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Pre-formulation

Corealis’ pre-formulation service sets-up and guides a biotech’s prospective therapeutic through the entire drug product development journey.

The pre-formulation process delivers key insights that help Corealis’ experts evaluate the active pharmaceutical ingredient’s (API) “druggability” (suitable to be developed into a pharmaceutical oral solid dosage form for the targeted therapeutic application). This can determine if the API is druggable, and set a well-defined development plan that is essential in the execution of an efficient drug product formulation development program.
From proof-of-concept to characterization, Corealis expedites clients’ drug product progress.

Proof of concept

At the initiation of a drug product formulation development project, Corealis makes a thorough review of all available information. This includes the API’s chemical and physical properties (e.g., solubility, permeability, stability, crystal forms, polymorphs), drug product developed or manufactured, pharmacokinetic (PK) properties in human and animals, clinical results, and the targeted drug product for the therapeutic application (e.g., targeted dose strengths, patient population, and PK profile).

This project information overview helps Corealis to recommend and justify a suitable characterization plan. This will fill any missing information in assuring that the API is druggable, and define an efficient drug product formulation development plan.

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Characterization

The API undergoes a characterization to generate any missing information. It includes:

  • Particle size, shape and distribution
  • Solvates
  • Hygroscopicity
  • Stability
  • Solubility
  • Crystal state stress study
  • Compressibility
  • Flowability
  • Forced degradation
  • Drug-drug compatibility
  • Drug-excipient compatibility

Characterization of the API involves the use of analytical techniques. These include, but are not limited to:

  • SEM
  • XRPD
  • DSC
  • TGA
  • Laser and optical particle sizer
  • HPLC

Pre-formulation is an integral step in any successful drug development program.

Contact Corealis

Corealis’ experts are ready to answer any queries about the company’s oral solid dose offering, including its development and manufacturing capabilities.