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A framework for transferring sinomenine hydrochloride sustained-release tablet from batch to continuous direct

Guoming Zhou1, Hao Chang1, Guangpu Fang1

  • 1College of Pharmaceutical Engineering of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, China.

Drug Development and Industrial Pharmacy
|February 10, 2026
PubMed
Summary

This study validates a framework for transferring pharmaceutical manufacturing from batch to continuous direct compression. The new process ensures product quality and equivalence to the original batch, offering a low-risk modernization pathway.

Keywords:
Continuous direct compressionNIR spectroscopybatch-to-continuous transferprocess analytical technologyquality equivalenceresidence time distribution

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Area of Science:

  • Pharmaceutical Manufacturing
  • Chemical Engineering
  • Process Chemistry

Background:

  • Continuous Manufacturing (CM) presents challenges for transferring legacy pharmaceutical products without reformulation.
  • Developing a data-driven pathway can de-risk the transition to CM.
  • Aligning with Quality by Design principles and ICH Q13 guidelines is crucial for successful CM implementation.

Purpose of the Study:

  • To establish and validate a practical framework for transferring a Sinomenine Hydrochloride sustained-release tablet from batch to pilot-scale Continuous Direct Compression (CDC).
  • To demonstrate a replicable strategy for modernizing legacy pharmaceutical products through CM.
  • To achieve enhanced cost-effectiveness and process sustainability.

Main Methods:

  • Utilized an integrated pilot-scale CDC line (1.9 kg/h) with loss-in-weight feeders, a continuous blender, and a rotary tablet press.
  • Implemented a Process Analytical Technology (PAT)-enabled control strategy with a Partial Least Squares (PLS) model for real-time API quantification via in-line NIR spectroscopy.
  • Characterized process dynamics and material traceability using Residence Time Distribution (RTD) analysis.

Main Results:

  • Demonstrated robust stability and control during a 300-minute steady-state CDC run.
  • Confirmed consistent API content uniformity within ± 3% tolerance via real-time monitoring.
  • Proved equivalence of CDC-produced tablets to the reference batch across all critical quality attributes, including dissolution profiles.

Conclusions:

  • Successfully validated a comprehensive framework for batch-to-continuous transfer of a sustained-release tablet.
  • The PAT-enabled control strategy ensures process robustness and reliable real-time quality verification.
  • The demonstrated product quality equivalence confirms a low-risk, guideline-compliant pathway for modernizing existing pharmaceutical manufacturing.