Novel materials enable controlled and sustained release of chlorhexidine across a multitude of applications
10 October 2017: Pertinax Pharma today announces the commercial launch of its unique, proprietary Pertinax® technology, which provides controlled and sustained delivery of chlorhexidine (CHX). The revolutionary new technology has a wide range of potential applications across the wound care, dentistry, medical device and veterinary markets. The advantage of Pertinax is that, unlike conventional CHX products, it does not dissipate rapidly and can provide precisely measured antimicrobial efficacy over days, weeks, months or even years. Consequently, Pertinax has the potential to significantly improve a wide range of existing CHX products, whilst also opening up a number of entirely new applications.
Pertinax was originally developed at the University of Bristol with primarily dental and oral hygiene applications in mind but over the past 2 years the company has validated the material in a very broad range of clinical and veterinary applications. A UK patent for the technology was granted in November 2015, and a US patent was granted in August of this year. To date, eight peer reviewed papers* have been published on the use of Pertinax in a variety of applications, demonstrating the technology’s broad applicability, efficacy and safety.
Pertinax offers two key advantages over conventional CHX formulations. The material requires lower quantities of CHX, with continuous antimicrobial function provided by less frequent applications than conventional CHX products. The material also exhibits lower cytotoxicity than equivalent concentrations of conventional CHX.
Ashley Cooper, CEO at Pertinax Pharma, commented: “Since the inception of the company, we have focussed our efforts and investment on the characterisation of Pertinax materials and the development of a scalable manufacturing process. Having achieved these major milestones, we are now ready and eager to engage with prospective commercial partners”.
Dr. Michele Barbour, CSO, remarked: “Our unique, patented technology has wide potential application across human and vetinerary medicine. While there is scope for application across multiple sectors, wound care is our initial focus. Our technology is especially well suited to this field including in polyurethanes, alginates, acrylics and silicones”.
The company is actively seeking commercial partners in the wound care and medical device industries. Pertinax is available in kilogram quantities for development purposes, and the company plans to establish commercial cGMP production over the next 12 to 18 months.
Pertinax materials will be regulated under the EU Medicines Directive as a new active pharmaceutical ingredient (API) or under the EU Biocide Regulations as a biocide depending on the intended use – with the reduction of antiseptic usage an appealing plus point for regulators.
Sector specific applications
One potential application is in wound care where doped wound dressings incorporating Pertinax would be able to maintain the antimicrobial efficacy of CHX on the wound bed or in the dressing matrix to control biohazard build up from zero to 14 days as required. As a consequence, Pertinax significantly reduces the number of dressing changes required, which are in themselves an opportunity for secondary bacterial infection, as well as being time consuming and uncomfortable for the patient. Moreover, the material can replace the conventional, aqueous CHX digluconate present in existing wound dressings, sprays, rinses and cream products for direct topical application to wounds or skin. This providessuperior antimicrobial and antifungal function from these products, which may now provide days and even weeks of protection (as required) from infection compared to just a few hours in many cases. The company is also developing its own film forming polymers containing Pertinax – formulating them as sprays and gels as well for direct topical wound care usage.
In the field of dentistry, Pertinax can be used as a functional component of a number of dental materials, including those used for fillings (composites), adhesives and fissure sealants. Dentists are very familiar with CHX, using it to treat and prevent oral infections**. The incorporation of Pertinax into commonly used dental materials offers the potential to significantly reduce the incidence of secondary bacterial infections in the oral cavity.
Notes to the editor
Wound care products offering sustained antimicrobial protection are a growth industry in both human and veterinary markets. There are growing concerns over the current use of silver as the antimicrobial active in many commercially available products, in terms of efficacy, biocompatibility and environmental contamination. Moreover, the CHX digluconate contained in wound care materials is costly and technically challenging to manufacture as well as exhibiting only a short-term CHX release. Pertinax provides augmented function to all polyurethane, alginate and hydrogel wound dressings as well as commonly used wound care adhesives such as acrylics and silicones.
** Bacterial infection is one of the leading causes of filling failure and thus repeat or revision work by a dentist, and although dental materials have been created and marketed to combat this, they have proven largely ineffective. The technology can be used as a dopant for composite materials including dental impression and wound care materials and biomedical cements.
Pertinax can be used as an antimicrobial component of coatings on implants and catheters. In addition, the material can be used way beyond the healthcare sector in components of coatings for glass, metals and various polymer materials. * The technology has been shown to be efficacious against a wide range of microorganisms including methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa, Escherichia coli, Candida albicans, Streptococcus mutans, Streptococcus gordonii and Porphyromonas gingivalis.
The current internal non-GMP production capacity at Pertinax Pharma is several kilograms per week – amply sufficient to supply prospective commercial partners with evaluation and research material. The commercial scale cGMP production of Pertinax will be outsourced to CMP partners in Europe and the US during 2018 and early 2019 with requisite Quality Assurance and Quality Control procedures already in development and a Quality Management System in the process of being implements.
Pertinax® materials will be regulated under the EU Medicines Directive as a new active pharmaceutical ingredient (API) and under the EU Biocide Regulations as a biocide depending on their intended use. Pertinax will be regulated as a new API when it is used to treat an existing infection on broken skin - for example when used in human or veterinary wound care applications. The technology will be regulated as a biocide when used, for Example, as a topical foot sprays for livestock animals, to prevent infections.
The company is in the process of implementing its regulatory plans with the objective of submitting an Active Substance Master File for an API and Biocide in early 2019.
About Pertinax Pharma
Pertinax Pharma Ltd – originally a spin out from the university of Bristol - was established in April 2015 to commercialise its proprietary and patented Pertinax® technology. The antimicrobial material has wide ranging potential application across wound care, dentistry, medical device, veterinary and broader markets. Pertinax provides controlled and sustained release of chlorhexidine (CHX) – overcoming the short duration of antimicrobial activity of conventional CHX products. The antimicrobial can be formulated to persist for days, weeks, months or years – depending on the application. Pertinax requires lower quantities of CHX - with continuous antimicrobial function provided by less frequent applications – and it also exhibits lower cytotoxicity than equivalent concentrations of conventional CHX.
