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Related Experiment Videos

Effects of mechanical processing on phase composition.

Harry G Brittain1

  • 1Center for Pharmaceutical Physics, 10 Charles Road, Milford, New Jersey 08848, USA. hbrittain@earthlink.net

Journal of Pharmaceutical Sciences
|July 13, 2002
PubMed
Summary

Pharmaceutical manufacturing processes can change drug characteristics, impacting bioavailability. Scale-up operations require careful characterization to avoid issues with particle size reduction and compression.

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Area of Science:

  • Pharmaceutical Sciences
  • Chemical Engineering
  • Materials Science

Background:

  • Drug manufacturing processes can significantly alter the physical properties of pharmaceutical compounds.
  • Scale-up of manufacturing operations can introduce unforeseen challenges and changes to drug substances or dosage forms.
  • Altered physical characteristics may lead to undesirable changes in solubility, dissolution rate, and ultimately, bioavailability.

Purpose of the Study:

  • To review the impact of pharmaceutical manufacturing processes on drug characteristics.
  • To highlight the importance of characterization during scale-up.
  • To focus on mechanical manipulations like particle size reduction and compression.

Main Methods:

  • Literature review of pharmaceutical manufacturing processes.

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  • Analysis of scale-up challenges in drug development.
  • Discussion of mechanical manipulation techniques such as particle size reduction and compression.

    • Main Results:

    • Manufacturing processes, especially mechanical manipulations, can alter drug substance physical characteristics.
    • Insufficient characterization during scale-up can lead to unanticipated problems.
    • Changes in drug properties can negatively affect bioavailability.

    Conclusions:

    • Thorough characterization of drug substances and processes is crucial during pharmaceutical development and scale-up.
    • Mechanical manipulation techniques require careful control to ensure consistent drug product quality and performance.
    • Understanding these effects is vital for achieving desired bioavailability and therapeutic efficacy.