Preformulation

 

When selecting a new drug-candidate and initiating its Phase I development, a “Preformulation Package” data set has to be assembled, in order to:

  • Secure the compound selection final decision
  • Prevent potential issues in the production of the first API GMP batch
  • Facilitate the analytical and formulation development work by producing a detailed and focused description of the compound profile
  • Ensure appropriate CMC documentation is prepared to support ethics and regulatory submissions


Drugabilis team has over 80 years experience in conducting development in major pharmaceutical companies (e.g. Rhône-Poulenc Rorer, Parke-Davis and Pfizer) and biotechs.


Drugabilis has developed experimental methodologies to quickly and accurately deal with small API quantities (e.g. tens of milligrams).


Drugabilis Preformulation Package is customized to the targeted administration route to help define the most suitable drug delivery options.

Typical Preformulation Plans could include:

  • Initial physical characterization of the bulk
  • Solubility profile of the compound in aqueous media as a function of pH
  • Chemical stability of the compound in aqueous solution
  • Chemical and physical stability of the powder under stress conditions
  • Feasibility assessment of various formulation options (intravenous/liposomal solution, topical gel) to secure the targeted dosage forms to be used in regulatory animal studies and later on in clinical studies are appropriate and do not require costly rework. Drugabilis has a broad and deep experience in dealing with low soluble drug candidates
  • Pilot stability studies on prototype formulations to collect preliminary and supportive data and anticipate potential issues to be dealt with in development