Shawn Kellie

Publication Date

8-1998

Advisor(s) - Committee Chair

Wei-Ping Pan, John Riley, Eric Conte

Comments

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Degree Program

Department of Chemistry

Degree Type

Master of Science

Abstract

The United States Pharmacopeia/National Formulary currently contains no thermal analysis standards for unit-of-use blister film packaging. As part of a study to provide standards, the glass transitions of eight blister films and six lid-stocks were assigned using temperature-modulated DSC and standard DSC. The blister film samples had either a glass transition occurring between 72°C and 86°C or between 61°C and 71°C or both. The lid-stock samples had a glass transition occurring between 70°C and 78°C or between 60°C and 67°C. Additionally, the study provided an opportunity to compare temperature-modulated DSC and standard DSC data. The study showed TA Instrument’s 2920 Modulated DSC to be more sensitive than DuPont Instrument’s 910 DSC for the experimental conditions used.

The results of this study lead to four recommendations for the USP/NF. First, the glass transition temperature should be used to characterize the thermal properties of unit-dose blister film packaging. Second, temperature-modulated DSC is preferable to standard DSC for assigning the glass transition temperature of blister containers. Third, for a blister film or lid-stock to be interchangeable with another blister film or lid-stock they must have a glass transition between 60°C and 86°C. Finally, acceptable standard deviations for the glass transition temperatures should be set in order to ensure the quality of the blister films and lid-stocks.

Disciplines

Chemistry | Physical Sciences and Mathematics

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