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Challenges in inhaled product development and opportunities for open innovation.

Forbes, Ben and Asgharian, Bahman and Dailey, Lea Ann and Ferguson, Douglas and Gerde, Per and Gumbleton, Mark and Gustavsson, Lena and Hardy, Colin and Hassall, David and Jones, Rhys and Lock, Ruth and Maas, Janet and McGovern, Tim and Pitcairn, Gary R and Somers, Graham and Wolff, Ron K (2011) Challenges in inhaled product development and opportunities for open innovation. Advanced drug delivery reviews, 63 (1-2). pp. 69-87. ISSN 1872-8294

Abstract

Dosimetry, safety and the efficacy of drugs in the lungs are critical factors in the development of inhaled medicines. This article considers the challenges in each of these areas with reference to current industry practices for developing inhaled products, and suggests collaborative scientific approaches to address these challenges. The portfolio of molecules requiring delivery by inhalation has expanded rapidly to include novel drugs for lung disease, combination therapies, biopharmaceuticals and candidates for systemic delivery via the lung. For these drugs to be developed as inhaled medicines, a better understanding of their fate in the lungs and how this might be modified is required. Harmonised approaches based on 'best practice' are advocated for dosimetry and safety studies; this would provide coherent data to help product developers and regulatory agencies differentiate new inhaled drug products. To date, there are limited reports describing full temporal relationships between pharmacokinetic (PK) and pharmacodynamic (PD) measurements. A better understanding of pulmonary PK and PK/PD relationships would help mitigate the risk of not engaging successfully or persistently with the drug target as well as identifying the potential for drug accumulation in the lung or excessive systemic exposure. Recommendations are made for (i) better industry-academia-regulatory co-operation, (ii) sharing of pre-competitive data, and (iii) open innovation through collaborative research in key topics such as lung deposition, drug solubility and dissolution in lung fluid, adaptive responses in safety studies, biomarker development and validation, the role of transporters in pulmonary drug disposition, target localisation within the lung and the determinants of local efficacy following inhaled drug administration.

Item Type: Article
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Additional Information: author can archive post-print (ie final draft post-refereeing); Publisher's version/PDF cannot be used
Keywords: aerosol dosimetry deposition inhalation toxicology ADME Isolated perfused lung Transporter Pharmacokinetics Pharmacodynamics
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Date Deposited: 13 Oct 2015 13:15
Last Modified: 13 Oct 2015 13:15
URI: https://oak.novartis.com/id/eprint/4847

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