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Comparison between Mechanical Properties of Dry Blended and Granulated Pharmaceutical Powder Formulations

机译:干混和粒化药物粉末制剂的力学性能比较

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Pharmaceutical tablets are formed using various powder ingredients such as filler, binder, disintegrant, and active pharmaceutical ingredients (APIs). Tablets are formed either by dry blending the above ingredients or wet granulation of the powder mixfollowed by compaction. In the present study, the powder ingredients were dry blended using a manual blender and granulated using a high shear mixer. The granules were oven dried and sieved to get the desired size range. Both the dry blend and granulated powders were tested to determine mechanical properties using a medium pressure flexible boundary cubical triaxial tester (CTT). Hydrostatic triaxial compression (HTC) tests were conducted at pressures upto 10 MPa. The data obtained from the HTC tests used for determining the various fundamental elastic, elastoplastic, and rate-dependent properties such as bulk modulus, compression index, and spring-back index. The bulk modulus increased linearly in all cases with pressure. At 10 MPa/min loading rate,the bulk modulus value increased with binder content. The increase in bulk modulus values were more in case of granulated powder formulation as compared to dry blended powder formulation. In case of dry blended powder formulation, the compression index values increased with pressure in all cases. At 10 MPa/min loading rate, for dry blended powder formulation the compression index generally decreased with binder content. In case of granulated formulation the compression index increased with binder content. In general, the compressibility of the powder was increased by granulation. The spring back index increased with increase in pressure in all cases. In case of dry blended formulation, at 10 MPa/min loading rate, the spring-back value decreased with binder content. In case of granulated powder formulation, the spring back index for 10% binder content was higher than for 5% binder content. Granulation decreased the spring-back index of the powder formulation.
机译:使用各种粉末成分如填料,粘合剂,崩解剂和活性药物成分(API)形成药片。通过将上述成分或通过压实制成的粉末的湿法制粒而形成片剂。在本研究中,使用手动搅拌器干混和使用高剪切混合器造粒干混。将颗粒干燥并筛分以获得所需的尺寸范围。通过中压柔性边界立方三轴测试仪(CTT)测试干混合物和粒状粉末以确定机械性能。在高达10MPa的压力下进行静水三轴压缩(HTC)试验。从用于确定各种基本弹塑性,弹性塑料和速率相关性的HTC测试获得的数据,例如散装模量,压缩指数和弹簧反射率。大量模量在所有压力下线性增加。在10MPa / min加载速率下,散装模量值随粘合剂含量增加。与干混粉末制剂相比,在粒化粉末制剂的情况下,大量模量值的增加更大。在干混粉末制剂的情况下,压缩指数值随着压力而增加。在10MPa / min加载速率下,对于干混粉制剂,压缩指数通常用粘合剂含量降低。在粒化制剂的情况下,压缩指数随粘合剂含量增加。通常,通过造粒增加粉末的可压缩性。在所有情况下,弹簧背指数随着压力的增加而增加。在干混制配制的情况下,在10MPa / min加载速率下,弹簧背部用粘合剂含量降低。在粒状粉末制剂的情况下,10%粘合剂含量的弹簧背指数高于5%粘合剂含量。造粒降低了粉末制剂的弹簧背指数。

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