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[Sustained release double-layered progesterone suppository for luteal support therapy]

M Iwata1, Y Takahashi, S Shirotake

  • 1Department of Pharmacy, Yokohama City University Hospital, Kanagawa, Japan.

Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan
|November 14, 1997
PubMed
Summary

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This study developed a double-layered progesterone suppository for luteal phase defect treatment. Crystalline cellulose controlled drug release, showing sustained release properties in rabbit vaginal administration.

Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems

Background:

  • Luteal phase defect (LPD) requires effective progesterone treatment.
  • Conventional suppositories may have limitations in sustained drug release.

Purpose of the Study:

  • To develop and characterize a novel double-layered sustained-release progesterone suppository for LPD treatment.
  • To investigate the effect of formulation components on drug release kinetics.

Main Methods:

  • Prepared double-layered suppositories using Hydroxypropylcellulose-H (HPC), Carbopol-934P (CP), and Witepsol W35.
  • Investigated the impact of crystalline cellulose (CC) concentration on inner layer strength and progesterone release.
  • Evaluated in vivo sustained release and serum concentration profiles in rabbits.

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Main Results:

  • Increasing CC content in the inner layer decreased stick strength but increased progesterone release.
  • Suppositories with 60% CC exhibited a 12-fold increase in drug release area and halved mean release time compared to controls.
  • Both suppository types demonstrated sustained release in vivo, with reduced peak serum concentrations compared to standard Witepsol suppositories.

Conclusions:

  • Drug release of progesterone from the double-layered suppository can be effectively controlled by adjusting crystalline cellulose content.
  • The developed double-layered suppository shows promise for sustained progesterone delivery, warranting further formulation optimization for clinical use.