmental policies have boosted the investigation of pressurized metered-dose inhalers (pMDI) that have a minimal impact on climate change. There is a current move away from existing hydrofluorocarbon (HFC)-based propellants, specifically the hydrofluoroalkane (HFA)-134a and HFA-227ea based pMDI products that are approved for the treatment of asthma and chronic obstructive pulmonary disease (COPD), towards those that use low global warming potential (LGWP) propellants. Changing the propellant to, for example, the less environmentally-damaging HFA-152a, is a focus for many manufacturers. In this paper, we report an innovative approach to developing new pMDI drug products with a LGWP propellant. Moreover, proof of the hypothesis that products containing the current propellant and those using a LGWP propellant can achieve equivalent performance is reported, by showing comparability of a triple combination pMDI (Trimbow®) formulated using the LGWP HFA-152a propellant compared with HFA-134a. This paper will present the use of in silico mathematical modelling, leveraging on Chiesi proprietary Modulite® principles to predict and validate in vitro performances of the drug product under development. Validation is carried out using realistic aerodynamic particle size distribution (rAPSD), a novel approach that offers a more accurate prediction of aerosol distribution by incorporating variations compared to the standard aerodynamic particle size distribution (APSD). Additional in vitro testing validates the prediction of in silico models and confirms good comparability in terms of aerodynamic performance between HFA-152a and HFA-134a, which translates in vivo as evidenced by the preliminary pharmacokinetics (PK) in animal models and the formal clinical PK bioequivalence (BE) studies. (Rony et al. in Pulm Pharmacol Ther 85, 2024).

Indexed as

Aerosol PropellantsDrug DevelopmentGlobal WarmingHydrocarbons, FluorinatedMetered Dose InhalersAdministration, InhalationAerosolsAsthmaFluorocarbonsHumansPulmonary Disease, Chronic ObstructiveAerosol PropellantsAerosolsapafluraneFluorocarbonsHydrocarbons, FluorinatedAPSDbioequivalenceglobal warming potential (GWP)inhalationlow global warming potential (LGWP)pharmacokineticspressurized metered-dose inhaler (pMDI) propellant

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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.