Preformulation involves the characterization of a drug’s physiochemical properties and its behavior under stress conditions. These data provide insight into formulation development, as well as useful efficacy information during lead identification and optimization. A thorough preformulation package is important  to the success of the compound and can considerably reduce the time and cost of product development.

Pharmatek offers a customized preformulation testing program based on the composition and intended delivery of your drug candidate. Physiochemical testing based on compound solubility and stability across a broad range of conditions is critical to identifying the best formulation strategy for a particular compound. You will know more about the physical characteristics of your compound and have better insight into how to make it more “druggable”.

Pharmatek offers a range of preformulation services designed to facilitate dosage form development and assist the development of drugs exhibiting inadequate solubility, stability, and/or polymorphic behavior, including:

  • Solubility in Buffered Aqueous Media, Critical Media and Analytical Solvents
  • Stability in Aqueous Media & Organic Solvents
  • Log P & Log D
  • Photo & Heat stability
  • Water Content & Hygroscopicity
  • Melting Point
  • Glass Transition Temperature
  • Flowability
  • Bulk & Tapped Density
  • Particle Shape & Size
  • Excipient Compatibility
  • Aggregation Analysis (Peptides)

Data Driven Development

Preformulation studies in combination with strong analytical methods provide the scientific backbone on which clinical formulations are based. The supporting data generated during these studies is fundamental to a successful development program and can impact:

  • Candidate Selection
  • Formulation Design
  • Choice of Drug Delivery Technology
  • Manufacturing Process
  • Drug Substance and Product Stability
  • Product Packaging

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