particle engineering services

Particle engineering at Lonza

Particle engineering applications span oral, inhaled and transdermal drug delivery routes inclusive of:

• Improve flow properties
• Enhance dissolution rate and solubility of drug compounds
• Improve the palatability of compounds (mouth feel)
• Generate particles fine enough for effective nasal and lung delivery and absorption
• Help ensure absorption of a drug across the skin

Particle size reduction technologies have an established track record and are highly flexible:

• Easily applicable to different chemical properties
• Good for substances with poor thermal stability
• Ease of industrial scale-up
• Cost-effective and well-known manufacturing process
• High reproducibility (in dissolution terms) and size control

We provide customized and fit-for-purpose particle engineering as part of our integrated drug substance and drug product development services. Phase-appropriate particle size reduction processing, spray dryers or hot melt extrusion is in place to advance your compound from concept to clinical and commercialization. Particle size reduction to precise particle size distribution is in place across pin mill, hammer mill, jet mill and nano-mill processing at our Monteggio (CH) and Quakertown (US)) sites. Particle engineering services using spray drying or hot-melt extrusion is provided at our Bend (US) site.

Particle size reduction via micronization or nano-milling and amorphous solid dispersion technology via hot-melt extrusion or spray drying are often utilized to improve stability, flowability, dissolution rate and solubility. The choice of technology is dependent upon the API characteristics, target product profile and application. We have advanced thousands of molecules across a myriad of API parameters, applications and target product profiles. This experience has been used to develop technology selection methodologies incorporating models and reference maps over key formulation parameters.  This experience has also been utilized by our engineers to develop proprietary lab-scale processing that requires minimal amounts of API for feasibility assessments.  Our product development teams utilize these tools to rapidly select and employ the best particle engineering approach to address the problem statement(s) and meet the target product profile in a phase-appropriate manner.

We have invested in specialized processing to ensure that the needs of any compound can be addressed. High containment capability are in place so that mechanical, jet milling and spray drying can be safely conducted with highly potent API or cytotoxics. Before processing, every drug substance is evaluated by our HS&E team to determine the containment system required.

Specialized cryogenic milling is also in place for those friable compounds needing cooling due to low melting points or to avoid polymorphism.