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Pharmaceutics

Preformulation

Physicochemical Characterization

SRI’s Pharmaceutical Formulation Design group’s preformulation services include the following physicochemical characterization studies

• Dissociation constants
• Hygroscopicity and lipophilicity
• pKa, partition coefficients and tissue distribution coefficients
• Thermal properties via Differential Scanning Calorimetry and Differential Thermal Analysis
• Moisture Content via Karl Fischer analysis
• Loss on drying
• Excipient compatibility

High Throughput Solubility Screening

Does your drug candidate have poor solubility or no solubility in water?

If so, High Throughput Solubility (HTS) screening can be the solution.

HTS screening is an effective way to screen and identify the co-solvent systems with the desired soluble concentration from a library of co-solvent systems.

It is

• Fast and economical
• Needs very small quantities of the compound
• Ideal for preclinical formulations
• Helps develop superior clinical formulations

SRI has developed several levels of HTS screens with hundreds of co-solvent combinations suitable for both Oral and parenteral administration. We have employed this technology for developing formulations for BCS class II - IV type compounds. An exemplary SRI proprietary HTS screen is shown below.

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In Vitro Drug Permeation Studies

Does your drug exhibit poor in vitro permeability?

Do you want to know your compound’s permeability characteristics?

Do you want to know the best site of intestinal absorption for your drug?

If so SRI’s expertise in in vitro permeability studies using Caco-2 cells and Ussing Chambers can help you.

Using our state of the art HTS screening and in vitro testing on Ussing Chamber apparatus we can develop formulations for your drug with enhanced permeability.

Information obtained can be used to tailor the formulations and target to a specific part of the intestine using one of our several Formulation Development technologies offered at SRI.

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     Last Updated Jan 25, 2010