一种代过程和混合物设计方法,用于干颗粒的填充剂-结合剂的三元混合物
Niclas Märkle1,2, Gernot Warnke2, Miriam Pein-Hackelbusch1
1Ostwestfalen-Lippe University of Applied Sciences and Arts, Institute for Life Science Technologies (ILT.NRW), Campusallee 12, 32657 Lemgo, Germany.
International journal of pharmaceutics: X
|April 17, 2025
概括
滚筒压缩/干颗粒 (RC/DG) 优化了制药粉末的性能. 统计建模确定了最佳的过程参数和配方,平衡了药片强度和可制造性,以改善药物输送.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 材料科学 材料科学 材料科学
- 化学工程是化学工程的重要组成部分.
背景情况:
- 在制药生产中,滚筒压缩/干颗粒 (RC/DG) 对于提高粉末的性能,如流动性和密度至关重要.
- 直接压缩通常更简单,但RC / DG为特定配方提供了优势.
- 优化RC/DG需要仔细考虑工艺参数和材料组成.
研究的目的:
- 使用统计建模优化滚筒压缩/干颗粒 (RC/DG) 过程参数.
- 为了确定最佳的粘合剂成分,以改善颗粒和片剂的性能.
- 为RC/DG应用中选择配方和工艺参数提供指导.
主要方法:
- 过程和混合物设计实验被用于统计建模.
- 微晶纤维素 (MCC),化MCC (SMCC) 和二酸 (DCP) 被用作填充剂粘合剂.
- 补充方法分析了颗粒和平板电脑的特性,包括流动性,密度和抗压力.
主要成果:
- 证实,与直接压缩相比,RC/DG可以降低制造能力.
- 在20到60之间确定了最佳加工条件 (特定压缩力 * 螺丝对滚筒速度比) [kN/cm].
- 混合物设计实验确定了最佳的SMCC,MCC和DCP平衡,以达到所需的性能.
结论:
- 具体压缩力 (SCF) 乘以螺丝对滚动速度比 (θ),表示为"SCF * θ",有效量化颗粒强度.
- 一个叠加的混合物设计模型成功地根据目标散装密度,流量和断裂力确定了最佳配方.
- 这些发现为使用RC/DG工艺的制药制造商提供了宝贵的见解.
相关概念视频
01:29Additives and Fillers in Concrete
65
Additives and fillers are integral to enhancing the properties of concrete. Pozzolans and blast-furnace slag are additives or admixtures due to their reactions with calcium hydroxide released during cement hydration. Fillers, which are finely ground and similar in fineness to Portland cement, improve concrete attributes such as workability density, and reduce capillary bleeding or cracking. Some fillers possess hydraulic properties or participate in benign reactions within the cement paste.
The...
The...
65
01:24Design Example: Aggregate Gradation
81
The right type and quality of aggregates are crucial for concrete as they significantly influence its properties, mix proportions, and cost-effectiveness. If different sources are available for sand, the commonly used fine aggregate in concrete, the selection of sand is primarily based on its gradation.
The grading, or particle-size distribution, of sand is determined using sieve analysis, with standard sizes ranging from 150 μm to 10 mm (ASTM No. 100 sieve to 3⁄8 in. sieve). Sand is...
The grading, or particle-size distribution, of sand is determined using sieve analysis, with standard sizes ranging from 150 μm to 10 mm (ASTM No. 100 sieve to 3⁄8 in. sieve). Sand is...
81
01:28Factors Influencing Drug Absorption: Pharmaceutical Parameters
101
Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
101
01:31Plasticizers
56
Water-reducers, or plasticizers, are chemical admixtures used in concrete to improve strength and workability. These additives reduce the water-cement ratio without compromising workability, lower the cement content while maintaining the same workability, or increase workability to assist concrete placement in inaccessible areas.
Plasticizers function by using surface-active agents to create repulsive electrostatic forces between cement particles. This dispersion enhances the concrete's...
Plasticizers function by using surface-active agents to create repulsive electrostatic forces between cement particles. This dispersion enhances the concrete's...
56
01:30Mixing Concrete
91
Concrete mixing ensures a homogenous blend where aggregates are well-coated with cement paste. Concrete mixing is typically done using two main types of mixers: batch and continuous. Batch mixers handle one batch at a time, thoroughly combining materials before discharging and receiving the next batch. In contrast, continuous mixers receive a steady flow of ingredients, mixing them consistently and discharging without interruption. Within batch mixers, tilting drum mixers mix with internal...
91
00:52Washing, Drying, and Ignition of Precipitates
772
After filtration, the precipitate is washed to remove coprecipitated impurities and any remaining mother liquor. Colloidal precipitates, such as silver chloride, are washed with an electrolyte (such as dilute nitric acid) to prevent the peptization of the precipitate. In the case of slightly soluble precipitates, the wash solution contains a common ion to reduce solubility. Lead sulfate, which is slightly soluble in water, is washed with dilute sulfuric acid. Similarly, wash solutions may be...
772