- Device mechanics and evaluation of inspiratory flow rate required of the beclomethasone dipropionate breath-actuated inhaler. [Journal Article]
- AAAllergy Asthma Proc 2019 May 01; 40(3):162-166
- CONCLUSIONS: The BDP BAI consistently triggered actuation at an airflow rate of 20 L/min and was successfully used based on guidance from the IFU only. This device provides an alternative for patients who find it difficult to use metered-dose inhaler devices correctly.
- Development of a novel digital breath-activated inhaler: Initial particle size characterization and clinical testing. [Clinical Trial]
- PPPulm Pharmacol Ther 2018; 53:27-32
- CONCLUSIONS: The DBAI generated highly respirable aerosols containing albuterol sulfate that were similar to the MDI and SMI in respirable fraction but lower in dose. Subsequent pharmacodynamic studies delivering albuterol sulfate alone and in combination with ipratropium bromide confirmed similar responses for the DBAI compared with the other inhalers, which could possibly be related to a response ceiling. The DBAI breath-activated capability combined with the ability to monitor actual delivery of medication may improve effectiveness by overcoming patient miscoordination.
- Clinical implications of the tiotropium/olodaterol inhaler for patients with chronic obstructive pulmonary disease. [Review]
- PMPostgrad Med 2018; 130(6):515-522
- Oral inhalation is the recommended delivery method of medications for the treatment of patients with chronic obstructive pulmonary disease (COPD). However, patients may struggle when using the variou…
Oral inhalation is the recommended delivery method of medications for the treatment of patients with chronic obstructive pulmonary disease (COPD). However, patients may struggle when using the various available inhaler platforms, and, as a result, may fail to achieve the benefit of the prescribed medication. Propellant-based, pressurized metered-dose inhaler and powder-based, dry powder inhaler devices are currently the most commonly prescribed delivery systems. Each of these devices has its own advantages and challenges. The Respimat® Soft Mist™ inhaler (SMI) (Boehringer Ingelheim) is a delivery system that incorporates features intended to improve orally inhaled drug delivery to these patients. These features include simple device actuation, patient inspiratory effort-independent aerosol generation, and a slower spray emission with a longer spray duration, helping to mitigate issues with precise aerosol release and breath coordination. We review the clinical trials assessing lung deposition, efficacy, and safety, and patient satisfaction for the Respimat® SMI. These data indicate that the Respimat® SMI is a device capable of delivering a consistent, clinically effective dose of medication that patients can use and prefer, which may provide significant clinical benefits for patients with COPD.
- Mishandling of pMDI and DPI inhalers in asthma and COPD - Repetitive and non-repetitive errors. [Journal Article]
- PPPulm Pharmacol Ther 2018; 51:65-72
- CONCLUSIONS: Improper inhalation technique is very common and the majority of errors made in inhalation technique are repetitive. This emphasizes the role of an ongoing verification and training of a proper inhalation technique in all patients that are regularly treated with inhalers.
- Investigation of multiphase multicomponent aerosol flow dictating pMDI-spacer interactions. [Journal Article]
- IJInt J Pharm 2017 Aug 30; 529(1-2):264-274
- The use of Pressurized metered dose inhalers (pMDIs) for the treatment of asthma and other chronic obstructive pulmonary diseases is frequently associated with breath-actuation synchronization proble…
The use of Pressurized metered dose inhalers (pMDIs) for the treatment of asthma and other chronic obstructive pulmonary diseases is frequently associated with breath-actuation synchronization problems and poor pulmonary delivery, particularly amongst the pediatric and geriatric population groups. Spacers, or Valved Holding Chambers (VHCs), are frequently used to address these problems. However, the performance of spacers with different pMDIs is also highly variable and needs to be investigated. The purpose of the current study is to develop a computational fluid dynamics (CFD) model which can characterize multiphase multicomponent aerosol flow issuing from a commercial suspension-based pMDI into a spacer. The CFD model was initially calibrated against published experimental measurements in order to appropriately model the spray characteristics. This model was subsequently used to examine several combinations of inhaler, spacer and USP Throat geometries under different discharge rates of coflow air. The CFD model predictions compared favorably with experimental measurements. In particular, the predictions show, in accordance with experimental determinations, a decrease of drug retained by the spacers with increasing coflow air. The recirculation observed near the obstructions in axial path of the spray within either spacer is considered to be central for increasing spray retention and drug deposition behavior. Fluid flow patterns within the spacers were correlated with drug deposition behavior through a dimensionless variable, the Recirculation index (RCI). Bigger particles were found to be selectively retained within the spacer.
- Factors Determining In Vitro Lung Deposition of Albuterol Aerosol Delivered by Ventolin Metered-Dose Inhaler. [Journal Article]
- JAJ Aerosol Med Pulm Drug Deliv 2017; 30(4):256-266
- CONCLUSIONS: In an in vitro experimental model based on inhalation data from patients with asthma and COPD, we demonstrated that aerosol lung deposition emitted from Ventolin HFA-MDI is most optimal for MDI actuation in the first half of inspiration at high flow rates (60-90 L/min).
