inhalation formulation services

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 using dry powder inhaler (DPI) devices.

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 allows 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. Our customers benefit from a flexible, integrated service offering inclusive of API development, API characterization and assessment, technology selection, particle engineering, formulation development, specialized analytical method development, and the manufacture of encapsulated DPI formulations at development, clinical and commercial scale. Phase-appropriate jet mills and spray dryers are in place to facilitate rapid proof of concept evaluations, cGMP clinical trial manufacture and commercialization.

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.