Creating formulations that are truly effective means finding an answer to the question of solubility – and that answer can be found in LEON’s unique approach to nano. For New Chemical Entities and generics alike, our intelligence in nanotechnology provides a clear solution for addressing poor solubility and smoothing the path for downstream processing to answer unmet patient needs and unlock new value from APIs for pharmaceutical partners.
It is based on patented technology to deliver a classic bottom-up approach to the synthesis of SMART nanoparticles or microparticles. This results in the continuous precipitation of particle sizes for nano between 10 nm and 1000 nm and for micro 1-70 µm with consistent reproducibility and at a cost comparative to standard technologies.
Stable crystalline or polymeric particles
Measurable tailored size: 10 nm 70 µm
Achievable easy scale-up: bench to commercial
Relevant for all application forms
Timebound: fast continuous precipitation < 0.1 ms easily integrated into downstream processes
Scalability is built into our development pathway and equipment, with easy scale-up facilitating transfer between the equipment and process trains used to test prototype nano formulations and the process to support clinical and commercial availability. With us, new formulations can be developed faster and the process successfully validated sooner, so that positive impacts can be felt by patients more quickly.
Standardized, continuous Processing
Particle tolerances between 10 nm - 1000 nm and 1-70 µm
Suitable for range of drug delivery dosage forms
Nanoformulations can overcome the complex hurdles that block an API’s successful path to market. For New Chemical Entities and established drugs, our proprietary bottom-up precipitation method results in the creation of tailored nanoparticles that form the basis of targeted, effective treatments via oral, parenteral or transmucosal delivery.
It is a consistently repeatable process with easy scalability from bench through clinical trials to commercial. By employing mathematical modeling and avoiding any change to reactor hardware, the scale up and validation process can be expedited from months to a matter of weeks.
High-precision particle synthesis.
At LEON, we employ proprietary nano technology (including (MJR®)) to provide a highly controlled environment for the repeatable production of stable nanoparticles between 10 nm and 1000 nm and for micro 1-70 µm in size.
Because we take a bottom-up approach to particle synthesis, we avoid the known difficulties associated with top-down nano methods, such as wet-milling, where the presence of heat and the impact of shearing, together with the inherently high investment cost and the high failure rate, make it an unsuitable option for many candidate molecules and their organizations.
LEON can quickly and reliably produce a wide range of nano particles by tailoring to the API and modifying process conditions. These include surface-stabilized nanocrystals, micelles, liposomes, nanoemulsions, polymeric nanoparticles and even solid lipid nanoparticles. Our proprietary approach shares the same fundamental process for small-scale testing as it does for full-scale production, providing a swift and cost-effective route to commercial development.
How it works
A solvent and non-solvent collide inside the reactor’s chamber.
This results in the precipitation of insoluble compounds.
Nanoparticles suspended in the liquid are ready for downstream processing.
LEON offers a broad range of particle types to meet a variety of needs, whenever there is a need to re-produce easily and with scale, including:
At LEON, we provide all the services needed to support Drug Product formulation delivery at nano scale, from initial concept through to product approval.
We work collaboratively with our pharmaceutical partners on a contract or co-development basis, and the engagement process typically follows five key stages:
Understanding and clarification of objectives from a market and scientific perspective, whether looking to reformulate established APIs or working with new API formulations.
Using minimal quantities of the API in question for rapid screening of nano potential and to identify any considerations, undertaking feasibility studies.
Analysis of the processing required to optimise nanoparticle production using our proprietary technology.
Small-scale GMP production of clinical trial materials and commercially high-value / low-volume products, supported by continual assessment.
Scaling to commercial production within GMP facilities.