Low-Temperature Thermal Analyses are Key to Formulation Design

Product and process development of a lyophilized preparation is a critical step in bringing a new product to market. When designing a formulation, it is helpful to have a general knowledge of the thermal characteristics of each excipient as well as an understanding of the potential synergistic effec...

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Bibliographic Details
Published inPharmaceutical Technology p. 20
Main Authors Thomas, Michael, Cannon, Anthony J
Format Trade Publication Article
LanguageEnglish
Published Monmouth Junction MultiMedia Healthcare Inc 02.02.2004
Subjects
Analyzers
Cooling
Design
Electric currents
Freezing
Heat
Microscopy
Pharmaceutical industry
Pharmaceuticals
Phase transitions
Scientific apparatus & instruments
Temperature
Thin films
United States > US
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Summary:Product and process development of a lyophilized preparation is a critical step in bringing a new product to market. When designing a formulation, it is helpful to have a general knowledge of the thermal characteristics of each excipient as well as an understanding of the potential synergistic effects of various combinations of excipients and active pharmaceutical ingredients. Methodologies and the instrumentation for identifying the critical temperatures of a formulation to be lyophilized have technologically progressed from simple devices constructed by the user to sophisticated instrumentation now commercially available. This article evaluates the instrumentation and methods now commonly used to determine these critical values and to characterize the thermal behavior of the product. Examples of the innovations and applications of the various methods are provided.
ISSN:1543-2521
2150-7376