Flexible grinding processes for sterile nanopharmaceutical manufacturing
Nano-based delivery systems are on the rise, as they enable manufacturers to deliver therapeutic agents to specific targeted tissue in a more controlled manner. Data indicates that the global nanopharmaceutical drugs market size reached USD 53.85 Billion in 2021 and is expected to reach USD 102.4 Billion in 2030.
Overcoming the process limitations of wet nanomilling for pharmaceutical drug substances
When Dr Keck and her team from the Faculty of Pharmacy of the Phillips-Universität Marburg required a solubilisation-enhancing technology to improve the bioavailability of poorly soluble natural flavonoids, they turned to milling experts Frewitt to tackle the challenge. The team required narrow nanoparticle size distribution with a short processing time and a stable low temperature milling profile. Download this application note to find out why Frewitt’s NanoWitt-Lab mill was selected as the perfect solution, and how the system performed across Dr Keck’s tests.
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According to GlobalData’s Nanopharmaceuticals Thematic Research report, the vast majority of marketed and pipeline nanopharmaceuticals are being used to treat a wide range of cancer indications, highlighting the ongoing unmet needs in this area. Soon, nanopharmaceuticals will play a key role in the fight against the rise of chronic diseases due to the growing ageing population. It indicates that nanomedicine also has the potential to combat the threat of antibiotic resistance via the use of nanomaterials with intrinsic antibacterial properties, as well as using nanoparticles as effective drug delivery systems for antibacterial agents.
Regulations and guidelines for nanopharmaceuticals are still relatively in their infancy, including for cleaning processes and the prevention of cross-contamination. While research focuses on designing more potent, but less toxic nanopharmaceuticals, labs can be at risk when working with unstable and reactive nanoscale materials if they are not correctly handled.
Cleaning-in-place (CIP) and sterilisation-in-place (SIP) systems are designed for automatic cleaning and disinfecting without major disassembly and assembly work. In nanopharmaceuticals, this is useful to apply to the equipment used for milling processes that break down coarse particles into finer ones. Bead mills, which use grinding media to disperse particles in slurry, are generally the preferred technology.
Sterilisation-in-place nano grinding technology
One company that is leading the way when it comes to milling processes is Frewitt, an innovative manufacturer of premium-quality mills. The company was established in Switzerland in 1946 and offers an array of mills for R&D laboratories.
According to the company’s commercial director, Roy Housh: “At Frewitt we have mastered the nano milling process and are proud of this accomplishment that pushes the boundaries of nano milling technology further.”
Frewitt’s FlexMill-Lab integrates six different milling processes in one system. A quick and simple change of process heads allows users to switch from metric-milling (dry) to micronisation (dry) to nano-milling (wet). One of these process heads is the patented NanoWitt, a bead mill, which can be used to reduce micron-sized powder down to nano-size. Unique to the system, the FlexMill_Lab platform allows users to pre-condition their solids to micron proportions before using the NanoWitt bead mill head to reduce to nano size.
The updated NanoWitt offers five milling chambers, allowing the user to choose the size that best suits their production requirement. The largest of these chambers can be used for SIP nano grinding, which was introduced due to high demand.
Multiple considerations have been made to ensure a sterile process when using the NanoWitt bead mill. The milling head, for example, is designed with a mechanical seal to ensure the process is completely sealed while also allowing for easy disassembly if needed. A CIP cycle cleans all conduits of the circuit, meaning the equipment can be readied for a new process without any dismantling. Suspension samples can be safely taken at any time during milling without compromising the sterility of the process.
Nanowitt also has a gas bleeding system which ensures that no air remains in the process and eliminating the creation of foam.
Improved bead grinding efficiency
The NanoWitt is equipped with actuators, enabling the system to run automatically without human intervention. This feature has both ergonomic and quality advantages, protecting operators as well as the consistency of the product quality. The process head also includes a patented product and grinding media separation unit that ensures the machine never clogs and that the grinding beads remain in the grinding chamber.
Along with the five other process heads – pin mill, hammer mill, conical mill, oscillating mill, and rotary sifter – the NanoWitt is validated as compatible with integration into a tried and proven isolator. No mock-up is necessary, saving weeks of time and considerable costs. Within minutes, the system can be removed from the isolator and used in a standard mobile execution if containment is not critical.
As the pharmaceutical industry continues to grow the field of nanotechnology, an increasing number of companies will benefit from the flexibility and efficiency that the NanoWitt bead mill brings to their laboratories.
To learn more about Frewitt and its premium-quality milling systems, download the whitepaper below.
Overcoming the process limitations of wet nanomilling for pharmaceutical drug substances
When Dr Keck and her team from the Faculty of Pharmacy of the Phillips-Universität Marburg required a solubilisation-enhancing technology to improve the bioavailability of poorly soluble natural flavonoids, they turned to milling experts Frewitt to tackle the challenge. The team required narrow nanoparticle size distribution with a short processing time and a stable low temperature milling profile. Download this application note to find out why Frewitt’s NanoWitt-Lab mill was selected as the perfect solution, and how the system performed across Dr Keck’s tests.
Thank you.Please check your email to download the Whitepaper.
