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Journal articles on the topic 'Pharmaceutical aerosol'

Author: Grafiati

Published: 11 December 2022

Last updated: 26 January 2023

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1

Martí-Bonmatí, Ezequiel, Gustavo Juan, Luis Martí-Bonmatí, and Mercedes Ramon. "Effect of Low Temperatures on Drug-Delivery Efficacy of Aerosols." Journal of Pharmacy Technology 12, no. 5 (September 1996): 220–22. http://dx.doi.org/10.1177/875512259601200508.

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Objective: To determine how low temperatures affect the pharmaceutical properties of oral inhalation aerosols pressurized with chlorofluorocarbons (CFCs). Design: Inhalation aerosols of the beta-adrenergic receptor agonist terbutaline sulfate were exposed at three different environmental temperatures [22, 0, and −10 °C; (±2)]. Three groups of 10 canisters each, at different drug loads (100%, 50%, and 20%), were studied at these temperatures. Canisters with mouthpieces were weighed before and after 40 actuations in order to study the mass propelled in each experimental condition. Photographs were also taken of the aerosol mist at each temperature. Results: A statistically significant decrease in the average mass of the aerosol discharged was evidenced at low temperatures. The temperature and aerosol output were linearly correlated. The weight loss at–10 °C was 35.4%. At this temperature the emitted doses were discharged as liquefied droplets. This effect was quickly manifested and proved reversible. Conclusions: Low temperatures modify the pharmaceutical properties of oral inhalation aerosols pressurized with CFCs. This technical information should be included as a note of caution in the prescribing information.

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2

McGrath, James A., Andrew O’Sullivan, Gavin Bennett, Ciarraí O’Toole, Mary Joyce, Miriam A. Byrne, and Ronan MacLoughlin. "Investigation of the Quantity of Exhaled Aerosols Released into the Environment during Nebulisation." Pharmaceutics 11, no. 2 (February 12, 2019): 75. http://dx.doi.org/10.3390/pharmaceutics11020075.

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Background: Secondary inhalation of medical aerosols is a significant occupational hazard in both clinical and homecare settings. Exposure to fugitive emissions generated during aerosol therapy increases the risk of the unnecessary inhalation of medication, as well as toxic side effects. Methods: This study examines fugitively-emitted aerosol emissions when nebulising albuterol sulphate, as a tracer aerosol, using two commercially available nebulisers in combination with an open or valved facemask or using a mouthpiece with and without a filter on the exhalation port. Each combination was connected to a breathing simulator during simulated adult breathing. The inhaled dose and residual mass were quantified using UV spectrophotometry. Time-varying fugitively-emitted aerosol concentrations and size distributions during nebulisation were recorded using aerodynamic particle sizers at two distances relative to the simulated patient. Different aerosol concentrations and size distributions were observed depending on the interface. Results: Within each nebuliser, the facemask combination had the highest time-averaged fugitively-emitted aerosol concentration, and values up to 0.072 ± 0.001 mg m−3 were recorded. The placement of a filter on the exhalation port of the mouthpiece yielded the lowest recorded concentrations. The mass median aerodynamic diameter of the fugitively-emitted aerosol was recorded as 0.890 ± 0.044 µm, lower the initially generated medical aerosol in the range of 2–5 µm. Conclusions: The results highlight the potential secondary inhalation of exhaled aerosols from commercially available nebuliser facemask/mouthpiece combinations. The results will aid in developing approaches to inform policy and best practices for risk mitigation from fugitive emissions.

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Y.K. Chew, Nora, and Hak-Kim Chan. "Pharmaceutical Dry Powder Aerosol Delivery." KONA Powder and Particle Journal 19 (2001): 46–56. http://dx.doi.org/10.14356/kona.2001010.

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4

Mishra, Raghav, and Radhika Agarwal. "A Concise Overview on Recent Advances in Pharmaceutical Aerosols and their Commercial Applications." Current Materials Science 15, no. 2 (July 2022): 125–41. http://dx.doi.org/10.2174/2666145414666211111102425.

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Background: Localized drug delivery to the respiratory system has become an increasingly successful and essential treatment strategy for several pulmonary diseases, including asthma, chronic abstractive disease, pneumonia, bronchitis, and cystic fibrosis. The rising incidence of respiratory diseases is a significant factor driving the worldwide market for respiratory inhaler devices. Objective: The objective of this article is to present various aspects of pharmaceutical aerosols, including their types, components, fundamentals, in-process and finished product quality control tests based on pharmacopeial standards and specifications, and commercial utility considering the pharmaceutical aerosol dosage forms that have been patented from 2000 to 2020, along with a list of marketed pharmaceutical products. Method: Aerosol, collectively referred to as a pressurized device, operates by triggering an appropriate valve system with a continuous or metered dosage of tiny mist spray. It is used not only in the treatment of asthma and chronic obstructive pulmonary disease but also in the treatment of cancer, diabetes, migraine, angina pectoris, acute lung injury, bone disorders, tuberculosis, and many more. A multitude of different variables, including types and properties of propellants, active substances, containers, valves, actuators, spray patterns, valve crimping efficiency, and particle size of the aerosols, influence the therapeutic effectiveness of pharmaceutical aerosols. Conclusion: Based on the current findings, distinct characteristics such as the elimination of firstpass metabolism, quick drug absorption, ease of therapy termination, as well as a larger surface area have attributed to the success of pharmaceutical aerosols.

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Pasteka, Richard, Lara Alina Schöllbauer, Joao Pedro Santos da Costa, Radim Kolar, and Mathias Forjan. "Experimental Evaluation of Dry Powder Inhalers during Inhalation and Exhalation Using a Model of the Human Respiratory System (xPULM™)." Pharmaceutics 14, no. 3 (February 24, 2022): 500. http://dx.doi.org/10.3390/pharmaceutics14030500.

