The effects of packaging on the stability of a moisture sensitive compound

Packages that provided stability (less than a 10% loss in potency) of a moi sture sensitive compound (PGE-7762928) in tablet form at accelerated condit ions for 6 months were identified. The equilibrium moisture content of the tablets at 25 degreesC/60%RH, 30 degreesC/60%RH and 40 degreesC/75%RH were 2.3, 2.4, and 2.9% respectively. The tablet equilibrium moisture content, d egradation rate of unpackaged product, and the moisture barrier properties of the packages were used to predict the stability of the packaged product. The physical and chemical stability (HPLC assay) of the products were meas ured after 2, 4, 6, 8, 12, and 24 weeks at ICH conditions. The Containers-P ermeation(1) of polyvinyl chloride blisters, cyclic olefin blisters, aclar blisters, cold-form aluminum blisters was 0.259, 0.040, 0.008 and 0.001 mg per blister per day, respectively. At 6 months at 40 degreesC/75%RH, the pe rcent active was 84% in polyvinyl chloride blisters, 91%, in cyclic olefin blisters, 97% in aclar blisters, 100% in cold-form aluminum blisters and 99 % in an high density polyethylene bottle with a foil induction seal. The st ability results for the packaged product were fairly consistent with the pr edictions based on the moisture sensitivity of the product and the moisture barrier properties of the respective package. To gain a better prediction, the flux value determined by the Containers-Permeation procedure was adjus ted for the internal moisture concentration of the blister. (C) 2001 Elsevi er Science B.V. All rights reserved.