Solutions for Poorly Soluble Molecules
Problematic Drug Compounds
Approximately 70% of drugs in the development pipeline are considered to have either poor bioavailability, nonlinear pharmacokinetics, or a significant food effect on drug bioavailability due to poor solubility. Conventional formulation strategies may no longer provide acceptable in-vivo performance. The need to utilize advanced formulation technologies to overcome these issues is important.
AustinPx, Pharmaceutics and Manufacturing, offers several technologies to improve the bioavailability of molecules:
- Amorphous Dispersions, including KinetiSol® Technology
- Particle Size Reduction
- Lipid Delivery
- Fluid-bed Processing
- Hot-melt Granulations
- Micro-Precipitated Amorphous Powder (MAP)
AustinPx's team of scientists are expertly trained in applying bioavailability enhancement technologies to a range of molecules.
What Technology is Right for your Molecule?
As the number of bioavailability enhancement technologies available increase, how do you know which technology is best for your molecule? And when you're limited on available API, time or budget, how do you know where to concentrate development efforts? At AustinPx, we take a logical, nonbiased, and data-driven approach to formulation development. The formulation strategy is a combination and consideration of:
- The molecule's Developability Classification System (DCS)
- A thorough understanding of the characteristics of the drug substance
- The preformulation solubility and stability evaluation
- The patient compliance needs
- The strategic goals of the company
Rapid Screening Program
We also offer rapid screening programs to quickly evaluate the feasibility of multiple technologies. In as little as 6 weeks, we can screen your drug candidate and provide prototypes for animal PK testing. We then work with you to determine the best path forward for development toward a toxicology and human formulations. For those looking for additional support, we can manage the PK study, including providing input into the animal model.
Each drug candidate is unique, as is each Company. Our goal is to match the best enabling technology for clinical success with our your Company's corporate goals, timelines and budget. We work closely with you to develop a custom project plan tailored to their specific needs. This is combined with our client-centric service, collaborative communication, project management and scientific insights.
With a range of bioavailability enhancement technologies and GMP manufacturing capabilities to produce oral drug products, AustinPx can take you from clinical candidate to clinical trial material no matter what your solubility challenges may be.
Contact us today to learn how AustinPx can improve the solubility of your poorly soluble molecule.