Radioaerosol assessment of mucociliary clearance: towards definition of a normal range

Agnew, J. E.; Sutton, Philip P.; Pavia, D; Clarke, S W

doi:10.1259/0007-1285-59-698-147

Cited by 21 publications

(9 citation statements)

References 6 publications

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“…The pulmonary barrier is also comprised of important extracellular elements. Any particulate matter deposited in the conducting airways will be removed relatively quickly with a half-life of approximately 1 to 1.5 h by the "mucocillary escalator" (Agnew et al 1986). Mucus is a natural glycoprotein-hydrogel and has some unique structural and rheological features that enable it to trap particles while also acting as a diffusional barrier for dissolved solutes.…”

Section: Mucus and Surfactant As A Non-cellular Barriermentioning

confidence: 99%

Scope and relevance of a pulmonary biopharmaceutical classification system AAPS/FDA/USP Workshop March 16-17th, 2015 in Baltimore, MD

Hastedt

Bäckman

Clark³

et al. 2016

AAPS Open

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The Biopharmaceutics Classification System (BCS), developed in the 1990s for oral immediate release drugs, is utilized by R&D scientists and regulators to streamline product development and regulatory approval timelines. This elegant, science-based approach is based on three in vitro parameters representing a combination of drug substance physicochemical and physiological properties with respect to oral administration; specifically a dose number, dissolution number, and absorption number. Interest in applying similar principles to pulmonary drug products is increasing. To date the focus has been on dissolution of drugs in the lung. A workshop co-sponsored by the AAPS, FDA, and USP was held in March 2015 in Baltimore to evaluate if a systematic framework to classify pulmonary drugs could be established, and the scope and relevance of such a classification scheme. The focus of the workshop was to address factors influencing drug delivery and action in the lungs rather than the development of a specific model or system. Presentations included: the history and evolution of the oral BCS (described as the "giBCS" by Gordon Amidon), lung physiology and the fate of inhaled drugs, regional aerosol deposition and dose, macroscopic clearance mechanisms, particle dissolution, drug permeability, absorption and their interplay with pharmacokinetics and pharmacodynamics. Background discussions were followed by three separate breakout sessions each focused on the BCS concepts of dose, dissolution, and absorption numbers as they would apply to pulmonary drug delivery. The workshop concluded that a classification system, if fully developed, would be a useful tool for formulators and discovery chemists. The scope of such a system, at this point in time, would not include aspects relevant to regulatory relief. The goals of the workshop were met by identifying an opportunity to develop a model to classify pulmonary drugs based on physicochemical attributes specific to lung physiology and drug delivery.

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Section: Mucus and Surfactant As A Non-cellular Barriermentioning

confidence: 99%

Scope and relevance of a pulmonary biopharmaceutical classification system AAPS/FDA/USP Workshop March 16-17th, 2015 in Baltimore, MD

Hastedt

Bäckman

Clark³

et al. 2016

AAPS Open

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“…The measurements of clearance may be improved by "normalising" data using a penetration index derived from a S lmKr ventilation scan (Agnew et al 1986). Monodisperse, non-hydroscopic aerosols of MMAD> 5 gm are used.…”

Section: Mucociliary Clearancementioning

confidence: 99%

Pulmonary nuclear medicine

Miller

O’Doherty

1992

Eur J Nucl Med

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“…In the conducting airways, deposited particles are removed relatively quickly by MCC, the primary mode of defence of the respiratory system, with a half-life of approximately 1.5 h 14 . The conducting airways are lined by epithelium consisting primarily of two types of cells e i.e.…”

Section: Physiological Barriers and Clearance Mechanismsmentioning

confidence: 99%

Contemporary Formulation Development for Inhaled Pharmaceuticals

Sou

Bergström

2021

Journal of Pharmaceutical Sciences

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Pulmonary delivery has gained increased interests over the past few decades. For respiratory conditions, targeted drug delivery directly to the site of action can achieve a high local concentration for efficacy with reduced systemic exposure and adverse effects. For systemic conditions, the unique physiology of the lung evolutionarily designed for rapid gaseous exchange presents an entry route for systemic drug delivery. Although the development of inhaled formulations has come a long way over the last few decades, many aspects of it remain to be elucidated. In particular, a reliable and well-understood method for in vitro-in vivo correlations remains to be established. With the rapid and ongoing advancement of technology, there is much potential to better utilise computational methods including different types of modelling and simulation approaches to support inhaled formulation development. This review intends to provide an introduction on some fundamental concepts in pulmonary drug delivery and inhaled formulation development followed by discussions on some challenges and opportunities in the translation of inhaled pharmaceuticals from preclinical studies to clinical development. The review concludes with some recent advancements in modelling and simulation approaches that could play an increasingly important role in modern formulation development of inhaled pharmaceuticals.

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Radioaerosol assessment of mucociliary clearance: towards definition of a normal range

Cited by 21 publications

References 6 publications

Scope and relevance of a pulmonary biopharmaceutical classification system AAPS/FDA/USP Workshop March 16-17th, 2015 in Baltimore, MD

Scope and relevance of a pulmonary biopharmaceutical classification system AAPS/FDA/USP Workshop March 16-17th, 2015 in Baltimore, MD

Pulmonary nuclear medicine

Contemporary Formulation Development for Inhaled Pharmaceuticals

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