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i2c Pharmaceutical Services is the trading name for a Cardiff University spin-out company based on Cardiff University research excellence and specialising in pharmaceutical inhaler product research and development. i2c's research in formulation technologies and clinical testing has enabled development of new inhalational medicinal products for the healthcare markets in both developed and emerging countries. Impacts arising from research are at local, national and international levels and evidenced by marketed products, the improved business performance of commercial concerns and the creation of highly skilled jobs.
The transition, at the end of the 20th century, from ozone-depleting chlorofluorocarbons (CFCs) to hydrofluoralkane (HFA) propellants in metered dose inhalers (MDIs), for drug delivery to the upper airways in the lungs, taxed the ingenuity of formulation scientists and device design engineers. The regulatory requirement for clinical equivalence between the CFC and HFA products demanded an unchanged drug dosing regimen and identical lung deposition profiles.
Research funded by Chiesi Farmaceutici (Parma, Italy) in the Centre of Drug Formulation Studies (CDFS) at the University of Bath led to development of the Modulite® technology which met the challenges posed and mimicked the performance of CFC MDI using HFA propellants. The proprietary technology enabled Chiesi to re-formulate and commercialise a number of products, which now represent mainstay therapies in the treatment of asthma and chronic obstructive pulmonary disease (COPD).
The Modulite® technology has provided the greatest contribution to both the turnover and the global development of the Chiesi group, via several successful in-house developmements and collaboration agreements with leading pharmaceutical companies. Global sales of Chiesi's Atimos Modulite®, Fostair/Foster (25% of sales) and Clenil Modulite® (14.4% of sales) MDI products produced revenue of in excess of $450 Million in 2012.
Research by the School of Pharmacy played a key role in the 2008 regulatory approval of Janssen Pharmaceutica's HIV drug Intelence®. As a poorly soluble drug, Intelence® required specialist formulation and was the first formulation of its type to be approved by the FDA and EMA. Intelence® offers significantly improved clinical outcomes due to its efficacy in patients with HIV resistance. Global Intelence® sales in 2012 were $349M, with additional not-for-profit supplies to resource-limited countries. As a result of this landmark regulatory approval formulation development strategies at Janssen were adapted enabling a further poorly soluble drug to reach the market. Telaprevir, a second-generation Hepatitis C treatment (marketed as Incivek®, Incivo® & Telavic®), gained global regulatory approval in 2011. 2012 sales exceeded $1bn in the US alone.
Research at the University of Sheffield developed pharmacokinetic tools that enable prediction of drug absorption, distribution, metabolism and excretion, and potential drug-drug interactions. In 2001 the University created a spinout company, Simcyp Ltd, to commercialise the technology. The impacts are:
Biomedical devices that need to be implanted into the body typically experience the so-called foreign-body reaction: proteins adhere to the surface of the devices, leading to rapid loss of function and, eventually, to a requirement for replacing the device. Between October 2006 and September 2011, The University of Reading, in collaboration with the UK SME BioInteractions Ltd., developed and evaluated a range of new polymers for coating implantable biomedical devices, especially coronary stents and catheters. The result was a coating system that can deliver a drug controllably over a pre-defined period, leading to the commercial biomaterials platforms AdaptTM and AssistTM. This work resulted in capital investment by Biointeractions Ltd and a substantial increase in their research staffing.
Labelled compounds form an essential part of drug discovery and development within the pharmaceutical industry. Novel iridium catalysts, developed by Kerr at WestCHEM since 2008, have introduced a step-change in the ability to label pharmaceutical candidate compounds with radioactive (tritium) or non-radioactive (deuterium) isotopes.
The catalysts are applicable to specific types of compounds that comprise approximately one-third of all drug candidates. Advantages of the catalysts include greater efficacy (less catalyst needed and higher yield of labelled product, giving cost savings), greater speed (efficiency savings), and a significant decrease in radioactive waste compared with previous methods (environmental and safety benefits).
Even since 2008, their adoption within the pharmaceutical industry has been extremely rapid; e.g., the multinational pharmaceutical company AstraZeneca now applies the Kerr methodology to 90% of their relevant candidate compounds. Additional impact has been achieved by Strem Chemicals who have been manufacturing and marketing the catalysts worldwide since October 2012. Even in that very short period, multiple sales have been made on three continents providing economic benefit to the company.
Research by Professor Abdul Basit's group at the UCL School of Pharmacy is leading to improved treatments for ulcerative colitis and other conditions through increased knowledge of the complex physiology of the gastrointestinal tract. Improved understanding of in vivo drug release and uptake has allowed development of three patent-protected technologies for improved drug delivery: PHLORALTM, for release of drugs in the colon, and DuoCoatTM and ProReleaseTM formulations designed to allow intact transit through the stomach followed by immediate release upon gastric emptying. These technologies are the subject of licences and ongoing development programmes, with PHLORALTM currently in phase III clinical trials. The impact is therefore the introduction of enabling technologies that have positively influenced the drug development programmes of pharmaceutical companies.
A routine test to screen for patients genetically disposed to serious side effects from treatment with thiopurine drugs has been widely adopted following research by the Academic Unit of Clinical Pharmacology at the University of Sheffield. The test has spared patients painful and potentially life-threatening sepsis, and saved the considerable associated treatment costs which have been estimated to be over £9,000 per patient for a 17 day hospital stay. It has also led directly to a change in clinical guidelines and recommendations in both the USA and UK.
The health of people who inject illicit drugs, the formulation of harm-reduction policies, and the work of associated businesses and social enterprises have all benefited from the University's laboratory and practice research into the safety and efficacy of materials and equipment used in needle-exchange programmes. The research has informed the development of safer acids for injection preparation, safer injecting paraphernalia (e.g., spoons and filters) and an information film which has been distributed from needle exchanges on DVD and viewed over 50,000 times online. The research has led to enhanced support and protection for injecting drug misusers, and to advances in harm reduction in the UK, France and Canada.
Nearly all solid dosage forms contain drugs in crystalline form; and all crystals have the potential to `morph', suddenly, into different forms which can affect the safety and efficacy of the medicinal product. A number of high-profile cases in which marketed medicines had to be withdrawn [Lee, et al., Annu. Rev. Chem. Biomol. Eng. 2011, 2, 259-280] led multinational drug company Pfizer to conclude that a greater understanding of polymorphism was required to enable drug product design for the 21st Century. The University of Greenwich pioneered methods to predict crystal behaviour on the shelf and during manufacture that were affordable, timely and effective. It enabled Pfizer to select the optimal polymorphic drug form and manage risk associated with uncontrolled solid-state transformations, thereby safeguarding patients and avoiding huge costs.