Microencapsulated Eudragit(R) RS30D-coated controlled-release pellets: The influence of dissolution variables and topographical evaluation

The air suspension technique was employed to prepare Eudragit(R) RS30D-coated controlled-release pellets of salbutamol. Drug release in dissolution studies can be dependent on the dissolution method and medium used. Thus, the aim of this study was to investigate the influence of various dissolution methods and dissolution medium pH values on drug release from a batch of pellets which displayed controlled drug-release characteristics over an 8-h period in deionized water using the rotating basket method. In vitro testing using the official USP XXII (rotating basket and rotating paddle) and nonofficial (rotating bottle) methods showed drug release to be independent of the method used. The prepared pellets displayed pH-dependent drug-release characteristics when tested in hydrochloric acid (pH 1.5), phosphate buffer (pH 6.8) and deionized water (pH 7.2). Also, in vitro testing, which exposed the pellets to a changing pH gradient that simulated the gastrointestinal pH conditions following oral administration, was used to confirm the drug-release characteristics. The results showed controlled-release characteristics to be maintained, with the drug being released over an 8-h period. Scanning electron microscopic evaluation proved useful in the elucidation of the physical characteristics of the controlled-release pellets as well as in the identification of a possible mode of drug transfer into the dissolution medium.