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Dry powder inhalers are used by a large number of patients worldwide to treat respiratory diseases. The objective of this work is to experimentally investigate changes in aerosol particle diameter and particle number concentration of pharmaceutical aerosols generated by four dry powder inhalers under realistic inhalation and exhalation conditions. To simulate patients undergoing inhalation therapy, the active respiratory system model (xPULM™) was used. A mechanical upper airway model was developed, manufactured, and introduced as a part of the xPULM™ to represent the human upper respiratory tract with high fidelity. Integration of optical aerosol spectrometry technique into the setup allowed for evaluation of pharmaceutical aerosols. The results show that there is a significant difference (p < 0.05) in mean particle diameter between inhaled and exhaled particles with the majority of the particles depositing in the lung, while particles with the size of (>0.5 μm) are least influenced by deposition mechanisms. The fraction of exhaled particles ranges from 2.13% (HandiHaler®) over 2.94% (BreezHaler®), and 6.22% (Turbohaler®) to 10.24% (Ellipta®). These values are comparable to previously published studies. Furthermore, the mechanical upper airway model increases the resistance of the overall system and acts as a filter for larger particles (>3 μm). In conclusion, the xPULM™ active respiratory system model is a viable option for studying interactions of pharmaceutical aerosols and the respiratory tract regarding applicable deposition mechanisms. The model strives to support the reduction of animal experimentation in aerosol research and provides an alternative to experiments with human subjects.

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6

Angel, A., J. Robson, T. L. Muchnick, R. C. Moretz, and R. B. Patel. "SEM evaluation of pharmaceutical inhalation aerosols deposited in an andersen cascade impactor." Proceedings, annual meeting, Electron Microscopy Society of America 50, no. 2 (August 1992): 1328–29. http://dx.doi.org/10.1017/s0424820100131279.

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Particle size characterization is a critical parameter used for inhalation aerosol formulation development, batch control and product performance evaluation. Both the United States Pharmacopeia optical microscopy method and multistage cascade impaction methods are used for particle size evaluation and control of inhalation aerosols. Particle size determination based on aerodynamic properties is considered more relevant than other techniques for assessing product performance during patient-use. The cascade impaction technique for evaluation of inhalation aerosols is typically used with a suitable inlet to facilitate introduction of the aerosol spray into the impactor. The drug particles deposited on the impaction stages are extracted and analyzed by an appropriate method to relate drug mass to the aerodynamic cut-off size and thereby determine respirable fractions (particles of < 5.8 μm aerodynamic size). This approach does not provide information relating to the physical character of the formulation (aggregates, agglomerates, particle shapes and morphology) or its deposition characteristics both within and between stages.

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7

Almeling, Stefan, David Ilko, and Ulrike Holzgrabe. "Charged aerosol detection in pharmaceutical analysis." Journal of Pharmaceutical and Biomedical Analysis 69 (October 2012): 50–63. http://dx.doi.org/10.1016/j.jpba.2012.03.019.

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8

Kuhn, Robert J. "Pharmaceutical Considerations in Aerosol Drug Delivery." Pharmacotherapy 22, no. 3 Part 2 (March 2002): 80S—85S. http://dx.doi.org/10.1592/phco.22.6.80s.33907.

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9

Golshahi, Laleh, P. Worth Longest, Landon Holbrook, Jessica Snead, and Michael Hindle. "Production of Highly Charged Pharmaceutical Aerosols Using a New Aerosol Induction Charger." Pharmaceutical Research 32, no. 9 (March 31, 2015): 3007–17. http://dx.doi.org/10.1007/s11095-015-1682-6.

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10

Borojeni, Azadeh A. T., Wanjun Gu, Bahman Asgharian, Owen Price, Andrew P. Kuprat, Rajesh K. Singh, Sean Colby, Richard A. Corley, and Chantal Darquenne. "In Silico Quantification of Intersubject Variability on Aerosol Deposition in the Oral Airway." Pharmaceutics 15, no. 1 (January 3, 2023): 160. http://dx.doi.org/10.3390/pharmaceutics15010160.

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The extrathoracic oral airway is not only a major mechanical barrier for pharmaceutical aerosols to reach the lung but also a major source of variability in lung deposition. Using computational fluid dynamics, deposition of 1–30 µm particles was predicted in 11 CT-based models of the oral airways of adults. Simulations were performed for mouth breathing during both inspiration and expiration at two steady-state flow rates representative of resting/nebulizer use (18 L/min) and of dry powder inhaler (DPI) use (45 L/min). Consistent with previous in vitro studies, there was a large intersubject variability in oral deposition. For an optimal size distribution of 1–5 µm for pharmaceutical aerosols, our data suggest that >75% of the inhaled aerosol is delivered to the intrathoracic lungs in most subjects when using a nebulizer but only in about half the subjects when using a DPI. There was no significant difference in oral deposition efficiency between inspiration and expiration, unlike subregional deposition, which shows significantly different patterns between the two breathing phases. These results highlight the need for incorporating a morphological variation of the upper airway in predictive models of aerosol deposition for accurate predictions of particle dosimetry in the intrathoracic region of the lung.

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11

Cunningham, Seán M., and David A. Tanner. "A Review: The Prospect of Inhaled Insulin Therapy via Vibrating Mesh Technology to Treat Diabetes." International Journal of Environmental Research and Public Health 17, no. 16 (August 10, 2020): 5795. http://dx.doi.org/10.3390/ijerph17165795.

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Background: Inhaled insulin has proven to be viable and, in some aspects, a more effective alternative to subcutaneous insulin. Past and present insulin inhaler devices have not found clinical or commercial success. Insulin inhalers create a dry powder or soft mist insulin aerosol, which does not provide the required uniform particle size or aerosol volume for deep lung deposition. Methods: The primary focus of this review is to investigate the potential treatment of diabetes with a wet insulin aerosol. Vibrating mesh nebulisers allow the passive inhalation of a fine wet mist aerosol for the administration of drugs to the pulmonary system in higher volumes than other small-volume nebulisers. Results: At present, there is a significant focus on vibrating mesh nebulisers from the pharmaceutical and biomedical industries for the systemic administration of pharmaceuticals for non-traditional applications such as vaccines or the treatment of diabetes. Systemic drug administration using vibrating mesh nebulisers leads to faster-acting pharmaceuticals with a reduction in drug latency. Conclusions: Systemic conditions such as diabetes, require the innovative development of custom vibrating mesh devices to provide the desired flow rates and droplet size for effective inhaled insulin administration.

