Milton Pharmaceutical Company enjoys the opportunity to engage with our clients as early as possible to create robust formulation development strategies tailored to the characteristics of each individual API.
To that end, Milton Pharmaceutical Company can complement the drug discovery process by optimising dosing formulations ahead of efficacy, pharmacokinetic and toxicological pre-clinical 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.
In addition to optimising formulation ahead of pre-clinical 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. paediatrics). In addition to solubility and stability screening, mini forced degradation studies can be performed to select the optimal formulation ahead of prototype production.
Our Pre-Clinical Capabilities Include:
- Tailored Solvent & Excipient Selection
- Bespoke Solubility Assessment
- Short-term Stability Evaluation
- Mini Forced Degradation Study
- Minimal API required
- Rapid Turnaround
- Cost Effective