Issue link: https://www.e-digitaleditions.com/i/1267517
Tablets & Capsules July 2020 41 • Recognizing exclusive tool configurations as an alternative to standard dies. Pistillo and Giatti: A study comparing the character- istics of tablets compressed using TSM punches to tab- lets compressed using EU punches would give users an idea of the effective advantages of each standard on the tableting process. Insight into multi-tip tooling applica- tions is missing as are studies comparing blend feeding systems, which strongly affect tablet quality. Also, exter- nal lubrication technology is now available, fulfilling mar- ket requests to help ease challenging processes and meet the needs of the trend toward continuous manufacturing. Hoskin: Continuous manufacturing is a big area of change in tableting and should certainly be addressed, including best practices, solutions, and technology to help with implementation. Examples of this are tool steel and coating choices that should be used for continuous tablet- ing and specialized tooling that can help achieve more reliable run times. Other topics that deserve space are tooling maintenance programs and management systems and scientific research relevant to tablet manufacture. T&C The Tableting Specification Manual is available for pur- chase at: ebusiness.pharmacist.com/PersonifyEbusiness/Shop- APhA/Product-Details/productId/115810. Elizabeth, McKeesport, PA 412 751 3000 eliz.com I Holland, Nottingham, UK +44 115 972 6153 tablettingscience.com IMA North America, Leominster, MA 978 537 8534 www.ima.it Korsch America, South Easton, MA 508 238 9080 www.korsch.com Natoli Engineering, St. Charles, MO 636 926 8900 natoli.com SMI, Bethlehem, PA 908 534 1500 www.smitmc.com Techceuticals, Cleveland, OH 216 658 8038 www.techceuticals.com Wilson Tool, White Bear Lake, MN 800 467 8444 www.wilsontool.com Pistillo and Giatti: Tooling specifications might need to be revised to include analysis of new technolo- gies applied to force calculation—such as finite element method (FEM)—that include the effects of the material and coating on the final result. Regarding tablet press specifications, new companies and tablet press models are in the market. Also, tablet presses that use centrifugal force feeding, such as the IMA Comprima, have not been taken into account. Compatibilities between materials in contact with the formulation and the most recognized APIs should be revised. It might be interesting to have suggestions for coatings/tip materials depending on the API or excipi- ent characteristics as well as advice for handling abrasive compounds. The same approach could be used for the troubleshooting section, which could include more dis- cussion covering the most commonly found tablet defects. Should any new topics be added to the TSM? Martin: I would recommend adding the following: • Guidance on the proper take-off position for differ- ent tablet shapes (keying angle for polygons); • A new section on minitablet tooling; • FEA guidance for determining force ratings (such as Von Mises versus maximum principal stress, mesh size, and endurance limits); • Include maximum force values for punch head profiles; • Include guidance on which presses need keyed rounds to prevent double impressions (from insufficient anti-turning between pre- and main compression). Tousey: I would like to see a comprehensive section on wear issues. There are significant differences between older tablet presses and current machines that should be recognized and defined in the TSM. For instance, lower punch diameters have changed, but the TSM doesn't explain that the change has to do with the introduction of punch seals and may not benefit companies using older machines. The original smaller diameter barrels allowed more clearance to reduce the potential for binding. The distinction should be clear, so manufacturers that have some older machines and some newer machines will understand how changing to "current" standards may impact performance. The TSM is an important tool; too many manufacturers rely solely on the tooling supplier to interpret their appli- cation and their vintage and mix of tablet presses. This has a direct impact on tablet quality and productivity. Natoli: New topics that would be beneficial for a new edition include: • A more comprehensive and updated troubleshoot- ing guide; • A better understanding of clearances between the tablet compression tooling and the tablet press; • A better understanding of clearances between the punch tip and the die; and