The scientific process that MedPharm follows often starts with the presentation of a new chemical entity (NCE), which a company wishes to turn into a medicinal product. The first step in the process is to carry out a rigorous search on the physiochemical properties of the molecule and then to use established predictive equations to evaluate the potential routes by which it is most likely to be absorbed.

Topical drug formulations can be developed to meet all regulatory criteria and to achieve the required drug delivery into or through the skin. Considerable experience exists within the unit in the pharmaceutical development of creams, ointments, gels, lotions, vesicular formulations and patches. Stability indicating assays can be developed and stability testing (physical, chemical and microbiological) performed to ICH guidelines.

The skin provides an appealing site for the non-invasive delivery of drugs and has numerous advantages over more conventional routes. Hence, penetration of the skin by chemicals or drugs is an extremely important area of research, and a variety of experimental models have been developed to increase understanding of these processes.

Commonly, in vitro studies involve the use of a diffusion cell designed to mimic the physiological and anatomical conditions of skin in situ. Various models exist in the unit including partition cells (in house developed) and diffusion cells that can be used to screen and optimise topical formulations to achieve the delivery of the drug either to the various layers of the skin for localised delivery. In addition drug that has diffused through the skin can be measured. In addition to skin, our services also include work with human nail and synthetic membranes.

These skin models have also been adapted so as to be able to test anti-infective agents in skin diseases caused by microorganisms. A diffusion cell has also been designed that can house pieces of human nail infected with fungal conditions such as onychomychosis. This model has been successfully used to develop formulations, that have been shown to be capable of diffusing into the nail, and killing the organism whether it is present as a growing mycelium or a spore. The model has also been used as a performance test in routine stability of the product.

A cell culture group has been established within MedPharm. These services can be utilised with larger projects where other formulation expertise is being used or as a separate service. Cell culture drug absorption models mimic epithelial absorption barriers. Cell culture systems provide many advantages over conventional in vitro and in vivo models and are useful for determining drug permeability, mechanisms of drug absorption and assessing mucosal toxicity.

Preclinical dosages are regularly prepared with the appropriate documentation. MedPharm can help to undertake the full preclinical package to support proof-of-concept study, and to test a concept or provide scientific support for a clinical trial.

Clinical trial supplies: MedPharm has the ability to manufacture dosages to GMP. A number of our projects are currently in phase I/II clinical evaluation.

Industrial scale-up: Development work can be undertaken to scale up from laboratory scale to development scale and include process validation and cleaning validation.

Our clients normally conduct early phase clinical studies in human volunteers and patients however, we are usually involved in the design. MedPharm has strong connections to the clinical dermatological department and other clinical centres in King’s College and can advance projects into clinical development (phase I/II).