MedPharm Ltd. services

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.

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.

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.

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.