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Tabletting specialists

Tackling Sticking Issues and Ensuring Batch Consistency

Merlin has worked with a leading US-based pharmaceutical manufacturer to address two critical formulation challenges: Tablet sticking during compression and batch-to-batch variation. Using a hydraulic compaction simulator and expertise in compaction science, Merlin helped the client overcome production uncertainty, enhance quality control and improve manufacturing reliability.

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The Challenge

In one project, the client was experiencing tablet adhesion (sticking) during production.  Sticking is a common but complex issue that can appear unexpectedly at late stages, disrupting output and quality. At the same time, they needed to ensure consistency across batches to maintain performance, especially when sourcing API from multiple suppliers or synthetic routes.

Both challenges demanded fast, data-driven solutions to guarantee process reliability and high-quality products for patients.

 

The Results

  • Merlin provided data to allow the optimal level of lubrication to be calculated to eliminate sticking while maintaining tablet strength.
  • Recommended process conditions that ensure reliable, scalable tablet manufacture.
  • Confirmed consistency across batches, validating new material sources for uninterrupted production.
  • Delivered rapid turnaround testing under tight project timelines.

Our Case Study Highlights:

  • Identified the optimum lubricantion level and punch conditions to remove tablet sticking.
  • Compared API batches from multiple suppliers and routes to confirm reliable compactibility, compressibility and overall tablet performance.
  • Using only 20g of material to generate detailed performance fingerprints.
  • Delivered fast, data-driven recommendations for scalable process settings.

Merlin's Approach

We designed a custom testing programme using powder characterisation technology and applying compaction best practice.

1) Assessing Sticking and Lubrication:

  • Measured Ejection Force to determine the optimum level of lubricant in the formulation.
  • Used an instrumented adhesion punch to quantify the adhesion force on the upper punch to identify sticking risk.
  • Evaluated the effect of punch coatings and lubricant concentration on tablet strength and surface adhesion.
  • Simulated full-scale production conditions using our compaction simulator for rapid, realistic testing.

2) Ensuring Batch-to-Batch Consistency:

  • Compared API powder batches from different production routes and suppliers to assess compactibility, compressibility and tabletability.
  • Performed tests such as Heckel analysis and Strain Rate Sensitivity (SRS) to understand deformation and yield pressure and potential differences in performance between batches.
  • Used only 20g of material to generate comprehensive “fingerprints” of performance data – providing insight into potential variations before full-scale manufacture.

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