For the last 20 years Encap has been involved in the development of First-in-Man and early clinical formulations for our clients. We can provide clinical supplies in the most appropriate formulation to achieve your goals in these crucial first clinical evaluations. Whether a simple powder in capsule or powder in a bottle for reconstitution prior to dosing is required, Encap will provide the analytical, pre-formulation and formulation data necessary for your clinical trial application.

Our aim is to rapidly and cost effectively produce a product that can be used for early clinical evaluation and to provide you with all the information required for your IMPD submission.

Formulations covered:

• API / Blend in Bottle
• API / Blend in Capsule
• Liquid Filled Hard Capsule

Suitable for cytotoxic and non-cytotoxic APIs

To find out more about our Fast Track Into Man programmes and how we can take your API to the clinic in as little as 16 weeks please contact us.

Why consider a liquid fill formulation for a First in Man Study?

For the oral dosing route of administration, there are several dosage form options generally used for first-in-human studies: API in bottle, powder in bottle, API into capsule, and traditional formulation for tablets/capsules. Each approach has associated advantages and disadvantages.  At Encap, we believe that in many instances a liquid filled hard capsule may be a more appropriate formulation.

• Best chance bioavailability for API
• Protects hygroscopic and oxidation sensitive compounds including proteins and peptides
• Ideal for cytotoxic APIs
• Removes issues caused by API variability (particle size, shape, crystal habit, density, polymorphic form or moisture)
• Eliminates compatability issues between shell and API
• Provides a scalable formulation that may be suitable up to Proof of Concept and beyond