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Summary

Single cell processing in the ConsiGma™-25 system predicts full-scale manufacturing quality. The ConsiGma™-1 unit’s tablet quality also forecasts larger-scale production outcomes, despite granule variations.

Keywords:
Continuous twin screw granulation and dryingFormulation developmentGranule and tablet qualityProcess optimizationProcess scale-upRepeatability

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Area of Science:

  • Pharmaceutical Manufacturing
  • Chemical Engineering
  • Materials Science

Background:

  • Continuous manufacturing is crucial for pharmaceutical formulation development and process optimization.
  • Small-scale processing must accurately predict large-scale continuous manufacturing outcomes for successful implementation.

Purpose of the Study:

  • To assess if single-cell processing in the ConsiGma™-25 system predicts granule and tablet quality during full-scale continuous manufacturing.
  • To compare the performance of the ConsiGma™-1 laboratory unit with the ConsiGma™-25 system.

Main Methods:

  • Granulation and drying of a premix using the ConsiGma™-25 system (single cell and 1-hour continuous run) and the ConsiGma™-1 system.
  • Evaluation of process parameters (torque, temperature) and quality attributes of granules (moisture, particle size, density, flow) and tablets (hardness, disintegration, dissolution).

Main Results:

  • A stabilization period was observed in the 1-hour run, affecting initial process parameters and quality attributes.
  • Single-cell runs on the ConsiGma™-25 system yielded results comparable to the stabilized phase of the 1-hour run.
  • While granule properties differed between ConsiGma™-1 and ConsiGma™-25 due to design, tablet quality from ConsiGma™-1 was predictive of ConsiGma™-25 tablet quality.

Conclusions:

  • Single-cell processing in the ConsiGma™-25 system is predictive of full-scale continuous manufacturing quality.
  • The ConsiGma™-1 laboratory unit can reliably predict tablet quality for larger-scale continuous production, aiding formulation development.