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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

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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.

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:

Contraception Contraceptive Agents Contraceptive Agents, Female Contraceptive Methods Economic Factors Evaluation Family Planning Hormones Marketing Mestranol Norethindrone Oral Contraceptives Packaging Reproductive 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.