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12

Muralidharan, Priya, Don Hayes, Jeffrey R. Fineman, Stephen M. Black, and Heidi M. Mansour. "Advanced Microparticulate/Nanoparticulate Respirable Dry Powders of a Selective RhoA/Rho Kinase (Rock) Inhibitor for Targeted Pulmonary Inhalation Aerosol Delivery." Pharmaceutics 13, no. 12 (December 17, 2021): 2188. http://dx.doi.org/10.3390/pharmaceutics13122188.

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Pulmonary hypertension (PH) is a progressive disease that eventually leads to heart failure and potentially death for some patients. There are many unique advantages to treating pulmonary diseases directly and non-invasively by inhalation aerosols and dry powder inhalers (DPIs) possess additional unique advantages. There continues to be significant unmet medical needs in the effective treatment of PH that target the underlying mechanisms. To date, there is no FDA-approved DPI indicated for the treatment of PH. Fasudil is a novel RhoA/Rho kinase (ROCK) inhibitor that has shown great potential in effectively treating pulmonary hypertension. This systematic study is the first to report on the design and development of DPI formulations comprised of respirable nanoparticles/microparticles using particle engineering design by advanced spray drying. In addition, comprehensive physicochemical characterization, in vitro aerosol aerosol dispersion performance with different types of human DPI devices, in vitro cell-drug dose response cell viability of different human respiratory cells from distinct lung regions, and in vitro transepithelial electrical resistance (TEER) as air-interface culture (AIC) demonstrated that these innovative DPI fasudil formulations are safe on human lung cells and have high aerosol dispersion performance properties.

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13

Berlinski, Ariel, and Joshua Spiva. "In Vitro Characterization of Aerosolized Albuterol Generated by a Jet Nebulizer and Delivered through a Heated Flow Nasal Cannula System." Pharmaceuticals 15, no. 10 (October 18, 2022): 1281. http://dx.doi.org/10.3390/ph15101281.

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Pediatric patients receiving respiratory support with heated flow nasal cannula (HFNC) systems frequently receive inhaled medications. Most available data have been obtained with vibrating mesh nebulizers that are expensive. Data are lacking regarding the feasibility of using less expensive devices such as continuous output jet nebulizers. The characteristics of the aerosols generated by jet nebulizers operated at different conditions (6 and 9 L/min) were studied alone and connected to a HFNC system and different size cannulas using a cascade impactor and spectrophotometry (276 nm). Aerosol characteristics changed while traveling through the HFNC system. Initial size selection occurred at the exit of the circuit (before connecting to the cannula) with all aerosol <5 µm. Nasal cannula size further selected aerosols and reduced drug delivery. The operating flow of the nebulizer did not affect the delivered mass but higher flows generated smaller particle size aerosols. The addition of supplemental flow significantly reduced the delivered mass. The measured aerosol characteristics would likely result in intrapulmonary deposition. The delivery of aerosolized albuterol generated by a continuous output nebulizer placed in the inlet of a HFNC system and connected to large or XXL cannulas is feasible.

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14

Li, Xihao, Frank E. Blondino, Michael Hindle, William H. Soine, and Peter R. Byron. "Stability and characterization of perphenazine aerosols generated using the capillary aerosol generator." International Journal of Pharmaceutics 303, no. 1-2 (October 2005): 113–24. http://dx.doi.org/10.1016/j.ijpharm.2005.07.010.

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15

Shen, X., M. Hindle, and P. R. Byron. "Effect of energy on propylene glycol aerosols using the capillary aerosol generator." International Journal of Pharmaceutics 275, no. 1-2 (May 2004): 249–58. http://dx.doi.org/10.1016/j.ijpharm.2004.02.005.

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16

Sandell, Dennis. "Bioequivalence assessment of pharmaceutical aerosol products through IVIVC." Advanced Drug Delivery Reviews 176 (September 2021): 113895. http://dx.doi.org/10.1016/j.addr.2021.113895.

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17

Wu, Lang, Shuchang Lei, Yixia Wang, Shiyu Yang, Xiaoyan Lin, and Haijun Wang. "A Highly Efficient Biomass Compound Aerosol Suppressant in Purifying Radioactive Cesium Droplet Aerosols." Molecules 27, no. 19 (October 1, 2022): 6480. http://dx.doi.org/10.3390/molecules27196480.

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Nuclear accidents and decommissioning in the nuclear industry would release a large number of radioactive aerosols which endangers the natural environment and the health of workers. Therefore, there is an urgent need for environment-friendly aerosol suppressants to control and handle environmental pollution problems caused by radioactive aerosols. In this paper, sodium alginate (SA), a type of polyphenol material (TP), and alkyl glycosides (APGs) were selected as the components of the compound aerosol suppressant and the optimal proportion was generated via the method of D-optimal mixture design. Furthermore, the cesium aerosol sedimentation effect of the optimized compound aerosol suppressants was evaluated via sedimentation efficiency, the change in particle concentration cumulative concentration fraction of the cesium aerosol sedimentation process. The results showed that the aerosol sedimentation efficiency was 99.82% which was much higher than nature settlement, 18.6% and water spraying sedimentation, 43.3%. Moreover, after spraying the compound suppressant, it displayed a good effect on settling the cesium aerosol particles with a diameter of less than 1 µm, as the concentration of particles was reduced from 55.49% to 44.53%. Finally, the sedimentation mechanism of the compound aerosol suppressant and cesium aerosol particles, such as the coagulation effect, was analyzed using the particle size distribution.

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18

Zarogoulidis, Paul, Dimitris Petridis, Christos Ritzoulis, Kaid Darwiche, Ioannis Kioumis, Konstantinos Porpodis, Dionysios Spyratos, et al. "Internal mouthpiece designs as a future perspective for enhanced aerosol deposition. Comparative results for aerosol chemotherapy and aerosol antibiotics." International Journal of Pharmaceutics 456, no. 2 (November 2013): 325–31. http://dx.doi.org/10.1016/j.ijpharm.2013.09.004.

