EA982

Formulation Assessment

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.

Deliverables

  • 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

Substrate

  • 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

Assay System

  • 5.0 mL shake-flask

Assay Conditions

  • 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

Notes

  1. 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.
  2. 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.
  3. Pricing applies for a minimum of two test compounds in a shipment or one test compound evaluated via two dosing routes.

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