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 moisture sensitive compound (PGE-7762928) in tablet form at accelerated conditions for 6 months were identified. The equilibrium moisture content of the tablets at 25°C/60%RH, 30°C/60%RH and 40°C/75%RH were 2.3, 2.4, and 2.9%, r...

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Bibliographic Details
Published in:International journal of pharmaceutics 2001-06, Vol.221 (1), p.49-56
Main Authors: Allinson, Jennifer G, Dansereau, Richard J, Sakr, Adel
Format: Article
Language:English
Subjects:
Biological and medical sciences
Chemistry, Pharmaceutical
Chromatography, High Pressure Liquid
Container's permeation
Drug Packaging
Drug Stability
Drug Storage
Fick's law
General pharmacology
Medical sciences
Moisture sensitivity
Package
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Stability
Tablet
Tablets
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Summary:Packages that provided stability (less than a 10% loss in potency) of a moisture sensitive compound (PGE-7762928) in tablet form at accelerated conditions for 6 months were identified. The equilibrium moisture content of the tablets at 25°C/60%RH, 30°C/60%RH and 40°C/75%RH were 2.3, 2.4, and 2.9%, respectively. The tablet equilibrium moisture content, degradation 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 measured after 2, 4, 6, 8, 12, and 24 weeks at ICH conditions. The Containers-Permeation 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°C/75%RH, the percent 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 stability results for the packaged product were fairly consistent with the predictions 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 adjusted for the internal moisture concentration of the blister.
ISSN:0378-5173
1873-3476
DOI:10.1016/S0378-5173(01)00670-6