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home > pmps > autumn 2002 > why do dry powder inhaler developments take so long?
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Pharmaceutical Manufacturing and Packing Sourcer

Why Do Dry Powder Inhaler Developments Take So Long?

When comparing a dry powder inhaler (DPI) project to many other product developments, one is struck by the time it takes to get to market. Even when the drug formulation is well-understood, programmes regularly take in excess of eight years to reach the customer. Yet the basic design process of envisage, explore, evolve and embody is well understood and unchanged, so what is holding us up? A close inspection of past programmes shows that it is not these activities that are hindering the process - rather the repeated iterations, later in the programme, that arise from a changing specification and technical problems identified too late in the process.

The heart of the problem is that a DPI is an immensely complicated system. Even the simplest devices rely on a complex interaction of variables including patient inhalation, drug, static, humidity and material. Small variations in these variables can produce significant changes in the performance of the device. The first step to addressing this is to have a clear view of what the team is trying to achieve.


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By Charles Tavner, Leader of Cambridge Consultants' (CCL) Drug Delivery Device Group

Charles Tavner is leader of Cambridge Consultants' (CCL) drug delivery device group. The group carries out contract design and development work for clients developing inhalation, injection and infusion devices.

Charles has been at CCL for 9 years and has a Master's Degree in Engineering from Cambridge University, UK.

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Charles Tavner
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4th Annual Patient Recruitment and Retention in Clinical Trials

13-15 October 2008, Amsterdam

Patient recruitment is now consuming thirty percent of clinical trial time - more time than any other clinical trial activity - and almost half of all trial delays result from patient recruitment problems. As the recruiting culture becomes more sophisticated and the forces affecting patient enrollment grow more numerous and complex, pharmaceutical companies are striving to discover new strategies to facilitate enrollment in clinical trials. With increasing industry pressure to develop, test and market greater numbers of new drugs faster, pharmaceutical companies need to perform clinical trials as quickly as possible. Inefficient patient recruitment processes is a formidable barrier to pharmaceutical companies' success in launching new products. Improving the patient recruitment process is imperative to avoid wasted investments and eliminate costly delays in bringing new drugs to market -- today and even more so in the not-so-distant future. Improved patient recruitment presents one of the largest opportunities for pharmaceutical companies to eliminate delays in clinical trials, thereby making it possible to reduce time to market.  With patent time limits and large overheads meaning that any delays in the development timeline can be disastrous, a good understanding of how to successfully recruit patients for trials is vital for any company looking to succeed.
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