Disgrifiad o Effaith
Key achievements:• Welsh Government SMART Partnership funding (50% of total project cost) – supporting more Welsh businesses to innovate
• Product now trademarked and licensed for sale as a traditional balm – supporting trade
• Immediate and long-term job creation in line with the aspirations of the 2015 Wellbeing of Future Generations Act which aims to create a more prosperous Wales
Crynodeb Effaith ar gyfer y Cyhoedd
Project Timeline: • November 2017 – innovation funding support for a Technical & Commercial feasibility study at Bangor University • July 2018 – product successfully registered and licensed for sale to consumers as a traditional balm & brand name and intellectual property trademarked • August 2018 – product makes market debut at National Eisteddfod in Cardiff on sale to consumers for first timeDisgrifiad o'r ymchwil sylfaenol
The project was a collaboration between Mon Naturals Ltd and Bangor University (BioComposites Centre), and investigated the antimicrobial properties of a natural remedy (balm) developed over generations on Ynys Mon, for the treatment of burns and a range of skin conditions. The company is developing this formulation, with the aim of incorporating it into a commercial, class I medical device for applications in wound healing and the functionality testing. As proposed in the project is a key step in validating any claims for this application.The Mon Naturals Ltd balm, has been registered under the name Eliawen Cream™ and based on a combination of a specific type of rendered pork fat and locally sourced slate. The origins of Eliawen Cream™, can be traced back as far as the early 19th Century to Ynys Mon, where it was prepared and used successfully for treating and healing a victim with substantial burns to the skin. The formulation is made from unique ingredients, found only in Snowdonia, and has been used by local people on the island for generations. The product is applied externally as a cream and is used to treat a range of skin conditions, including burns, wounds, eczema and dermatitis. It leaves no visible marks or blemishes, and also gives instant pain relief.
The locally sourced purple slate, used in the Eliawen Cream, has high levels of aluminium and iron oxides present. Research published by researchers in the USA, on the antimicrobial properties of ‘healing clays’, described how working in tandem, chemically reduced iron (Fe2+) and aluminum (Al3+) cations in blue clays can kill pathogenic bacteria, such as E. coli. The reduced iron, which in small amounts is required by a bacterial cell for nutrition, results in an opening in the cell wall, which in combination with the reduced aluminium results in an overabundance of iron, effectively poisoning the cell and killing it as the reduced iron becomes oxidised.
The technical challenge for this SMART partnership project was to investigate how the Welsh purple slate effects the antimicrobial properties of the resultant formulation and whether the presence of iron (III) oxide in the slate is providing additional anti-microbial properties. The mechanism for this maybe through the generation of free radicals which damage and eventually destroy the bacterial cell walls and there may also be a synergistic effect between the aluminium and iron cations which may result in bacterial cell ‘poisoning’.
The aims of the project were as follows:
• Screening the antimicrobial and antifungal properties of the Eliawen cream against a range of bacteria and fungi
• Individual screening studies to look at the slate dust separately
• Determine options for incorporating the Eliawen formulation into other products e.g. medical devices (wound dressings), including regulatory requirements for registration of the product as a cosmetics ingredient.
The properties of the Eliawen Cream were assessed against a number of common pathogens as part of the three technical work packages, including:
• Acinetobacter baumannii – opportunistic pathogen in wound and surgical infections – problem with multi-resistance
• Escherichia coli – Gram negative bacteria, normally associated with faeces but can cause necrotizing fasciitis
• Pseudomonas aeruginosa – considered opportunistic pathogen – multi-resistant – produces toxins which enter blood stream
• Staphylococcus aureus – most common cause of skin infections such as boils etc – MRSA strains can cause necrotizing fasciitis with no available antibiotics
• Candida albicans and Candida glabrata – opportunistic yeasts associated with diabetes – many resistant to known fungicides in deep wounds – causes 20% of serious infections
The work plan proposed in the original application, relating to the screening of the functional (antimicrobial properties) of the Eliawen Cream, was followed without significant deviation and there were a number of conclusions:
i. Slate dust has complex effects on microorganisms and their growth
ii. Minor increase in population of Staphylococcus cells
iii. Stops secondary stage bacterial growth
iv Extractives show 36% reduction of Pseudomonas cells
In addition to the technical work packages relating to the screening of the functional properties of the Mon Naturals formulation, the project team collaborated with a third comapny, PWC Solutions Ltd, Ellesmere Port, to register the Eliawen cream as a cosmetics ingredient. The process can take several months to complete and there are fewer regulatory barriers than for a medicinal product.
To place a cosmetic product on the market in the EU the product must comply with legislation on Cosmetic Products 1223/2009. The main elements of this process include:
• Compilation of a CPSR (Cosmetic Product Safety Report)
• Production of a PIF (Product Information File)
• Registering the product on CPNP (Cosmetic Product Notification Portal)
• Ensure that product labelling is compliant with requirements highlighted in 1223/2009
The production of a CPSR involves compiling a large amount of information on the product to be registered, including:
• Product Formulation details
• Materials Safety Date Sheet (MSDS) for each Ingredient (EU REACH Standard)
• Allergen Declaration for any Perfume, Essential Oil, Fragrance or Flavour
• INCI Name, CAS number and Exact % value
• Stability Test Results
• Total Count + Specific Pathogens
• Challenge test if appropriate (water content + use)
• Copy of the Artwork (including any rebrands used in different countries)
• Packaging suitability including: Specification of pack material, composition of packaging
Mon Naturals Ltd and Bangor University supplied all of the relevant information to PWC Ltd, to assist with the registration process for the Eliawen Cream and this process was successfully completed before the National Eisteddod (Cardiff, August 2018), where the product was officially launche
| Statws effaith | Potensial |
|---|---|
| Dyddiad effaith | 1 Hyd 2017 → 30 Awst 2018 |
| Categori effaith | Economegol |