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19

Mazzo, David J., Robert Engerer, and John Egoville. "An automated aerosol actuator: Application to the uniformity testing of pharmaceutical aerosol dosage forms." Journal of Pharmaceutical and Biomedical Analysis 11, no. 4-5 (April 1993): 313–21. http://dx.doi.org/10.1016/0731-7085(93)80023-t.

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20

Sievers, R. E., E. T. S. Huang, J. A. Villa, J. K. Kawamoto, M. M. Evans, and P. R. Brauer. "Low-temperature manufacturing of fine pharmaceutical powders with supercritical fluid aerosolization in a Bubble Dryer®." Pure and Applied Chemistry 73, no. 8 (August 1, 2001): 1299–303. http://dx.doi.org/10.1351/pac200173081299.

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Aerosols play an important role in thin film deposition, fine powder generation, and drug delivery. Green processes to form aerosols are needed to eliminate the use of toxic organic solvents and minimize the production of liquid wastes and the emission of halogenated and oxidant-forming organic compounds. We have developed a new patented process, Carbon Dioxide-Assisted Nebulization with a Bubble Dryer® (CAN-BD), that can generate a dense aerosol with small droplet and microbubble sizes that are dried to form particles less than 3 µm in diameter [19]. The process uses carbon dioxide as an aerosolization aid, and this permits drying at lower temperature than usually needed in conventional spray-drying. Intimate mixing of supercritical carbon dioxide with aqueous protein solutions causes the formation of microbubbles, which are rapidly dried in less than 5 s. The process is more environmentally benign than traditionally used methods, and is superior when thermally unstable materials are being processed. Fine-particle pharmaceutical powders can be rapidly and easily made by this new CAN-BD process, requiring less energy and eliminating residues of toxicologically or environmentally objectionable solvents. Manufacturing dry powders of pharmaceuticals for pulmonary drug delivery and increasing bioavailability are the purposes of developing and marketing the new Temco Bubble Dryer.

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21

Cheng, Yung Sung. "Mechanisms of Pharmaceutical Aerosol Deposition in the Respiratory Tract." AAPS PharmSciTech 15, no. 3 (February 22, 2014): 630–40. http://dx.doi.org/10.1208/s12249-014-0092-0.

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22

Ratcliff, Eric. "Ball or aerosol? Sin, soap and the pharmaceutical industry." Australasian Psychiatry 21, no. 1 (January 23, 2013): 27–31. http://dx.doi.org/10.1177/1039856212469844.

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23

Wiegandt, Felix C., Ulrich P. Froriep, Fabian Müller, Theodor Doll, Andreas Dietzel, and Gerhard Pohlmann. "Breath-Triggered Drug Release System for Preterm Neonates." Pharmaceutics 13, no. 5 (May 4, 2021): 657. http://dx.doi.org/10.3390/pharmaceutics13050657.

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A major disadvantage of inhalation therapy with continuous drug delivery is the loss of medication during expiration. Developing a breath-triggered drug release system can highly decrease this loss. However, there is currently no breath-triggered drug release directly inside the patient interface (nasal prong) for preterm neonates available due to their high breathing frequency, short inspiration time and low tidal volume. Therefore, a nasal prong with an integrated valve releasing aerosol directly inside the patient interface increasing inhaled aerosol efficiency is desirable. We integrated a miniaturized aerosol valve into a nasal prong, controlled by a double-stroke cylinder. Breathing was simulated using a test lung for preterm neonates on CPAP respiratory support. The inhalation flow served as a trigger signal for the valve, releasing humidified surfactant. Particle detection was performed gravimetrically (filter) and optically (light extinction). The integrated miniaturized aerosol valve enabled breath-triggered drug release inside the patient interface with an aerosol valve response time of <25 ms. By breath-triggered release of the pharmaceutical aerosol as a bolus during inhalation, the inhaled aerosol efficiency was increased by a factor of >4 compared to non-triggered release. This novel nasal prong with integrated valve allows breath-triggered drug release directly inside the nasal prong with short response time.

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24

Berger, William. "Aerosol Devices and Asthma Therapy." Current Drug Delivery 6, no. 1 (January 1, 2009): 38–49. http://dx.doi.org/10.2174/156720109787048203.

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Fink, James, and Arzu Ari. "Aerosol delivery to intubated patients." Expert Opinion on Drug Delivery 10, no. 8 (April 24, 2013): 1077–93. http://dx.doi.org/10.1517/17425247.2013.790362.

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Kim, Yong-Hyun, Mi-Kyung Song, and Kyuhong Lee. "A Study on the Behavior Patterns of Liquid Aerosols Using Disinfectant Chloromethylisothiazolinone/Methylisothiazolinone Solution." Molecules 26, no. 19 (September 22, 2021): 5725. http://dx.doi.org/10.3390/molecules26195725.

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This study evaluates the behavioral characteristics of components (methylisothiazolinone (MIT) and chloromethylisothiazolinone (CMIT)) contained in disinfectant solutions when they convert to liquid aerosols. The analytical method for MIT and CMIT quantitation was established and optimized using sorbent tube/thermal desorber-gas chromatography-mass spectrometry system; their behavioral characteristics are discussed using the quantitative results of these aerosols under different liquid aerosol generation conditions. MIT and CMIT showed different behavioral characteristics depending on the aerosol mass concentration and sampling time (sampling volume). When the disinfectant solution was initially aerosolized, MIT and CMIT were primarily collected on glass filter (MIT = 91.8 ± 10.6% and CMIT = 90.6 ± 5.18%), although when the generation and filter sampling volumes of the aerosols increased to 30 L, the relative proportions collected on the filter decreased (MIT = 79.0 ± 12.0% and CMIT = 39.7 ± 8.35%). Although MIT and CMIT had relatively high vapor pressure, in liquid aerosolized state, they primarily accumulated on the filter and exhibited particulate behavior. Their relative proportions in the aerosol were different from those in disinfectant solution. In the aerosol with mass concentration of ≤5 mg m−3, the relative proportion deviations of MIT and CMIT were large; when the mass concentration of the aerosol increased, their relative proportions constantly converged at a lower level than those in the disinfectant solution. Hence, it can be concluded that the behavioral characteristics and relative proportions need to be considered to perform the quantitative analysis of the liquid aerosols and evaluate various toxic effects using the quantitative data.

