MedPharm supports customers from the very start of the development process to rapidly evaluate any potential risks and suggest mitigation techniques.
API’s are characterized using a variety of physiochemical methods to help advise the customer on the best formulation development strategy for their product.
Information obtained can be used directly in regulatory submissions.
MedPharm’s in silico models are based on 20 years of experience.
Each model ranks the ability of compounds to penetrate tissue based on key physiochemical information.
Combining in silico investigations with API characterization helps our clients to make informed decisions on compound selection early in the development pathway.
Our in vitro assessments allow compounds to be selected based on activity and permeability in ex vivo human tissue.
In Silico Prediction and In Vitro Assessment
Our rigorous approach to understanding potential interactions between APIs and excipients reduces the time and risk associated with formulation development.
Excipients are selected by applying MedPharm’s extensive experience to understanding API characteristics and target product profiles. These excipients are carefully matched to any regional requirements where the final formulation may be marketed.
We assess the solubility of our clients’ compounds in excipients, aiding the selection of compatible solvent systems for the formulation.
Cost-effective analysis of the originator product/RLD so that a new generic product can be clearly demonstrated to match.
MedPharm uses state of the art analytical techniques in tandem with their years of experience to identify the quality and quantity of the excipients in the originator product.
Microstructure of originator product is characterized so it can be duplicated in preliminary process assessment.
Preliminary Process Assessment
Formulation development is typically performed in conjunction with the most appropriate performance testing, depending on the stage in the development process.
The programme can be tailored to match customer budget so the maximum benefit for the client is achieved with minimal risk.
MedPharm prepares prototype formulations based on preformulation data and the target product profile, following close consultation with the client. Multiple formulations in the relevant dosage forms are developed in parallel to ensure that the most appropriate is selected.
Short term stability studies of the compound in excipients or solvent systems are performed to identify potential risks once formulation development is underway.
Preliminary process assessment is undertaken when developing a generic to match the character of the originator product/RLD.
Many RLDs are sub-optimal formulations but the new generic must still match in order to justify in vitro bioequivalence.
Processing of these formulations can be very sensitive to process parameters so preliminary process assessment reduces cost and increases chances of having a consistent scalable formulation.
Lead Formulation Selection
We don’t just provide data; we help you make sense of it.
Lead candidates are always selected in close consultation with the client. Development goals set at the start of the project are regularly reviewed and risk-assessed to confirm they are still valid.
MedPharm’s development strategy aims to minimise risk and retain flexibility with a lead and back up formulation.