STUDY OF DRUG LOADING TO ION EXCHANGE RESIN BY HOT-MELT EXTRUSION FOR TASTE MASKING

Abstract

Taste masking is an important operation to ensure product palatability and ion-exchange resin (IER) complexation is commonly used. IER-drug complexation approaches described in literature are mainly based on batch method, which has obvious limitations. However, there is little information on continuous IER-drug complexation by ‘dry’ hot-melt methods (HME). Thus, the objective of this study was to develop a single-step, solvent-free continuous HME process for IER-drug products. In this study, the IER-drug products were prepared by HME using design-of-experiments (DOE). In these DOEs, ratios of drug-IER, resin types, HME parameters and modifier effects were evaluated and compared against conventional batch method. IER-drug products were characterized for physicochemical properties and taste. This study demonstrated the feasibility of a single step, solvent-free, rapid and continuous HME method for complexation of drug to resin for taste masking purpose.