Innovators are actively seeking solutions to tablet manufacturing challenges, including perennial sticking issues and the newer challenge of designing tablets for functional scoring that have appropriate mechanical properties and content uniformity. Recent focus on tablet scoring by FDA, which is working on draft guidance, is driving companies to look more closely at tablet splitting. Both the European Pharmacopoeia (Ph. Eur.) Commission and the United States Pharmacopeia Convention (USP) are also working on tablet-splitting issues.
The Ph. Eur. Commission recently created chapter (2.9.47, “Demonstration of Uniformity of Dosage Units using Large Sample Sizes”) as an addition to the existing binding requirements in Chapter 2.9.40, “Uniformity of Dosage Units.” The new chapter discusses using process analytical technology (PAT) to assess content uniformity, explained Susanne Keitel in a Pharm Tech artile.
USP is interested in developing a general chapter to provide a test that would define specifications for demonstrating that a tablet is functionally scored, said USP’s Anthony DeStefano in another article.
Pharmaceutical Technology also spoke with several industry experts about tablet splitting and scoring. Their comments on handling the increased manufacturing and testing complexities involved in scored tablets can be read here.
Another tableting concern under investigation is sticking. I Holland, for example, is conducting a tableting science anti-stick research (TSAR) project in collaboration with the University of Nottingham in the United Kingdom. In a recent article, I Holland explained that the goal of the project is to develop a predictive tool for identifying anti-stick coating solutions without full-scale trials using the customer’s equipment. The TSAR project is about halfway through, and more will be published on this work in the future.
INTERPHEX is a great place to see firsthand what tablet equipment companies, such as
l Holland Limited, Fette Compacting America, and Thomas Engineering Inc. are up to. See them on the show floor, or attend conference sessions on tableting, such as Fette’s Technical Workshop; A Compressed View of Modern Tableting Technology, or Cetin Cetinkaya’s Conference Program presentation on Mechanical Characterization, Testing, and Defect Monitoring of Tablets.
Manufacturing editor, Pharmaceutical Technology