Malvern Pharmaceutical Industry Particle Characterization

The pharmaceutical industry represents one of the fastest growing industry sectors in the world today. Although the process of drug discovery has been key to the development of new therapies, increasingly pharmaceutical companies are relying on the development of novel product formulations to maintain market share. Within this, particle characterization is a key to developing an understanding of the functionality of new products, formulations and delivery systems.

In this section

	Laboratory pharmaceutical solutions Malvern Instruments has provided laboratory-based solutions for particle characterization for the pharmaceutical industry 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.
	On-line pharmaceutical solutions The US Food and Drug Administration’s (FDA’s) Process Analytical Technologies (PAT) initiative has provided the Pharmaceutical Industry with the opportunity to apply new technologies to understand and control manufacturing process. Key to this is the retrieval of real-time data, such as the tracking of particle size and size distribution changes, whist the process is running. Malvern Instrument’s on-line particle characterization systems provide manufacturers with the ability to follow pharmaceutical milling, classification, spray drying and granulation process, yielding closed loop process control and improved production efficiency and product quality.
	Process Analytical Technology solutions Malvern Instruments systems deliver industrially relevant information on particle characterization, rheological properties; chemical composition and spatial distribution that can help you comply with the US Food and Drug Administration's (FDA's) Process Analytical Technology (PAT) initiative to make your manufacturing processes more efficient and predictable.