Pharmaceutical Preformulation Services

At Ricerca, we believe that an adequate understanding of the properties of your drug substance will minimize problems in later stages of drug development, reduce drug development costs, and decrease your product's time to market.

Preformulation is a branch of pharmaceutical sciences that utilizes biopharmaceutical principles in the determination of physicochemical properties of a drug substance. The goals of preformulation studies are to choose the correct form of your drug substance, evaluate its physical properties, and generate a thorough understanding of the material's stability under various conditions, leading to the optimal drug delivery system.

Ricerca offers a wide range of analytical approaches to achieving these goals. These approaches are designed to help move your compound from drug candidate to marketable product.

Ricerca works closely with its clients in designing and conducting preformulation studies. Depending on the nature of your drug candidate, Ricerca can conduct special studies expanding the scope of information obtained on the drug molecule. Please call us to discuss your needs with a Ricerca professional.

Product Properties

• Polymorph screening (free base and salt forms)
• Solubility (aqueous/buffers/organic solvents)
• Dissociation Constant (pKa)
• Partition Coefficient (log p or log D)
• Salt screening (determination of preferred salt forms)

Solid State Characterization

• Powder properties (flow/compaction/ density/particle size/surface area)
• Microscopy (morphology, particle characteristics)
• Thermal Analysis (DSC, TGA)
• Molecular Spectroscopy (FTIR, NMR, MS)
• X-ray Diffraction

Stability Evaluation

• Stability (heat/light/acid/base/oxidizer)
• Moisture isotherm (formation of hydrates/deliquescence)
• Excipient compatibility (depending on dosage route)