Preformulation Development

GVK BIO provides valuable expertise to guide the preclinical candidates to next steps with very small quantities of active pharmaceutical ingredients (API) or candidate molecules. Our preformulation group has extensive experience in handling a wide range of NCEs and can suggest the path for successfully proceeding towards formulation development.

Our focus is on understanding and optimising the physical and chemical properties of API that enable the approaches for preclinical studies and subsequently for formulation development.

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GVK BIO offers preformulation services in the following areas:

  • Physical Properties: particle size, flow-ability, compressibility, bulk and tap density
  • Intrinsic Dissolution
  • Container Closure Interactions
  • Drug/Excipient Compatibility
  • Solubility (aqueous, non-aqueous, FaSSIF, FeSSIF and SGF mediums)
  • pH-Solubility profile
  • Impact of Particle Size on Dissolution
  • Polymorphic Screening
  • Solution State and Solid State Stability
  • Hygroscopicity

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