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Journal of Aerosol Medicine and Pulmonary Drug Delivery

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https://www.readbyqxmd.com/read/28708443/regulatory-approaches-and-considerations-in-establishing-bioequivalence-of-inhaled-compounds
#1
Irvin Mayers, Mohit Bhutani
To be considered bioequivalent to their branded counterparts, generic drugs must meet the standards for bioequivalence (BE) described by the regulatory agencies. While BE of generic inhalational drugs can be evaluated using a similar approach as that for oral dosage from products or drugs that are delivered systemically, the approach is insufficient to address the complexities of inhalational products (e.g., localized site of action, device-patient interface). Therefore, more considerations are needed and caution should be applied when evaluating BE of inhaled compounds...
July 14, 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/28708440/model-calculations-of-regional-deposition-and-disposition-for-single-doses-of-inhaled-liposomal-and-dry-powder-ciprofloxacin
#2
Andrew R Martin, Warren H Finlay
BACKGROUND: Model predictions of regional deposition in the respiratory tract are useful in assessing factors that influence the effectiveness of aerosol delivery. Regional deposition models have previously been coupled with models of mucous production and clearance to estimate initial concentrations of drug deposited in the airway surface liquid (ASL) lining tracheobronchial airways. METHODS: Established models of regional deposition and ASL volumes were used to provide input to a new model evaluating the disposition of drug resulting from dissolution or release, absorption, and mucociliary clearance...
July 14, 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/28696894/preference-of-aerosolized-pirfenidone-to-oral-intake-an-experimental-model-of-pulmonary-fibrosis-by-paraquat
#3
Rokhsana Rasooli, Hamid Rajaian, Abbas Pardakhty, Ali Mandegary
BACKGROUND: Inhalation drug delivery is a fast, effective, and safe route of delivering medication directly to the lungs. Thanks to the large surface area and highly vascularized epithelium in lung, pulmonary drug delivery has been considered as an effective route to deliver drugs to the systemic circulation. Pirfenidone (PF), an oral antifibrotic agent, has been shown to slow down the progression of the lung fibrosis. Inhalation or intrapulmonary delivery of PF appears to be a good alternative to optimize drug delivery and minimize the dosage, adverse and nonspecific effects...
July 11, 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/28683222/application-of-a-one-dimensional-computational-model-for-the-prediction-of-deposition-from-a-dry-powder-inhaler
#4
Konstantinos Gourgoulianis, Zoi Daniil, Katerina Athanasiou, Stavroula Rozou, Vasileios Bontozoglou
BACKGROUND: Accurate prediction of the regional deposition of inhaled dry powders as a function of powder properties and breathing pattern is a long-term research goal for pulmonary drug delivery. In the present work, deposition along the respiratory tract of dry powders of Fluticasone propionate and Salmeterol is predicted. METHODS: A one-dimensional particle transport and deposition model is used, whose novelty is in the treatment of the alveolar space of each airway generation as an efficient mixing chamber...
July 6, 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/28683218/biokinetics-of-aerosolized-liposomal-ciclosporin-a-in-human-lung-cells-in-vitro-using-an-air-liquid-cell-interface-exposure-system
#5
Otmar Schmid, Corinne Jud, Yuki Umehara, Dominik Mueller, Albert Bucholski, Friedrich Gruber, Oliver Denk, Roman Egle, Alke Petri-Fink, Barbara Rothen-Rutishauser
BACKGROUND: Inhalation of aerosolized drugs is a promising route for noninvasive targeted drug delivery to the lung. Nanocarrier systems such as liposomes have been explored for inhalation therapy opening new avenues, including stabilization of nonsoluble drugs (e.g., Ciclosporin A [CsA]) and controlled release. METHODS: The biokinetic behavior of the immunosuppressive drug CsA encapsulated in liposomes (L-CsA) at the lung epithelial barrier was studied in vitro...
July 6, 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/28683216/pulmonary-drug-delivery-following-continuous-vibrating-mesh-nebulization-and-inspiratory-synchronized-vibrating-mesh-nebulization-during-noninvasive-ventilation-in-healthy-volunteers
#6
Jean-Bernard Michotte, Enrico Staderini, Anne-Sophie Aubriot, Emilie Jossen, Jonathan Dugernier, Giuseppe Liistro, Gregory Reychler
BACKGROUND: A breath-synchronized nebulization option that could potentially improve drug delivery during noninvasive positive pressure ventilation (NIPPV) is currently not available on single-limb circuit bilevel ventilators. The aim of this study was to compare urinary excretion of amikacin following aerosol delivery with a vibrating mesh nebulizer coupled to a single-limb circuit bilevel ventilator, using conventional continuous (Conti-Neb) and experimental inspiratory synchronized (Inspi-Neb) nebulization modes...
