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Racemic therapeutics--ethical and regulatory aspects.

E J Ariëns

    European Journal of Clinical Pharmacology
    |January 1, 1991
    PubMed
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    Racemic therapeutics, mixtures of stereoisomers, often contain inactive "isomeric ballast." This ballast affects drug efficacy and safety, leading to questionable pharmacokinetic data for many medications.

    Area of Science:

    • Pharmacology
    • Medicinal Chemistry
    • Drug Development

    Background:

    • Racemic therapeutics are fixed-ratio mixtures of stereoisomers, often with only one isomer providing therapeutic action.
    • The inactive isomer, termed "isomeric ballast," can alter pharmacokinetics and patient exposure.
    • Historically, stereoselectivity has been overlooked in drug investigation and regulation.

    Purpose of the Study:

    • To discuss the implications of neglecting stereoselectivity in racemic drug investigation.
    • To highlight the acceptance of invalid pharmacokinetic data for a significant percentage of therapeutics.
    • To emphasize the continued patient exposure to "isomeric ballast" in commonly used drugs.

    Main Methods:

    • Review and discussion of stereoselectivity's impact on drug investigation.

    Related Experiment Videos

  • Analysis of pharmacokinetic data validity in the context of racemic mixtures.
  • Summary of findings related to isomeric ballast in established and new drugs.

    • Main Results:

    • Approximately 25% of therapeutics have accepted invalid pharmacokinetic data due to racemic nature.
    • About 50% of commonly used drugs contain "isomeric ballast," leading to prolonged patient exposure.
    • The necessity and benefit of general pharmacokinetics are questioned for such racemates.

    Conclusions:

    • Neglecting stereoselectivity in drug development leads to inaccurate pharmacokinetic data and suboptimal therapeutic outcomes.
    • Patient exposure to "isomeric ballast" is a persistent issue with significant health implications.
    • Future drug development will increasingly focus on chiral characteristics, favoring single-isomer drugs over racemates.