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首页> 外文期刊>Powder Technology: An International Journal on the Science and Technology of Wet and Dry Particulate Systems >Hot melt granulation of coarse pharmaceutical powders in a spouted bed
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Hot melt granulation of coarse pharmaceutical powders in a spouted bed

机译：喷射床中粗药物粉末的热熔制粒

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摘要

The hot melt granulation of a coarse pharmaceutical powder in a top spray spouted bed is described.The substrate was lactose-polyvinylpyrrolidone particles containing or not acetaminophen as a drug model.Polyethylene glycol(MW,4000)used as binder was atomized onto the bed by a two-fluid spray nozzle.The granulation experiments followed a 2~3 factorial design with triplicates at the center point and were carried out by varying the spray nozzle vertical position,the atomizing air flow rate and the binder feed rate.Granules were evaluated by their pharmacotechnical properties like size distribution,bulk and tapped densities,Carr index,Hausner ratio and tableting characteristics.Analysis of variance showed that granule sizes were affected by the PEG feed rate and atomizing air pressure at the significance levels of 1.0 and 5.0%,respectively,but spray nozzle distance to the substrate bed was not significant.The spray conditions also affected granule flow and consolidation properties,measured by the Carr index and Hausner ratio.Measured densities,Carr indexes and Hausner ratios proved that granules flowability and consolidation properties are adequate for pharmaceutical processing and tableting.Tablets prepared with acetaminophen-containing granules showed good properties and adequate release profiles in in vitro dissolution tests.The results indicate the suitability of spouted beds for the hot melt granulation of pharmaceutical coarse powders.
机译：描述了在顶喷喷头床中将粗制药物粉末进行热熔制粒，基质是含有或不含有对乙酰氨基酚的乳糖-聚乙烯吡咯烷酮颗粒作为药物模型，通过粘合剂将用作粘合剂的聚乙二醇（MW，4000）雾化到床上通过改变喷嘴的垂直位置，雾化空气流速和粘合剂进料速率进行造粒实验，并在中心点进行三次重复的2〜3因子设计，进行造粒实验。它们的药理学性质如粒度分布，堆积密度和堆积密度，卡尔指数，豪森纳比和压片特性。方差分析表明，颗粒大小受PEG进料速率和雾化气压的影响分别在1.0和5.0％的显着性水平。 ，但喷嘴到基质床的距离并不显着。喷雾条件也影响颗粒的流动和固结性能，密度，Carr指数和Hausner比值证明了颗粒的流动性和固结性足以用于药物加工和压片。含对乙酰氨基酚的颗粒制成的片剂在体外溶出时表现出良好的性能和足够的释放特性结果表明，喷头床适用于药物粗粉的热熔制粒。

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