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Adorni, Greta, Gerrit Seifert, Francesca Buttini, Gaia Colombo, Luciano A. Stecanella, Irene Krämer, and Alessandra Rossi. "Aerosolization Performance of Jet Nebulizers and Biopharmaceutical Aspects." Pharmaceutics 11, no. 8 (August 11, 2019): 406. http://dx.doi.org/10.3390/pharmaceutics11080406.

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In this work, 13 jet nebulizers, some of which in different configurations, were investigated in order to identify the biopharmaceutical constraints related to the quality attributes of the medicinal products, which affect their safety, efficiency, compliance, and effectiveness. The aerosolization parameters, including the aerosol output, aerosol output rate, mass median aerodynamic diameter, and fine particle fraction, were determined according to the European Standard EN 13544-1, using sodium fluoride as a reference formulation. A comparison between the aerosol output nebulization time and the fine particle fraction displayed a correlation between the aerosol quality and the nebulization rate. Indeed, the quality of the nebulization significantly increased when the rate of aerosol emission was reduced. Moreover, the performance of the nebulizers was analyzed in terms of respirable delivered dose and respirable dose delivery rate, which characterize nebulization as the rate and amount of respirable product that could be deposited into the lungs. Depending on which of these two latter parameters was used, the nebulizers showed different performances. The differences, in terms of the rate and amount of delivered aerosol, could provide relevant information for the appropriate choice of nebulizer as a function of drug product, therapy, and patient characteristics.

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Otto, Matthias, Jörg Krebs, Peter Welker, René Holm, Manfred Thiel, Luciano Gattinoni, Michael Quintel, and Charalambos Tsagogiorgas. "Inhalationally Administered Semifluorinated Alkanes (SFAs) as Drug Carriers in an Experimental Model of Acute Respiratory Distress Syndrome." Pharmaceutics 13, no. 3 (March 23, 2021): 431. http://dx.doi.org/10.3390/pharmaceutics13030431.

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Aerosol therapy in patients suffering from acute respiratory distress syndrome (ARDS) has so far failed in improving patients’ outcomes. This might be because dependent lung areas cannot be reached by conventional aerosols. Due to their physicochemical properties, semifluorinated alkanes (SFAs) could address this problem. After induction of ARDS, 26 pigs were randomized into three groups: (1) control (Sham), (2) perfluorohexyloctane (F6H8), and (3) F6H8-ibuprofen. Using a nebulization catheter, (2) received 1 mL/kg F6H8 while (3) received 1 mL/kg F6H8 with 6 mg/mL ibuprofen. Ibuprofen plasma and lung tissue concentration, bronchoalveolar lavage (BAL) fluid concentration of TNF-α, IL-8, and IL-6, and lung mechanics were measured. The ibuprofen concentration was equally distributed to the dependent parts of the right lungs. Pharmacokinetic data demonstrated systemic absorption of ibuprofen proofing a transport across the alveolo-capillary membrane. A significantly lower TNF-α concentration was observed in (2) and (3) when compared to the control group (1). There were no significant differences in IL-8 and IL-6 concentrations and lung mechanics. F6H8 aerosol seemed to be a suitable carrier for pulmonary drug delivery to dependent ARDS lung regions without having negative effects on lung mechanics.

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DiBlasi, Robert M., Kellie J. Micheletti, Joseph D. Zimmerman, Jonathan A. Poli, James B. Fink, and Masaki Kajimoto. "Physiologic Effects of Instilled and Aerosolized Surfactant Using a Breath-Synchronized Nebulizer on Surfactant-Deficient Rabbits." Pharmaceutics 13, no. 10 (September 29, 2021): 1580. http://dx.doi.org/10.3390/pharmaceutics13101580.

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Surfactant administration incorporates liquid bolus instillation via endotracheal tube catheter and use of a mechanical ventilator. Aerosolized surfactant has generated interest and conflicting data related to dose requirements and efficacy. We hypothesized that aerosolized surfactant with a novel breath-actuated vibrating mesh nebulizer would have similar efficacy and safety as instilled surfactant. Juvenile rabbits (1.50 ± 0.20 kg, n = 17) were sedated, anesthetized, intubated, and surfactant was depleted via lung lavage on mechanical ventilation. Subjects were randomized to receive standard dose liquid instillation via catheter (n = 5); low dose surfactant (n = 5) and standard dose surfactant (n = 5) via aerosol; and descriptive controls (no treatment, n = 2). Peridosing events, disease severity and gas exchange, were recorded every 30 min for 3 h following surfactant administration. Direct-Instillation group had higher incidence for peridosing events than aerosol. Standard dose liquid and aerosol groups had greater PaO2 from pre-treatment baseline following surfactant (p < 0.05) with greater ventilation efficiency with aerosol (p < 0.05). Our study showed similar improvement in oxygenation response with greater ventilation efficiency with aerosol than liquid bolus administration at the same dose with fewer peridosing events. Breath-synchronized aerosol via nebulizer has potential as a safe, effective, and economical alternative to bolus liquid surfactant instillation.

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30

White, Andrew D., Charlotte Sarfas, Laura S. Sibley, Jennie Gullick, Simon Clark, Emma Rayner, Fergus Gleeson, et al. "Protective Efficacy of Inhaled BCG Vaccination Against Ultra-Low Dose Aerosol M. tuberculosis Challenge in Rhesus Macaques." Pharmaceutics 12, no. 5 (April 25, 2020): 394. http://dx.doi.org/10.3390/pharmaceutics12050394.

