Preformulation deals with the characterization of the proposed drug product's physical and chemical properties. TetraGenx’s Preformulation experts will propose designs of experiments to yield a stable drug dosage form. The following Preformulation activities are typical but not limited to:
• Identifying and using the correct form of API – amorphous or crystalline.
• Determining the aqueous and pH solubility as well as non-aqueous solubility.
• Evaluating the physico-chemical properties of the chosen API form.
• Determining the pKa, partition coefficients and tissue distribution coefficients.
• Subjecting the chosen API form to compatibility tests with potential raw materials.
• Evaluating the dissolution profile and behavior of the API in the desired dosage form.
• Assessing the thermal stability of the chosen API in the desired dosage form.

TetraGenx’s Expert Preformulation team ensures on-time project delivery without compromising quality. Our Preformulation team members have an average of 15 years of pharmaceutical development experience.