We offer a customised screening service to develop phase-appropriate oral and parenteral formulations to assess the pharmacokinetic / toxicokinetic (PK/TK) characteristics of new chemical entities
Based on the experimental preformulation and in silico / in vitro ADME data generated, we are able to custom design and carry out small-scale dose-vehicle screening experiments to develop phase appropriate formulations to support various stages of the preclinical program. In particular, our expertise lies in overcoming complex bioavailability barriers often associated with development of poorly water soluble compounds, for instance reduced oral absorption and exposure on dose escalation, increased exposure variability between preclinical models and potentially exacerbated pH or food effects.
Supporting both oral and parenteral routes of administration, our screening platform has been specifically designed to work on minimal sample quantities, allowing customers to assess formulation options earlier in the development process.
The formulation options we implement at this stage include:
- Solutions and supersaturated liquids (aqueous and organic based)
- Complexation (e.g. cyclodextrins or polymeric)
- pH adjustment and / or salt formation
- Micronised suspensions
- Nanoparticulate suspensions
- Lipidic / oily liquids, including self micro-emulsifying drug delivery systems (SMEDDs)
- Micellar systems
- Solipure™ liposomes
Having successfully formulated over 200 NCEs to date for preclinical assessment, our expertise ensures that all dose-vehicles developed are safe, robust and tolerable for the preclinical species to be used and for the dosing volume, frequency and study duration.
Each product developed can be shipped to the preclinical dosing facility with an accompanying Certificate of Analysis (CofA) and stability package. If required, a detailed protocol for in-house formulation preparation can be also be supplied.