Pre-Clinical Formulation & in-vivo Pharmacology Delivery
The relationship between solid form and formulation is intricately connected. Our unique position here at Sygnature Discovery allows us to thoroughly understand the solid form properties of a compound, ensuring successful pre-clinical formulation.
This approach is designed to de-risk compounds during lead optimisation or selection stages, offering support for both stand-alone and integrated drug discovery projects. Our expertise in this area ensures a seamless transition from the laboratory to pre-clinical testing, underpinning the success of your pharmacological endeavours.
Our skilled team and state of the art laboratories have the capabilities to screen, test and develop conventional and novel enabling formulations to give your compound the best chance of success. Furthermore, our co-location with other departments such as DMPK and in vivo pharmacology allow us to design, make and rapidly test formulations to drive your project forward. We develop well tolerated formulations for small molecules and peptides for dosing via oral, intravenous, intramuscular, intraperitoneal, subcutaneous and inhalation routes in rodents (mice and rats), dogs and non-human primates.
We are passionate about progressing your molecule from lab to clinic. Our nimble, responsive and flexible approach means we communicate with you at every step to meet your needs; be it achieving a high drug loading and/or achieving linear pharmacokinetics. We offer the following formulation services at pre-clinical level:
In vitro and analytical services
- In-vitro lipolysis to rank order or optimise oral lipidic systems
- Dissolution and flux measurement using state-of-the-art Pion µDiss profiler in biorelevant media to predict performance and PK in animals.
- Stability assessment under ICH like conditions in 2 Memmert ICH110 chambers at 25°C/60%RH and 40°C/75%RH
- All above supported by suite of analytical instruments such as Zetasizer (DLS and zeta potential) and Morphologi G4 for particle size analysis, (U)HPLC-UV(+MS) and 500MHz NMR multinuclear probe for 13C, 31P, 19F etc. with VT capability, thermal analysis (TGA & DSC), XRPD and DVS.