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Discovery & Development Formulation

Complexity and Collaboration

Today’s patients and payers are demanding – they want the most effective medicines, in a convenient format, at a cost effective price, and there is huge pressure on pharma companies and formulators to get it right. On one hand, there is much criticism of the drug industry, but on the other there is also much confidence that the industry and its scientists have the ability to deliver. And why shouldn’t they? There are more drug development technologies than ever before to help with the task, including sophisticated modelling techniques to help with the selection process, and an ever-expanding number of contract development and manufacturing organizations (CDMOs) and other experts dedicated to formulation and drug delivery.

Solubility, bioavailability and permeability, however, continue to pose significant obstacles in development. Many formulators reading this will no doubt have come across a molecule at some point in their career that was impossible to get absorbed into the human body in the right amounts. The simple truth is that development is difficult – every molecule is unique and there is no one-size-fits-all formulation panacea that will produce an optimal drug every time.

Ironically, formulators are victims of their own achievements – with more approaches to tackle previously unviable drugs, and many success stories, companies are more confident that solubility and other issues can be overcome with clever thinking, meaning that more and more challenging molecules are filling development pipelines. Formulation is also challenging from a time and cost perspective. In all sectors of the industry, people are being asked to do more with less, and the temptation for a scientist to quickly look to a previously successful formulation technology he or she has used in the past, rather than evaluating all available options in the toolbox, is high. One approach that can be overlooked are lipid-based drug delivery systems (LBDDS), which can be tricky to get right but are highly effective at solubilizing hydrophobic compounds. LBDDS are already influencing commercial success stories and are expected to be a prominent tool in the future, particularly given their potential to assist with the oral delivery of biopharmaceuticals.

The complex task of formulation does not need to be tackled by just one person or one team; collaborating with research organizations, other companies, CDMOs and suppliers makes sense. This supplement embodies the spirit of collaboration – jointly sponsored by BASF and Catalent, who collaborate to develop high-quality formulation options. In the following pages, experts discuss the challenges facing formulators today, the importance of excipients, and best practice tips for formulation with LBDDS.

Stephanie Sutton

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