SERVICES
Correctly designed in vitro human skin absorption measurements are the gold standard for prediction of skin absorption in the patient or consumer. Our technology, with individually calibrated diffusion cells of several different designs, allows patient/consumer relevant doses of semi-solid (e.g. creams/gels), liquid or patch formulations to be assessed. Comparison of formulation performance can be a key benefit of in vitro assessment during optimisation stages or development of a generic product.
Optimisation of formulations for delivery of actives into or through the skin requires an understanding of the complex interactions both within the formulation and with the skin. An-eX can help develop the best formulations and provide hard-data via in vitro testing during the development process.
In vitro human skin penetration evaluation
Measurement of the diffusion of test compounds into and across human skin membranes for a variety of scientific purposes (including IVPT assessment). Typically involves full skin distribution and recovery assessment over a 24-hour period. Includes measurement of active on the skin surface, in the stratum corneum (SC), epidermis, dermis (if present) and on the diffusion cell donor chamber, as well as permeation profiling. This assessment is important for a locally active compound/pharmaceutical or compound undergoing risk assessment.
In vitro human skin permeation only measurement
Measurement of the permeation of test compounds across human skin membranes into an appropriate receptor phase at multiple time points (providing a permeation profile). This type of study is of lower cost and may be suitable for the initial assessment of a new transdermal active or during the development process for a transdermal pharmaceutical product (such as a transdermal patch or semi-solid formulation).
Analytical expertise
Development of highly sensitive and specific analytical assays used in the evaluation of skin penetration studies and formulation content/stability, via UHPLC and GC-MS techniques. A suite of Agilent 1290 UHPLC and Agilent GC-MS machines are available in-house. Analyte derivatisation procedures are possible where required. LC-MS/MS facilities available via contracted-out analysis if required.
In vitro release testing
Measurement of the rate of drug release from a variety of topical formulations to enable optimisation and selection of lead prototypes and assessment of equivalence (IVRT assessments). Often used as a quality assurance evaluation for topical formulations.
Formulation development
An-eX offers assistance in the development and optimisation of a variety of topical, transdermal and ungual formulations and evaluation of innovative delivery systems and devices. Formulation formats include creams, gels and patches.
Patent litigation support
An-eX staff have been involved with provision of expert opinion and associated experimentation in support of patent litigation for cases from around the World.