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Coprecipitation of nonoxynol-9 with polyvinylpyrrolidone to decrease vaginal irritation potential while maintaining

Philip T Fowler1, Gustavo F Doncel, Paul M Bummer

  • 1Division of Pharmaceutical Sciences, College of Pharmacy, University of Kentucky, Lexington, KY, USA.

AAPS Pharmscitech
|November 19, 2003
PubMed
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Polyvinylpyrrolidone (PVP) reduces nonoxynol-9 (N-9) irritation by increasing its critical micelle concentration (CMC). This formulation maintains spermicidal activity, offering a safer contraceptive option.

Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Reproductive Health

Background:

  • Nonoxynol-9 (N-9) is a widely used spermicide but can cause vaginal irritation.
  • Polyvinylpyrrolidone (PVP) is a polymer with potential to modify the properties of active pharmaceutical ingredients.

Purpose of the Study:

  • To investigate if polyvinylpyrrolidone (PVP) can reduce the irritation potential of nonoxynol-9 (N-9) while preserving its spermicidal efficacy.
  • To determine the effect of PVP on the critical micelle concentration (CMC) of N-9.

Main Methods:

  • Solid coprecipitates of N-9 and PVP were prepared using a modified lyophilization process.
  • Irritation potential was assessed via in vitro red blood cell hemolysis assay.
  • CMC values of N-9 were measured at varying PVP concentrations.

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  • Spermicidal activity was evaluated using a modified Sander-Cramer assay.

    • Main Results:

    • PVP significantly reduced the irritation potential of N-9, increasing 50% hemolysis values from 0.054 mM to over 0.2 mM.
    • The critical micelle concentration (CMC) of N-9 increased with higher PVP concentrations, from 0.085 mM (0% PVP) to 0.166 mM (10% PVP).
    • Spermicidal activity of N-9 remained consistent (0.213-0.238 mM) across different PVP concentrations.

    Conclusions:

    • N-9/PVP coprecipitates successfully altered the self-association properties and reduced the irritation potential of N-9.
    • This approach offers a promising method for developing spermicidal products with reduced vaginal epithelium toxicity.
    • The essential spermicidal activity of N-9 is maintained in the presence of PVP.