Chemicals & raw materials
Innovative excipient technologies optimise drug performance and shelf life, ensuring precise API delivery and meeting stringent regulatory standards.
efficient manufacturing processes, optimised supply chain logistics, and reduced waste in formulation development,” Barlas remarks.
Unprecedented complexity
As one of the leading global suppliers of polyethylene glycol (PEG)-based excipients, Clariant has seen countless cases where excipient selection directly impacted therapeutic outcomes. Arguably, that’s more likely now than at any time in the past. While today’s new drug candidates often show great promise, they are becoming increasingly challenging from a formulation point of view. Take water solubility. It’s estimated that around 40% of existing drugs are poorly water soluble, rising to around 90% of newly discovered therapeutic compounds. That means the drug can’t easily dissolve in the body and may not achieve an appropriate concentration in the blood.
Manufacturers have two choices – either increase the suggested dosage (a solution that brings challenges of its own) or apply clever formulation solutions to improve the solubility. That may, in turn, mean using the right excipients. Then there’s the rise of mRNA vaccines and biologics. More complex and less stable than small- molecule drugs, these products are particularly prone to degradation. For instance, they are typically very temperature-sensitive and require cold chain solutions when in transit. The appropriate choice of excipient might provide some stability against cold and heat, as well as other environmental factors such as moisture. “Modern drug development faces unprecedented complexity, particularly with biologics and poorly soluble compounds,” agrees Barlas. “This evolution creates several key challenges. Higher purity excipients are required to ensure stability of sensitive molecules. There is an increased demand for specialised excipient grades. Manufacturers must
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also navigate complex regulatory requirements across different markets while carefully considering compatibility with APIs.”
The regulatory requirements can be something of a sticking point. The FDA, for instance, only approves excipients in the context of a drug product – a novel excipient would receive no standalone approval or licensing. That means it needs to be incorporated into a drug product before it can be recognised. However, drugs containing novel excipients often take longer to receive approval, which may discourage drugmakers from using them.
The need for novel excipients Despite these challenges, excipient innovation has been continuing apace. In 2020, USP surveyed 264 professionals involved in drug formulation. The bulk of respondents (96%) said excipients are very important in advancing a product through drug development. Most respondents (84%) said that existing excipients have imposed limitations on the drug development process. For instance, they might struggle to overcome bioavailability issues or maintain the stability of the final product. As a result, 55% said they expected to use novel excipients within the next five years despite the regulatory issues they might encounter. Formulators, then, have been taking pains to develop ingredients that fit today’s fast-evolving market needs. Barlas says that Clariant employs several strategies to enhance drug performance. “We develop ultra-pure excipients that minimise unwanted interactions with the API and other formulation ingredients and ensure optimal drug efficacy,” he says. “We also develop advanced polymers aimed at improving rheological properties, bioavailability, and solubility, driving enhanced drug delivery and performance.”
In late 2023, the company announced it had expanded its range of functional excipients to solve
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