West launches pulmonary and nasal testing service
to help customers testing pulmonary and nasal drug products and
their delivery devices.
The launch takes West into one of the fastest-growing areas of the drug delivery market, according to recent data published by Freedonia. This predicted that the market for inhalable delivery methods will grow by 9 per cent a year through to 2012. driven by the increasing incidence of respiratory conditions such as asthma and chronic obstructive pulmonary disease. "Moving pulmonary and nasal drug products from early-stage development to the market is challenging for pharmaceutical, biopharmaceutical and medical device companies," said Fran DeGrazio, West's vice president for marketing and strategic business development. "The challenges include testing the drug product and delivery device," she added. Companies may not have a proven device selection process in place and may not have validated laboratory methods or instruments required to test the drug product and the device. Any misstep along the way runs the risk of costly project delays. West says its analytical services for pulmonary and nasal drug products encompass early-stage development, clinical development and post-product launch stages. The service covers chemistry, manufacturing and control (CMC) testing of nasal sprays, oral sprays, metered dose inhaler (MDI), dry powder inhaler (DPI) and nebulisers. The company can also offer in vitro bioavailability/bioequivalence (BA/BE) studies, in-use tests and long-term stability studies, including those involving high-potency compounds. Results are reported on a Certificate of Analysis (CoA), using a format consistent with the CMC Section of an annual report, it added. "We can help clients move their pulmonary and nasal drug products to market without undue delay by applying our knowledge and experience in pharmaceutical packaging, drug product development and regulatory guidances to provide clients with proven analytical laboratory support," said DeGrazio. The nasal and pulmonary product testing will be conducted at West's laboratory in Lionville, Philadelphia. West Analytical is a division of West Pharma Services.