July 6, 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/28683212/a-randomized-crossover-trial-evaluating-patient-handling-preference-and-ease-of-use-of-the-fluticasone-propionate-formoterol-breath-triggered-inhaler
#7
David Bell, Lucielle Mansfield, Mark Lomax
BACKGROUND: Appropriate inhaler selection is of fundamental importance in obstructive lung disease management. Key factors in device selection include a patient's capacity to operate a particular device and their preference for it. METHODS: This randomized, open-label, two-period, crossover study (NCT01739387) compared the ability of adolescent and adult patients with obstructive lung disease to correctly handle the fluticasone propionate/formoterol fumarate (FP/FORM; Flutiform(®)) pressurized metered-dose inhaler (pMDI) and FP/FORM K-haler(®), a novel breath-triggered inhaler (BTI), following a simple, standardized training regimen...
July 6, 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/28683210/pulmonary-toxicity-of-benzalkonium-chloride
#8
Neil F Johnson
The available toxicity data of benzalkonium chloride (BKC) clearly shows that it is toxic; however, the weight of evidence favors the view that at doses encountered in nasally and orally inhaled pharmaceutical preparations it is well tolerated. The adverse toxicological data predominantly come from in vitro and animal studies in which doses and exposure periods employed were excessive in relation to the clinical doses and their posology and, therefore, not directly applicable to the clinic. The conflict between the in vitro and animal data and the clinical experience can be reconciled by understanding some of the physicochemical properties of BKC, the nasal and respiratory tract microenvironments, the doses used, and the posology...
July 6, 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/28520510/abstracts-from-the-aerosol-society-drug-delivery-to-the-lungs-27-edinburgh-international-conference-centre-edinburgh-scotland-uk-december-7-9-2016
#9
(no author information available yet)
No abstract text is available yet for this article.
May 18, 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/28510491/short-term-growth-during-treatment-with-inhaled-fluticasone-propionate-formoterol-fluticasone-and-beclomethasone-treatment
#10
Ole D Wolthers, Ainslee Moore, Sabine Mersmann, Sanjeeva Dissanayake
BACKGROUND: Fluticasone propionate/formoterol (FP/FORM) is a pressurized metered-dose inhaler (pMDI; Flutiform(®)) approved for use in adolescents and adults and under development for pediatric use. OBJECTIVE: To compare short-term growth in asthmatic children treated with FP/FORM, FP pMDI with valved holding chamber, and beclomethasone dipropionate (BDP) in a breath-actuated device. METHODS: Children with persistent asthma (n = 48; 5 to <12 years) participated in an assessor-blinded, randomized, three-way crossover trial with run in, wash out, and active treatment periods, each of 2 weeks duration...
May 16, 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/28510480/dry-powder-inhaler-formulation-of-rifampicin-an-improved-targeted-delivery-system-for-alveolar-tuberculosis
#11
Tejal Rawal, Laurent Kremer, Iman Halloum, Shital Butani
BACKGROUND: The delivery of antitubercular drugs through direct lung targeting can lead to reduction in the dose as well as side effects of the drug. In the present investigation, carrier (lactose)-based dry-powder inhaler of rifampicin was prepared to achieve direct targeting of the drug into the lungs. METHODS: The dry powder inhaler formulation was prepared by simply mixing micronized rifampicin with coarse and fine lactose preblend. Preliminary blends of the drug were prepared with various lactose grades (Inhalac(®), Respitose,(®) and Lactohale(®))...
May 16, 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/28463044/aerosol-delivery-with-two-nebulizers-through-high-flow-nasal-cannula-a-randomized-cross-over-single-photon-emission-computed-tomography-computed-tomography-study
#12
Jonathan Dugernier, Michel Hesse, Thibaud Jumetz, Emilie Bialais, Jean Roeseler, Virginie Depoortere, Jean-Bernard Michotte, Xavier Wittebole, Stephan Ehrmann, Pierre-François Laterre, François Jamar, Gregory Reychler
BACKGROUND: High-flow nasal cannula use is developing in ICUs. The aim of this study was to compare aerosol efficiency by using two nebulizers through a high-flow nasal cannula: the most commonly used jet nebulizer (JN) and a more efficient vibrating-mesh nebulizer (VN). METHODS: Aerosol delivery of diethylenetriaminepentaacetic acid labeled with technetium-99m (4 mCi/4 mL) to the lungs by using a VN (Aerogen Solo(®); Aerogen Ltd., Galway, Ireland) and a constant-output JN (Opti-Mist Plus Nebulizer(®); ConvaTec, Bridgewater, NJ) through a high-flow nasal cannula (Optiflow(®); Fisher & Paykel, New Zealand) was compared in six healthy subjects...
May 2, 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/28463041/effect-of-pressurized-metered-dose-inhaler-spray-characteristics-and-particle-size-distribution-on-drug-delivery-efficiency
#13
Morteza Yousefi, Kiao Inthavong, Jiyuan Tu
BACKGROUND: A key issue in pulmonary drug delivery is improvement of the delivery device for effective and targeted treatment. Pressurized metered dose inhalers (pMDIs) are the most popular aerosol therapy device for treating lung diseases. This article studies the effect of spray characteristics: injection velocity, spray cone angle, particle size distribution (PSD), and its mass median aerodynamic diameter (MMAD) on drug delivery. METHODS: An idealized oral airway geometry, extending from mouth to the main bronchus, was connected to a pMDI device...
