Abstract
The object of this research is to determine the relationship between the characteristics of fine granules and the dividing and packaging characteristics during dispensing, in addition to the relationship between the preparation condition of fine granules and drug content uniformity.Fine granules of 7:3 lactose-corn starch mixtures were prepared by a high speed agitating granulator based on “The Standard Formula for Fine Granules” established by the Standard Formulation Reserach Association, the Particulate Preparation and Design Group, the Society of Powder Technology of Japan.Also, the influence of lactose particle size on drug content uniformity was investigated. As the results, the average partice size varied markedly due to the amount of added water in a range of from 100mL to 150mL.It was found that regardless of the particle size of lactose and the amount of HPC added as binding agent, the fine granules with an average particle size more than 130μm have suitable characteristics for dividing and packaging for dispensing.The drug contents of each fraction of particle size related closely to the amount of HPC added and particle size of lactose. Thus, the selection of the particle size of lactose was effective in reducing the variation of drug content during agitating granulation.
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