Abstract
The objective of this study was to evaluate the effects of drug load, spray rate and rotor speed and their combinations for production of lansoprazole pellets based on Balocel in a fluidized bed rotary processor and to investigate the influence of temperature and formulation factors on stability of optimum formulation. A Vertex-Centroid Design was used to find the optimal levels of factors for the chosen dependent variables, geometric mean diameter by weight and moisture content. Investigation of stability was conducted for pellets in the size range of 500 μm, prepared with a drug load of 12 %, spray rate of 10 rpm (23 g/min) and rotor speed of 65 %. The influence of alkaline agent magnesium carbonate-heavy at 7 % (w/w) and the presence of a protective coating of hydroxypropylmethyl cellulose at 4 % (w/w) on stability at temperatures of 30, 40, 55 and 60 °C at 79 % RH was investigated. The results of the study revealed that the influence of rotor speed, spray rate and inlet-air humidity should be highly controlled in preparing drug loaded microcrystalline cellulose (MCC) pellets, in terms of size, shape and dissolution. A combination of factors promoting higher powder bed moisture content had a positive effect on pellet size. Presence of MCC and sodium-carboxymethylcellulose in Balocel powder led to dissolution modifying properties depending on the powder bed moisture.
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