Product development

OPTIMISING DELIVERY IS OUR SPECIALTY

For topical pharmaceutical products, the formulation has an enormous impact on the performance of your product. Stability of the formulation, release of the active substances and permeation characteristics are all vital to overall performance including cost efficiency and clinical efficacy. To avoid delays and high costs of having to redo preclinical and Phase I studies, it is vital to determine and optimise the final formulation early on. Our experts in topical delivery help you to get it right through first class formulation development.

Formulation screening

  • Generation of preferred products properties
  • Selection of vehicle type
  • Intellectual property strategy

Pre-formulation

  • Sourcing
  • Drug selection
  • Solubility studies/particle properties
  • Compatibility with standard and proprietary formulations
  • Deformulation

Formulation development
- composition

  • Formulation compounding
  • Selection of formulation/formulation candidates
  • Stability studies (screening and accelerated studies)
  • In vitro release and permeation studies
  • Selection of lead candidate(s)

Formulation development
- manufacturing

  • Manufacturing process/method
  • Upscaling to 8 kg

Regulatory

  • Generation of data for regulatory evaluation
  • Generation of documentation to the CMC part of the registration file

Manufacture

  • Generation of SUPAC-SS method
  • Robustness testing of manufacturing method
  • Tech transfer of manufacture to c GMP at CMO

Intellectual property (IP)

  • Development of patentable compositions/products
  • Generation of patent applications
  • Investigation on patentability/potential infringement