PAT: A New Dawn for Drug Product Quality - Pharmaceutical Technology

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PAT: A New Dawn for Drug Product Quality
Leading experts share insight on the current and future direction of process analytical technology.


Pharmaceutical Technology
Volume 34, Issue 2

Advances in PAT

PharmTech: What are recent advances in instrumentation to apply PAT in solid-dosage manufacturing?

Strother (NIR spectroscopy): In addition to the development of Fourier transform NIR, the more significant advances in the industry probably relate specifically to blending applications. There are several companies that have instruments designed to attach to blenders to monitor a mixture of powders to ensure they are properly mixed without becoming 'overblended.'

There is also ongoing work to improve integrating NIR as part of a total analysis system. We've worked with organizations that would like to run a battery of tests on solid-dosage forms ranging from weight, hardness, and other physical properties to more in-depth chemical analysis from NIR. We also have found that NIR can also be used to accurately predict some physical properties such as particle size, crystalline polymorphs, hardness, and density.

Mattes (NIR spectroscopy): The latest technology is digital dispersive NIR. These instruments are fast and accurate and are not sensitive to vibration as Fourier-transform (FT) instruments can be. Due to higher noise levels, FT instruments require more co-added scans for a complete spectrum. FT instruments claim higher resolution but this is not an advantage in the NIR spectral region, where absorbance bands are broad and where using the higher resolution only makes the FT instrument signal-to-noise poorer. New applications are developed all the time. For example, digital dispersive diffuse transmission methods have been applied to prolonged release tablets for the prediction of dissolution profile, which can greatly reduce analysis time. The FOSS MasterLab has proven to be robust in harsh manufacturing environments and delivers extremely accurate and reliable results providing manufacturing with real-time feedback on content uniformity, moisture and other quality attributes.

Dubois (NIRCI): Automation of data acquisition and processing has allowed the rugged solid-state SyNIRgi (a Malvern NIRCI analyzer) to be brought to the process line for data acquisition at various sample thieving points. Minimally-trained personnel can now collect data enabling thorough process understanding.

Vaisman (particle-size analysis): Recent advances in integration and control software have significantly simplified embedding on-line size analyzers into manufacturing equipment. An embedded on-line analyzer, with fully integrated controls, serves to convert a traditional batch-manufacturing unit into a continuous operation with higher throughput, less waste, and better product quality. Availability of streaming on-line data reduces or removes the need for off-line sampling saving time and resources.

Freeman (powder-flow techniques): As mentioned above, the measurement of powder flow and other behavioral characteristics, in a process relevant way, is relatively new. As a result, advances in powder and process understanding are continuing at a rapid rate. Most leading global pharmaceutical manufacturers are employing this technology in process, development, and quality-assurance environments.

Reference

1. FDA, Guidance for Industry: PAT-A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance (Rockville, MD, Sept. 2004).


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