Overcoming Complexity

There are two key drug development trends that are reshaping the industry’s approach to formulation, leading to a rise in non-traditional dosage forms, such as nasal sprays, drug-eluting implants and more complex products. Firstly, there is the issue of poor solubility, which often forces companies to use a more complicated formulation strategy. Molecular targets can be quite hydrophobic and the therapeutic molecules intended to interact with these targets are increasingly insoluble. Around 40 percent of marketed drugs, and as many as 90 percent of drugs in the development pipeline, contain poorly water-soluble APIs that will not be effective if formulated as a standard solid oral dose. For many developers, this may be viewed as a concern or a road block; however, it is also an opportunity. There are multiple techniques available to increase the solubility or dissolution rate of drugs and improve their delivery, such as amorphous solid dispersions, lipidic-based systems, and nanoparticle suspension formulations. And there are also new benefits in terms of protecting intellectual property as a complex product often offers numerous opportunities in this area.