Comparative Stability of Aspirin in CSP Technologies Active-VialTM and Owens- Illinois L-8 Prescription Vials

Abstract

The traditional way of drug packaging includes a desiccant pouch along with the drug. The desiccant in the vial helps in preventing the drug degradation due to moisture in surrounding environment. This traditional packaging often proves to be ineffective especially in large vials due to uneven distribution of desiccant. Currently pharmaceutical companies are developing new vials that are made of desiccant embedded polymers to achieve effective drug storage. So it is of utmost importance to study the efficacy of such improved methods.

This study presents the results of a comparative study on aspirin stability in CSP Technologies Activ-vial (desiccant embedded polymer vial) with standard Owens-Illinois vials (control). A analytical methods were established and validated to quantify aspirin and its primary degradation products using automated high-pressure liquid chromatographic (HPLC) analysis on a silica column. The degradation kinetics of aspirin were evaluated with respect to loss of potency of acetylsalicylic acid and the appearance of three oxidative degradation products of acetylsalicylic acid; salicylic acid, salicylsalicylic acid, and acetylsalicylsalicylic acid under simulated use conditions in a humid environment.

The results of this study showed the extent of aspirin degradation was minimal in the time frame studied, although differences were observed in the formation of salicylic acid. Significant suppression of salicylic acid formation was observed in the CSP Technologies Activ-vial when compared to ordinary PET prescription vials. The CSP Technologies Activ-vial is expected to therefore provide an advantage under typical consumer use conditions, particularly in humid geographical regions, for the protection of moisture sensitive pharmaceutical products.