Optimum spray congealing conditions for masking the bitter taste of clarithromycin in wax matrix

The effects of operating conditions in the spray-congealing process on the release and the micromeritic properties of clarithromycin (CAM) wax matrix were evaluated. CAM was matrix with 30% CAM, 60% glyceryl monostearate (GM) and 10% aminoalkyl methacrylate copolymer E (AMCE) Has manufactured at var ious atomizer wheel speeds and liquid feed rates with a spray dryer, Releas e of CAM from the matrix exhibited a two-phase pattern, probably due to the dissolution of the fine portions broken on the surface of the matrix. The slope and the extrapolated y-intercept of the subsequent release pattern we re defined as the release rate and the initial amount of release of CAM fro m the matrix, respectively. These release parameters, as well as the volume median diameter and the specific surface area of matrix, were selected as response variables, and multiple regression analysis was performed, For spe cific surface area and initial amount of release, a minimum point was obser ved on the contour curve when the atomizer wheel speed was constant and the liquid feed rate was varied. For the release rate. a maximum point was obs erved on the contour curve under the same conditions. These points were con sidered preferable for masking the bitter taste of CAM preparation. Microsc opic observation revealed that a small spherical matrix with a smooth surfa ce could be obtained with a high atomizer wheel speed and optimum liquid fe ed rate. This matrix also possessed excellent properties for taste masking. with small initial amount of release and subsequent high rate of release. In conclusion, the congealing speed of melt droplets was the dominant facto r in masking the bitter taste of CAM.