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Ten million cases of tuberculosis (TB) were reported in 2018 with a further 1.5 million deaths attributed to the disease. Improved vaccination strategies are urgently required to tackle the ongoing global TB epidemic. In the absence of a validated correlate of protection, highly characterised pre-clinical models are required to assess the protective efficacy of new vaccination strategies. In this study, we demonstrate the application of a rhesus macaque ultra-low dose (ULD) aerosol M. tuberculosis challenge model for the evaluation of TB vaccination strategies by directly comparing the immunogenicity and efficacy of intradermal (ID) and aerosol BCG vaccination delivered using a portable vibrating mesh nebulizer (VMN). Aerosol- and ID-delivered Bacille Calmette-Guérin (BCG) induced comparable frequencies of IFN-γ spot forming units (SFU) measured in peripheral blood mononuclear cells (PBMCs) by ELISpot, although the induction of IFN-γ SFU was significantly delayed following aerosol immunisation. This delayed response was also apparent in an array of secreted pro-inflammatory and chemokine markers, as well as in the frequency of antigen-specific cytokine producing CD4 and CD8 T-cells measured by multi-parameter flow cytometry. Interrogation of antigen-specific memory T-cell phenotypes revealed that vaccination-induced CD4 and CD8 T-cell populations primarily occupied the central memory (TCM) and transitional effector memory (TransEM) phenotype, and that the frequency of CD8 TCM and TransEM populations was significantly higher in aerosol BCG-vaccinated animals in the week prior to M. tuberculosis infection. The total and lung pathology measured following M. tuberculosis challenge was significantly lower in vaccinated animals relative to the unvaccinated control group and pathology measured in extra-pulmonary tissues was significantly reduced in aerosol BCG-vaccinated animals, relative to the ID-immunised group. Similarly, significantly fewer viable M. tuberculosis CFU were recovered from the extra-pulmonary tissues of aerosol BCG-vaccinated macaques relative to unvaccinated animals. In this study, a rhesus macaque ULD M. tuberculosis aerosol challenge model was applied as a refined and sensitive system for the evaluation of TB vaccine efficacy and to confirm that aerosol BCG vaccination delivered by portable VMN can confer a significant level of protection that is equivalent, and by some measures superior, to intradermal BCG vaccination.

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Alcoforado, Luciana, Arzu Ari, Jacqueline Barcelar, Simone Brandão, James Fink, and Armele de Andrade. "Impact of Gas Flow and Humidity on Trans-Nasal Aerosol Deposition via Nasal Cannula in Adults: A Randomized Cross-Over Study." Pharmaceutics 11, no. 7 (July 7, 2019): 320. http://dx.doi.org/10.3390/pharmaceutics11070320.

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Background: Trans-nasal pulmonary aerosol delivery using high flow nasal cannula (HFNC) devices is described with the administration of high gas flows exceeding patient inspiratory flow (HF) and with lower flows (LF). The aim of this pilot clinical trial was to compare deposition and distribution of radiolabeled aerosol via nasal cannula in healthy adults across three rates of gas flow delivered with active heated humidification, and to further identify the impact of aerosol administration without heated humidity. Methods: Twenty-three (23) healthy adults (16F) were randomized to receive aerosol with active heated humidification or unheated oxygen at gas flows of 10 L/min (n = 8), 30 L/min (n = 7), or 50 L/min (n = 8). Diethylenetriaminepentaacetic acid labeled with 1 millicurie (37 MBq) of Technetium-99m (DTPA-Tc99m) was mixed with NaCl to a fill volume of 1 mL, and administered via mesh nebulizer placed at the inlet of the humidifier. Radioactivity counts were performed using a gamma camera and the regions of interest (ROIs) were delimited with counts from the lungs, upper airways, stomach, nebulizer, circuit, and expiratory filter. A mass balance was calculated and each compartment was expressed as a percentage of the total. Results: Lung deposition (mean ± SD) with heated humidified gas was greater at 10 L/min than 30 L/min or 50 L/min (17.2 ± 6.8%, 5.71 ± 2.04%, and 3.46 ± 1.24%, respectively; p = 0.0001). Using unheated carrier gas, a lung dose of aerosol was similar to the active heated humidification condition at 10 L/min, but greater at 30 and 50 L/min (p = 0.011). Administered gas flow and lung deposition were negatively correlated (r = −0.880, p < 0.001). Conclusions: Both flow and active heated humidity inversely impact aerosol delivery through HFNC. Nevertheless, aerosol administration across the range of commonly used flows can provide measurable levels of lung deposition in healthy adult subjects (NCT 02519465).

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Lip Kwok, Philip Chi. "Pharmaceutical aerosol electrostatics: a field with much potential for development." Therapeutic Delivery 6, no. 2 (February 2015): 105–7. http://dx.doi.org/10.4155/tde.14.96.

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Kim, Young, Stephen H. Atwell, and Robert G. Bell. "Determination of water in pressurized pharmaceutical metered dose aerosol products." Drug Development and Industrial Pharmacy 18, no. 20 (January 1992): 2185–95. http://dx.doi.org/10.3109/03639049209038756.

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34

Gallagher, Lauren, Mary Joyce, Barry Murphy, Marc Mac Giolla Eain, and Ronan MacLoughlin. "The Impact of Head Model Choice on the In Vitro Evaluation of Aerosol Drug Delivery." Pharmaceutics 14, no. 1 (December 23, 2021): 24. http://dx.doi.org/10.3390/pharmaceutics14010024.

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There are variations in the values reported for aerosol drug delivery across in vitro experiments throughout the published literature, and often with the same devices or similar experimental setups. Factors contributing to this variability include, but are not limited to device type, equipment settings, drug type and quantification methods. This study assessed the impact of head model choice on aerosol drug delivery using six different adults and three different paediatric head models in combination with a facemask, mouthpiece, and high-flow nasal cannula. Under controlled test conditions, the quantity of drug collected varied depending on the choice of head model. Head models vary depending on a combination of structural design differences, facial features (size and structure), internal volume measurements and airway geometries and these variations result in the differences in aerosol delivery. Of the widely available head models used in this study, only three were seen to closely predict in vivo aerosol delivery performance in adults compared with published scintigraphy data. Further, this testing identified the limited utility of some head models under certain test conditions, for example, the range reported across head models was aerosol drug delivery of 2.62 ± 2.86% to 37.79 ± 1.55% when used with a facemask. For the first time, this study highlights the impact of head model choice on reported aerosol drug delivery within a laboratory setting and contributes to explaining the differences in values reported within the literature.

