COREALIS PHARMA

PRE-FORMULATION

COREALIS Pharma’s pre-formulation development service takes clients from proof of concept to characterization. The pre-formulation process is crucial in order to provide practical insights to establish a clear and efficient formulation development plan that will accelerate the development of the drug product.

PROOF OF CONCEPT

A feasibility study is performed for the development of a solid oral dosage form of an active ingredient.

PRE-FORMULATION

The active pharmaceutical ingredient (API) undergoes characterization and salt selection. This process includes:

• Selection of the crystal state,
• Particle size,
• Solvates,
• Hygroscopicity,
• Stability,
• Solubility,
• Distribution,
• Compressibility,
• Flowability,
• Forced degradation,
• Stress tests,
• Tests specific to the API.

Compatibility studies of the API are thoroughly investigated. These include:

• Drug-drug compatibility,
• Drug-excipient compatibility.

Characterization of the API involves the use of analytical techniques including, but not limited to,

• SEM,
• XRPD,
• DSC,
• TGA,
• NMR,
• HPLC.