Abstract
A stabilized insulin formulation based on the concept of physical interaction of the hydrophobic regions of the insulin molecule with the hydrophobic portion of stabilizing compounds has been investigated. Stabilizing compounds of alkyl saccharide type surfactant structure have been synthesized. Simple mixing in phosphate-buffered saline serves as the formulation preparation. The specific interaction of dodecylmaltoside was found to produce the most stable complex of all stabilizers studied. A series of in vitro aggregation and surface adsorption studies were evaluated using circular dichroism and electron microscopy. FITC-labeled insulin was used to study in situ compatibility of insulin with intestinal mucus. In vivo absorption of stabilized insulin was studied in normal and diabetic rats. The stabilization of insulin against aggregation, enzymatic degradation and precipitation may be important factors in the successful development of dosage forms for intestinal insulin delivery.
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