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Sustained release systems for ethinylestrogens.

V Diaz-sanchez, J Garza-flores, M D Rosales

    Advances in Contraceptive Delivery Systems : CDS
    |January 1, 1985
    PubMed
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    This study measured ethinylestradiol (EE) levels after a Norethindrone (NET) and Mestranol (ME) injection. Results show sustained EE release for 21 days, indicating potential for long-acting fertility control.

    Area of Science:

    • Pharmacology
    • Endocrinology
    • Reproductive Health

    Background:

    • Hormonal contraceptives are widely used for fertility regulation.
    • Development of long-acting formulations is crucial for improving adherence and efficacy.
    • Understanding drug pharmacokinetics is essential for designing effective long-acting contraceptives.

    Purpose of the Study:

    • To determine the serum concentration profile of ethinylestradiol (EE) following intramuscular administration of a combined Norethindrone (NET) and Mestranol (ME) preparation.
    • To assess the pharmacokinetic characteristics of EE release from this combined injectable contraceptive.
    • To evaluate the suitability of this formulation as a long-acting fertility regulation method.

    Main Methods:

    • Radioimmunoassay was used to measure immunoreactive serum ethinylestradiol (EE) concentrations.
    Keywords:
    BiologyClinical ResearchContraceptionContraceptive AgentsContraceptive Agents, EstrogenContraceptive Agents, FemaleEconomic FactorsEndocrine SystemEthinyl EstradiolEvaluationFamily PlanningHormonesPhysiologyReproductive Control AgentsResearch And DevelopmentResearch MethodologyTechnology

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  • A single intramuscular injection of Norethindrone (NET) and Mestranol (ME) was administered to 6 women.
  • Serum samples were collected and analyzed over a 21-day period post-injection.

    • Main Results:

    • The mean peak serum EE concentration was 278.5 pg/mL/m² BSA, reached at 11.17 days.
    • The mean absorption half-life (T1/2 abs) was 9.37 days.
    • Ethinylestradiol (EE) was detectable in circulation for up to 21 days in 5 out of 6 subjects, demonstrating a sustained release pattern.

    Conclusions:

    • The Norethindrone (NET) and Mestranol (ME) combined injectable preparation exhibits a sustained release profile for ethinylestradiol (EE).
    • The observed pharmacokinetic characteristics suggest suitability for long-acting fertility regulation.
    • Further investigation into long-term efficacy and safety is warranted.