An Israeli drug delivery firm is developing a new vaginal drug delivery system, making use of bio-adhesive foams to offer a more convenient and effective treatment option for women with gynaecological complaints.
Foamix, a company specialising in foam formulations for a variety of applications, showed off its latest research into the vaginal foam product at last week's Controlled Release Society meeting in California, profiling its advantages over current products and presenting promising study results.
The foam products are set to challenge the traditional vaginal treatments, currently limited to ointments, pessaries, creams or gel-type formulations, which can be inconvenient and messy for the patient as well as tricky to administer and likely to leak.
The foam products, according to the company, solve all these problems in one go.
"Vaginal delivery is a neglected market," Doron Friedman, Foamix' chief technology officer told in-PharmaTechnologist.com at the CRS meeting.
"Women have a lot of trouble with current vaginal delivery systems - foam is simple."
The vaginal foam the company has developed is composed of US Food and Drug Administration (FDA) approved ingredients, is easy to apply with a simple disposable applicator, and spreads evenly over the vaginal cavity surface.
The foam is also bio-adhesive, of key importance in vaginal preparations as it affects the adhesion of the formulation to the mucosal surface and consequently the presence of the active drug at the target treatment site.
The company presented a poster showing the in vitro and in vivo adhesion profile of its vaginal foam at the annual meeting last week, with results showing that various formulation of the foam exhibit adhesive force in the same range as Dalacin (clindamycin), Pharmacia's antibiotic vaginal cream.
In in vivo studies with female sheep, the company found that the foam expanded effectively to cover the vaginal cavity and cervix area, which remained covered after 15 minutes. There were no signs of overflow, dripping or irritation after administration.
Foamix also studied the foam's lubrication profile, comparing it to the "gold standard" in vaginal lubrication - KY Gel. The company's research found that the foam's viscosity and lubricating properties were indeed comparable to the marketed KY product.
The foam itself can be formulated with a variety of drug compounds, and according to Friedman the company can reformulate almost any type of semi-solid to be compatible with the foam delivery system.
Due to the fact that initial products are also likely to be simple reformulations of existing treatments, the regulatory pathway will be relatively short, allowing for quicker time to market.
Friedman anticipates entering clinical studies with specific drugs next year, having only earlier this year inked a deal with women's healthcare and dermatology specialist Warner Chilcott to collaborate on the development of a therapeutic gynaecologic foam.
Aside from its gynaecological focus, Foamix also works on topical foam products for the delivery of active ingredients in the areas of dermatology, wound care and burn care. The company currently partners with eight pharmaceutical companies on ten products making use of the proprietary foam drug delivery system, as well as developing its own in-house pipeline of foam-based treatments.