Our highly skilled formulation development team has the capability to manage a pharmaceutical project from the preclinical stage to full scale commercial manufacturing.
We develop everything from simple formulations for early studies to more complex formulations suited for commercialisation. At each stage of the development process we are committed to achieving the right quality as quickly and cost effectively as possible. Our expertise in scale-up and industrialisation ensures that the final product will be suitable for large scale manufacture and commercialisation.
Additionally, through our Pathway to Clinic® offering, we guide you from formulation development to clinical supply manufacture and trial management
Our formulation development services include:
- Sourcing of excipients and API
- Preformulation studies
- Automated formulation screening
- Drug substance and excipient compatibility studies
- Early screening for structural and chemical stability
- Development of formulations for preclinical studies and clinical studies Phase I to III
- Manufacturing of batches for stability studies
- Development of formulations for application of marketing authorisation
- Packaging development
- Scale-up and pilot scale manufacturing
- Technology transfer and process validation
- Compilation of CMC regulatory documents
In conjunction with the above, we can develop a number of different dosage forms including:
- Capsules, coated capsules, capsules filled with coated or un-coated particles
- Coated pellets
- Formulations for poorly soluble drugs
- Liquids such as oral and topical, solutions, suspensions and emulsions
- Ophthalmic products
- Parenteral formulation development services
- Powders and granules
- Inhalation and nasal formulation development
- Rectal formulations
- Tablet formulation including immediate-release tablets, mini-tablets, coated tablets, effervescent tablets, enteric-coated tablets, controlled release tablets, misuse and abuse deterrent technology
- Transdermal and topical formulation development
- Vaginal formulations
We also have platform technologies to assist/improve drug delivery and formulation development:
- Metal coordinated pharmaceuticals – in collaboration with Synthonics Inc. we offer a new method to improve physicochemical and pharmacokinetic properties of drugs.
- Polymers for parenteral applications - we have the capabilities to develop and GMP manufacture polymers for use in sterile dosage forms.