Developing an In Vitro Understanding of Patient Experience with Hydrofluoroalkane-Metered Dose Inhalers

Doub, William H.; Shah, Vibhakar J.; Limb, Susan L.; Guo, Chunyi; Liu, Xiaofei; Ngo, Diem

doi:10.1002/jps.24167

Cited by 3 publications

(1 citation statement)

References 22 publications

(21 reference statements)

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“…Therefore, the FPF value obtained in this study was much lower than the formulation free of lecithin. For instance, QVAR 80 mg possesses an FPF value up to 70% (Dellamary et al, 2000 ; Mitchell et al, 2003 ; Buttini et al, 2014 ; Doub et al, 2014 ). By contrast, FPF values determined in those studies applying non-volatiles were basically less than 30% (Selvam et al, 2012 ; Shan et al, 2014 ; Ivey et al, 2015 ).…”

Section: Discussionmentioning

confidence: 99%

Anhydrous reverse micelle nanoparticles: new strategy to overcome sedimentation instability of peptide-containing pressurized metered-dose inhalers

Huang

Yang

et al. 2017

Drug Delivery

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The objective of this study was to develop a novel anhydrous reverse micelle nanoparticles (ARM-NPs) system to overcome the sedimentation instability of peptide-containing pressurized metered-dose inhalers (pMDIs). A bottom-up method was utilized to fabricate ARM-NPs. Tertiary butyl alcohol (TBA)/water system, freeze-drying and lipid inversion method were successively used to produce the ARM-NPs for pMDI. Various characteristics of ARM-NPs were investigated including particle size, morphology, secondary structure of the peptide drug, aerosolization properties and storage stability. As revealed by the results, ARM-NPs with spherical shape possessed 147.7 ± 2.0 nm of particle size with 0.152 ± 0.021 PdI. The ARM-NPs for pMDI had satisfactory fine particle fraction (FPF) value of 46.99 ± 1.33%, while the secondary structure of the peptide drug was unchanged. Stability tests showed no pronounced sedimentation instability for over 12 weeks at 4-6 °C. Furthermore, a hypothesis was raised to explain the formation mechanism of ARM-NPs, which was verified by the differential scanning calorimetry analysis. The lecithin employed in the reverse micelle vesicles could serve as a steric barrier between peptide drugs and bulk propellant, which prevented the instability of peptide drugs in hydrophobic environment. Homogenous particle size could avoid Ostwald ripening phenomenon of particles in pMDIs. It was concluded that the ARM-NPs for pMDI could successfully overcome sedimentation instability by the steric barrier effect and homogeneous particle size.

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Section: Discussionmentioning

confidence: 99%

Anhydrous reverse micelle nanoparticles: new strategy to overcome sedimentation instability of peptide-containing pressurized metered-dose inhalers

Huang

Yang

et al. 2017

Drug Delivery

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A novel approach to study the pMDI plume using an infrared camera and to evaluate the aerodynamic properties after varying the time between actuations

Kunda

Hautmann

Godoy

et al. 2017

International Journal of Pharmaceutics

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Effect of Inhalation Flow Rate on Mass-Based Plume Geometry of Commercially Available Suspension pMDIs

Moraga-Espinoza

Eshaghian

Shaver

2018

AAPS J

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Although high-speed laser imaging is the current standard to characterize the plume angle of suspension-based pressurized metered dose inhalers (pMDIs), this method is limited by the inability to identify the drug content in a droplet and simulate inhalation flow. The Plume Induction Port Evaluator (PIPE) is a modified induction port for cascade impactors that allows for the calculation of the angle of a plume based on direct drug mass quantification rather than indirect droplet illumination under airflow conditions. The objective of this study was to investigate the use of the PIPE apparatus to evaluate the effect of airflow on the Mass Median Plume Angle (MMPA) of commercially available suspension-based pMDIs (Ventolin® HFA, ProAir® HFA, and Proventil® HFA). Deposition patterns within PIPE were log-normally distributed allowing for the calculation of the MMPA for the three suspension products. Mass-based plume angles were significantly smaller (narrower angle) when inhalation airflow was used compared to no flow conditions (reduction of MMPA was 8, 16, and 13% for Ventolin® HFA, ProAir® HFA, and Proventil® HFA, respectively). Additionally, new parameters for characterizing plume geometry were calculated (MMPA ex-actuator and plume orientation). Mass-based plume angles of the suspension-based pMDI formulations were highly reproducible and demonstrated the effect of inhalation flow rate. These results suggest that plume geometry tests should be evaluated under flow conditions which is not possible using current methodologies. Graphical Abstract ᅟ.

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Developing an In Vitro Understanding of Patient Experience with Hydrofluoroalkane-Metered Dose Inhalers

Cited by 3 publications

References 22 publications

Anhydrous reverse micelle nanoparticles: new strategy to overcome sedimentation instability of peptide-containing pressurized metered-dose inhalers

Anhydrous reverse micelle nanoparticles: new strategy to overcome sedimentation instability of peptide-containing pressurized metered-dose inhalers

A novel approach to study the pMDI plume using an infrared camera and to evaluate the aerodynamic properties after varying the time between actuations

Effect of Inhalation Flow Rate on Mass-Based Plume Geometry of Commercially Available Suspension pMDIs

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