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This study details an advanced manufacturing technology (AMT) for producing albuterol sulfate, an asthma medication. The automated system aims to overcome drug shortages and enhance pharmaceutical supply chain resilience.

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Area of Science:

  • Pharmaceutical Manufacturing
  • Chemical Engineering
  • Drug Development

Background:

  • Albuterol sulfate is a critical bronchodilator for asthma treatment.
  • Current manufacturing methods face challenges, leading to drug shortages.
  • The FDA lists albuterol sulfate as a drug in shortage.

Purpose of the Study:

  • To describe the early conceptual development of a candidate advanced manufacturing technology (AMT).
  • To enable automated, continuous production of albuterol sulfate.
  • To address the current drug shortage and improve supply chain resiliency.

Main Methods:

  • Development of a novel synthetic pathway for albuterol sulfate.
  • Implementation of continuous flow manufacturing principles.
  • Integration of process analytical technologies (PAT) for real-time monitoring.
  • Analytical characterization using HPLC, LC-MS, GC-FID, and in-line NMR.

Main Results:

  • The candidate AMT system is designed for automated production of over 2,000 mg/h of albuterol sulfate.
  • Achieved a 78.4% solution yield at a 1.0 mL/min flow rate.
  • Demonstrated potential for 10-fold throughput scaling with minor modifications.

Conclusions:

  • The developed AMT offers a strategy to exceed batch efficiency in liquid drug formulation production.
  • This technology can potentially reduce capital costs and eliminate drug shortages.
  • Successful scale-up of automated continuous manufacturing strengthens pharmaceutical supply chain resiliency.