Inhalation Formulation Technologies

Demand for pulmonary and nasal delivery is a rapidly growing area, driven by the prevalence of chronic obstructive pulmonary disease, especially in developing countries.

Dry-powder-inhaler (DPI) technology using engineered particles has become the preferred approach for inhalation formulation – compared to other dry-powder technologies or aerosols.

Capsugel has invested in capabilities that provide the two critical components needed to develop effective inhalation dosage forms:

  • Inhalation formulation and process design using particle-engineering
  • A full range of custom-engineered DPI capsules

We currently support preclinical through Phase III clinical manufacturing. We are also working with device makers to develop equipment for the production of finished products to further optimize our 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 the lactose blend technology (micronized API and a lactose carrier) used in conventional DPI formulations:

  • Improved efficiency – more drug is delivered to the lung and less waste occurs
  • Improved formulation flexibility – spray-dried DPI formulations are not limited to crystalline drugs or dependent on jet milling, compatibility with lactose, or aerosolization suitability
  • Suitability for protein delivery – there are no lactose-incompatibility issues

Pioneered by Capsugel division, Bend Research, our spray-dried particle engineering technology is finding increasing applications in the biopharmaceutical industry. Customers have benefitted from our extensive intellectual property and formulation and process expertise 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 used. Selection depends on the characteristics of the drug and the target profile for the formulated product.

Dispersion

API and polymer dissolved in (co)-solvent

Crystalline API in Amorphous Matrix

API wet-milled or jet-precipitated in water with a dissolved polymer

Nano-amporphous API Amorphous Matrix

Emulsion formed with...

  • API dissolved in an immiscible organic solvent

  • Polymer dissolved in water

Mixed Approaches

Solution / suspension(s) combined prior to spray drying

Our development and clinical inhalation powder manufacturing capabilities are located in Bend, Oregon and support all phases of inhalation product development. The facility features state-of-the-art clean rooms for spray-drying and capsule-filling to enable safe progression of formulations through clinical testing. A high-containment suite supports safe handling of a wide range of safety classifications and compound types, including biologics and small molecules.