Benefit from a flexible, integrated service offering inclusive of:

  • API characterization and assessment
  • formulation development
  • Technology selection
  • Particle engineering
  • API development

And much more. Phase-appropriate jet mills and spray dryers are in place to facilitate rapid proof of concept evaluations, cGMP clinical trial manufacture and commercialization of particle-engineered intermediate.

 

Popularity for nasal or pulmonary delivery continues to rise

Inhaled drug products for nasal or pulmonary delivery continue in popularity due to the prevalence of respiratory diseases around the globe. Additionally, the lung’s absorptive capacity continues to be explored as an attractive delivery point for both local and systemic applications. Particle engineering, a core strength of Lonza, is critical in achieving the particle size distribution required for effective drug delivery  (inhalation formulation development) using dry powder inhaler (DPI) devices.

 

Get the most appropriate technology for your specific DPI application

DPI technology has become the preferred approach for inhalation formulation vs. other dry powder technologies or aerosols. Lactose-blend or carrier-free based approaches to DPI require precise particle engineering through either micronization / jet milling or spray drying, respectively. Expertise and depth of capabilities in both particle size reduction and spray drying allow our scientists to choose the most appropriate technology for your specific DPI application.

Our premier particle engineering platform is complemented by a full range of product development. Our product development teams are well versed in powder performance parameters for capsule-based devices.

 

 

Locally administered biologics are of great interest for the treatment of lung diseases, but the development of shelf-stable, dry-powder formulations for inhalation has remained a challenge. This innovative work describes manufacture of a monoclonal antibody (mAb) as a stable, respirable, biologically active pulmonary formulation using spray drying.

Watch the RDD 2021 Program Presentation

Pulmonary Delivery of Monoclonal Antibody Spray-Dried Dispersions.

The choice between jet milling and spray drying technology is dependent upon a number of factors including:

  • API characteristics and ability to be jet milled
  • Lactose compatibility
  • Physical properties of the API
  • Process and scale-up issues
  • Content uniformity concerns (especially for combination therapies)
  • Particle size distribution requirements
  • Amount of NCE available for feasibility work

Our scientists have the expertise and experience to rapidly identify the formulation and enabling technology required to meet your target product profile. Both particle engineering approaches continue to find broad application in inhaled formulations. However, spray drying is finding increased application in DPI approaches for larger molecules or when dispersion, nano-amorphous matrices, crystalline API in amorphous matrices, or mixed approaches are required.

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-amorphous 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 at our Bend (OR), US site and support all phases of inhalation product development. Small scale spray drying, wet milling and jet milling are all in place for early feasibility work. State-of-the-art clean rooms for spray drying and capsule-filling are also in place, as is a high containment suite for the safe handling of higher potency small and biologic compounds. Clinical scale and commercial scale jet milling capabilities are in place at our Quakertown (PA), US and Monteggio, CH locations.

Have a Question?

David Lyon, Ph.D.

Area of Expertise: Bioavailability Enhancement

Ask David

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