Compressional Behavior of a Mixture of Granules Containing High Load of Phyllanthus niruri Spray-Dried Extract and Granules of Adjuvants: Comparison between Eccentric and Rotary Tablet Machines

被引:4
作者
Spaniol, Barbara [1 ]
Bica, Vinicius Claudino [1 ]
Ruppenthal, Lisias Rafael [2 ]
Volpato, Maria Ramos [2 ]
Petrovick, Pedro Ros [1 ,2 ]
机构
[1] Univ Fed Rio Grande do Sul, Programa Posgrad Ciencias Farmaceut, BR-90610000 Porto Alegre, RS, Brazil
[2] Univ Fed Rio Grande do Sul, Fac Farm, BR-90610000 Porto Alegre, RS, Brazil
关键词
eccentric tablet machine; image analysis; Phyllanthus niruri; rotary tablet machine; spray-dried extract; SPEED; CONSOLIDATION; PARAMETERS;
D O I
10.1208/s12249-009-9297-z
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
The purpose of this paper was to evaluate the compressional behavior of granules containing high load of a Phyllanthus niruri spray-dried extract in eccentric (ETM) and rotary (RTM) tablet presses. Tablets were constituted by spray-dried extract granules (SDEG, 92%), excipient granules (EXCG, 7.92%), and magnesium stearate (0.08%). SDEG was obtained by dry granulation and EXCG, composed of microcrystalline cellulose (62.9%) and sodium starch glycolate (37.1%), by wet granulation. Particle size distribution was fixed between 0.250 and 0.850 mm. Tablets did not evidence any mechanical failures, such as lamination or capping, or anomalous weight variation in either tablet machine types. Upper and lower tablet surface photomicrographs from ETM and RTM tablets showed differences in porosity and texture. Different RTM speeds suggested the visco-plastic behavior of the formulation, since, by slowing down rotation speeds, the tensile strength of the tablets increased significantly, but the porosity and disintegration time were not affected. Tablets produced in RTM showed lower friability and porosity than ETM tablets, which did not reflect on higher tensile strength. The EXCG distribution at upper and lower surfaces from ETM and RTM tablets was quantified by image analysis and evaluated through statistical methods. Spray-dried extract release was not influenced by the type of equipment or operational conditions to which the compacts were submitted. Construction and operation differences between both tablet presses influenced the final product, since tablets with similar tensile strength, made by distinct tablet machines, exhibited different quality parameters.
引用
收藏
页码:1013 / 1023
页数:11
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