This assay is used to develop dose vehicle(s) for a test compound, as a solution or suspension prior to in vivo pharmacokinetic testing
Required from Customer
- A minimum of 10 mg of powder
- Intended dose and route(s) of administration for PK study
- Formula weight of test compound
- Any available information on solubility, chemical purity, ionizable groups (acidic, basic, or non-ionizable between pH 2 and 10), pKa
- MSDS or handling and storage information,
e.g., light sensitive, store at -20°C, etc.
- Visually estimated solubility in up to three dose vehicles
- Visual evaluation of test compound formulations diluted in saline and/or 0.1 N HCl
- Instructions for dose vehicle prototype preparation
- Test compound at target dosing concentration (to be determined; TBD) via dosing route TBD
- Co-solvents, surfactants, and complexing agents suitable for the chosen route of administration
- Mixtures of different vehicles, composition TBD based on route of administration and physicochemical properties of test compound
- 5.0 mL shake-flask
- This assay is run at room temperature
- Prepare test compound at target dosing concentration in up to three vehicles: co-solvents, co-solvent/surfactant mixtures, and/or complexing agents
- Evaluate solubility of test compound visually
- Identify vehicle(s) in which test compound is soluble at the target dosing concentration
- Visually evaluate the precipitation of test compound in vehicle(s) intended for IV dosing by diluting the formulation in physiological saline
- Visually evaluate the precipitation of test compound in vehicle(s) intended for oral dosing by diluting the formulation in 0.1 N HCl
- The results from this study are provided to the customer in the ExpressPlus report format, which may include graphical representations of data and comparison with historical data for reference compounds.
- The stability of the test compound is not assessed and no LC-MS/MS analysis is performed.In the absence of information to the contrary, it is assumed that the test compound is 100% pure.
- Pricing applies for a minimum of two test compounds in a shipment or one test compound evaluated via two dosing routes.