Topical Drug Delivery

FORMULATION DEVELOPMENT

Analytical method development

MedPharm can develop a suitable analytical method or use a method provided by the client.

MedPharm will ensure that the method is 'fit for purpose' in order to assay the drug concentration in the presence of any of the formulations.

(See Analytical Services)

Pre-formulation / Formulation development and optimisation

MedPharm will identify a range of excipients, which are suitable to achieve the formulation target, and will then test compatibility of these excipients with the drug.

Based on the results from the compatibility tests, simple formulations will be generated and assessed for macroscopic and microscopic appearance, aesthetics and short-term physical stability.

Candidates for the next stage of formulation development will then be selected in consultation with the client and laboratory scale batches of the selected formulations will be prepared.

Formulation optimisation – release and deposition testing

A crucial step in formulation development is to achieve optimum release of the drug from the matrix in an in-use situation. Particularly with topical administration, a formulation is a major factor for controlling extent and rate of drug release, and thus for maximising bioavailability.  MedPharm have an in-depth understanding of the mechanisms involved in controlling drug release from topical formulations.

(See in-vitro performance testing)

Formulation optimisation – efficacy screening

Formulations developed and refined using the release tests can also be screened for their efficacy in-vitro. For this purpose, MedPharm have developed a number of microbiological models, which allow bacterial or fungal skin and nail infections to be simulated.

(See in-vitro performance testing)

Laboratory scale stability studies

Stability indicating drug assays can be developed and stability testing (physical, chemical and microbiological) performed to ICH guidelines.

Packaging Material and Compatibility

Primary packaging material can be selected in agreement with the client and compatibility can be tested with the selected formulations.

Pre-clinical and clinical trials

MedPharm can supply GLP and/or GMP samples for pre-clinical and/or clinical investigation.