Laboratory Pharmaceutical Solutions

Malvern Instruments has provided laboratory-based solutions for particle characterisation for the pharmaceutical industry for over 30 years, enabling size analysis from the molecular scale through to millimetre-sized granules using laser diffraction and dynamic light scattering.

This delivers the understanding required for rapid product development from early phase formulation screening right through to the definition and assessment of critical quality control (QC) parameters. Size measurements provide an important in vitro indicator of the bioavailability of a given formulation, allowing formulators to predict the dynamics of drug release for both traditional dosage forms, such as tablets or suspensions, and novel systems based around aerosol, transdermal or other delivery modes. The addition of image analysis systems ensures that the impact of both the particle size and shape of pharmaceutical intermediates or excipients on the product form and bioavailability can be assessed. Finally, the stability of a given formulation can also predicted, either through controlling the particle size or through understanding the interactions which occur between particle when in suspension either via rheological or zeta-potential measurements.

Particle characterisation for the pharmaceutical industry

The key role of particulate materials throughout the pharmaceutical industry drives Malvern Instruments’ close involvement in drug discovery, development and manufacture. As suppliers to the industry, we seek to work alongside our pharmaceutical partners and customers. In this way, we can understand and anticipate concerns and be aware of emerging trends.

This involves entering into and funding long-term collaborations where the objectives are to improve fundamental processes involved in drug development. It entails working with biotechnology and drug discovery companies to develop and support novel applications for Malvern’s instrumentation. It also means designing and developing new accessories, software and instrumentation for drug discovery applications and emerging pharmaceutical manufacturing processes. We also take a lead where validation issues are concerned and build into our systems the necessary facilities and checks for easy implementation, supporting improvements in standard practices.

Malvern Instruments’ particle characterization and rheometry systems have applications right from the start of the drug discovery process, through early method development stages, into manufacturing and through to final quality control. This applies for both particle and droplet size measurement and dispersion stability applications.

The ability to understand and control parameters such as particle size distribution and rheology contribute significantly to the development of effective medicines and efficient manufacturing processes.

Appreciating the effect of zeta potential on the stability of particles in suspension enhances formulation procedures, adding another measurable parameter that can be used to reduce formulation time and help improve shelf life. Measurement of the rheological properties of the bulk sample allows simulation of how the material will perform in the process or under its “end use” conditions.

Rapid particle shape characterisation provides more data to understanding the reasons for deviations from manufacturing specifications and enables the development of more robust production processes.

As pressure increases to reduce production time and costs, Malvern’s Insitec system, specifically developed for in-process particle sizing, is now an integral part of many process lines, bringing insight and control to manufacturing procedures.

Accurate characterisation is essential and compliance with FDA and GMP guidelines must be clearly documented. The analytical instruments used must be designed, manufactured and serviced using practices and procedures that guarantee the accuracy and precision of the results. These instruments must be relied upon today and for many years into the future.

Whether you need to provide a justification for deviation from a manufacturing specification, or to simply measure particle size and/or rheology with the highest degree of precision, Malvern Instruments has a high quality solution tailored to your needs.