- Pharmacokinetics, pharmacodynamics, and clinical efficacy of albuterol RespiClick(™) dry-powder inhaler in the treatment of asthma. [Review]
- EOExpert Opin Drug Metab Toxicol 2016; 12(9):1109-19
- CONCLUSIONS: The albuterol mDPI has an efficacy/tolerability profile consistent with other inhaled forms of albuterol, and is reliable, easy to use, and associated with a high level of patient satisfaction. This is the first albuterol dry-powder inhaler (DPI) to become available in the USA, with most other formulations being delivered using a pressurized metered-dose inhaler (pMDI). The availability of a breath-actuated device avoids the challenge of coordinating actuation and breathing when using pMDIs, and could simplify treatment for patients also using a DPI for controller medication. Additional features of RespiClick, such as an integrated dose counter and minimal pre-inhalation preparation, facilitate its use.
- [Feasibility study of dynamic contrast enhanced magnetic resonance imaging qualitative diagnosis of musculoskeletal tumors]. [Journal Article]
- BDBeijing Da Xue Xue Bao Yi Xue Ban 2016 Apr 18; 48(2):287-91
- CONCLUSIONS: DCE-MRI technique is useful to evaluate the pathological behaviour of musculoskeletal tumors. The quantitative analysis of DCE parameters in conjunction with conventional MR images can improve the accuracy of musculoskeletal tumor qualitative analysis.
- Optical diagnostics study of air flow and powder fluidisation in Nexthaler®--Part I: Studies with lactose placebo formulation. [Journal Article]
- IJInt J Pharm 2015 Dec 30; 496(2):780-91
- Effective drug delivery to the lungs by a DPI device requires the air-stream through the device to have sufficient power to aerosolise the powder. Furthermore, sufficient turbulence must be induced, …
Effective drug delivery to the lungs by a DPI device requires the air-stream through the device to have sufficient power to aerosolise the powder. Furthermore, sufficient turbulence must be induced, along with particle-wall and particle-particle collisions, in order to de-aggregate small drug particles from large carrier particles. As a result, the emitted and the fine particle doses produced by many commercially available DPI devices tend to be strongly affected by the natural inter-patient variability of the inhaled air flow. The Nexthaler® is a multi-dose breath-actuated dry-powder inhaler with minimum drug delivery-flow rate dependency and incorporating a dose protector. The actuation mechanism of the dose-protector ensures that the dose is only exposed to the inhaled air flow if the flow has sufficient power to cause complete aerosolisation. For this study, a proprietary lactose placebo powder blend was filled into "transparent" Nexthaler® to allow application of high-speed imaging and particle image velocimetry (PIV) techniques to successfully interrogate and reveal details of the powder entrainment and emission processes coupled with characterisation of the flow environment in the vicinity of the mouthpiece exit. The study showed that fluidisation of the bulk of the powder occurs very quickly (∼20ms) after withdrawal of the dose protector followed by powder emission from the device within ∼50ms thereafter. The bulk of the metered placebo dose was emitted within 100-200ms. The visualisation study also revealed that a very small fraction of powder fines is emitted whilst the dose protector still covers the dosing cup as the flow rate through the device accelerates. The PIV results show that the flow exiting the device is highly turbulent with a rotating flow structure, which forces the particles to follow internal paths having a high probability of wall impacts, suggesting that the flow environment inside the Nexthaler® DPI will be very beneficial for carrier-drug de-aggregation.
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- Pulmonary monoclonal antibody delivery via a portable microfluidic nebulization platform. [Journal Article]
- BBiomicrofluidics 2015; 9(5):052603
- Nebulizers have considerable advantages over conventional inhalers for pulmonary drug administration, particularly because they do not require coordinated breath actuation to generate and deliver the…
Nebulizers have considerable advantages over conventional inhalers for pulmonary drug administration, particularly because they do not require coordinated breath actuation to generate and deliver the aerosols. Nevertheless, besides being less amenable to miniaturization and hence portability, some nebulizers are prone to denature macromolecular drugs due to the large forces generated during aerosolization. Here, we demonstrate a novel portable acoustomicrofluidic device capable of nebulizing epidermal growth factor receptor (EGFR) monoclonal antibodies into a fine aerosol mist with a mass median aerodynamic diameter of approximately 1.1 μm, optimal for deep lung deposition via inhalation. The nebulized monoclonal antibodies were tested for their stability, immunoactivity, and pharmacological properties, which confirmed that nebulization did not cause significant degradation of the antibody. In particular, flow cytometry demonstrated that the antigen binding capability of the antibody is retained and able to reduce phosphorylation in cells overexpressing the EGFR, indicating that the aerosols generated by the device were loaded with stable and active monoclonal antibodies. The delivery of antibodies via inhalation, particularly for the treatment of lung cancer, is thus expected to enhance the efficacy of this protein therapeutic by increasing the local concentration where they are needed.