MedPharm undertake bespoke formulation development by gaining a fundamental understanding of the drug to be formulated . Once an analytical method is developed preformulation studies are performed in order to determine the solubility and stability of the drug in a panel of excipients taken from the MedPharm’s library in order to develop a formulation suitable for the clinical indication and the end user.

Once completed formulations are developed and optimized  with regards to safety, drug release, aesthetic and cosmetic appearance (where appropriate) and stability. These studies along with data derived from performance testing and the disease models (where appropriate) are used to select one lead and one back-up formulation for preclinical and clinical evaluation.

With the increasing difficulties associated with in vivo animal studies and the ethical and cost restraints of human studies in vitro, drug permeation and deposition studies are becoming increasingly important for the regulatory assessment of the absorption of drugs from topical formulations.

Upon completion of the early stages of our projects, with the development of a panel of formulations, the effect of the formulation variables on drug release/absorption and disposition can be assessed in vitro using synthetic membrane and  skin and nail tissue . MedPharm have developed various models to perform such work. All of these models can be used with human tissue to ensure that the formulations developed can be tested and optimised to achieve the delivery of therapeutic levels of drug to the pathological site whilst minimising systemic exposure.

Enzymes and microflora of the skin can metabolise and bioconvert a wide variety of drugs which can affect their dermal delivery. MedPharm can perform in vitro studies to determine the metabolism/bioconversion of drugs in the various layers of the skin, as they are percutaneously delivered. Analytical methods available include HPLC, GC-MS, LC-MS and immunoassay; alternative bioassays can also be developed.

MedPharm has the capabilities to also assess the effect of the formulation variables on drug release/absorption and disposition on and in other topical membranes  including the, nasal, lung, eye vagina and rectum . All of these models can be used with human or animal tissue to ensure that the formulations developed can be tested and optimised to achieve the delivery of therapeutic levels of to the pathological site.

The current gold standard in terms of in vitro testing of inhalation formulations is inertial impaction, more specifically assessment using the Andersen cascade impactor or the next generation impactor (NGI) (as detailed in the European Pharmacopoeia). MedPharm has the capability to perform impaction testing using these collection devices, but has also developed several laser diffraction particle size analysis methods to act as pre-formulation screening techniques.

Data from laser diffraction assessment can be obtained in a fraction of the time compared to inertial impaction, providing accurate particle size information that can be used to assess the potential of the formulation to deliver particles to the lung. These techniques are fused with rational implementation of the multi stage liquid impinger and or the twin-stage impinger to streamline the development process. Speeding up the inhaled development process, increases the number of formulations that can be investigated and thus maximising the chances of formulation success.