Our science-led approach to improving bioavailability in formulation saves you time, money and clinical drug substance and materials.
We help solve solubility challenges that impact your drug candidate’s reproducible absorption in the gastrointestinal tract. Where poor drug substance solubility limits oral bioavailability, we have dedicated technologies and expertise to apply formulation techniques that increase dissolution rate and/or apparent solubility at the absorption site.
We use screening to identify the most effective formulation technology for your compound, developed in our formulation laboratory and with facilities engineered to ensure a seamless transition to GMP manufacturing.
With a range of solubility-enhancing methods and technologies, our approach optimizes project timelines and quality while minimizing costs and risks.
Amorphous solid dispersions increase solubility by eliminating the impact of crystal lattice energy on the dissolution process.
The physical stabilization of the amorphous state of the drug substance is accomplished via dispersion in a polymer matrix. We identify polymers with sufficient solid-state miscibility with the drug substance to prevent recrystallization and ensure consistent performance over time via a combined approach of precipitation assays and solvent evaporation trials, both conducted at a milligram scale.
Formulation concepts with adequate performance and physical stability are subsequently scaled-up and GMP-produced via spray drying or bead coating.
We provide a comprehensive solution to your solubility, stability and bioavailability problems by combining experience and capabilities in formulation, analytical and process development and technologies including spray drying. We also have suites capable of handling highly potent active substances.
Lipid-based delivery systems range from simple oil solutions to complex mixtures of oils, surfactants, co-surfactants and co-solvents. These formulations present the drug substance to the body in a pre-dissolved state and increase oral bioavailability primarily by enhancing the solubilizing capacity of the gastrointestinal environment.
The wide variety of lipophilic excipients available and the intricacy of their interplay may render lipid formulation development complex.
We develop lipid formulations with a science-based approach that balances solubilizing capacity, in vitro performance and manufacturability.
Nanosuspensions show accelerated dissolution rates as a result of reducing the particle size, which leads to an increased surface area of these particles.
The key to nanosuspension development is the identification of a suitable stabilizer system, such that crystal growth and agglomeration effects are suppressed during the lifetime of the formulation.
In addition to a broad range of milling systems, we have the technologies to convert (liquid) nanosuspensions into solid forms.
Our team members share their deep, scientific understanding and insights into bioavailability enhancement.
Get in touch to see how we can craft your path to the clinic with dedicated capabilities.
Using the right standards at the right development phase, our comprehensive program management services streamline your small molecule drug development.
Using the right standards at the right development phase, our comprehensive program management services streamline your large molecule drug development.
Using the right standards at the right development phase, our comprehensive program management services streamline your nanomedicine drug development.