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Related Concept Videos

Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

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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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The selection of a drug's delivery route depends upon its physicochemical properties, including lipid or water solubility and ionization, as well as the therapeutic requirement, such as immediate or sustained effect. These routes can be divided into three primary categories: enteral, parenteral, and topical.
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Developing a Modular Continuous Drug Product Manufacturing System with Real Time Quality Assurance for Producing

Varun Sundarkumar1, Wanning Wang1, Madeline Mills1

  • 1Davidson School of Chemical Engineering, Purdue University, West Lafayette, IN 47907, USA.

Journal of Pharmaceutical Sciences
|October 3, 2023
PubMed
Summary
This summary is machine-generated.

This study developed a modular manufacturing system using drop on demand (DoD) printing for personalized solid oral medicines. The prototype successfully produced pediatric mini-tablets, demonstrating agile and flexible pharmaceutical production capabilities.

Keywords:
3D printingContinuous manufacturingModularizationPharmaceutical mini-tabletsReal time monitoring

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Area of Science:

  • Pharmaceutical manufacturing
  • Drug delivery systems
  • Process engineering

Background:

  • The pharmaceutical industry seeks agile, small-scale modular manufacturing for rapid drug production during crises.
  • Development of modular facilities for solid oral drug products has faced challenges.
  • Need for flexible manufacturing solutions for personalized medicine and emergency drug supply.

Purpose of the Study:

  • To develop a prototype modular system for personalized solid oral drug production using drop on demand (DoD) printing.
  • To demonstrate the system's capability in manufacturing pediatric mini-tablets.
  • To integrate real-time process monitoring for critical quality attributes and process parameters.

Main Methods:

  • Utilized a drop on demand (DoD) printer to create molten formulation drops.
  • Solidified drops into mini-tablets, followed by integrated extraction, washing, and drying.
  • Incorporated process monitoring tools for real-time tracking of critical quality attributes and process parameters.
  • Operated the system in both continuous and semi-batch modes.

Main Results:

  • Successfully developed and demonstrated a prototype modular system for solid oral drug manufacturing.
  • Manufactured pediatric mini-tablets using DoD printing in continuous and semi-batch modes.
  • Integrated downstream processing (filtration, drying) with the printing unit.
  • Implemented real-time monitoring of critical process parameters and product quality.

Conclusions:

  • The developed prototype demonstrates a viable platform for agile, personalized solid oral drug manufacturing.
  • The system offers flexibility for producing pediatric formulations and potentially other solid dosage forms.
  • Future innovations can enhance the prototype for advanced drug manufacturing systems.