Segment Market Manager Pharma

What are excipients

Anything other than the active ingredient, that is part of the drug formulation is called excipient. It’s also called as inactive ingredient. As much as 90% of a drug could be excipients. Pharmaceutical excipients refer to non-active substances that are added to a drug formulation for various purposes. These substances can alter drug absorption, pharmacokinetics, and drug stability, and can help address the challenges associated with manufacturing the active ingredient. In addition, excipients are used to enhance the taste and appearance of the drug and to extend its shelf life.

Functionalities of excipients

Excipients play one or multiple roles in a drug formulation. There are numerous types of excipients used in formulation. The below table captures the different types of excipients used in drug formulation. While the below table is not exhaustive, it should cover most excipient functionalities.

Selecting the appropriate excipients

In each category of excipients formulators may have more than choice for excipient, but several factors determine the appropriate excipient for the formulation. Achieving the required pharmacokinetic profile is the primary goal that will drive the selection of excipients. On top of that, factors such as cost, manufacturing efficiencies, availability, stability, and intellectual property will drive the selection of an appropriate excipient. Also, things like whether the drug is for pediatric population or geriatric population will impact the excipient selection.

Need for innovation in excipients

Formulating a drug has many complex challenges including bioavailability and stability. As much as 90% of a drug could be excipients.  Excipients play a vital role in addressing the complex challenges. Yet, formulators have limited set of excipient choices. While the number of new molecular entities increase, challenges formulate them also will increase. Addressing such challenges will require new set of excipient tools. Historically excipient has not been a focus area for innovation and that needs to change to bring the new cures and therapies to advance health.

About the author:

Rajendran (Raj) Arunagiri has been in the pharma industry for a decade and has successfully developed and launched a new excipient. He is a co-author of technical articles and is an invited speaker at conferences focused on excipients and drug delivery. Raj is a guest columnist for Pharmatechoutlook.com and he welcomes you to reach out to him for questions, comments, and collaboration ideas at rajendranarunagiri@eastman.com