Physical and chemical properties of DMP 504, a polyalkylammonium-based bile acid sequestrant

Pharmaceutical Development and Technology
K S RaghavanM A Hussain

Abstract

The purpose of this study was to characterize the physicochemical properties of DMP 504 and lay the foundation for formulation development. Thermal properties were characterized by DSC and TGA and moisture sorption and desorption by TGA. The association rate and equilibrium binding capacity of the polymer for a prototype bile acid was evaluated using cholic acid, and solid state stability was examined at 25 degrees C, 40 degrees C (with and without 5% added water), 60 degrees C, and 600 foot candles/25 degrees C. The solid state excipient compatibility of binary mixtures of DMP 504 and several commonly used pharmaceutical excipients was also evaluated. Thermal analysis of the polymer showed a glass transition temperature at approximately 95 degrees C and no melting point, indicating a highly amorphous macromolecular structure with thermal stability up to 250 degrees C. Moisture sorption and desorption isotherms at controlled humidity ranging from 11% to 97% RH did not display hysteresis. Cholic acid associated with DMP 504 extremely rapidly so that binding was essentially complete within 5 min. Scatchard analysis of the equilibrium binding of cholic acid to DMP 504 was unconventional, and indicated that the system was exhibitin...Continue Reading

References

Jan 1, 1974·Annual Review of Biophysics and Bioengineering·G G Hammes, C W Wu
Aug 27, 1981·The New England Journal of Medicine·M S Brown, J L Goldstein

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Citations

Mar 4, 2000·Drug Development and Industrial Pharmacy·R K Chang, M A Hussain
May 20, 1998·Journal of Pharmaceutical Sciences·R K ChangM A Hussain

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