Preclinical Development
Getting a molecule to IND enabling studies and first-in-human testing represents a major milestone for most companies. And for VC backed companies, it can represent a major financial milestone - enabling future development activities. AustinPx understands the importance of the preclinical development phase, and provides key services to support the transition from discovery to clinical development, including:
- Molecule Characterization
- Preformulation Testing
- Formulations for Toxicology Studies
- Formulation Technology Screening
Molecule Characterization and Preformulating Testing
Understanding the physiochemical characteristics and the behavior of a new molecule under various stress conditions is critical to developing a suitable formulation and robust dosage form that can survive processing and allow for a prolonged shelf life. A poor or limited preformulation study, could lead to increased time and cost, an unstable product, or worse the abandonment of the program. AustinPx’s preformulation capabilities include:
- Physiochemical Characteristics
- Solubility & Stability
- Thermal Properties
- Permeability
- Particle-State Characterization
- Photo/Heat Stability
- Powder Properties
- Quantitative XRD
- Lot to Lot Comparison
- Excipient Screening & Compatibility
Formulations for Toxicology Studies
Formulation development plays an important role in the success of preclinical phase of development. Overcoming solubility issues and maximizing exposure can be a key aspect of GLP toxicology study. Investment in formulation upfront can help avoid costly delays and poor outcomes. AustinPx supports development of preclinical formulations for oral delivery. Our goal is to develop a formulation for toxicology studies that can help optimize exposure, while:
- Conserving limited API
- Ensuring quick turnaround to meet aggressive timelines
- Developing a formulation that is transferable and easy for the animal site to replicate and administer
- Building upon the development of a human formulation
Formulation Technology Screening
Formulation Technology Screening
As the number of bioavailability enhancement technologies available increase, how do you know which technology is best for your molecule? At AustinPx, we take a logical, nonbiased, data-driven approach to formulation development.
We then utilize a rapid and cost-effective screening of the feasibility of multiple formulation technologies, such as:
- Dry & Wet Granulations
- Amorphous Dispersions
- Cyclodextrin Complexations
- Particle Size Reduction
- Lipid Based Formulations
Chosen strategies are based on a combination and consideration of:
- A thorough understanding of the characteristics of the drug substance, including the Developability Classification System
- The preformulation solubility and stability evaluation
- The patient compliance needs
- The strategic goals of the company
Formulations are prepared, prototypes assessed, placed on short-term stability, and tested in appropriate PK models. We then review the PK data and recommend the best formulation strategy to move forward for clinical development.
Contact Us
Getting a molecule to IND enabling studies and first-in-human testing represents a major milestone for most companies. Contact AustinPx to see how we can help.