Developing low-carbon salbutamol MDI: assessment of relative bioavailability and pharmacodynamic relative potency of salbutamol MDI with propellant HFA-152a
低炭素サルブタモールMDIの開発：プロペラントHFA-152aを用いたサルブタモールMDIの相対的バイオアベイラビリティおよび薬力学的相対効力の評価 (AI 翻訳)
Sebastian Moreira, Laura Clow, Emily Coles-Piper, Alison Donald, Christer Janson, Dave Singh, David Slade, Pankaj Tiwari, Stephen Weng, M Plank
🤖 gxceed AI 要約
日本語
2つの第I相試験により、HFA-134aに比べ約90%低温暖化係数のプロペラントHFA-152aを使用したサルブタモールMDIが、薬物動態および薬力学において同等であり、安全性も同様であることが示された。これは治療効果を損なわない低炭素代替品としての可能性を支持する。
English
Two phase I studies demonstrate that salbutamol MDI using HFA-152a, a propellant with ~90% lower global warming potential than HFA-134a, shows pharmacokinetic and pharmacodynamic equivalence and similar safety. This supports a low-carbon replacement without compromising therapeutic efficacy.
Unofficial AI-generated summary based on the public title and abstract. Not an official translation.
📝 gxceed 編集解説 — Why this matters
日本のGX文脈において
医療セクターのGHG排出削減は日本のGX政策でも重要。吸入器からの排出は欧州で規制が進むが、日本でもSSBJ対応や企業のカーボンフットプリント削減に直結する。本研究は製薬業界の低炭素製品開発の事例として、日本の医薬品メーカーや医療機関に示唆を与える。
In the global GX context
This paper addresses healthcare's carbon footprint, a growing focus in global climate disclosure. Replacing high-GWP propellants in inhalers is a tangible Scope 1/3 reduction strategy, aligning with ISSB and TCFD's encouragement of product-level emissions data. For international audiences, it provides clinical evidence for a scalable low-carbon solution.
👥 読者別の含意
🔬研究者:Provides clinical evidence for low-GWP propellant equivalence, useful for further product development and lifecycle assessment studies.
🏢実務担当者:Pharmaceutical companies and healthcare providers can use these results to justify transitioning to low-carbon inhalers.
🏛政策担当者:Supports regulatory frameworks encouraging low-GWP propellants in medical devices, relevant for national decarbonization strategies.
📄 Abstract（原文）
Introduction Climate change is a global threat. Propellant hydrofluoroalkane (HFA)-134a in metered-dose inhalers (MDIs) contributes to healthcare-related greenhouse gas emissions. HFA-152a is a new propellant with ~90% lower global warming potential than HFA-134a. Two phase I studies ( NCT06433908 /NCT06433921) compared the pharmacokinetics (PK), pharmacodynamics (PD) and safety of salbutamol MDI with HFA-152a or HFA-134a. Methods Relative bioavailability (Study 1): healthy adults received single salbutamol doses (200/800 µg) via MDI with HFA-152a or HFA-134a. Primary PK endpoints were areas under the plasma concentration–time curve (0–30 min (AUC) 0–30 min , zero to infinity (AUC 0–∞ ) and maximum plasma concentration (C max )). Relative PD potency via methacholine challenge (Study 2): patients with mild asthma received MDI placebo and salbutamol doses (100/200/400 µg) with HFA-152a or HFA-134a. The primary PD endpoint was provocative methacholine concentration (PC) causing ≥20% (PC 20 ) forced expiratory volume in 1 s reduction. Results Study 1: 60 participants (30 per cohort) enrolled. In cohort 1 (200 µg), AUC 0–30 min was within the predefined PK bioequivalence (BE) range (0.80–1.25); in cohort 2 (800 µg), AUC 0–∞ and C max were within the BE range. Study 2: 21 participants enrolled. PD relative potency of HFA-152a was within the predefined BE range (0.67–1.50). No serious treatment-related adverse events (AEs) were reported; all AEs were mild and occurred at similar frequencies with both propellants. Conclusions Salbutamol with HFA-152a demonstrated equivalence in key PK and PD parameters, as well as a similar safety profile to salbutamol with HFA-134a, supporting salbutamol MDI with HFA-152a as a therapeutically equivalent, low-carbon replacement.
🔗 Provenance — このレコードを発見したソース
- openalex https://doi.org/10.1136/bmjresp-2025-004036first seen 2026-06-19 04:54:26
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