Stability Predictions with Calorimetry: Characterization of Glass Dynamics by Calorimetry and Correlations with Pharmaceutical Stability.
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Accession number;01A0903148
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| Title;Stability Predictions with Calorimetry: Characterization of Glass Dynamics by Calorimetry and Correlations with Pharmaceutical Stability. |
| Author;
PIKAL M J
(Univ. Connecticut, Ct)
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Journal Title;Netsu Sokutei Toronkai Koen Yoshishu
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Journal Code:F0840B
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ISSN:
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VOL.36th;NO.;PAGE.22(2000)
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| Figure&Table&Reference; |
| Pub. Country;Japan |
| Language;English |
| Abstract;Since many pharmaceuticals are intrinsically reactive systems, stability over the several years of storage time typically required of a product is frequently a significant problem. Stability is extremely formulation sensitive, and formulation strategies are often based upon the concept of dispersing the unstable drug moiety in an inert glassy matrix of "stabilizer", such as sucrose or trehalose. Our hypothesis is that differences in dynamics in the glassy state, as reflected by differences in the structural relaxation time, are partially responsible for formulation specific stability behavior of materials stored well below their Tg's. Using theoretical concepts and experimental structural relaxation time data, it will be demonstrated that dynamics in a glass at fixed T/Tg is a complex function of the nature(i.e., fragility) and thermal history of a glass. Experimental stability data, though limited, suggest stability and structural relaxation are coupled. (author abst.) |
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