Final Report Summary - HIPODERM (High Potency Dermatologicals)
HIPODERM (from high-potency dermatologicals) is a multi-disciplinary, cross-sector European partnership dedicated to the development of innovative drug delivery solutions for disease management. The consortium was founded to develop a core scientific platform for the design and manufacture of dermal-translocation devices for the controlled delivery of highly potent drug candidates. One of the primary aims of the HIPODERM project was the establishment of a sustainable research cluster involving the members of the consortium and intersectorial and international knowledge transfer within that cluster. The collaborations involved within each of the four partners of HIPODERM were established initially at the commencement of the project and have been grown and nurtured over the lifetime of the project. Regular contact through HIPODERM meetings, video and tele-conferences in addition to both long and short-term secondments has trained and upskilled members from both industry and academia on current practise within each related field and has also facilitated the exchange of knowledge across a range of expertise, between different sectors. Furthermore, this contact between the seconded fellows placed with the industrial partners and the academic institutes across both countries has served to strengthen and enhance the collaborations formed. In addition, all except one of the newly recruited researchers have successfully secured employment following the completion of the project in both the academic and industrial sectors, a testament to the quality and success of the project in terms of intersectorial knowledge transfer and upskilling.
The overall project objectives included the development of a core scientific platform for novel dermal-translocation high potency drug delivery in addition to designing and producing a controlled drug release system (CDRS) for these high potency target drug molecules. The design and development of a microneedle array system and incorporation of the CDRS into the microneedles with subsequent dermal delivery studies were also key objectives of the project. Furthermore, optimisation of the drug delivery system and release profiles for a number of drug molecules in animal and human skin formed key objectives of the project. In order to meet these objectives, knowledge and expertise originally residing at individual partner sites was shared facilitating laboratory experimental work to design and develop a number of novel drug delivery systems. A number of transdermal delivery methods were designed, formulated produced and evaluated including microneedles and transdermal patches and each system was assessed for its ability to deliver the target drug into the skin, using both animal and human skin (full ethical approval was sought and granted facilitating these components to be used). Analytical techniques were used to determine the concentration and depth of penetration of the drug with results compared to the use of the current commercial formulation. Furthermore, polymeric drug delivery systems were developed in order to control the rate of drug delivery and minimise side effects which may be caused by the sudden, rapid release of drug into the skin.
The project has achieved all of its objectives as well as delivering a number of additional outcomes, as evidenced by the many outputs of the project, including general advancement of knowledge and the generation of commercially relevant intellectual property in the field of transdermal drug delivery. The main results of the project are best summarised in the titles of some of the aforementioned outputs. For example, “Dissolving polymeric microneedles for the treatment of non-melanoma skin cancers” and “Fabrication and characterization of polymeric microneedles for transdermal drug delivery of high-potency drugs” were both presented at an international conference while a peer-reviewed article entitled “Structural characterisation and transdermal delivery studies on sugar microneedles: Experimental and finite element modelling analysis” was published in the European Journal of Pharmaceutics and Biopharmaceutics. Furthermore, one of the long term seconded staff used her research work in the project as the subject of her PhD thesis entitled “The Development of Novel Dermal Translocation, High Potency Drug Delivery Systems” and this PhD was awarded to her (graduation January 2015).
Overall, the research undertaken in the HIPODERM project has led to over 22 distinct appearances in conference proceedings composed of national and also two large international conferences, a number of press releases for dissemination to the wider public, an award nomination for the highly prestigious Pharma industry Awards in the Partnership Alliance of the Year category, and will result in 3 invention disclosures and 6 peer reviewed publications.
The results from the project have a wide impact to the scientific community in the field of transdermal drug delivery in addition to potentially having a wider societal impact in the medium to longer term. The development of microneedle and transdermal devices delivering controlled quantities of chemotherapeutics will serve a number of purposes; the devices are single administration (and can be self-applied) which will improve patient compliance, the method of administration will allow targeted delivery of significantly lower concentrations of chemotherapeutic agents reducing exposure to the compounds and as such, the associated side-effects. Both aspects contribute to an improved patient quality of life (ease of treatment and reduced side-effects). Due to the incredibly high incidence of skin cancers (50% of Caucasians aged 65 and over will develop skin cancer) the development of a new therapeutic option has the potential to make a significant socio-economic impact.
The overall project objectives included the development of a core scientific platform for novel dermal-translocation high potency drug delivery in addition to designing and producing a controlled drug release system (CDRS) for these high potency target drug molecules. The design and development of a microneedle array system and incorporation of the CDRS into the microneedles with subsequent dermal delivery studies were also key objectives of the project. Furthermore, optimisation of the drug delivery system and release profiles for a number of drug molecules in animal and human skin formed key objectives of the project. In order to meet these objectives, knowledge and expertise originally residing at individual partner sites was shared facilitating laboratory experimental work to design and develop a number of novel drug delivery systems. A number of transdermal delivery methods were designed, formulated produced and evaluated including microneedles and transdermal patches and each system was assessed for its ability to deliver the target drug into the skin, using both animal and human skin (full ethical approval was sought and granted facilitating these components to be used). Analytical techniques were used to determine the concentration and depth of penetration of the drug with results compared to the use of the current commercial formulation. Furthermore, polymeric drug delivery systems were developed in order to control the rate of drug delivery and minimise side effects which may be caused by the sudden, rapid release of drug into the skin.
The project has achieved all of its objectives as well as delivering a number of additional outcomes, as evidenced by the many outputs of the project, including general advancement of knowledge and the generation of commercially relevant intellectual property in the field of transdermal drug delivery. The main results of the project are best summarised in the titles of some of the aforementioned outputs. For example, “Dissolving polymeric microneedles for the treatment of non-melanoma skin cancers” and “Fabrication and characterization of polymeric microneedles for transdermal drug delivery of high-potency drugs” were both presented at an international conference while a peer-reviewed article entitled “Structural characterisation and transdermal delivery studies on sugar microneedles: Experimental and finite element modelling analysis” was published in the European Journal of Pharmaceutics and Biopharmaceutics. Furthermore, one of the long term seconded staff used her research work in the project as the subject of her PhD thesis entitled “The Development of Novel Dermal Translocation, High Potency Drug Delivery Systems” and this PhD was awarded to her (graduation January 2015).
Overall, the research undertaken in the HIPODERM project has led to over 22 distinct appearances in conference proceedings composed of national and also two large international conferences, a number of press releases for dissemination to the wider public, an award nomination for the highly prestigious Pharma industry Awards in the Partnership Alliance of the Year category, and will result in 3 invention disclosures and 6 peer reviewed publications.
The results from the project have a wide impact to the scientific community in the field of transdermal drug delivery in addition to potentially having a wider societal impact in the medium to longer term. The development of microneedle and transdermal devices delivering controlled quantities of chemotherapeutics will serve a number of purposes; the devices are single administration (and can be self-applied) which will improve patient compliance, the method of administration will allow targeted delivery of significantly lower concentrations of chemotherapeutic agents reducing exposure to the compounds and as such, the associated side-effects. Both aspects contribute to an improved patient quality of life (ease of treatment and reduced side-effects). Due to the incredibly high incidence of skin cancers (50% of Caucasians aged 65 and over will develop skin cancer) the development of a new therapeutic option has the potential to make a significant socio-economic impact.