10103375Delivery of a Flexible, Agile and Sustainable Supply Chain for the Development of a Generic Triple Dry Powder Inhaler FormulationClosedCollaborative R&DInnovate UKThe annual economic burden of asthma and chronic obstructive pulmonary disease (COPD) on the NHS in the UK is in the order of £4.9 billion. A National Institute of Health and Care Excellence (NICE) statement suggests that two thirds of asthma deaths would be preventable with better access to basic care and the right treatment. Latest guidelines for treatment of asthma and COPD advocate escalation to triple therapy (with inhaled corticosteroids / long-acting beta-agonists and long-acting anti-muscarinic antagonists) for patients who have experienced one exacerbation in the previous 12 months. The leading innovator medicines formulate such actives in a single inhaler. This aids good patient compliance to the triple therapy with aim of providing maximum benefit for the patient. However, all triple inhalers on the market are currently patent protected, which means they have no direct competition and are expensive. At patent expiry others can register an equivalent cheaper product as a 'generic' medicine. Before generic medicines are approved, they must be proven to be equivalent to the branded medicine. Proving equivalence is not an easy matter and many of today's inhaled medicines have faced no generic competition for many years after patent expiry. This is most particularly true for those that contain multiple actives. Aston Particle Technologies (APT) has developed a unique technology, isothermal Dry Particle Coating (iDPC) which will simplify the development of triple Dry Powder Inhalers (DPIs). IDPC has been proven to be able to handle complex powder mixtures beyond the capability of established DPI formulation and manufacturing technologies. IDPC is an efficient, low energy process which provides exceptional ability to control the dosing performance from complex mixtures. In this study, APT is developing a generic to match the performance of a targeted market leader. This product will be characterised in collaboration with Nanopharm using their unique toolbox, SmartTrack, to match the formulation performance of a leading triple therapy DPI over a period of 18 months. If successful, this study will accelerate the development of a clinically-ready triple DPI so that the necessary preclinical and clinical studies can be progressed rapidly with high confidence of success. These two innovative UK technologies will bring a step function change in the speed with which generic inhalers can be brought to the market and significantly reduce the market exclusivity period of the leading therapy to meet the NICE prevention ambition by providing the right treatment, sustainably and cost effectively.