Factors to consider when selecting a nebulizer for a new inhaled drug product development program

Abstract

Introduction: Nebulizers are a common device choice for use when developing a new drug product, but the range of nebulizer devices available can make it difficult to select the right device. Increasingly, companies are only able to promote a drug with the device that was used during the development program; therefore, choosing the best device at an early stage is important in order to achieve commercial success. Selecting a device that is inappropriate for the intended drug can result in poor drug delivery from the nebulizer to the patient, which would have obvious implications for the development program. As device performance varies, it is important to ensure that the most appropriate device is chosen for the intended drug to ensure optimal drug delivery to the patient population.

Areas covered: In this review, the types of nebulizer devices available are highlighted, and the factors that should be taken into consideration when selecting the most appropriate device for a new drug are discussed. The review is broadly divided into drug, device, patient and trial characteristics.

Expert opinion: Efficient nebulizer devices that combine electronic monitoring capabilities as a form of telehealth are likely to provide superior drug delivery to patients and accurate clinical trial data. Their use in adaptive clinical trials may help to vastly reduce the time and costs associated with achieving drug approval.

Keywords:

• adherence
• clinical trials
• drug formulations
• electronic monitors
• nebulizer
• therapeutic window

Acknowledgments

The authors acknowledge R Giles for drafting assistance and S Kuperman for editorial assistance (PS5 Consultants Ltd, Portsmouth, Hampshire, UK).

Declaration of interest

M Elphick and D von Hollen are employees of Respironics, Inc., a Philips Healthcare Company, Murrysville, PA, USA. RHM Hatley, JN Pritchard and LEA Hardaker are employees of Respironics Respiratory Drug Delivery (UK) Ltd, a business of Philips Electronics UK Limited, Chichester, West Sussex, UK. K Nikander is the owner of InDevCo AB, Nyköping, Sweden.

Notes

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