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[Study on compound levonorgestrel microspheres]

R Guo, B Lu

    Hua Xi Yi Ke Da Xue Xue Bao = Journal of West China University of Medical Sciences = Huaxi Yike Daxue Xuebao
    |December 1, 1993
    PubMed
    Summary
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    This study developed stable levonorgestrel (LNG) and estradiol (E2) gelatin-microspheres for sustained drug release. The compound microspheres reduced side effects like ovary congestion, potentially alleviating irregular bleeding.

    Area of Science:

    • Pharmacology
    • Materials Science
    • Reproductive Biology

    Context:

    • Hormone replacement therapy and contraception often involve levonorgestrel (LNG) and estradiol (E2).
    • Developing effective drug delivery systems is crucial for optimizing therapeutic outcomes and minimizing side effects.
    • Biodegradable polymers like gelatin offer potential for controlled drug release applications.

    Purpose:

    • To prepare and characterize compound levonorgestrel (LNG) and estradiol (E2) gelatin-microspheres.
    • To evaluate the stability, encapsulation efficiency, and in vitro sustained release properties of the microspheres.
    • To assess the histological effects of the compound microspheres on the mouse ovary compared to LNG alone.

    Summary:

    • Compound LNG and E2 were formulated into gelatin-microspheres (10-40 microns) with 65-75% encapsulation efficiency using a phase-separation method.

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  • Stability tests confirmed good microsphere integrity, and differential scanning colorimetry (DSC) determined a thermal degradation activation energy of 134.4 kJ/mol.
  • In vitro dissolution studies demonstrated significant sustained release of both LNG and E2 from the microspheres compared to unencapsulated forms (P < 0.01).

    • Impact:

    • The compound LNG gelatin-microsphere injection exhibited good stability and sustained release properties.
    • Histological analysis revealed that the compound microspheres reduced ovary congestion, a side effect associated with LNG administration.
    • This novel dosage form shows clinical potential for alleviating irregular bleeding caused by levonorgestrel therapy.