scholarly journals Inspiratory Flows and Volumes in Subjects with Non-CF Bronchiectasis Using a New Dry Powder Inhaler Device

2014 ◽  
Vol 8 (1) ◽  
pp. 8-13 ◽  
Author(s):  
Mark R. Elkins ◽  
Sandra D. Anderson ◽  
Clare P. Perry ◽  
Evangelia Daviskas ◽  
Brett Charlton

Introduction: Drug inhalation via a dry-powder inhaler (DPI) is a convenient, time efficient alternative to nebulizers in the treatment of cystic fibrosis (CF) or non-CF bronchiectasis. Efficient drug administration via DPIs depends on the device resistance and adequate (≥45L/min) inspiratory flows and volumes generated by individuals. Drypowder mannitol is delivered using a RS01 breath-actuated device developed by Plastiape, for Pharmaxis. The study aim was to determine in vivo if non-CF bronchiectasis patients’ inspiratory flows and volumes are adequate to use the RS01 DPI device. Materials and Methodology: An open, non-interventional study; enrolled 17 subjects with non-CF bronchiectasis, 18 to 80 years, with baseline FEV1 ≥1.0L and ≥50‰ predicted. Inspiratory flows and volumes were measured when subjects inhaled in a controlled manner through the RS01 device in series with a spirometer. Results: The mean inspiratory volume (IV) of non-CF bronchiectasis subjects was 2.08 ± 0.5L and achieved a mean PIF of 78.6 ± 11.2L/min with the inhaler device. Conclusion: Use of the RS01 DPI device allowed adequate inspiratory flow and volume for dispersion of dry-powder mannitol in non-CF bronchiectasis patients.

2014 ◽  
Vol 8 (1) ◽  
pp. 1-7 ◽  
Author(s):  
Mark R. Elkins ◽  
Philip Robinson ◽  
Sandra D. Anderson ◽  
Clare P. Perry ◽  
Evangelia Daviskas ◽  
...  

Introduction: Drug inhalation via a dry-powder inhaler (DPI) is a convenient, time efficient alternative to nebulizers in the treatment of cystic fibrosis (CF). Efficient drug administration via DPIs depends on the device resistance and adequate (≥ 45L/min) inspiratory flows and volumes generated by individuals. Dry-powder mannitol is delivered using a RS01 breath-actuated device developed by Plastiape, for Pharmaxis. The study aim was to determine in vivo if CF patients’ inspiratory flows and volumes are adequate to use the RS01 DPI device. Materials and Methodology: An open, non-interventional study; enrolled 25 CF subjects, aged ≥ 6 years with FEV1 ≥ 30 to < 90‰ predicted. Inspiratory flows and volumes were measured when subjects inhaled in a controlled manner through the RS01 device in series with a spirometer. Results: The mean inspiratory volume (IV) of CF subjects was 1.83L ± 0.97. Their achieved mean ± SD peak inspiratory flow (PIF) was 75.5 ± 27.2L/min. Twenty-three subjects (92%) achieved PIF of > 45L/min with the inhaler device; eighteen of those subjects (78%) had a baseline FEV1 of > 1L. Conclusion: Use of the RS01 DPI device allowed adequate inspiratory flow and volume for dispersion of dry-powder mannitol in CF patients.


2006 ◽  
Vol 6 (9) ◽  
pp. 3001-3009 ◽  
Author(s):  
Mahavir Bhupal Chougule ◽  
Bijay Kumar Padhi ◽  
Ambikanandan Misra

