Swelling and drug release behavior of tablets coated with aqueous hydroxypropyl methylcellulose phthalate (HPMCP) nanoparticles

Organic solvent-based enteric coating technology using hydroxypropyl methyl cellulose phthalate (HPMCP) has been developed for many years due to low water solubility of HPMCP. In this work, aqueous HPMCP nanoparticles (HPMCP-NPs) were prepared by neutralization emulsification method using HPMCP powder and ammonium hydroxide (NH₄OH) in the absence of any organic solvent and emulsifier. Tablets for enteric use were coated with HPMCP-NP dispersions having different degree of neutralization that was manipulated by ion-exchange process. Disintegration and dissolution behavior of coated tablets were investigated using UV-visible spectrophotometer based on USP method (pH 1.2 and at 37°C) and simulated intestinal fluid (pH 6.8 and at 37°C for 60 min), respectively. The ion-exchange process, which was directly achieved by the protonation of dissociated carboxylic acid group of the aqueous HPMCP-NPs, was introduced as a useful way to control the release rate of drug and hydrophobic nature of HPMCP coating layer with a view for pharmaceutical application. The drug release and swelling were increased with increase in conductivity of aqueous HPMCP-NPs. On the other hand, particle size and polydispersity were decreased with increase in degree of neutralization.