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Onepill - variable dose combination bilayer tablets via multi-layered extrusion platforms

Description:

Global life expectancy has increased significantly over the last half century. Recent estimates suggest that on average, life expectancy reaches 80 years, a gain of more than 10 years since 1960. It is well accepted that placing greater emphasis on public health and disease prevention, and improving the quality and performance of health care systems, can achieve further progress in life expectancy. Chronic (non-communicable) diseases including cancer, cardiovascular diseases, chronic respiratory conditions and diabetes, are now the main causes of disability and death in developed countries.

In the United States, 71 million people have cardiovascular disease (CVD), whereas in the UK, CVDs cause one quarter of all deaths annually. The cost of premature death, hospital treatment and prescriptions is estimated at £19 billion, with hospital admissions due to heart failure set to rise by over 50% over the next 25 years, largely due to an ageing population. Drugs used to treat CVD are ACE inhibitors, beta-blockers, statins, aspirin and calcium channel blockers, among others. Typically, statins and antiplatelet drugs are prescribed together and a recent prescription cost analysis for England in 2012 showed that 80% of all antiplatelet drugs prescribed where 75mg aspirin at a cost of £27.7 million to the NHS. Similarly, 66% of all statins prescribed were simvastatin at a total cost of £59.7 million. Interestingly, the optimum clinical benefit when prescribed a statin and aspirin combination is achieved when aspirin is taken around midday whereas simvastatin should be taken in the evening when cholesterol biosynthesis is at its peak. This dosage regime often leads to non-compliance with regard to simvastatin. Unfortunately, due to the short half-life of simvastatin, a missed dose may have a significant negative therapeutic effect, with an increased likelihood of hospital treatment, increasing an already heavily strained NHS budget.

There is therefore a definite need for a drug platform capable of delivering both compounds (aspirin and simvastatin) in a single administration. In providing such, patient compliance, clinical outcomes and management of CVD may be improved. Through the use of advanced extrusion technologies that have been developed at Queen’s University Belfast over the last decade, multi-layer solid dosage forms will be manufactured that will offer immediate release of aspirin and controlled release of simvastatin in a single solid dosage form. In doing this we aim to address a real and significant problem associated to non-compliance through reformulation of two important CVD drug compounds. This project is positioned at the rapidly developing interface between pharmaceutical and chemical engineering technologies. The manufacture of solid dosage form pharmaceutical products is evolving rapidly, with a significant movement away from standard unit operations (milling, mixing, drying and tableting) that are both time-consuming and expensive. Over the last five years several important developments in continuous pharmaceutical processing have been made, the most notable being the $40 million collaboration between Novartis and MIT to establish continuous manufacturing facilities for solid dosage forms. This project builds upon this paradigm shift through the use of advanced engineering technologies developed at QUB that will be applied to manufacture innovative delivery platforms tackling a major health problem (CVD). Moreover, given that simvastatin and aspirin are the top two prescribed drugs in the UK (37 and 34 million, respectively), the market for this new delivery platform is vast.

The researchers are part of the Medical Polymers Research Institute (Interdisciplinary Research Centre) and have a successful track record in commercially–focused research and development. They also work closely with leading local and leading international Pharmaceutical companies and have developed significant IPR in polymeric drug delivery.

 

Patent Information:
Category(s):
  • Pharmacy
  • For Information, Contact:
    Ann Mcconnell
    The Queen's University of Belfast
    02890 971510
    Ann.McConnell@qub.ac.uk
    Keywords:
  • Cardiovascular Diseases
  • Medical drug delivery
  • Case ID
    1516-011
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