Abstract
Objective The goals of this study were to (1) delineate a technique to prepare stable aqueous vitamin E/Soluplus (R) dispersions; (2) characterize films cast from the aqueous dispersions; and (3) demonstrate the utility of the aqueous dispersions in fluid bed coating applications. This study demonstrated the feasibility of using vitamin E in the preparation of amphiphilic film withs potential use in delayed-release coating applications.
Methods Low viscosity aqueous vitamin E/Soluplus (R) dispersions were prepared by first spray drying ethanolic vitamin E/Soluplus (R) solutions followed by high-shear homogenization of the solid dispersions in water. Concentrated (10%) aqueous dispersions containing 0%, 10%, 20%, and 30% of vitamin E in the binary blend with Soluplus (R) were then cast into films and characterized for contact angle and mechanical strength by texture analysis.
Results All films were hydrophilic and homogenous, which confirmed the utility of vitamin E as a plasticizer for the Soluplus (R) polymer. The 0% and 10% films were brittle whereas the 30% were tacky. The 20% dispersion was subsequently used to coat acetaminophen granules by a fluidized bed process to a dry weight gain of 10-30%. When tested by a dissolution study, a delay in acetaminophen release was observed as a function of weight gain.
Conclusion The results from this study demonstrated that it is feasible to produce stable vitamin E/Soluplus (R) aqueous dispersions to be used as solvent-free functional film coating materials.