Preparation of Spherical Beads without Any Use of Solvents by a Novel Tumbling Melt Granulation (TMG) Method.

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  • Preparation of Spherical Beads without

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A new method, the tumbling melt granulation (TMG) method, for preparing spherical beads without any use of solvents, was developed. A powdered mixture of meltable materials and non-meltable materials was fed gradually and successively onto the seed materials, which were blown with hot slit air using a centrifugal fluidizing bed granulator. As a consequence, the mixture adhered to the seed materials to spontaneously from the spherical beads. First, the effects of several factors concerned with granulatability were investigated using nonpareil as the seed materials; lactose as the non-meltable material; and polyethylene glycol, hydrogenated rape oil, and fatty acids as meltable material. In order to prepare spherical beads with a narrow particle size distribution and a smooth surface, it was concluded from this series of experiments that the bed temperature during the processing should be maintained at least 5°C higher than the melting point of the meltable material; particle sizes of both the meltable and the non-meltable materials should be lowered below one-sixth of the diameter of the seed materials; and the mixing ratio of the meltable material in the powdered mixture should be set at an optimum value. Then, the TMG method was applied to several kinds of drugs with various physicochemical properties. It was revealed that this method was very useful and widely applicable since even bisbentiamine, with which it was difficult to prepare spherical beads by the wet powder coating method, could be granulated easily by this new method. Further, it was shown that this method could be applied successfully to seed materials whose shape was non-spherical, such as cube-shaped sucrose crystals.

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