Project: Phytate/zinc: a synergic combination in mouthwashes and dentifrices for the treatment and prevention of dental calculus

The members of the consortium agreement (CA) for the ASB-01 development project are Laboratoris Sanifit S.L. (Spain) and Italmed srl (Italy)._x000D_Sanifit is a biotech company, founded as a spin off from the University of the Balearic Islands (UIB) in 2004, focused on the research and development of pharmaceutical products in diseases related to pathological processes of calcification and resorption. Currently, Sanifit dedicates its resources primarily to the development of phytate (InsP6) as active ingredient (AI) in such diseases. On the other hand, Italmed srl is a company with an international presence with the aim to research, develop and commercialize innovative products in the dental field._x000D__x000D_The CO goals of the ASB-01 project are:_x000D__x000D_• To develop commercial products in the form of mouthwashes or rinses and toothpastes which contain InsP6 as AI and zinc in order to avoid and/or reduce the accumulation of dental calculus (DC), also known as tartar, on teeth._x000D_• To establish trade agreements with leading companies in the oral healthcare market for commercialization of products derived from this project._x000D__x000D_The tartar is an insoluble deposit of calcium phosphate around the teeth formed by the calcification of dental plaque (a bacterial biofilm that is formed on the surface of the teeth). These bacteria favours the deposition of calcium salts and generates acids that cause tooth decay and leads to gingivitis and periodontal disease. The tartar formation rate varies among individuals depending on factors such as the presence or absence of crystallization inhibitors (CI). Crystallization is the process by which the calcium salts join in a microscopic lattice of characteristic geometry, separating out of the solution to form a solid phase. CI are substances which by adsorption on the faces of a crystal core, prevent or reduce growth of the crystals._x000D_InsP6 is a natural molecule abundant in vegetable seeds and legumes. In animals that feed on such plant material, it is present as ionized form in all organs and tissues in animals, but it cannot be endogenously synthesized so that its concentration in biological fluids is dependent on its presence in the diet._x000D_The basis of this project is the fact that InsP6 acts as a potent inhibitor of crystallization of hydroxyapatite (HAP) in the treatment of DC (constituted by HAP). InsP6 adsorbs on the surface of HAP preventing the development of microparticles adhered to the teeth which would be the seeds for new deposition of insoluble HAP. In vitro and prospective clinical studies carried out by Sanifit’s founders and the UIB have demonstrated the remarkable efficacy of an InsP6/zinc synergic combination in the treatment of DC. It is one of the few products with the ability to directly inhibit the growth of DC. To date, no effective inhibitory combination of substances to prevent the formation and growth of HAP encrustation has been explicitly used in any commercial product intended for oral hygiene._x000D_This project is supported by a patent (WO/2007/093611) which protects the specific compositions of InsP6 and zinc that are effective in inhibiting the accumulation of DC. This patent relates to inventions by Sanifit’s founders and the UIB and is licensed by UIB exclusively to Sanifit in the whole territory protected by the patent and during the entire period of patent life. In 2009 Sanifit signed an agreement with Italmed which granted Italmed rights to certain countries for co-development, registering and marketing products of Sanifit for the prevention and treatment of DC from the dental care area. The license covers the specific Sanifit’s know-how related to this project and rights on the patent._x000D_The advantage of our product for the general population is its demonstrated superior anti-tartar effectiveness. Moreover, this project helps European public health programs aimed at reduce dental hygiene deficiencies._x000D_Strategy for the ASB-01 project aims to develop the commercial version of a line of products and then to be able to license both the finished product as well as the patent to industry Ps for further marketing to added value involved. These products will be commercialized in the pharmacy/chemist’s/drugstore channel, at least during the early years of its commercial life and will allow the industry Ps to develop a new brand (or a line extension) to exploit the demand for effective products to gain the market share necessary to return a profit to all participants._x000D_Sanifit and Italmed join in a consortium to run this project by sharing their know-how and necessary resources to successfully develop innovative products to monitor health problems in the general population._x000D_

Acronym ASB-01 (Reference Number: 5101)
Duration 01/01/2010 - 31/12/2012
Project Topic The project’s goal is to develop a commercial line of products containing zinc and phytate as active ingredients in order to avoid and/or reduce the accumulation of tartar, on teeth. Two cosmetic products and two products falling under medical devices regulation will be developed.
Project Results
(after finalisation)
The CO results of the ASB-01 project were:_x000D_to develop commercial products in the form of mouthwashes or rinse and toothpastes which contained InsP6 as active ingredient and zinc in order to avoid and/or reduce the accumulation of dental calculus (also known as tartar), on teeth; to create agreements with companies in oral healthcare market to commercialize products derived from this report and to create new subjets of interest._x000D_The ASB project has gone ahead fulfilling the expected goals un every WP and ended on last 31st december 2012._x000D_Since the starting date of the project and from the financial point o view, there was no significant deviation of the project envisaged by the members of the consortium._x000D_The contribution of Italmed in the Project achieved the following results:_x000D_Development of a formulation for the commercial cosmetic products;_x000D_Development for the commercial medical devices products_x000D_To manage and develop R&D projects._x000D_To improve our dental field know out._x000D_To establish trade agreements._x000D_The work package developed by Italmed were:_x000D_WP3: with its team (Regulatory and quality, pharmacological, commercial adviser) Italmed followed all the steps of the development concerning formulation, stability and biocompatibility studies, challange test, product test._x000D_WP4: with its team (Regulatory and quality, pharmacological, commercial adviser, Technical chimical physical dept.) Italmed studied the realization of a MD._x000D_Italmed followed with Sanifit all the WP (1,2,5)_x000D__x000D_
Network Eurostars
Call Eurostars Cut-Off 3

Project partner

Number Name Role Country
2 Laboratoris Sanifit S.L. Coordinator Spain
2 Italmed srl Partner Italy