Enabling formulation

Services to support formulation

• Solution based Forced Degradation studies including stability as a function of pH, temperature, oxidative stress and photostability using in-house HPLC/ UPLC generic or customer methods as appropriate. Knowing the potential degradation triggers for a compound helps us to design suitable formulations that prevent failure by protecting against known possible sources of degradation.
• Stability studies on the drug substance to investigate the influence of temperature and humidity during storage – understanding the stability boundaries of your API is critical for understanding control measures needed during preparation, isolation and storage to ensure materials can be shipped, stored and packaged appropriately.
• Early stability studies on solution based formulation prototypes to evaluate any possible changes in chemical purity and assess propensity for precipitation or solid form changes over time. Evaluating stability and tracking key impurities over time gives an idea of shelf-life and short term stability for early stage studies such as in-vitro tox. Even simple early stage formulations need to have some stability data which will feed into how prototypes may need to be handled and stored in clinical houses for use during these early stage in-vitro studies.
• Excipient compatibility and surfactant screening work for poorly soluble APIs, including lipid based screening. If aqueous solubility is problematic the addition of excipients and surfactants both in solid and liquid dosage forms can help to improve properties such as stability, handleability and solubility. It is however also important to understand both the short and long term influence of these different components on the integrity of drug substance by monitoring for any adverse interactions such as changes in form or loss in chemical purity.
• Comparison of performance for lead formulation prototypes. Once lead prototypes have been selected it’s important to evaluate their performance against one another to make recommendations to our clients on which prototypes demonstrate the greatest benefits in terms of stability and uplifts in solubility.

Through our in-house physicochemical and analytical services, and working collaboratively alongside the solid form team, we are able to drive informative and data led formulation development for the early stages of pharmaceutical development.