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Peer-reviewedCC BY 4.0Cureus

Particle Morphometrics of Glycopyrronium-Formoterol-Budesonide Inhalation Blends Influence Pulmonary Deposition and Bronchodilator Response in Chronic Obstructive Pulmonary Disease (COPD): A Gamma Scintigraphy Study

  • Gaurav K Jain1
  • Abha Mishra2
  • Nilesh Chandra3
  • Manu Madan4,5
5 affiliations
  1. 1DSIR-DPSRU-CRTDH (Department of Scientific and Industrial Research–Delhi Pharmaceutical Sciences and Research University–Common Research and Technology Development Hub), Center for Advanced Formulation Technology, Department of Pharmaceutics, DPSRU, New Delhi, IND
  2. 2Department of Physiology, Jodhpur Institute of Engineering and Technology (JIET) Medical College and Hospital, Jodhpur, IND
  3. 3Division of Discovery Research, Indian Council of Medical Research, New Delhi, IND
  4. 4Department of Respiratory and Sleep Medicine, Medanta Hospital, Noida, IND
  5. 5Department of Pulmonology, Max Smart Super Speciality Hospital, Saket, New Delhi, IND
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Abstract

Background: The therapeutic efficacy of inhaled triple-combination therapy in chronic obstructive pulmonary disease (COPD) depends on efficient delivery to peripheral airways. This study evaluated the influence of particle morphometrics on pulmonary deposition and bronchodilator response to glycopyrronium-formoterol-budesonide (GFB) inhalation formulations.

Methods: Three commercial GFB formulations (X, Y, and Z) delivered via metered-dose inhaler (MDI) and dry powder inhaler (DPI) were characterized using dynamic light scattering and scanning electron microscopy. In a randomized, open-label pilot study, twenty-four patients with mild-to-moderate COPD inhaled technetium-99m (99mTc) radiolabeled formulations. Regional lung deposition was assessed by planar gamma scintigraphy, and central-to-peripheral (C/P) ratios were calculated. Forced expiratory volume in one second (FEV1) was measured at baseline and 30 minutes post-inhalation.

Results: Significant inter-brand differences in particle morphometrics were observed. Brand X demonstrated a narrow particle distribution (1.3±0.26 µm) with uniform spherical morphology, while brands Y and Z showed relatively broader, polydisperse distributions with irregular particles. MDIs (MIX, MIY, MIZ) consistently outperformed DPIs (DIX, DIY, DIZ), producing greater total lung deposition (23.4% vs 13.7%; P < 0.001) and improved peripheral deposition. Among MDIs, MIX achieved higher intrathoracic deposition (28.8 ± 2.2% vs 19.0-22.5%; P < 0.001) and peripheral deposition (15.8 ± 3.0% vs 9.8-11.5%; P = 0.012), with a lower C/P ratio (0.82 vs 0.96-1.0). Greater spirometric improvement correlated with enhanced deposition, with the MIX producing the highest FEV1 increase (12.8%; P < 0.05).

Conclusions: The findings suggest that particle size distribution, polydispersity, and surface morphology may influence pulmonary deposition and acute spirometric response in COPD. A relatively narrow respirable particle distribution may support more consistent peripheral airway deposition and short-term spirometric response.

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Cite

BibTeXRIS
BibTeX
@article{jain2026particle,
  title = {{Particle Morphometrics of Glycopyrronium-Formoterol-Budesonide Inhalation Blends Influence Pulmonary Deposition and Bronchodilator Response in Chronic Obstructive Pulmonary Disease (COPD): A Gamma Scintigraphy Study}},
  author = {Gaurav K Jain and Abha Mishra and Nilesh Chandra and Manu Madan},
  journal = {Cureus},
  year = {2026},
  month = sep,
  doi = {10.7759/cureus.116954},
  url = {https://doi.org/10.7759/cureus.116954},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Particle Morphometrics of Glycopyrronium-Formoterol-Budesonide Inhalation Blends Influence Pulmonary Deposition and Bronchodilator Response in Chronic Obstructive Pulmonary Disease (COPD): A Gamma Scintigraphy Study
AU  - Gaurav K Jain
AU  - Abha Mishra
AU  - Nilesh Chandra
AU  - Manu Madan
PY  - 2026
DA  - 2026/09/26
JO  - Cureus
DO  - 10.7759/cureus.116954
UR  - https://doi.org/10.7759/cureus.116954
AB  - Background: The therapeutic efficacy of inhaled triple-combination therapy in chronic obstructive pulmonary disease (COPD) depends on efficient delivery to peripheral airways. This study evaluated the influence of particle morphometrics on pulmonary deposition and bronchodilator response to glycopyrronium-formoterol-budesonide (GFB) inhalation formulations.  Methods: Three commercial GFB formulations (X, Y, and Z) delivered via metered-dose inhaler (MDI) and dry powder inhaler (DPI) were characterized using dynamic light scattering and scanning electron microscopy. In a randomized, open-label pilot study, twenty-four patients with mild-to-moderate COPD inhaled technetium-99m (99mTc) radiolabeled formulations. Regional lung deposition was assessed by planar gamma scintigraphy, and central-to-peripheral (C/P) ratios were calculated. Forced expiratory volume in one second (FEV1) was measured at baseline and 30 minutes post-inhalation.  Results: Significant inter-brand differences in particle morphometrics were observed. Brand X demonstrated a narrow particle distribution (1.3±0.26 µm) with uniform spherical morphology, while brands Y and Z showed relatively broader, polydisperse distributions with irregular particles. MDIs (MIX, MIY, MIZ) consistently outperformed DPIs (DIX, DIY, DIZ), producing greater total lung deposition (23.4% vs 13.7%; P < 0.001) and improved peripheral deposition. Among MDIs, MIX achieved higher intrathoracic deposition (28.8 ± 2.2% vs 19.0-22.5%; P < 0.001) and peripheral deposition (15.8 ± 3.0% vs 9.8-11.5%; P = 0.012), with a lower C/P ratio (0.82 vs 0.96-1.0). Greater spirometric improvement correlated with enhanced deposition, with the MIX producing the highest FEV1 increase (12.8%; P < 0.05).  Conclusions: The findings suggest that particle size distribution, polydispersity, and surface morphology may influence pulmonary deposition and acute spirometric response in COPD. A relatively narrow respirable particle distribution may support more consistent peripheral airway deposition and short-term spirometric response.
SN  - 2168-8184
ER  -