Inhalation Capsules

At Capsugel, we believe that robust product design is key to successfully advancing compounds and results in overall speed to market. Having formulated over 4,000 compounds, we routinely develop custom approaches that address a range of drug-delivery challenges.

The number of inhalation formulations for nasal and pulmonary drug delivery continue to grow, driven by the prevalence of respiratory diseases, especially chronic obstructive pulmonary disease (COPD). Capsugel offers an inhalation drug-delivery approach based on proven particle engineering through spray-drying technology, as well as specially designed capsules for dry-powder inhalation (DPI) drug applications.

Specialized Enabling Technologies

In response to evolving market trends, regulatory guidance and customers’ needs, Capsugel has developed specialized enabling technologies and capabilities to address a range of formulation challenges. Specialized formulation expertise based on particle engineering and specialized capsule technologies provides a major drug-development opportunity for nasal and pulmonary drug delivery.

Dry-powder-inhalation 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 three effective inhalation dosage forms:

  • Inhalation formulation and process design using particle engineering
  • Specialized filling equipment to deal with the low dose and handling requirements for inhalation drug products
  • A full range of custom-engineered dry-powder-inhalation 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 dry-powder inhalation formulations is based on spray-drying technology. Spray-dried engineered particles have been shown to offer substantial advantages over the lactose blend technology (micronized drug 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 dry-powder inhalation 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

Capsugel Center of Excellence at Bend, Oregon

Pioneered by Capsugel division Bend Research, our spray-dried particle-engineering technology is finding increasing applications in the biopharmaceutical industry. Customers have benefited 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. Technology selection depends on the characteristics of the drug and the target profile for the formulated product.

Dispersion

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API and polymer dissolved in (co)-solvent

Crystalline API in Amorphous Matrix

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

Nano-amorphous  API Amorphous Matrix

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Emulsion formed with...

  • API dissolved in an immiscible organic solvent

  • Polymer dissolved in water

Mixed Approaches

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Solution / suspension(s) combined prior to spray drying

Our development and clinical manufacturing capabilities for dry-powder inhalation formulations 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.