Excipients are not inactive: innovation in the ingredients around the drug
New excipients can enable abuse-deterrent and better-absorbed medicines. Why regulators created a special review route, and what it means for formulators.
In this article
In a typical tablet, the active ingredient is only part of the weight. The rest — binders, fillers, disintegrants, coatings, capsule shells — are excipients. They decide how a medicine is made, how stable it is and how it releases its drug.
Why new excipients are hard
Formulators usually stick to excipients already used in approved medicines, because a new one brings extra safety and quality questions. That caution can hold back better medicines.
A regulatory route for innovation
The US FDA’s Center for Drug Evaluation and Research created a voluntary Novel Excipient Review Pilot Program, which lets excipient makers obtain FDA review of certain new excipients before they are used in a drug formulation. It covers excipients not previously used in FDA-approved drugs and without established use in food. CDER planned to accept four initial proposals over two years.
FDA said priority would go to excipients with public health benefits, such as enabling abuse-deterrent opioid formulations, supporting new therapies for serious diseases, or meaningfully improving how a drug is absorbed.
What excipients do
| Function | Examples of what matters |
|---|---|
| Manufacturability | Flow and compression on high-speed presses |
| Release | Coatings and polymers for delayed or extended release |
| Stability | Protection from moisture and light |
| Patient experience | Taste masking, capsule choice |
Why it matters for Pakistan
As exporters move from simple generics towards complex generics and specialised dosage forms, excipient choice becomes a competitive skill. Pharma Asia’s exhibitor profile covers pharmaceutical raw materials, enzymes and biochemicals, and coating materials, and the 2026 list includes excipient and capsule suppliers such as Livewell Capsules and Multicaps.
See also 3D-printed medicines, another route to new release profiles, and meet suppliers at Pharma Asia 2026.
