Emerging inhalation aerosol devices and strategies: Where are we headed?

Zhou, Qi Tony; Tang, Patricia A.; Leung, Sharon Shui Yee; Chan, John Gar Yan; Chan, Hak‐Kim

doi:10.1016/j.addr.2014.03.006

Cited by 167 publications

(133 citation statements)

References 149 publications

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“…(1) The most common application is treatment of chronic pulmonary diseases such as asthma and cystic fibrosis. (2,3) In recent years aerosol inhalation has also been considered as an alternative route of vaccine delivery.…”

Section: Introductionmentioning

confidence: 99%

Optimization and Dose Estimation of Aerosol Delivery to Non-Human Primates

MacLoughlin

AmerongenGeert

FinkJames

et al. 2016

Journal of Aerosol Medicine and Pulmonary Drug Delivery

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Background: In pre-clinical animal studies the uniformity of dosing across subjects and routes of administration is a crucial requirement. In preparation for a study in which aerosolized live-attenuated measles virus vaccine was administered to cynomolgus monkeys (Macaca fascicularis) by inhalation, we assessed the percentage of a nebulized dose inhaled under varying conditions. Methods: Drug delivery varies with breathing parameters therefore we determined macaque breathing patterns (tidal volume, breathing frequency and inspiratory to expiratory (I:E) ratio) across a range of 3.3 -6.5 kg body weight, using a pediatric pneumotachometer interfaced either with an endotracheal tube or a facemask. Subsequently, these breathing patterns were reproduced using a breathing simulator attached to a filter to collect the inhaled dose. Albuterol was nebulized using a vibrating mesh nebulizer and the percentage inhaled dose was determined by extraction of drug from the filter and subsequent quantification. Results: Tidal volumes ranged from 24 to 46 ml, breathing frequencies from 19 to 31 breaths per minute and I:E ratios from 0.7 to 1.6. A small pediatric resuscitation mask was identified as the best fitting interface between animal and pneumotachometer. The average efficiency of inhaled dose delivery was 32.1% (standard deviation 7.5, range 24-48%), with variation in tidal volumes as the most important determinant. Conclusions: Studies in non-human primates aimed at comparing aerosol delivery with other routes of administration should take both the inter-subject variation and relatively low efficiency of delivery to these low body weight mammals into account.

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Section: Introductionmentioning

confidence: 99%

Optimization and Dose Estimation of Aerosol Delivery to Non-Human Primates

MacLoughlin

AmerongenGeert

FinkJames

et al. 2016

Journal of Aerosol Medicine and Pulmonary Drug Delivery

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“…These add-on devices increase the time between device actuation and inhalation allowing patients to inhale drug over longer periods of time thereby enhancing drug delivery to the deep lungs and decreasing deposition in the oropharyngeal regions and upper airways Kunda et al, 2017). More recently, pMDIs have been designed to operate on breath-activation rather than hand-breath coordination (Newman, 2005;Zhou et al, 2014).…”

Section: Problems Associated With Different Inhaler Devicesmentioning

confidence: 99%

Challenges Associated with the Pulmonary Delivery of Therapeutic Dry Powders for Preclinical Testing

Price

Kunda

Muttil

2019

KONA

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Significant progress has been made over the last half-century in delivering therapeutics by the pulmonary route. Inhaled therapeutics are administered to humans using metered-dose inhalers, nebulizers, or dry powder inhalers, and each device requires a different formulation strategy for the therapeutic to be successfully delivered into the lung. In recent years, there has been a shift to the use of dry powder inhalers due to advantages in the consistency of the dose delivered, ease of administration, and formulation stability. Numerous preclinical studies, involving small and large animals, have evaluated dry powder drugs, vaccines, and immunotherapeutics delivered by the pulmonary route. These studies used different dry powder delivery devices including nose-only, whole-body, and intratracheal administration systems, each of which works with different aerosolization mechanisms. Unfortunately, these delivery platforms usually lead to variable powder deposition in the respiratory tract of animals. In this review, we will discuss obstacles and variables that affect successful pulmonary delivery and uniform powder deposition in the respiratory tract, such as the type of delivery device, dry powder formulation, and the animal model used. We will conclude by outlining factors that enhance the reproducible deposition of dry powders in the respiratory tract of preclinical animal models and identifying knowledge and technology gaps within the field. We will also outline the important factors necessary for successful translation of studies performed in preclinical models to humans.

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“…TwinCaps (Hovione, East Windsor, New Jersey) is a prefilled low-cost disposable that has been approved in Japan for the delivery of laninamivir and is currently undergoing phase-1 and phase-2 trials in the United States (NCT02014649). 39 The Staccato device (Alexza Pharmaceuticals, Mountain View, California) uses thermal aerosol technology that allows flow-independent aerosolization of a drug by rapidly heating the drug that coats a heating substrate. 40 The aerosol cools off and is inhaled at ambient temperature, with a peak temperature of 30 -40°C.…”

Section: Dpimentioning

confidence: 99%

Assessing New Technologies in Aerosol Medicine: Strengths and Limitations

Berlinski

2015

Respir Care

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Aerosols are the mainstay of treatment for pulmonary diseases such as asthma, cystic fibrosis, and COPD. In addition, aerosols are also being used for systemic drug delivery. Patients need devices that are safe, reliable, portable, and easy to use; have few steps in their operation; help them keep track of the remaining doses; are not expensive; and provide age-appropriate positive reinforcement and feedback. Computational fluid dynamics, human factor sciences, and quality by design are now applied to device development. Matching patient, drug, and device remains a challenge. Formulary restrictions, the current status of the industry-academia relationship, and the need to use multiple platforms hinder the process. Patients and families need to participate in the selection of a device that is appropriate for them. Practitioners need comparative data to help them choose the right device. New devices and drugs can be compared with the existing technology using in vitro and in vivo methods (lung imaging, pharmacokinetic and pharmacodynamics studies). Drug manufacturers need to be able to justify coverage of new products by third-party payers by showing a positive cost/benefit relationship. Finally, post-market surveillance is necessary for old drugs with new devices or for new drugs and devices to ensure patient safety.

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Emerging inhalation aerosol devices and strategies: Where are we headed?

Cited by 167 publications

References 149 publications

Optimization and Dose Estimation of Aerosol Delivery to Non-Human Primates

Optimization and Dose Estimation of Aerosol Delivery to Non-Human Primates

Challenges Associated with the Pulmonary Delivery of Therapeutic Dry Powders for Preclinical Testing

Assessing New Technologies in Aerosol Medicine: Strengths and Limitations

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