Systematic interpretation of pH-degradation profiles. A critical review

In this study we discuss the application of the general models for pH degradation profiles for specific acid, solvent and base catalysis, both in the absence and presence of ligands, and for the general acid and base catalysis, that we have published recently, we also present a systematic step by st...

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Bibliographic Details
Published in:International Journal of Pharmaceutics Vol. 155; no. 2; pp. 137 - 152
Main Authors: van der Houwen, O.A.G.J., de Loos, M.R., Beijnen, J.H., Bult, A., Underberg, W.J.M.
Format: Book Review Journal Article
Language:English
Published: Amsterdam Elsevier B.V 26-09-1997
Elsevier
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Summary:In this study we discuss the application of the general models for pH degradation profiles for specific acid, solvent and base catalysis, both in the absence and presence of ligands, and for the general acid and base catalysis, that we have published recently, we also present a systematic step by step procedure for the interpretation of pH profiles, which we apply to a number of recent publications. To facilitate the comparison of the mathematical treatment of the data the model equations reported in these studies have been transformed analogous to our equations. Many of these studies raise minor to serious objections. These objectives vary from unjustified conclusions regarding the content of specific reactions to the degradation, mathematical errors in the model equations, unjustified neglect of pK a values close to or within the pH range investigated, unjustified linearization of non linear relationships to the application of model equations with non integer exponents without any theoretical foundation. Application of our model equations explains discrepancies in some of the original publications and offers acceptable alternatives to some rather stretched hypotheses.
ISSN:0378-5173
1873-3476
DOI:10.1016/S0378-5173(97)00156-7