Diclofenac salts : their synthesis, characterization and lyophilization cake characteristic

UNCW Author/Contributor (non-UNCW co-authors, if there are any, appear on document)
John W Burke (Creator)
The University of North Carolina Wilmington (UNCW )
Web Site: http://library.uncw.edu/
John Tyrell

Abstract: Lyophilization has become a more acceptable approach in developing potentially unstable chemical entities. For the purposes of this research, diclofenac, a very stable small molecule was chosen as the model. The goal of this research was two fold. First, different salts of diclofenac were prepared and characterized. The characterizations of the diclofenac salts included appearance, crystalline characteristics, melting point, DSC, TGA, solubility in water and different pH buffers, and assay by High Performance Liquid Chromatography (HPLC). Secondly, the salts were lyophilized to determine if the salts cation affected the physical characteristics of the lyophilization cake. Comparisons were be made between salts with monovalent cations versus divalent and trivalent cations and different sizes of cations. The resulting lyophilized cakes were analytically compared as to the lyophilization cake’s appearance, reconstitution time, color and clarity of solution, percent moisture in the vial (Karl Fischer analysis) and assay by UV. This research demonstrated that the different salts of diclofenac do have an effect on the final lyophilization cake. The lyophilization cake appearance, reconstitution time, percent moisture and primary drying time were all affected by the different salts of diclofenac.

Additional Information

A Thesis Submitted to the University of North Carolina at Wilmington in Partial Fulfillment of the Requirement for the Degree of Masters of Science
Language: English
Date: 2009

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