The rise of independent excipients

The pressure to innovate faster than their competitors has drug formulators exploring new ways to optimise manufacturing processes

Article in manufacturingchemist.com

Continuous manufacturing, for example, has evolved at a relatively fast pace, leaving drug manufacturers feeling equally challenged and encouraged to evaluate their current production methods and adopt new technologies. The end result will be the creation of better drugs, increased speed to market and more accessible healthcare worldwide.

For many, the gateway to realising these advancements has been excipients. Time and costs during the production stage of drugs are of constant concern to manufacturers and drug costs remain a top priority for insurers and governmental agencies. The efficiency made possible by novel excipients makes them ideal to facilitate continuous manufacturing.

Designed for purpose

The potential of continuous manufacturing is somewhat predicated on the industry’s ability to create and approve new excipients, which is a vital component of supporting continuous manufacturing’s ever-advancing landscape. Existing excipients may not be able to address all the needs of the continuous process and there is a clear need for excipients that are designed for the purpose of the continuous process. For this reason, as formulations become more complex, drug formulators will no longer be able to depend on current solutions and must explore unique, adjacent pathways to optimise solutions to their furthest extent.

To better meet the demands of each individual drug formulation, the term “Designed for Purpose” has gained major traction to represent the need to create independent excipients that fit specific formulation needs and challenges. Individualised solutions will enable drug formulators to handpick excipients to ensure that they are fit for a given formulation, all while optimising end-use performance. These excipients enable robust formulations that can accommodate production variability without impacting the performance, stability or quality of the drug.

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