Initiating first in man clinical studies quickly is often critical, especially for companies with limited budgets or investor milestones tied to this step. Of equal importance is the creation of a dosage form that will give the candidate a best chance at success. A poorly formulated drug product can lead to poor clinical data, which may result in termination of the project or extended timelines and costs for reformulation.
Pharmatek’s phase-appropriate approach to development is designed to get you from the bench to the clinic quickly – with the least complex, yet most effective formulation and manufacturing process, while never skimping on quality. From API-in-a-capsule to bioavailability enhancement technologies for insoluble compounds, we match the best solution with the physiochemical characteristics of the compound and your corporate goals, clinical timelines and development budget. We offer several strategies to expedite product development for first in man clinical testing, including:
- API in a Capsule / Bottle
- Reconstitutable Powders in a Bottle
- Oral Liquids
- Liquid-filled Capsules
- Injectable (Liquid and Lyophilized) Product Formulations
When conventional formulation technologies are not enough to achieve targeted in-vivo performance, Pharmatek offers several solutions to meet the needs of challenging compounds. Click here to learn more about Pharmatek’s formulation development capabilities.