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Avinash B. Gangurde,Ritesh A. Fule,Sharadchandra D. Javeer,Rahul K. Patole,Jaywant N. Pawar,Purnima D. Amin 한국약제학회 2015 Journal of Pharmaceutical Investigation Vol.45 No.2
Choline bitartrate (CBT) is a water solubleessential nutrient belongs to vitamin-B family. It is moisturesensitive in nature and marketed formulation has stabilityrelated problems during storage which curtails itseffectiveness. Waxes such as hydrogenated soya bean oil(HSO) reported to be an excellent coating carrier to reducemoisture sensitivity or hygroscopic nature of drug candidates. However, literature dictates HSO applications hasbeen explored mostly using non-aqueous methods or hotmelt techniques of formulation development. In this work,microparticles of choline bitartrate with aqueous coatingdispersion of HSO as primary carrier was successfullydeveloped using fluidized bed coating technique. Aqueousdispersion of HSO was prepared using selected binder in ahomogenizer and formed aqueous dispersion was thensprayed through 0.8 mm gun in fluidized bed processor. The microparticles were evaluated for parameters like flowproperties, morphological characteristics, drug content,encapsulation efficiency and drug release behaviour. Thesolid state characterization of optimized microparticlebased formulation was done by differential scanning calorimetry,X-ray diffractometry, infrared spectroscopy andscanning electron microscopy. The results showed thatmicroencapsulation of choline bitartrate were successfullydone by aqueous wax coating dispersion without using anyorganic solvent or hot melt techniques. Discolouration,fishy odour and drug content variation was not observedafter 6 months stability studies. Choice of proper carrier todrug ratio and selective formulation technique are criticalparameters for dispensing CBT microparticle based formulationwhich might significantly enhance itseffectiveness.