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Pharmaceutical Manufacturing and Packing Sourcer

The Dry Deal

It is clear that the respiratory route is highly effective for the delivery of an increasingly wide variety of therapeutic drugs, both locally acting and systemic. A number of different delivery platforms exist, and one currently receiving much attention is the dry powder inhaler (DPI). Requiring no propellant, these devices are simple to use, have a wide dose range and offer advantages over other systems when delivering a range of molecules, small or large.

Successful drug delivery with DPIs relies on closely matching the formulation and delivery device, and optimising the two in tandem. The efficacy of delivery will be affected by the particle size and velocity of the inhaled aerosol cloud which determine, for example, whether the drug is deposited into the lungs or in the throat. Consequently, a large part of the design process involves detailed analysis of the inhaled cloud, including measuring the size of the constituent particles. Laser diffraction-based particle size analysis is used extensively in this work, providing insight that promotes a ‘quality by design’ (QbD) approach and more efficient product development.

This article will examine how the technique improves understanding of both formulation and device behaviour. It is also relevant to include some discussion of the factors affecting powder dispersion, as well as present experimental work that illustrates how different excipients can enhance the performance of a formulation.

ADVANTAGES OF DPIS

DPIs offer a number of advantages over other inhalation devices. For example, since the delivery process is actuated by inspiration, the user is not required to coordinate different actions. DPIs do not suffer from the...

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Dr David Morton gained a PhD from Bristol University in the UK in Structural Chemistry. He then spent 8 years in the UK nuclear industry with AEA Technology, developing expertise in the generation and transport of aerosols. In 1997, he joined the Centre for Drug Formulation Studies, University of Bath, managing their dry powder inhaler product development programmes. In 1999, this group spun out into the drug delivery company Vectura, where David was Head of Pulmonary Research, and latterly Head of Intellectual Property and Technology. He is currently Senior Lecturer in Formulation Science at the Victorian College of Pharmacy, Monash University, Australia. David has had a major role in developing the annual ‘Drug Delivery to the Lung’ international series of conferences on behalf of the Aerosol Society since 1997.

Dr Paul Kippax has a degree in Chemistry and a PhD in Colloid and Interface Science, both obtained at the University of Nottingham, UK. He joined Malvern Instruments in 1997 as an applications scientist and in 2002 became product manager for the company’s laser diffraction particle size analysis systems. He has worked closely with the pharmaceutical industry in understanding how laser diffraction techniques can be best applied to characterising the performance of medical devices. This has included the publication of several joint research articles relating to the optimisation of drug delivery from dry powder inhalers and nasal sprays.

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Dr David Morton
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Dr Paul Kippax
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