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Dry-powder-inhaler (DPI) technology using engineered particles has become the preferred approach for inhalation formulation as compared to other dry-powder technologies or aerosols.
Capsugel Dosage Form Solutions has invested to provide two critical components needed to develop effective inhalation dosage forms for its clients:
We currently support preclinical through Phase III clinical manufacturing scales. We are also working with device makers to develop finished products and further optimize this offering.
Our industry-leading expertise in the production of engineered particles for DPI formulations is based on spray-drying technology. Spray-dried engineered particles have been shown to offer substantial advantages over conventional lactose blend technology (micronized API and a lactose carrier) used in DPI formulations:
Our Bend Research division is the recognized leader in spray-dried dispersion (SDD) technology and particle engineering for the pharmaceutical industry. Our extensive intellectual property, formulation and process expertise has been utilized by clients in the development of proprietary inhalation formulations. Several technology options - amorphous drug dispersions, crystalline drug in amorphous matrices, nano-amorphous drug in amorphous matrices, and combination approaches - can be utilized. The approach selected depends on the drug characteristics and the target product profile for a specific application.
Our development and clinical inhalation powder-manufacturing - based in Bend, Oregon - supports all phases of inhalation product development. The facility features state-of-the-art cleanrooms for spray-drying and capsule-filling to enable safe progression of formulations through clinical testing. A high-containment suite handles a wide range of compound types and safety classifications ranging from biologics to small molecules.