Current issues
SkyePharma and PA Consulting announce collaboration agreement - new inhalation products
The world market for inhaled drugs to treat respiratory disease is estimated at more than $10 billion. In recent years there has been an increase in the diversity of products available and the technologies being applied in this field. The traditional CFC based pressurised metered dose inhaler (MDI) is being reformulated with non-CFC propellants and improved to meet demanding new regulatory requirements, in addition to other demands from patients and physicians.
Increasingly, inhaled asthma drugs will be delivered by products offering important new features such as breath-actuation, dose counters and improved product ergonomics. Each of these is aimed at improving patient compliance, which will make drug delivery by this route safer and more effective.
The British Thoracic Society guidelines for the treatment of asthma advocate the early use of inhaled steroids to treat the underlying inflammatory condition, and the use of a long acting bronchodilator to suppress symptoms between doses. Overcoming the problem of patient co-ordination in the use of MDIs is vital when inhaled steroids and long acting bronchodilators are used prophylactically. This is because there is no immediate feedback to the patient that a dose has been taken correctly, or indeed, incorrectly.
The use of a robust, reliable, low cost breath-actuated delivery system, in combination with environmentally friendly propellants, for the delivery of steroids and long acting bronchodilators will provide a major step forward in ensuring that patients receive a therapeutically effective dose every time. Such a system will eliminate the possibility of an increase in asthma symptoms and a decrease in lung condition, occurring as a consequence of poor patient co-ordination of inhalation and MDI actuation which often means that a sub-optimal dose of the drug is delivered to the lung.
SkyePharma has developed patented technologies (SkyeDry™,SkyeProtect™, SkyeFine™), to formulate a range of highly effective and safe anti-asthmatic products with the new non-CFC propellants (HFA 134a and HFA 227). PA has developed a novel breath actuation mechanism that has broad applicability across a range of formulations. The mechanism is specifically configured to suit high volume manufacture, and the design of the delivery system also includes new compliance - assisting features including dose counting.
The products will allow important drugs for the treatment of asthma to be delivered safely and effectively across the broad spectrum of patients groups for whom the MDI is the delivery system of choice.
PA Consulting Group and SkyePharma have signed an agreement to work together to develop new inhalation products to allow the effective delivery of a steroid and bronchodilator via the MDI, eliminating the problems of poor co-ordination experienced by the majority of patients using existing MDIs. PA will undertake the design and development of the breath actuated device mechanism while SkyePharma will undertake the pharmaceutical formulation work, and performance and clinical testing of the new product.
PA Consulting Group combines pharmaceutical industry expertise with an innovative and pragmatic approach to client assignments.
The company has an enviable track record in inhaler design and development, ranging from initial concept through to product realisation. The company's expertise spans all aspects of inhaler technology, encompassing metered dose inhalers, dry powder inhalers, nebulisers and novel enhanced delivery systems.
PA assignment teams comprise senior people who understand the drug development process within the context of today's pharmaceutical, market place pressures - development timescales, product launch, sales and market share, brand impact and market distribution.
Expertise - PA's 100+ consultants recruited from senior positions within the pharmaceutical industry represent many hundreds of man - years' experience.
Partnership - PA works in a collaborative and integrated way, often as a catalyst and enabler for a client's own resources.
Know-how - PA teams are multidisciplinary, able to blend skills together into a single, effective entity,
Delivery - focusing with a focus on seamless, timely implementation, PA is proud its clients say 'PA makes it happen'.
PA's broad management expertise:
- Strategic management
- Accelerating business growth
- Improving business design and performance
- Mobilising human resources
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