|
The skin has an extremely good barrier function, and to improve topical bioavailability it is usually necessary to employ enhancement strategies.
Based on the current scientific knowledge, it appears very likely that drug penetration into and through the skin involves a most complex interaction of various mechanisms and factors, such as diffusion processes of the active along chemical and/or electro-chemical gradients and sophisticated interactions of certain formulation ingredients with special components and structures of the skin.
Overcoming the barrier function of the skin already poses a great challenge to modern drug delivery systems, but no less important are safety and tolerability aspects. In the past, many common drug penetration enhancement strategies turned out to destroy the natural barrier function of the skin and cause irritations and other partially severe side-effects. Therefore, right from the beginning MIKA Pharma GmbH has focused on the development of primarily safe and efficient drug delivery technologies.
The safety of MIKA´s drug delivery technologies was assessed in a large number of preclinical and clinical trials, as well as during routine use over a period of more than 6 years, covering treatment in more than 3 million patients in various countries for 30 million days. Only a handful of non-serious adverse drug reactions were observed.
With respect to drug transportation, MIKA´s drug delivery technologies proved to exhibit up to 20fold increased skin penetration rates compared to worldwide leading conventional topical ointments and gels.
However, even proven and superior efficacy and safety do not make a successful international drug delivery technology. New products developed on the basis of MIKA´s technologies comply with all international regulatory demands and allow production at competitive costs in comparison to even conventional ointments and gels.
MIKA Pharma GmbH - together with experienced and reliable contract manufacturers, producing under international GLP and GMP conditions (incl. FDA compliance) - has established production facilities guaranteeing production capacities for the world market.
|