Feasibility Study
Feasibility Study: The First Step
Oakwood Labs prides itself on its ability to create sustained release formulations that work. Feasibility studies provide the first important step. We offer proof-of-concept studies designed specifically to achieve your product requirements.
The purpose of the feasibility study is to conceptualize, design, and develop sustained release prototype formulations using our CRONIJECT™ technology. The work determines the initial compatibility of your API with various polymer matrix materials, excipients, and our patented process at small laboratory scale.
What is involved?
Oakwood uses a comprehensive approach to design and execute our feasibility studies. We sign a Confidentiality Agreement, discuss details, deliverables and strategize “best approach” scenarios to produce results quickly.
Typical activities performed in a CHRONIJECT™ feasibility study include work to:
- Identify API compatible polymers, excipients, materials, components, and equipment
- Identify initial product container/closure package (vial, stopper, seal)
- Develop analytical tests for raw materials and prototype formulations
- Develop formulation process parameters at lab scale
- Identify initial lyophilization parameters
- Manufacture prototype microsphere formulations at selected scale
- Perform analytical tests for prototype formulations
- Perform prototype stability as required
- Perform in-vivo animal studies as required (R&D low bioburden material)
Each study is tailored to meet our partner’s requirements. We work with you to ensure rapid progress and to achieve our goal of drug delivery excellence.
