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The particle size of the API and excipients affects more than just the stability and appearance of the product.
May 13, 2024
By: Emil W. Ciurczak
While at IFPAC (N. Bethesda, MD) in March, I noted that particle size, morphology, and physical performance were being highlighted by both speakers and exhibitors. This makes sense for traditional cGMP production of products but becomes more than “nice to know” for PAT and QbD-based production paradigms and pretty much an absolute necessity when producing a solid dosage form via continuous manufacturing (CM). It makes sense, in that case, that we need to begin the characterizing of all materials used in a dosage form even before the formulation is finalized. Fortunately, I ran into a colleague whom I’ve known for over 30 years and grilled him about his new software suite for characterizing particle size and morphology. Since his work in near-infrared (NIR) was well-thought out and his familiarity with Chemometrics and statistics were first rate, I wanted to learn more about his software package. When developing a new pharmaceutical product, particularly where the delivery mechanism involves a dry power-based active pharmaceutical ingredient (API), particle size is a very important property to understand and control. The particle size of the API and excipients affects more than just the stability and appearance of the product. Particle size can influence properties such as friability, dissolution, bioavailability, release rate, and can even influence manufacturing processes and parameters: in short, all critical to quality (CtQ) parameters. As important as measuring particle size is, understanding and controlling the particle’s shape or morphology is every bit as critical. A recent example of this importance was seen at a commercial facility, where one batch of API was failing its bioequivalence test. Analysis of this API in comparison to a passing batch, using traditional methods including Laser Light Diffraction (LLD) proved inconclusive as the particle sizes were apparently (to the device) the same. It wasn’t until the product was analyzed using Image Analysis (IA) that the solution of the situation was found. The morphology of the particles clearly showed a change in aspect ratio, intensity, and area, pointing to a change in the milling and crystallization processes used early in the manufacture of the API (see Figure 1).
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