Excipients services are professional solutions that help pharmaceutical, nutraceutical, and sometimes cosmetic manufacturers work with the inactive ingredients in their products.
Although excipients don’t provide therapeutic effects, they’re crucial for the safety, stability, and performance of a medicine or supplement.
Specialist providers offer a range of services to ensure the right excipients are chosen, tested, and used correctly.
| Service Area | Typical Activities | Why It Matters |
|---|---|---|
| Sourcing & Supplier Qualification | Identify reliable excipient manufacturers, audit their facilities, confirm GMP compliance. | Prevents contamination, ensures consistent quality. |
| Characterization & Testing | Analyze purity, particle size, moisture, functionality-related characteristics (FRCs), compatibility with active ingredients. | Guarantees that excipients perform as intended and remain stable. |
| Formulation Development | Select and optimize excipient blends for tablets, capsules, injectables, or liquid dosage forms. | Improves drug release profile, taste, shelf life, and manufacturability. |
| Troubleshooting & Deformulation | Investigate stability problems, batch variability, or performance issues; reverse-engineer competitor products if needed. | Saves time and money by quickly identifying root causes of failures. |
| Regulatory & Documentation Support | Prepare Certificates of Analysis, pharmacopeial compliance reports, safety/toxicity data, DMFs (Drug Master Files). | Essential for global market approvals (FDA, EMA, WHO, etc.). |
| Quality Control & Ongoing Monitoring | Inspect each lot, monitor batch-to-batch consistency, manage change control. | Protects product integrity and patient safety. |