The purpose of this study was to encapsulate Amiloride Hydrochloride into nano-liposomes, incorporate it into dry powder inhaler, and to provide prolonged effective concentration in airways to enhance mucociliary clearance and prevent secondary infection in cystic fibrosis. Liposomes were prepared by thin film hydration technique and then dispersion was passed through high pressure homogenizer to achieve size of nanometer range. Nano-liposomes were separated by centrifugation and were characterized. They were dispersed in phosphate buffer saline pH 7.4 containing carriers (lactose/sucrose/mannitol), and glycine as anti-adherent. The resultant dispersion was spray dried. The spray dried powders were characterized and in vitro drug release studies were performed using phosphate buffer saline pH 7.4. in vitro and in vivo drug pulmonary deposition was carried out using Andersen Cascade Impactor and by estimating drug in bronchial alveolar lavage and lung homogenate after intratracheal instillation in rats respectively. Nano-liposomes were found to have mean volume diameter of 198 ± 15 nm, and 57% ± 1.9% of drug entrapment. Mannitol based formulation was found to have low density, good flowability, particle size of 6.7 ± 0.6 μm determined by Malvern MasterSizer, maximum fine particle fraction of 67.6 ± 0.6%, mean mass aerodynamic diameter 2.3 ± 0.1 μm, and geometric standard deviation 2.4 ± 0.1. Developed formulations were found to have prolonged drug release following Higuchi's Controlled Release model and in vivo studies showed maximal retention time of drug of 12 hrs within the lungs and slow clearance from the lungs. This study provides a practical approach for direct lung delivery of Amiloride Hydrochloride encapsulated in liposomes for controlled and prolonged retention at the site of action from dry powder inhaler. It can provide a promising alternative to the presently available nebulizers in terms of prolonged pharmacological effect, reducing systemic side effects such as potassium retention due to rapid clearance of the drug from lungs in patients suffering from cystic fibrosis.


Author(s):  
Krishnat D. Dhekale ◽  
Ravindra N. Kamble

A dry-powder inhaler (DPI) carries medication to lungs as a dry powder, useful against respiratory diseases. The current research was endeavoured to examine the capabilities of Multi-walled carbon nanotubes (MWCNT) as a pulmonary transporter for directing cefdinir to cystic fibrosis (CF). Functionalized MWCNTs were loaded with cefdinir to formulate DPI (F-CEF FMWCNTs DPI) having efficient treatment against lung infections and were evaluated successfully. The outcomes demonstrated that cefdinir loaded FMWCNTs were non-toxic and accomplished 79.73 % entrapment with better flow properties. The optimized formulation had Mass Median Aerodynamic Diameter (MMAD), Fine particle fraction (FPF), and particle size of 3.45±0.09 μm, 58.52±1.06%, 5.25 ± 0.03 μm (CEF FMWCNT DPI) and 4. 29±0.16μm 38.74±1.02%, 7.54 ± 0.02 μm (C-DPI) respectively. The loaded nanotubes showed 72. 63 % release after 15 hours in a controlled manner. The outcome of work recognized a unique, simple, and stable product having improved drug loading and increased dispersibility of carbon nanotubes (CNTs) thus improved bioavailability at a lung infection place with less adverse actions.


Author(s):  
Thomas Kopsch ◽  
Darragh Murnane ◽  
Digby Symons

The release of drug from dry powder inhalers is strongly dependent on the patient's inhalation profile. To maximise the effect of the treatment, it is necessary to optimise dry powder inhalers to achieve drug delivery that (A) is independent of the inhalation manoeuvre and (B) is targeted to the correct site in the lung. The purpose of this study is to develop a dry powder inhaler with an adaptive bypass element that achieves desired drug delivery behaviour. Computational and experimental methods are used. First, the effect of a generic variable bypass element on entrainment behaviour is modelled. This is done by modelling a dry powder inhaler as a network of flow. Second, the behaviour of a potential variable bypass element, a flap valve, is studied both computationally and experimentally. Third, the flow resistances are optimised to achieve consistent and desired entrainment behaviour for patients with very different inhalation manoeuvres. A simulated dry powder inhaler device design was found that achieves an approximately constant entrainment flow rate of 12 L/min when total flow rates larger than 20 L/min are applied. The developed dry powder inhaler is predicted to accurately deliver drug for patients with highly different inhalation manoeuvres.


2017 ◽  
Vol 14 (7) ◽  
Author(s):  
Ashwin Jagannath Mali ◽  
Chellampillai Bothiraja ◽  
Ravindra Nandlal Purohit ◽  
Atmaram Pandurang Pawar

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