AVS 52nd International Symposium
    Applied Surface Science Monday Sessions
       Session AS-MoP

Paper AS-MoP7
Investigation of Pharmaceutical Packaging Materials using XPS and TOF-SIMS

Monday, October 31, 2005, 5:00 pm, Room Exhibit Hall C&D

Session: Aspects of Applied Surface Science Poster Session
Presenter: X. Dong, Eli Lilly
Authors: X. Dong, Eli Lilly
R.G. Iacocca, Eli Lilly
J. Janimak, Eli Lilly
M.C. Allgeier, Eli Lilly
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The surface composition of packaging materials is of great interest to the pharmaceutical community because of potential interactions between the packaging surface and the drug product. The surface sensitivity of XPS and TOF-SIMS makes these techniques ideally suited to the surface characterization of packaging materials. In this work, XPS was utilized to evaluate surface compositions of three Type I glass vials from different sources. The bulk compositions of three glass vials are similar to each other, and the surface of one glass vial is ammonium sulfate treated. To thoroughly understand the surface composition, survey and high resolution spectra, as well as small spot images, were collected from all three samples. The XPS results revealed marked difference in surface compositions of the three vials. Significantly higher amounts of B and Na were detected on one vial than on the other two, suggesting that this glass had been exposed to excessive heat. Sodium sulfate residues were present on the ammonium sulfate treated vial, suggesting the rinsing process performed by the manufacturer is not thorough enough. In addition to glass vials, plastic liners, another commonly used packaging material for Active Pharmaceutical Ingredient (API) powders, were also examined. API stored in plastic liners under different conditions were investigated, and compared to that stored in glass vials using TOF-SIMS. It is obvious that the additives present on the surface of the plastic liner were transferred to the API during storage. The preliminary results also suggest that the increase of additives on the API is consistent with the decrease in surface area. This work clearly demonstrates that XPS and TOF-SIMS are highly valuable techniques in evaluation of pharmaceutical packaging materials, as well as in the investigation of the interactions between drug products and the packaging.