May 2, 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/28463040/pharmacokinetic-comparison-of-a-unit-dose-dry-powder-inhaler-with-a-multidose-dry-powder-inhaler-for-delivery-of-fluticasone-furoate
#14
Rashmi Mehta, Alison Moore, Kylie Riddell, Shashidhar Joshi, Robert Chan
BACKGROUND: The unit dose dry powder inhaler (UD-DPI) is being considered as an alternative inhaler platform that, if developed, has the potential to improve access to inhaled respiratory medicines in developing countries. AIM: This study compared the systemic exposure of fluticasone furoate after delivery from the UD-DPI with that from the ELLIPTA(®) inhaler. METHODS: This open-label, five-way cross-over, randomized, single-dose study in healthy subjects evaluated fluticasone furoate systemic exposure of three dose strengths (using four inhalations), 4 × 80 μg [320 μg], 4 × 100 μg [400 μg], and 4 × 140 μg [560 μg]), and two percentages of drug in lactose blends (0...
May 2, 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/28504922/abstracts-international-society-for-aerosols-in-medicine-e-v-21st-isam-congress-santa-fe-nm-june-3-7-2017
#15
(no author information available yet)
No abstract text is available yet for this article.
June 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/28418758/inhaled-heparin-therapeutic-efficacy-and-recent-formulations
#16
Ayca Yildiz-Pekoz, Yildiz Ozsoy
Heparin is well known for its anticoagulant and anti-inflammatory properties. Inhaled heparin regimens are increasingly being used to manage lung disease. It has been used to treat cystic fibrosis, thromboembolism, and pulmonary fibrosis, as well as bronchial asthma and asthma-induced airway hypersensitivity. Several preclinical studies attained some useful effects of heparin-administered, parenterally and through inhalation, treatment of lung disease. Besides, recent clinical trials suggest that inhaled heparin for lung diseases is beneficial and safe, but such data remain to be limited...
June 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/28170282/pharmacokinetics-of-salbutamol-delivered-from-the-unit-dose-dry-powder-inhaler-comparison-with-the-metered-dose-inhaler-and-diskus-dry-powder-inhaler
#17
Alison Moore, Kylie Riddell, Shashidhar Joshi, Robert Chan, Rashmi Mehta
AIM: To compare the systemic exposure of salbutamol following delivery from the unit dose dry powder inhaler (UD-DPI) system with that from the Diskus(®) and metered dose inhaler (MDI). MATERIALS AND METHODS: This open-label, two-part, six-way crossover, randomized single-dose study in healthy subjects evaluated salbutamol systemic exposure of three dose strengths (using three inhalations: 3 × 150 μg [450 μg], 3 × 200 μg [600 μg], and 3 × 250 μg [750 μg]) and 2% of drug in lactose blends (1...
June 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/28075194/aerosol-drug-delivery-during-noninvasive-positive-pressure-ventilation-effects-of-intersubject-variability-and-excipient-enhanced-growth
#18
Ross L Walenga, P Worth Longest, Anubhav Kaviratna, Michael Hindle
BACKGROUND: Nebulized aerosol drug delivery during the administration of noninvasive positive pressure ventilation (NPPV) is commonly implemented. While studies have shown improved patient outcomes for this therapeutic approach, aerosol delivery efficiency is reported to be low with high variability in lung-deposited dose. Excipient enhanced growth (EEG) aerosol delivery is a newly proposed technique that may improve drug delivery efficiency and reduce intersubject aerosol delivery variability when coupled with NPPV...
June 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/28075182/dispersing-the-mists-an-experimental-history-of-medicine-study-into-the-quality-of-volatile-inhalations
#19
Barry Murnane, Cathal T Gallagher, Noel Snell, Mark Sanders, Ramin Moshksar, Darragh Murnane
BACKGROUND: Dr. Nelson's Improved Inhaler was first marketed with an advertisement in The Lancet in 1865. Revolutionary at the time for its ease of use and patient-friendliness, the inhaler is still in use for self-treatment by many all over the world. On the occasion of its 150th anniversary, this study reports an experimental historical medicine approach to identify evidence for the quality of vapor inhalers. METHODS: Through accessing reviews of the device's use by the contemporary medical establishment, it was established that Dr...
June 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/27977309/drug-delivery-in-asthmatic-children-following-coordinated-and-uncoordinated-inhalation-maneuvers-a-randomized-crossover-trial
#20
Ariel Berlinski, Dirk von Hollen, Ross H M Hatley, Lucy E A Hardaker, Kurt Nikander
BACKGROUND: Valved holding chambers (VHCs) are used in children to deliver pressurized metered dose inhalers (pMDI). In vitro data suggest that uncoordinated use decreases the amount of drug available for inhalation. We hypothesize that in an ex vivo study, the coordinated maneuver will deliver more drug than the uncoordinated one. PATIENTS AND METHODS: Thirty-two clinically stable asthmatic children, ages 5-8 years, completed the study. An aerosol filter was interposed between a small-volume nonelectrostatic VHC and a mouthpiece to capture the drug emitted by one puff of Flovent(®) 220 mcg during tidal breathing...
June 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
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