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35

Denyer, J., K. Nikander, and N. J. Smith. "Adaptive Aerosol Delivery (AAD®) technology." Expert Opinion on Drug Delivery 1, no. 1 (November 2004): 165–76. http://dx.doi.org/10.1517/17425247.1.1.165.

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SIDHU, B. K., C. WASHINGTON, S. S. DAVIS, and T. S. PUREWAL. "Rheology of Model Aerosol Suspensions." Journal of Pharmacy and Pharmacology 45, no. 7 (July 1993): 597–600. http://dx.doi.org/10.1111/j.2042-7158.1993.tb05659.x.

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37

Le Gall, Tony, Mathieu Berchel, Lee Davies, Angélique Mottais, Rosy Ghanem, Alain Fautrel, Deborah Gill, et al. "Aerosol-Mediated Non-Viral Lung Gene Therapy: The Potential of Aminoglycoside-Based Cationic Liposomes." Pharmaceutics 14, no. 1 (December 23, 2021): 25. http://dx.doi.org/10.3390/pharmaceutics14010025.

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Aerosol lung gene therapy using non-viral delivery systems represents a credible therapeutic strategy for chronic respiratory diseases, such as cystic fibrosis (CF). Progress in CF clinical setting using the lipidic formulation GL67A has demonstrated the relevance of such a strategy while emphasizing the need for more potent gene transfer agents. In recent years, many novel non-viral gene delivery vehicles were proposed as potential alternatives to GL67 cationic lipid. However, they were usually evaluated using procedures difficult or even impossible to implement in clinical practice. In this study, a clinically-relevant administration protocol via aerosol in murine lungs was used to conduct a comparative study with GL67A. Diverse lipidic compounds were used to prepare a series of formulations inspired by the composition of GL67A. While some of these formulations were ineffective at transfecting murine lungs, others demonstrated modest-to-very-efficient activities and a series of structure-activity relationships were unveiled. Lipidic aminoglycoside derivative-based formulations were found to be at least as efficient as GL67A following aerosol delivery of a luciferase-encoding plasmid DNA. A single aerosol treatment with one such formulation was found to mediate long-term lung transgene expression, exceeding half the animal’s lifetime. This study clearly supports the potential of aminoglycoside-based cationic lipids as potent GL67-alternative scaffolds for further enhanced aerosol non-viral lung gene therapy for diseases such as CF.

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Aramendia, Iñigo, Unai Fernandez-Gamiz, Alberto Lopez-Arraiza, Carmen Rey-Santano, Victoria Mielgo, Francisco Jose Basterretxea, Javier Sancho, and Miguel Angel Gomez-Solaetxe. "Experimental Evaluation of Perfluorocarbon Aerosol Generation with Two Novel Nebulizer Prototypes." Pharmaceutics 11, no. 1 (January 5, 2019): 19. http://dx.doi.org/10.3390/pharmaceutics11010019.

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The potential of non-invasive ventilation procedures and new minimally invasive techniques has resulted in the research of alternative approaches as the aerosolization for the treatment of respiratory distress syndrome (RDS). The aim of this work was to design two nebulizer prototypes and to evaluate them studying the particle size distribution of the inhaled droplets generated with distilled water and two perfluorocarbons (PFCs). Different experiments were performed with driving pressures of 1–3 bar for each compound. An Aerodynamic Particle Sizer was used to measure the aerodynamic diameter (Da), the mass median aerodynamic diameter (MMAD) and the geometric standard deviation (GSD). The results showed that both prototypes produced heterodisperse aerosols with Da mean values in all cases below 5 µm. The initial experiments with distilled water showed MMAD values lower than 9 µm and up to 15 µm with prototype 1 and prototype 2, respectively. Regarding the PFCs, relatively uniform MMAD values close to 12 µm were achieved. The air delivery with outer lumens of prototype 1 presented more suitable mass distribution for the generation and delivery of a uniform aerosol than the two half-circular ring geometry proposed in the prototype 2.

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Ochowiak, M., A. Kasperkowiak, M. Doligalski, T. R. Sosnowski, M. Matuszak, S. Włodarczak, M. Markowska, A. Krupińska, and K. Jabłczyńska. "The thermostated medical jet nebulizer: Aerosol characteristics." International Journal of Pharmaceutics 567 (August 2019): 118475. http://dx.doi.org/10.1016/j.ijpharm.2019.118475.

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Corcoran, TE. "Aerosol drug delivery in lung transplant recipients." Expert Opinion on Drug Delivery 6, no. 2 (February 2009): 139–48. http://dx.doi.org/10.1517/17425250802685332.

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41

Mac Giolla Eain, Marc, Ronan Cahill, Ronan MacLoughlin, and Kevin Nolan. "Aerosol release, distribution, and prevention during aerosol therapy: a simulated model for infection control." Drug Delivery 29, no. 1 (December 28, 2021): 10–17. http://dx.doi.org/10.1080/10717544.2021.2015482.

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42

Brunelli, C., T. Górecki, Y. Zhao, and P. Sandra. "Corona-Charged Aerosol Detection in Supercritical Fluid Chromatography for Pharmaceutical Analysis." Analytical Chemistry 79, no. 6 (March 2007): 2472–82. http://dx.doi.org/10.1021/ac061854q.

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Longest, P. Worth, Laleh Golshahi, and Michael Hindle. "Improving Pharmaceutical Aerosol Delivery During Noninvasive Ventilation: Effects of Streamlined Components." Annals of Biomedical Engineering 41, no. 6 (February 20, 2013): 1217–32. http://dx.doi.org/10.1007/s10439-013-0759-9.

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T. B. Martonen, I. M. Katz, C. J. M. "A Nonhuman Primate Aerosol Deposition Model for Toxicological and Pharmaceutical Studies." Inhalation Toxicology 13, no. 4 (January 2001): 307–56. http://dx.doi.org/10.1080/08958370117552.

