Baher Daihom1, Alaadin Alayoubi2, Dejian Ma2, Lijia Wang3, Sanjay Mishra3, Richard Helms4, Hassan Almoazen2. 1. a Department of Pharmaceutics and Industrial Pharmacy, College of Pharmacy , Cairo University, Cairo , Egypt ; 2. b Department of Pharmaceutical Sciences, College of Pharmacy , University of Tennessee Health Science Center , Memphis , TN , USA ; 3. c Department of Physics , University of Memphis , Memphis , TN , USA ; 4. d Department of Clinical Pharmacy, College of Pharmacy , University of Tennessee Health Science Center , Memphis , TN , USA.
Abstract
PURPOSE: To evaluate the physicochemical characteristics of clindamycin HCl in a complex form (resinate) with ion exchange resin (IER) (Amberlite IRP69). METHODS: Drug-resin complex was prepared by simple aqueous binding method. Drug binding study was carried out at different drug and resin concentrations. Several physicochemical characterization studies were conducted to evaluate the resinate complex. These studies included flow properties, in vitro drug release in SGF and SIF, DSC, TGA, mass spectroscopy and XPRD evaluations. In addition, stability study of resinate complex was conducted at 25 and 40 °C for up to 1 month. RESULTS: Clindamycin and Amberlite IRP69 have formed a complex (resinate) and have shown good flow properties, good thermal properties and chemical stability (short term over 4 weeks) at 25 and 40 °C. Clindamycin release profiles from resinate in SGF and SIF have shown immediate release characteristics and release in simulated saliva has shown dependence on water volume. CONCLUSION: The clindamycin stable complex with IER (Amberlite IRP69) has the potential for further development as a compatible pediatric liquid formulation (suspension) or a fast disintegrating tablet.
PURPOSE: To evaluate the physicochemical characteristics of clindamycin HCl in a complex form (resinate) with ion exchange resin (IER) (Amberlite IRP69). METHODS: Drug-resin complex was prepared by simple aqueous binding method. Drug binding study was carried out at different drug and resin concentrations. Several physicochemical characterization studies were conducted to evaluate the resinate complex. These studies included flow properties, in vitro drug release in SGF and SIF, DSC, TGA, mass spectroscopy and XPRD evaluations. In addition, stability study of resinate complex was conducted at 25 and 40 °C for up to 1 month. RESULTS:Clindamycin and Amberlite IRP69 have formed a complex (resinate) and have shown good flow properties, good thermal properties and chemical stability (short term over 4 weeks) at 25 and 40 °C. Clindamycin release profiles from resinate in SGF and SIF have shown immediate release characteristics and release in simulated saliva has shown dependence on water volume. CONCLUSION: The clindamycin stable complex with IER (Amberlite IRP69) has the potential for further development as a compatible pediatric liquid formulation (suspension) or a fast disintegrating tablet.
Authors: Amir Ibrahim Mohamed; Amr Mohamed Elsayed Abd-Motagaly; Osama A A Ahmed; Suzan Amin; Alaa Ibrahim Mohamed Ali Journal: Pharmaceutics Date: 2017-01-16 Impact factor: 6.321