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Preparation and Characterization of a Compounded Aqueous Human Insulin Suspension

Author(s):  Al-Achi Antoine, Parekh Bhavita

Issue:  Nov/Dec 2004 - Endotoxin
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Abstract:  Human insulin, used in the management of diabetes, is commercially available in the form of solutions or suspensions for injection. This study investigated the preparation and characterization of an oral suspension for insulin. The suspension was prepared by adding human insulin to aqueous soy extract and adjusting the pH of the preparation to 4.0. The mean diameters of insulin particles at this pH were measured to be 29.93 and 28.30 micrometers for voume-surface mean and volume-number mean, respectively. After 24 hours of the suspension standing at room temperature, the sedimentation volume reached a constant value of 0.22. The suspension exchibited shear-thinning rheological properties, since its viscosity decreased when the rate of shear was increased. The formulation was stable for about 18 days when stored in the refrigerator (4 degrees C). Compared to a simple solution of insulin stored at a similar acidic pH reported in the literature, the stability of insulin in the suspension has improved over 2000-fold.

Related Keywords: Antoine Al-Achi, PhD, Bhavita Parekh, MS, human insulin, diabetes, oral suspension, aqueous soy extract, pH, proteolytic enzyme inhibitor, inhibition of proteolytic enzymes


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