Munir A. Hussain, Senior Research Fellow, Bristol-Myers Squibb Company, New Brunswick, NJ
Microenvironmental pH can affect solid dosage form performance, particularly stability and dissolution profile. Modulation of the microenvironmental pH through the use of pH modifiers can be a very effective tool in maximizing solid dosage form stability. Judicial selection of the appropriate pH modifier, its concentration and the manufacturing process used to incorporate the pH modifier is necessary to enhance stability. Microenvironmental pH modulation can also control the dissolution rate and oral absorption of both immediate and controlled release dosage forms of compounds with pH dependent solubility. Examples on the utilization of microenvironmental pH control to enhance stability and dissolution/oral absorption will be presented.
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