Solving tableting scale-up challenges

At this year's ACHEMA Congress, Natoli Engineering will premiere two new and innovative products that will help tablet manufacturers better evaluate a formulation's tabletability and solve tableting issues before scale-up to production

Developing a robust solid dose formulation that can be scaled up for manufacturing without encountering tableting issues is an ongoing challenge. During tablet development researchers need to collect data that will characterise formulation performance and help them understand compaction and compression characteristics before full-scale production begins. Changes to a production-ready formulation due to compaction issues are costly and time-consuming, and domestic manufacturers must follow the FDA's scale-up and post-approval change (SUPAC) guidelines. Ensuring a formulation performs correctly after scale-up will minimise the risk of post-approval changes and the associated delays and costs.

One critical component to consider during scale-up from an R&D press to a large manufacturing press is compaction dwell time. Dwell time – expressed in milliseconds – is the time in which punches achieve maximum penetration in the die under the main compression rollers and are no longer moving vertically. It is a contributing factor to tablet strength.

Production can be a challenge if strain rate sensitivity isn’t determined before scale-up

However, because of differences in turret speed between an R&D press and a production press, dwell time can be difficult to replicate on a production press. A punch head flat can be designed to address this difference in dwell time. A longer head flat results in a longer dwell time. Depending on a formulation's deformation characteristics and strain rate sensitivity, a longer dwell time may be needed to produce a robust tablet. A formulation might be successfully tableted during research and development, but production can be a challenge if strain rate sensitivity isn’t determined before scale-up.

At this year's ACHEMA Congress, Natoli Engineering will premiere two new and innovative products that will help tablet manufacturers better evaluate a formulation's tabletability and solve tableting issues before scale-up to production.

Natoli Quick-Release Tooling

Natoli Quick-Release Tooling allows researchers to test different dwell times during the tablet R&D process without the expense of buying several different sets of tools or the time needed to change complete sets of tooling or turret speed.

Prior to the introduction of Natoli Quick-Release Tooling, researchers had to buy several different sets of tooling with different punch head configurations to change the dwell time on an R&D press. In addition to not having to incur this expense, Natoli Quick-Release Tooling eliminates the time and labor required to remove and replace multiple sets of tooling during R&D.

Natoli Quick-Release Tooling allows R&D teams to evaluate dwell times with respect to both turret speed and head flat profile by quickly and easily changing the punch heads, which are a critical component of dwell time. This permits a much more detailed analysis of a formulation's compressibility as well as greater troubleshooting capacity in the early development stages.

Being able to use different head profiles provides the unique opportunity to determine the ideal dwell time for a given formulation or product. The ability to achieve a specific dwell time is invaluable for continuous manufacturing because as powder is fed at a specific rate, there is little ability to adjust turret speed to achieve the ideal dwell time or resolve related tablet defect issues. By changing the head – which can be done simply by squeezing the tabs on the side of the barrel, removing the head, and snapping a different head into the punch barrel – it is possible to determine the ideal compression profile for a product while keeping the turret speed at the specific requirement relative to powder feed and desired tablet output.

NP-RD30 R&D Press

NP-RD30 R&D Press

Natoli Engineering is quickly becoming the leader in R&D tablet presses with this next-generation rotary tablet press. Designed to help solve formulation and scale-up challenges, the NP-RD30 rotary R&D tablet press replicates the design and functionality of a production press. The turret velocity of the NP-RD30 can reach that of production presses, meaning dwell time can be more accurately established during research and development.

The NP-RD30 rotary R&D tablet press replicates the design and functionality of a production press

While operators of other rotary R&D tablet presses find it difficult to replicate dwell time, the velocity of the NP-RD30 can reach that of production presses, meaning dwell time can be more easily reproduced. Dwell time based on a 9.5 mm head flat ranges from 91 ms to 9.1 ms, which is shorter than any other rotary R&D tablet press. While designed to meet the needs of research and development teams, the NP-RD30 could be used as a small tablet production press.

The NP-RD30 minimises tablet defects by allowing researchers to discover potential tableting issues before production begins. It can determine formulation characteristics for successful tableting using minimal APIs, saving costs at the R&D stage. The NP-RD30 also easily replicates the dwell time and functionality of production presses.

The NP-RD30's integrated Natoli AIM Plus data acquisition and analytical software is designed to ease formulation and process development and minimize production during scale-up:

  • Provides tablet press scalability parameters
  • Quickly measures and evaluates tablet formulations and properties
  • Provides projected data from formulation changes
  • Reduces trial and error
  • Evaluates compaction properties of APIs and potential formulations
  • Measures and reports data for tabletability, compactibility, compressibility, and strain rate profiles

Natoli Engineering will be demonstrating Quick-Release Tooling and the NP-RD30 rotary R&D tablet press at the ACHEMA Exhibition 11-15 June in Frankfurt, Germany. Come see us in Hall 3.1 Booth F13, or visit Natoli's website for more information: https://natoli.com/well-be-at-achema-2018-will-you/.

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