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Related Experiment Videos

New packaging specifications prompt OC shelf life study.

    PIACT Product News. Program for the Introduction and Adaptation of Contraceptive Technology (U.S.)
    |December 1, 1983
    PubMed
    Summary

    New packaging for norethindrone/mestranol oral contraceptives (OCs) may increase exposure to heat and humidity. Stability trials indicate OCs remain stable for at least six months without the protective overpack.

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    Area of Science:

    • Pharmaceutical Sciences
    • Reproductive Health

    Background:

    • Changes in packaging specifications for norethindrone/mestranol oral contraceptives (OCs) raised concerns about product shelf life.
    • New bulk packaging involves earlier removal of blister packs from protective overpacks, increasing potential exposure to heat and humidity.

    Purpose of the Study:

    • To assess the stability of norethindrone/mestranol OCs under conditions simulating the revised packaging specifications.
    • To determine if the protective aluminum overpack is essential for maintaining OC integrity.

    Main Methods:

    • Stability trials were conducted by Kabalikat ng Pamilyang Pilipino in Manila.
    • Blister packs without the protective overpack were exposed to high humidity and temperatures up to 60°C for six months.
    • Evaluated parameters included drug content, content uniformity, tablet hardness, disintegration time, and blister pack integrity.
    Keywords:
    ContraceptionContraceptive AgentsContraceptive Agents, FemaleContraceptive MethodsEconomic FactorsEvaluationFamily PlanningHormonesMarketingMestranolNorethindroneOral ContraceptivesPackagingReproductive Control Agents

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    Main Results:

    • No significant deterioration was observed in norethindrone or mestranol content.
    • Content uniformity, tablet hardness, and disintegration time remained within acceptable limits.
    • Blister pack integrity was maintained, suggesting stability even without the aluminum overpack.

    Conclusions:

    • Norethindrone/mestranol OCs demonstrate stability for at least six months under high heat and humidity conditions, even without the aluminum overpack.
    • Further studies under actual field conditions are recommended to confirm long-term stability.
    • The findings suggest that OCs may remain stable regardless of the presence of the aluminum overpack, potentially impacting supply chain and packaging decisions.