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European Pharmaceutical Contractor

Plotting the Route

Progressing a drug to first-in-human (FIH) studies is a complex process. Formulation development is an important and often overlooked step that has to be integrated with active pharmaceutical ingredient (API) manufacture, Good Manufacturing Practice manufacture, small-scale manufacture and Phase 1 trial management. Managing the different aspects of a Phase 1 programme while also reducing risk, time and cost, requires a clear roadmap.

Early Phase Formulation

Simplicity Will Succeed

While in late phase development, a formulation should be as close as possible to the intended marketable product. The main focus in early phase development is ensuring the drug is able to achieve results during preclinical and FIH studies. The rate of attrition is high during clinical trials, with just 10% of new drug candidates making it to market. As a result, early phase development focuses on simple formulations where possible, with the aim to reduce both time and cost. For example, an oral suspension may not be suitable for commercial sale, but, at the same time, be satisfactory for a Phase 1 study. An important advantage is that relatively little development time is needed and it is easy to vary the dose.

If a formulation is successful in the early phase, it will soon need a new formulation that is suitable for large clinical studies, large-scale manufacture and commercial marketing in terms of shelf life, economy and maximum therapeutic benefit. Smaller companies often plan to sell the project at an early stage, but this is still relevant, as a more complicated path to market will affect the price negatively. For this reason, it is advantageous if the development of the early phase product is planned in such a way that it provides a basis for later stages. This must, of course, be balanced against the need for speed, cost-effectiveness and simplicity, as stated above. However, the use of formulation principles and excipients that are suitable for a commercial product should be considered whenever possible. The trend towards specialisation in pharmaceutical development is making this more difficult since those active in early development often have limited experience of development in later stages.

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Dr Torkel Gren is General Manager at Recipharm Pharmaceutical Development. He holds degrees in pharmacy and business administration, as well a PhD in pharmaceutics from Uppsala University, Sweden. He has worked in the pharma industry since 1988 and has held a number of scientist and manager positions in Europe and the US. He was lead formulator and co-inventor of Detrol OD/Detrusitol SR. Torkel is a member of the board of the Swedish Pharmaceutical Society.

Anders Millerhovf is Chief Executive Officer at CTC Clinical Trial Consultants. He holds a degree in medical biology from Linköping University, Sweden. He has worked in the life sciences industry since 2002 and has been focused on Phase 0-2a projects in various project management and director positions. Anders has been a partner at CTC since 2012.
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Dr Torkel Gren
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Anders Millerhovf
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