Pharmacokinetics and tolerability of formoterol in healthy volunteers after a single high dose of Foradil dry powder Inhalation via aerolizer TM

1999 ◽  
Vol 55 (2) ◽  
pp. 131-138 ◽  
Author(s):  
J. B. Lecaillon ◽  
G. Kaiser ◽  
M. Palmisano ◽  
J. Morgan ◽  
G. Della Cioppa
Keyword(s):  
Healthy Volunteers ◽  
High Dose ◽  
Dry Powder Inhalation ◽  
Dry Powder ◽  
Single High Dose

Efficient optimization of high-dose formulation of novel lyophilizates for dry powder inhalation by the combination of response surface methodology and time-of-flight measurement

2020 ◽  
Vol 581 ◽  
pp. 119255
Author(s):  
Ryo Ohori ◽  
Sakurako Kiuchi ◽  
Shintaro Sugiyama ◽  
Kahori Miyamoto ◽  
Tomomi Akita ◽  
...  
Keyword(s):  
Response Surface Methodology ◽  
Response Surface ◽  
Time Of Flight ◽  
High Dose ◽  
Dry Powder Inhalation ◽  
Dry Powder ◽  
Dose Formulation ◽  
Flight Measurement

A single high dose of escitalopram disrupts sensory gating and habituation, but not sensorimotor gating in healthy volunteers

2011 ◽  
Vol 186 (2-3) ◽  
pp. 431-436 ◽  
Author(s):  
Bob Oranje ◽  
Malene Wienberg ◽  
Birte Y. Glenthoj
Keyword(s):  
Healthy Volunteers ◽  
Sensorimotor Gating ◽  
Sensory Gating ◽  
High Dose ◽  
Single High Dose

scholarly journals Automated Filling Equipment Allows Increase in the Maximum Dose to Be Filled in the Cyclops® High Dose Dry Powder Inhalation Device While Maintaining Dispersibility

Pharmaceutics ◽  
2020 ◽  
Vol 12 (7) ◽  
pp. 645
Author(s):  
Imco Sibum ◽  
Paul Hagedoorn ◽  
Carel O. Botterman ◽  
Henderik W. Frijlink ◽  
Floris Grasmeijer
Keyword(s):  
Fine Particle ◽  
Pressure Range ◽  
Maximum Dose ◽  
Vacuum Pressure ◽  
High Dose ◽  
Dry Powder Inhalation ◽  
Dry Powder ◽  
Fine Particle Dose ◽  
Nominal Dose ◽  
Particle Dose

In recent years there has been increasing interest in the pulmonary delivery of high dose dry powder drugs, such as antibiotics. Drugs in this class need to be dosed in doses far over 2.5 mg, and the use of excipients should therefore be minimized. To our knowledge, the effect of the automatic filling of high dose drug formulations on the maximum dose that can be filled in powder inhalers, and on the dispersion behavior of the powder, have not been described so far. In this study, we aimed to investigate these effects after filling with an Omnidose, a vacuum drum filler. Furthermore, the precision and accuracy of the filling process were investigated. Two formulations were used—an isoniazid formulation we reported previously and an amikacin formulation. Both formulations could be precisely and accurately dosed in a vacuum pressure range of 200 to 600 mbar. No change in dispersion was seen after automatic filling. Retention was decreased, with an optimum vacuum pressure range found from 400 to 600 mbar. The nominal dose for amikacin was 57 mg, which resulted in a fine particle dose of 47.26 ± 1.72 mg. The nominal dose for isoniazid could be increased to 150 mg, resulting in a fine particle dose of 107.35 ± 13.52 mg. These findings may contribute to the understanding of the upscaling of high dose dry powder inhalation products.

Dry powder inhalation of colistin sulphomethate in healthy volunteers: A pilot study

2007 ◽  
Vol 335 (1-2) ◽  
pp. 41-45 ◽  
Author(s):  
E.M. Westerman ◽  
A.H. de Boer ◽  
P.P.H. Le Brun ◽  
D.J. Touw ◽  
H.W. Frijlink ◽  
...  
Keyword(s):  
Pilot Study ◽  
Healthy Volunteers ◽  
Dry Powder Inhalation ◽  
Dry Powder

A Single High Dose of Ascorbic Acid and Iron Is Not Correlated with Oxidative Stress in Healthy Volunteers

2008 ◽  
Vol 53 (2) ◽  
pp. 79-85 ◽  
Author(s):  
Elisângela Colpo ◽  
Andreza Fabro de Bem ◽  
Simone Pieniz ◽  
Sally Danuta Schettert ◽  
Rosane Maria Souza dos Santos ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Ascorbic Acid ◽  
Healthy Volunteers ◽  
High Dose ◽  
Single High Dose

A single high dose of escitalopram increases mismatch negativity without affecting processing negativity or P300 amplitude in healthy volunteers

2009 ◽  
Vol 24 (8) ◽  
pp. 1183-1192 ◽  
Author(s):  
M. Wienberg ◽  
BY Glenthoj ◽  
KS Jensen ◽  
B. Oranje
Keyword(s):  
Healthy Volunteers ◽  
Mismatch Negativity ◽  
P300 Amplitude ◽  
High Dose ◽  
Single High Dose ◽  
Processing Negativity

A generic fluticasone propionate and salmeterol dry powder inhaler: Evidence of usability, function, and robustness

2021 ◽  
Vol 42 (1) ◽  
pp. 30-35 ◽  
Author(s):  
Donald P. Tashkin ◽  
Arkady Koltun ◽  
Róisín Wallace
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Fluticasone Propionate ◽  
Healthy Volunteers ◽  
Pulmonary Disease ◽  
Dry Powder Inhaler ◽  
Chemical Degradation ◽  
Chronic Obstructive ◽  
Dry Powder ◽  
Obstructive Pulmonary Disease ◽  
Flow Rates

Background: A generic combination of fluticasone propionate and salmeterol xinafoate inhalation powder in a premetered, multidose, nonreusable inhaler was recently approved. Objective: To assess the performance of the generic device. Methods: Findings from three studies with regard to device usability, function, and robustness were reviewed. Results: In a study to assess device function in patients and healthy volunteers, the generic device was successfully used by patients with asthma and chronic obstructive pulmonary disease who were either dry powder inhaler users or dry powder inhaler‐naive, even though they were not trained beyond being provided the instructions for use. In a study to measure inhaled flow rates generated by patients and healthy volunteers, the generic device consistently simulated the delivery of a full dose of drug, even to patients with severe respiratory disease and reduced inspiratory flow rates. Although the generic device had a slightly higher airflow resistance, this study demonstrated that this difference did not result in any clinically meaningful differences in terms of drug delivery. Pressure drop, a key parameter that drives the fluidization and aerosolization of the powder dose, was found to be comparable between the devices. In an open-label study, the generic device met all U.S. Food and Drug Administration specifications for device robustness after 21.5 days of twice-daily dosing via oral inhalation among 111 participants with asthma or chronic obstructive pulmonary disease. All inhalers tested demonstrated conformity with a pharmacopeia with respect to key quality parameters (assay, delivered dose uniformity, aerodynamic size distribution). There was no evidence of chemical degradation of the active ingredients, nor of microbial or water ingress into the powder, as a result of inhaler use.

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