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 services as part of our integrated drug substance and drug product development services. Phase-appropriate particle size reduction processing, spray dryers, hot melt extrusion, and melt-spray-congealing is in place to advance your compound from concept to clinical and commercialization. Particle size reduction to precise particle size distribution is in place for API milling 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, hot-melt extrusion, or melt-spray-congealing is provided at our Bend (US) site.
Particle Size Reduction
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.
Our particle size reduction 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.
Particle Size Optimization Expertise
Our product development teams are well versed in particle size reduction to low micron or sub-micron levels, as well as amorphous solid dispersion technologies. Specialized jet mill and spray dryer designs have resulted from decades of engineering study and provide optimized particle size distribution and performance.
We offer fully integrated product development from active pharmaceutical ingredients through particle-engineered intermediates to finished drug products. Our particle engineering service packages include feasibility trials, robustness studies, design of experiment (DOE) in non-GMP and GMP environments, process development and optimization, analytical services, QC / QA, CMC and regulatory services.
Dedicated product development teams are in place for dry powder inhaler applications using either jet milling or spray dry processing. Encapsulation for clinical trial materials and commercialization are in place to service your particle engineering or particle size distribution requirements from concept to commercial.
We have decades of particle engineering experience across thousands of compounds spanning the full range of formulation challenges.
Specialized Particle Engineering Focus
We have invested in specialized particle engineering processing to ensure that the needs of any compound can be addressed. High containment capabilities 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 API milling is also in place for those friable compounds needing cooling due to low melting points or to avoid polymorphism.