nir-vana innovation network

A leading Polish medical university has designed a pharmaceutical composition containing roxithromycinfor to be used as a medicinal product for the treatment of androgenetic alopecia and/or acne vulgaris.
Treatment of acne vulgaris and androgenetic alopecia is a difficult and long-lasting process. In the treatment of androgenogenic alopecia, the only approved formulation for topical use by the Food and Drug Administration is 2% and 5% Minoxidil. On the other hand, this substance is suitable for oral therapy, but it is associated with serious side effects and only men can be treated with it. There are no alternative pharmacological agents typically applied in the therapy for alopecia. Acne vulgaris is one of the most common dermatoses and despite the fact that many pharmaceuticals are available in the pharmaceutical market to combat it, more effective and innovative solutions are still sought after.
Roxithromycin is an antibiotic from the group of semi-synthetic macrolides. It is a 10-oxy-ether derivative of erythromycin with increased acid resistance and better pharmacokinetic parameters. It is a lipid type of compound. It is used orally in the treatment of Gram-positive infections, less often Gramnegative infections. Its mechanism of action consists of blocking the biosynthesis of bacterial proteins. In addition to the typically antimicrobial activity, roxithromycin also inhibits the production of proinflammatory compounds by bacteria that contribute to the development of acne. There have also been reports of roxithromycin inhibition of free radical formation in neutrophils and inhibition of keratinocyte apoptosis.

An innovative pharmaceutical composition containing roxithromycin has been developed which can be used for example for the treatment of androgenetic alopecia and/or acne vulgaris. In order to produce the proposed preparation, lipid micro- and nanoparticles were used as carriers of roxithromycin for hair follicles.

The university is offering to sell license/IP rights for the composition of this medicinal product to a foreign partner. The substance must undergo clinical trials in order to be authorised for the market. Potential partner would have to create branding and visual identification of the market-ready product.

Advantages & innovations

As the etiology of both androgenic alopecia and acne vulgaris is related to the skin hair follicle unit, targeted treatment of the follicle becomes a key element of the therapy. In vitro studies on human hair follicles have shown that roxithromycin inhibits hair transitions in the catagene phase by inhibiting keratinocyte apoptosis and thereby causing hair length increase. Within in vivo conditions, however, after using an external 0.5% roxithromycin solution for 24 weeks, restoration of hair growth was noted in more than half patients affected by androgenetic alopecia. Lipid micro and nanoparticles, as medicine carriers, are a suitable matrix for the incorporation of roxithromycin because of its lipophilic nature. The carriers are characterized by low toxicity and are biodegradable. Their crucial advantage is also the protection of the drug incorporated in them from chemical degradation. It has been shown that they effectively reach the human hair follicles, and by accumulating there form a reservoir of drug incorporated in them, and provide extended release and action for up to 10 days. The available data show that roxithromycin has not yet been incorporated into micro and nano-sized lipids. There are no registered preparations with this antibiotic for external use yet worldwide. The use of roxithromycin in the technology of drug production for external use in the treatment of acne vulgaris and androgenetic alopecia is a novel approach and an important one for the needs of the modern society.

Stage of development

Available for demonstration

Partner sought

Most suitable partners would be companies from Life Science sector with experience in carrying research and development works as well as in implementation of medicinal products on local and international markets. The partner would be granted a license and would be responsible for introducing the drug into the market and for all the marketing activities.