Effects Of Particle Agglomeration On Pharmaceutical Processing

From concept to compound discovery and synthesis, through multiple levels of exhaustive testing to mass production of a final product — the drug development process involves a long, often arduous (and invariably expensive) journey. Even after the confirmation of safety, tolerability and efficacy of an active pharmaceutical ingredient (API), successful pharmaceutical manufacturing ultimately depends on the careful formulation of an optimal delivery vehicle, which can be mass produced with utter consistency. Often, this takes the form of tablets or pills suitable for oral consumption.

Among other technical challenges, process engineers must determine which inert ingredients — in what specific amounts — are suitable for use in the production of a tablet or pill with the appropriate, “user-friendly” (and FDA-compliant) characteristics. In some cases, the amount of potent API needed for a single dose is minuscule. To arrive at a conveniently sized, shelf-stable tablet requires the uniform admixture of an API with appropriate inactive ingredients (excipients).

The Importance of A Mixing Process in Pharmaceutical Manufacturing

The key term here is “uniform.” Owing to classical mixing theory, the API in such an example must be in the form of an extremely fine powder to guarantee its relatively uniform, random distribution throughout the inert powder base. For process engineers, one challenge is that fine API powders — consisting of appropriately small particles with tight particle size distributions — tend to agglomerate into larger granules.

This may interfere with the random mixing process. Thus, preventing undesirable particle agglomeration and ensuring uniform mixing are essential for successful pharmaceutical manufacturing. For instance, if too little API is present in a given tablet, due to improper mixing, the drug could be ineffective. Conversely, if too much API is included in a given tablet, the dose could be toxic or even lethal.

Effects of Powder Conditioning on Processing Efficiency

Particle size and density are key variables that affect processing efficiency. Various raw materials pose challenges due to characteristics such as flowability, hardness, abrasiveness, friability and moisture content. By improving powder flow and compressibility, while reducing segregation potential, The Fitzpatrick Company’s industry-leading granulation and milling equipment excels at powder conditioning prior to encapsulation or tableting. This conditioning is crucial to prevent segregation of constituent powders. 

For example, the CCS – Contained Compaction System series of roller compactors, commonly known as the [SW1] Chilsonator®, passively removes trapped air and ensures uniform particle size and density of your powders to improve downstream powder flow. Featuring a unique pre-compression feed system and precision real-time roll gap control, the CCS series of roll compaction equipment provides best-in-class containment features, such as wash-in-place design. The CCS series has also been designed for superior process scalability. We recommend the CCS to all of our clients that are interested in achieving dry granulation of pharmaceutical powders.

We also offer the FitzMill® series of hammer mill comminution equipment for the processing of APIs and excipients. As with the CCS (or Chilsonator®) series, clients enjoy the ability to choose from among various options and configurations to customize their processes and optimize results.

Contact Us

For more information about how The Fitzpatrick Company can help you achieve optimum process solutions, regardless of your industry or application, contact our knowledgeable sales staff today.