Formulation Development

We not only have the expertise to develop phase appropriate formulations for stability, pre-clinical and clinical assessment, but we also have the technology and team to provide innovative solutions for challenging molecules, that will leverage long term value.

What we can provide you with in terms of formulation development:

We can provide you formulation development options with our rapid screening service. Our wealth of experience in drug delivery systems and developing formulations will deliver formulations for APIs in each class of the Biopharmaceutics Classification System (BCS). We also offer a platform of Enabling Technologies for overcoming API permeability and solubility issues.

Our Enabling Technologies include:

  • Hot melt extrusion
  • Particle size reduction (micronisation and nano-milling)
  • Lipid-based self-emulsifying systems
  • Spray-drying
  • Melt granulation

We manufacture the following dosage forms:

  • Solid oral dosage forms
    • API in capsules
    • API in bottles
    • Conventional tablet and capsule formulations (immediate and controlled release)
  • Semi-solid dosage forms
    • Creams, ointments and gels
  • Inhaled dosage forms
    • Dry powder inhalation formulations
  • Non sterile liquid dosage forms
    • Suspensions and solutions

Analytical development/ validation and testing

We also develop and validate analytical methods to support pharmaceutical product development from early development (chemical and physical stability, formulation-packaging compatibility) to manufacture (QC release testing and ICH stability testing).

Advanced analytical chacterisaton

Alongside our wealth of practical analytical and development experience, we combine our specialist expertise in advanced characterisation and drug delivery systems.  This unique combination assists our screening approaches and helps optimise and trouble shoot development, ensuring your product will move quickly and efficiently to clinic.