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Formulation Assessment and Dose Vehicle Development
Absorption Systems had a dedicated Formulation group and offers a range of preclinical formulation options to support customers performing preclinical PK or toxicology studies. They include the determination of a compound's physicochemical properties as well as Express Plus or Custom formulation assessment. Don’t throw out a good compound due to a bad formulation!
Express Plus formulation assessment involves testing up to three different dose vehicles in a shake-flask, with solubility assessed visually. This is followed by visual assessment of precipitation potential following dilution into 0.1 N HCl (for oral dose vehicles) or physiological saline (for IV). Custom formulation assessment proceeds similarly, but the in vitro performance of each test vehicle is assessed quantitatively by LC-MS/MS and additional vehicles will be tested as needed. Then we will test selected formulations in vivo to determine the absolute bioavailability (for a single formulation) or the relative bioavailabilities of a series of formulations. In either case (Express Plus or Custom), we approach the problem rationally, based on the physicochemical characteristics (acid, base, pKa) of the test compound as well as the test species and route(s) of administration.
How much difference does the vehicle make? Here is one example, for the steroid Danazol administered orally to rats:
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Please contact Absorption Systems to learn how our Formulation group can assist you in your next project.
Related Literature
This assay is used to determine the quasi-equilibrium solubility of a test compound at a specified temperature and pH in a specified matrix using the shake-flask method.
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In this assay a Sirius GLpKa system is used to determine the pKa, LogP, and LogD values of a test compound.
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This screening assay is used to determine the bioavailability of test compounds relative to a reference compound after oral administration to rats.
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This assay is used to determine the absolute bioavailability of a test compound in mice.
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This assay is used to determine the bioavailability of a test compound in dogs when the compound is administered by at least two different routes.
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This screening assay is used to determine the bioavailability / exposure of test compounds after two routes of administration to male mice.
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This screening assay is used to determine the bioavailability / exposure of test compounds after two routes of administration to male rats.
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This assay is used to determine the bioavailability / exposure of test compounds in male dogs after two routes of administration.
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This assay is used to determine the bioavailability / exposure of a test compound in dogs after two routes of administration (non-crossover).
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This assay is used to develop dose vehicle(s) for a test compound, as a solution or suspension prior to in vivo pharmacokinetic testing.
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