The custom-made solutions in inhalation
A growing number of diseases are being treated with inhalation medicines. Many treatments now use Dry Powder Inhalers, which invariably need a high quality inhalation grade of lactose to power the formulation. Each Dry Powder Inhaler device is different; often they need a specific grade of lactose to ensure correct product performance, particularly for highly regulated markets. Due to regulatory demands, all our inhalation grade lactose is produced in dedicated inhalation production sites.
Regulatory Support
A Drug Master File is available to support the registration of a new formulation in the United States. For optimal control on the functionality and to comply with regulatory requirements, additional testing above the current pharmacopoeiais in place.
Technical Support
DFE Pharma Inhalation develops pharmaceutical lactose that facilitates delivery of your active ingredient to the lung. We work closely with pharmaceutical companies to design lactose particles with the required functionality for the drug, device and filling-platform. Our inhalation development team is available for customer's new product development. Please contact us to discuss your project in more detail.
Research and Development
Through our own research and close co-operation with research institutes and universities, we are continuously expanding our knowledge of lactose and other excipients that can be used for inhaled delivery. Of particular interest to us is the physiochemical behaviour of lactose under conditions relevant for use as an excipient in advanced pharmaceutical applications. With this knowledge we can advise our customers on the latest scientific developments.