Pre-formulation Studies | SRI International

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Pre-formulation Studies

SRI specializes in developing “problem” compounds–those with poor solubility, low bioavailability, short half-life, and/or gastric intolerability. We conduct preformulation studies to guide the formulation strategy for your drug candidate. Typical preformulation studies of pharmaceuticals offer characterization and determination of

  • Physicochemical properties

  • Aqueous and pH solubility, organic solvent solubility

  • Dissociation constants

  • Hygroscopicity and lipophilicity

  • pKa, partition coefficients, and tissue distribution coefficients

  • Thermal properties

  • Moisture content

  • Polymorphisms

  • Particle size morphology

  • Drug-excipient compatibility

Our high-throughput screening system for solubility is based on an SRI-developed database of solvent combinations based on compatibility and miscibility at FDA-acceptable concentration levels. Drug candidate screening is conducted against single, binary, and ternary solvent combinations to identify optimal solubilizing agents or cosolvents that will provide the best compatibility and solubility.

SRI has developed an in vitro Ussing system that can estimate drug transport through different sections of the intestine. This information can guide targeted drug delivery approaches and functional excipient selection to develop a product with maximum absorption. While the Ussing system is primarily used to determine absorption through intestinal tissues and thus is useful for development of oral drug delivery formulations, it can be tailored to estimate absorption through other systems such as mucosal cells and skin.

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Innovative Science Overcomes Formulation Challenges

Innovative Science Overcomes Formulation Challenges