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Formulation Development and Stability Testing of Extemporaneous Suspension Prepared From Dapsone Tablets

Author(s):  Kaila Nitin, El-Ries Mohamed, Riga A, Alexander Kenneth S, Dollimore D

Issue:  May/Jun 2003 - Diabetes and Wound Care
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Abstract:  The qualification and quantification of dapsone in suspension were developed and shown to be stability indicating by means of a reverse-phase high-performance liquid chromatographic method. The real solubility of dapsone in water was calculated to be 0.208 mg/mL at 25°C. The enthalpy of solution and the entropy of solution were calculated to be -175.6 J/g and -43605.7 J/K/M, respectively. An extemporaneous suspension was formulated from commercially available dapsone tablets, and the chemical stability of dapsone in the suspension was determined by means of accelerated stability testing. The 91-day analytical stability testing study was conducted at 4, 30, 50, 60, and 70°C. The energy of activation for the suspension was determined to be –23288.35 J/K/M. The zero-order rate of degradation for dapsone (k0,25) in suspension at 25°C was found to be 0.040845 day-1. The first-order rate of degradation for dapsone in solution was found to be 0.196370 (mg/mL)(day-1). The shelf life for the suspension was calculated to be 31.67 days at 25°C and 230.76 days under refrigeration at 4°C.

Related Keywords: Dapsone tablets, formulation development of extemporaneous suspension prepared from, Dapsone tablets, stability testing of extemporaneous suspension prepared from


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