Research and development
Through our own research and close co-operation with research institutes and universities, DFE Pharma is 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.
Our research activity has made us a leading authority on dry Powder Inhalation lactose. This growing knowledge Base is a key resource that is always available to clients and partners. With this knowledge we can advise our customers on the latest scientific developments and play an active part in driving better performance.
Dedicated production sites
DFE Pharma is the only excipient supplier with 3 production sites on 2 different continents dedicated to inhalation-grade lactose, offering customers the possibility of security of supply from production locations. This combination of specialist centers allows us to cover any combination of excipient formulation and ensure rapid supply to any geographical location.
Each of these production locations has their own unique capabilities and product range: Veghel (Netherlands) for production of Respitose® products, and Borculo (the Netherlands) and Kapuni (New Zealand) for production of Lactohale®.
All our inhalation production sites operate under GMP standards and are supplying to commercialized end-products currently available in the market. For more information on our production sites, please slect one of the 3 production sites:
Veghel (the Netherlands) for production of Respitose®
Respitose® products are characterized by the excellent control of the particle size of the lactose. Respitose® is produced by using a sieving process from a range of starting materials. The application of various sieving steps allows DFE Pharma to offer an extended range of sieved inhalation lactose.
On request of customers, the different grades can be blended to achieve an optimal performance.
Borculo (the Netherlands) for production of Lactohale®
In Borculo, Lactohale® Inhalation lactose is produced in a dedicated inhalation lactose production site. The plant was designed to meet the strict quality requirements that are demanded by the FDA.
The Lactohale® products from Borculo can be divided in three categories, each of which reflects the primary manufacturing technique that is used in its production. Lactohale® 100 is produced by sieving, Lactohale® 200, 210, 220 and 230 by milling and Lactohale® 300 by micronising.
Lactohale® can also be customised in order to meet specific particle size profiles. This can include combining the products mentioned above in the final blending stage so that the flow properties can be matched to the correct fines content for product performance. In the final processing step all Lactohale® products are blended in order to ensure that the batch is homogeneous.
Kapuni (New Zealand) for production of Lactohale®
In Kapuni, a combination of the following production techniques can be applied to produce and customise a range of coarse lactose products: milling, classification and blending. State-of-the-art particle size techniques are available to evaluate the resulting products.
The Lactohale® products from Kapuni are available for all DPI customers who need either an unique lactose product or consider to invest in risk mitigation. Security of supply by production at multiple sites can be developed in joint collaboration between DFE Pharma and our customers. Even though specifications of specific grades are similar, fine-tuning of the lactose properties might be required to achieve similar performance for your specific needs.