New packaging specifications prompt OC shelf life study.

Abstract

when a major donor of contraceptives changed the packaging specifications of norethindrone/mestranol oral contraceptives (OCs), the change raised some questions as to product shelf life. The new specifications called for the OCs to be packaged in bulk with 100 blister packs/aluminum/plastic overpack. These revised packaging specifications would lead to removal of the blister pack from the protective overpack at an earlier point in the supply chain, and therefore to earlier potential exposure to high temperatures and humidity. However, stability trials conducted by Kabalikat ng Pamilyang Pilipino in Manila have shown no significant deterioration in norethindrone or mestranol content, content uniformity, tablet hardness, disintegration time or blister pack integrity after blister packs without the protective overpack were exposed for 6 months to high humidity and temperatures as high as 60 degrees Celsius. Stability for longer than 6 months remains speculative and should be tested in actual field conditions. Within the limits of the study, however, these results suggest that OCs remain stable with or without the aluminum overpack.