A new Dynamic Light Scattering (DLS) service for measuring nanoparticles in pharmaceutical products has been introduced by RSSL, with the acquisition of a Malvern Zetasizer Nano ZSP into the physical chemistry department. The new instrument will assist in the evaluation of nano-sized particles to aid quality control and development of pharmaceutical and biopharmaceutical products, and through determination of zeta potential as an indicator of stability to help screen formulations thus reducing the time to market.
RSSL is already a leading provider of particle sizing services to the pharmaceutical sector, with expertise and equipment for measuring and analysing particles in sizes ranging from 11mm down to 0.02µm (analytical sieving through to laser diffraction). The arrival of this new equipment allows RSSL to quantify particles between 0.3 and 10µm, thus completing the company's comprehensive sizing service, combined with the quality of service and data integrity that customers are familiar with.
Passive and active nanoparticles represent an opportunity and a challenge for the pharmaceutical industry, both for regulatory authorities e.g. MHRA and FDA and for product developers. Many see the positive side of nanoparticle applications e.g. as a potential route for drug delivery, perhaps targeting cancer cells, or as a carrier of vaccines or enzymes that might destroy a virus. Nanoparticles are also being investigated as potential ‘sponges’ for toxic chemicals in the body. Applications in diagnostics, antibacterial effects and cell repair are also under evaluation. Conversely, nanoparticles could represent a potential threat to health, especially in products where their presence is unintended, unknown or when arising from environmental pollutants.
Particle sizes can affect the performance of many pharmaceutical products, and the specification of APIs and excipients usually involves a size range parameter. RSSL will be able to use the Zetasizer in supporting QC as well as troubleshooting R&D problems where particle size is likely to be a factor. An extensive range of sophisticated microscopy techniques are also available from RSSL to complement this work.
As its name implies, the Zetasizer can also measure the zeta potential of particles. The zeta potential gives a rapid indication of the stability of emulsions and suspensions, and by determining zeta potential of new formulations, it is possible to identify the best candidates for long term stability studies at the earliest possible stage. Performing zeta measurements can streamline the development process by identifying and excluding formulations that are most likely to suffer from flocculation, aggregation and separation. Zeta potential also gives an indication of protein stability, an issue of major importance in biopharma developments.
'This new technology furthers our commitment to the sector and demonstrates RSSL’s willingness to pioneer technology in the commercial arena that has thus far mainly been seen only in the academic research environment,' said Rachel Henton, General Manager at RSSL. 'The Zetasizer will help us move to the fore in helping clients navigate the nanoparticle challenge. Additionally, in terms of stability, the Zetasizer will allow us to identify vulnerable formulations and help customers focus their development efforts on formulations that have a better chance of getting to market.'