为此目的, Quay Pharma can complement the drug discovery process by optimising dosing formulations ahead of efficacy, pharmacokinetic and toxicological preclinical studies by assessing solubility and short-term stability using minimal API. Utilising a rapid turnaround and cost-effective screening platform, the selection of solvents and/or excipients will be tailored to the individual API depending on critical factors such as indication, route of administration and intended species. By optimising formulation at this stage, bioavailability profiles can be improved and the exposure levels achieved during toxicology studies can be enhanced.
We can incorporate rodent PK assessment for formulation comparison and PK/dose prediction modelling by working closely with our preferred partners.
In addition to optimising formulation ahead of preclinical studies, these screens are equally helpful in fast-tracking re-formulation for bioequivalence studies when an API is to be trialled for a new indication or different patient group (e.g. 儿科). In addition to solubility and stability screening, gap analysis assessments can be performed, reviewing any work performed to date along with literature data in order to propose a theoretical formulation and analytical development strategy based on the properties of the API and intended use.