Excipient Particle Characterization

Excipient particle characterization is an important part of the drug development process in the pharmaceutical industry.

Excipient particle characterization is used to assess the physical and chemical properties of excipients, which are substances used as a base to bind, fill, or dilute active pharmaceutical ingredients (APIs). Characterization of excipients can help to determine their suitability for use in different formulations, as well as their compatibility with APIs and other excipients. The morphology of the particles, or their size and shape, can also provide insight into their performance, helping to ensure that the formulation is stable and has the desired release profile and drug absorption. Additionally, particle characterization can help to identify potential safety risks associated with the excipients and can help to optimize the formulation design.

The particle size and shape of excipients can also affect the physical stability of a formulation. For example, particles that are too small can cause an API to settle out of solution, while particles that are too large can lead to poor wetting or mixing. Similarly, particles that are not of uniform size or shape can lead to clumping or sedimentation of the API, resulting in an unstable formulation. Thus, Excipient particle characterization can help to identify any particles that are too small or large, or of an irregular shape, and can help to optimize the formulation design to ensure that the API is stable over time.

There are also functionality-related characteristics (FRC) included in the excipient monographs of the European Pharmacopoeia. FRCs provide guidance on the definition of specifications based on standard analysis procedures but they have a non-mandatory character. Particle size distribution is one of the examples of such functionality-related excipient characteristics. Characterization of raw materials creates a body of information that is very useful for validating raw material suppliers and understanding processes in the development of products.

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