The Power of Particle Characterization - Pharmaceutical Technology

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The Power of Particle Characterization
Pharma's drive for manufacturing efficiency is bolstering particle-characterization technologies.

Pharmaceutical Technology
Volume 35, Issue 7, pp. 42-43

Indeed, during the past few years, industry has placed a growing emphasis on particle characteristics other than size, such as shape, surface charge, and roughness. "Particle sizing is just one element of particle characterization," says Rideal. "Other disciplines in this sector include particle shape, flow properties, both in the dry state and as suspensions (rheology), morphology—including crystal structure, and porosity. Particle sizing alone is therefore not always the sole answer to efficacy.... A combination of physical properties is invariably investigated in arriving at the final solution."

According to Kippax, particle shape, in particular, has become an important parameter for both processing and final product quality. "In direct compression tableting, for example, shape is known to have an impact on blend uniformity, the consistency of powder flow through the press, compressibility, and the mechanical strength of the finished tablet," he says. "On the imaging front, many are also already looking beyond shape to composition."

Process development

Sidebar 1: Inhaled Pharmaceuticals
Particle characterisation is used in many areas of the pharma industry, including excipient characterization and other quality control applications. Additionally, particle charcterization has a large role to play in the development of inhaled pharmaceuticals (see sidebar 1: Inhaled pharmaceuticals). The industry’s drive for improved manufacturing efficiencies has also increased the uptake of particle characterization technologies during process development. Particle characterization data help manufacturers to better understand their product, and provide the opportunity for process optimization according to the product’s characteristics. In isolation, however, particle characterization data do not always provide sufficient information to achieve this. In this case, techniques that characterize the powder, rather than the constituent particles, can play an important role. Over the past few years, there have been a number of advances in the area of powder characterization have helped manufacturers better understand their processes, ultimately leading to more efficient manufacturing (see sidebar 2: Powder characterisation).

Sidebar 2: Powder Characterization
Understanding particle characteristics can benefit process development in several ways. The latest technologies, such as the on-line laser-diffraction systems noted above, enable processes to be monitored in real time during development work, which provides better control and facilitates scale up. "The sector's interest in on-line, real-time measurement has risen sharply as it works toward greater manufacturing efficiency," says Kippax. "Real-time monitoring accelerates the reliable identification of 'cause and effect' during process development and has a valuable role to play in the transition to smarter operation."

Real-time monitoring, however, is not yet available in all areas of particle characterization. Tim Freeman, director of operations at Freeman Technology, which specializes in powder characterization, adds, "I would perhaps highlight particle shape analysis—automated imaging—as a prime example of a technique with proven applicability, that would be a desirable addition to the real-time selection for pharma, but has yet to make this transition."


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