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Martonen, T. B., I. M. Katz, and C. J. Musante. "A Nonhuman Primate Aerosol Deposition Model for Toxicological and Pharmaceutical Studies." Inhalation Toxicology 13, no. 4 (April 1, 2001): 307–56. http://dx.doi.org/10.1080/089583701750127412.

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46

Tian, Geng, Michael Hindle, Sau Lee, and P. Worth Longest. "Validating CFD Predictions of Pharmaceutical Aerosol Deposition with In Vivo Data." Pharmaceutical Research 32, no. 10 (May 6, 2015): 3170–87. http://dx.doi.org/10.1007/s11095-015-1695-1.

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47

Chang, Kyung Hwa, Sang-Hyub Moon, Sun Kook Yoo, Bong Joo Park, and Ki Chang Nam. "Aerosol Delivery of Dornase Alfa Generated by Jet and Mesh Nebulizers." Pharmaceutics 12, no. 8 (July 31, 2020): 721. http://dx.doi.org/10.3390/pharmaceutics12080721.

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Recent reports on mesh nebulizers suggest the possibility of stable nebulization of various therapeutic protein drugs. In this study, the in vitro performance and drug stability of jet and mesh nebulizers were examined for dornase alfa and compared with respect to their lung delivery efficiency in BALB/c mice. We compared four nebulizers: two jet nebulizers (PARI BOY SX with red and blue nozzles), a static mesh nebulizer (NE-U150), and a vibrating mesh nebulizer (NE-SM1). The enzymatic activity of dornase alfa was assessed using a kinetic fluorometric DNase activity assay. Both jet nebulizers had large residual volumes between 24% and 27%, while the volume of the NE-SM1 nebulizer was less than 2%. Evaluation of dornase alfa aerosols produced by the four nebulizers showed no overall loss of enzymatic activity or protein content and no increase in aggregation or degradation. The amount of dornase alfa delivered to the lungs was highest for the PARI BOY SX-red jet nebulizer. This result confirmed that aerosol droplet size is an important factor in determining the efficiency of dornase alfa delivery to the lungs. Further clinical studies and analysis are required before any conclusions can be drawn regarding the clinical safety and efficacy of these nebulizers.

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Patel, Aateka, Ewelina Hoffman, Doug Ball, Jan Klapwijk, Rory T. Steven, Alex Dexter, Josephine Bunch, et al. "Comparison of Oral, Intranasal and Aerosol Administration of Amiodarone in Rats as a Model of Pulmonary Phospholipidosis." Pharmaceutics 11, no. 7 (July 17, 2019): 345. http://dx.doi.org/10.3390/pharmaceutics11070345.

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‘Foamy’ alveolar macrophages (FAM) observed in nonclinical toxicology studies during inhaled drug development may indicate drug-induced phospholipidosis, but can also derive from adaptive non-adverse mechanisms. Orally administered amiodarone is currently used as a model of pulmonary phospholipidosis and it was hypothesized that aerosol administration would produce phospholipidosis-induced FAM that could be characterized and used in comparative inhalation toxicology. Han-Wistar rats were given amiodarone via (1) intranasal administration (6.25 mg/kg) on two days, (2) aerosol administration (3 mg/kg) on two days, (3) aerosol administration (10 mg/kg) followed by three days of 30 mg/kg or (4) oral administration (100 mg/kg) for 7 days. Alveolar macrophages in bronchoalveolar lavage were evaluated by differential cell counting and high content fluorescence imaging. Histopathology and mass-spectrometry imaging (MSI) were performed on lung slices. The higher dose aerosolised amiodarone caused transient pulmonary inflammation (p < 0.05), but only oral amiodarone resulted in FAM (p < 0.001). MSI of the lungs of orally treated rats revealed a homogenous distribution of amiodarone and a putative phospholipidosis marker, di-22:6 bis-monoacylglycerol, throughout lung tissue whereas aerosol administration resulted in localization of both compounds around the airway lumen. Thus, unlike oral administration, aerosolised amiodarone failed to produce the expected FAM responses.

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Chen, Yiting, Shilin Du, Zhirui Zhang, Wenxiu He, Enhao Lu, Rui Wang, Xianyi Sha, and Yan Ma. "Compatible Stability and Aerosol Characteristics of Atrovent® (Ipratropium Bromide) Mixed with Salbutamol Sulfate, Terbutaline Sulfate, Budesonide, and Acetylcysteine." Pharmaceutics 12, no. 8 (August 15, 2020): 776. http://dx.doi.org/10.3390/pharmaceutics12080776.

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(1) Background: It is common practice in the treatment of respiratory diseases to mix different inhalation solutions for simultaneous inhalation. At present, a small number of studies have been published that evaluate the physicochemical compatibility and aerosol characteristics of different inhalation medications. However, none of them studied Atrovent®. Our work aims to address the lack of studies on Atrovent®. (2) Methods: Portions of admixtures were withdrawn at certain time intervals after mixing and were tested by pH determination, osmolarity measurement, and high-performance liquid chromatography (HPLC) assay of each active ingredient as measures of physicochemical compatibility. The geometrical and aerosol particle size distribution, active drug delivery rate, and total active drug delivered were measured to characterize aerosol behaviors. (3) Results: During the testing time, no significant variation was found in the pH value, the osmotic pressure, or the active components of admixtures. With the increase in nebulization volume after mixing, fine particle dose (FPD) and total active drug delivered showed statistically significant improvements, while the active drug delivery rate decreased compared to the single-drug preparations. (4) Conclusions: These results endorse the physicochemical compatibility of Atrovent® over 1 h when mixed with other inhalation medications. Considering aerosol characteristics, simultaneous inhalation is more efficient.

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Pettis, Ronald J., Iris Hall, Daniel Costa, and Anthony J. Hickey. "Aerosol delivery of muramyl dipeptide to rodent lungs." AAPS PharmSci 2, no. 3 (September 2000): 53–61. http://dx.doi.org/10.1208/ps020325.

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