The API needs to be delivered with desirable release characteristics, minimal degradation, and adequate bioavailability at the target site. Therefore, once a formulation has been developed, it must undergo a range of testing to characterize and determine the stability of the dosage form.
The Rohan Lab is a well-resourced group, with ample equipment and methods, which can handle a thorough formulation assessment. These formulation assessments can include the following: appearance, mass, pH, identification and assay of specific formulation components including the API, viscosity, osmolality, specific gravity, tensile strength, puncture strength, breaking point, melting point, water content, disintegration, in vitro dissolution/release, cellular toxicity, and tissue permeability and safety.
Once a formulation has been developed and displays desirable characteristics, it can then undergo in vivo animal testing for safety and efficacy and be placed on a formal stability program.