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Miphargel® technology: an innovative system for vaginal delivery

The dosage forms traditionally used to treat vaginal diseases, e.g. creams, douches, vaginal suppositories and tablets, present a series of disadvantages leading to a transitory pharmacological effect, like:
- very short contact time
- non uniform distribution of the active ingredient
- the immediate release

tech Mipharm developed a new formulation based on breakthrough technology, Miphargel®, providing a vaginal delivery system so innovative to be granted in the European Patent (2008) by the European Patent Office, in China (2010), Japan (2011) and Canada (2011), recently, the United States of America (2014); the patent application is also already been extended in other major markets (eg: Brazil); the patent application has already been extended in all the other main markets (e.g. USA, India, Brazil). The Miphargel® technology is based on the use of hydroxyethylcellulose (HEC), a polymer exhibiting a specific profile:
- can adhere to the mucous membranes in human beings (muco-adhesion)
- does not contain acid groups
- shows high swelling capability (uptake of water up to 40% by weight)
- is suitable for a wide range of water-soluble or insoluble active ingredients and is not influenced by their physico-chemical characteristics (e.g. the ionic strength)
- is stable at vaginal temperature and pH
- can release the included active ingredient homogeneously and progressively

tech All these factors provide an optimal contact time between the carried actives and the vaginal surface (up to 24 hours) in order to obtain the intended final result. Miphargel® shows different characteristics from the gels available up to now, as it evolved to become a reliable system for vaginal delivery, able to obtain the required efficacy in the concerned area without the disadvantages related to the systemic route.

Miphargel® can deliver:
- antimycotics
- antiseptics
- antinflammatory agents
- anaestetics
- hormones and other actives

techtech

Moussina® Technolgy

Topical dosage forms like solutions (drops and sprays) and gels are often suitable for limited areas that sometimes need a longer application time.On the other hand, foams are suitable for large areas. They are not greasy and require a shorter application time with optimal spreadability and penetration. Topical aerosol water-based foams are in particular suitable for open wounds, abrased or very sensitive areas like mucous membranes and dry skin but they have limitations, like being environmentally non-friendly (due to propellants) and showing poor dose reproducibility (due to non-metered pumps).
Besides, aerosol foams often contain alcohol and can be used only on intact skin.

technology

Mipharm's non-aerosol foam (Moussina®) overcomes most of these limitations

Moussina® results from the development of a basic alcohol-free formulation able to:
- better deliver the active ingredient into the skin (increased penetration)
- increase local efficacy of the topical product
- avoid significant systemic absorption deliver a precise amount of product (metered pump)

It has been demonstrated that the Moussina® technology grants high patient acceptability (no stain and residues) and achieves high patient compliance (easy to distribute onto the skin, non greasy, non tacky)