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Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though...
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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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Accelerated drug development using a digital formulator and a self-driving tableting data factory.

Faisal Abbas1, Mohammad Salehian1, Peter Hou1

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This study introduces an integrated platform for drug product development, reducing formulation and manufacturing timelines. The novel approach significantly cuts down active pharmaceutical ingredient (API) material use and speeds up the process from material characterization to in-specification tablets.

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Area of Science:

  • Pharmaceutical Science
  • Chemical Engineering
  • Drug Development

Background:

  • Drug discovery advancements have shifted development bottlenecks to Chemistry, Manufacturing, and Controls (CMC).
  • Traditional drug product formulation and process development are resource-intensive and can yield suboptimal results.
  • Current CMC processes require adaptation to accelerate timelines while maintaining quality and safety.

Purpose of the Study:

  • To present an integrated platform for tablet formulation and process development.
  • To shorten drug development timelines and reduce resource utilization.
  • To ensure product quality and safety through advanced manufacturing and testing.

Main Methods:

  • Coupling a digital formulator (in-silico optimization tool with a predictive material-to-tablet model).
  • Utilizing a self-driving tableting data factory with Bayesian optimization.
  • Implementing an automated, integrated workflow for per-tablet manufacturing and testing.

Main Results:

  • Achieved a reduction in time from material characterization to in-specification tablets to 6 hours.
  • Demonstrated a 65% reduction in active pharmaceutical ingredient (API) material use.
  • Validated the platform's efficiency compared to current state-of-the-art methods.

Conclusions:

  • The integrated platform significantly accelerates tablet formulation and process development.
  • The approach optimizes resource utilization, particularly API material consumption.
  • This innovation addresses the CMC bottleneck, enabling faster delivery of quality medicines.