Sovány Tamás, Hódi Klára
Acta Pharm Hung. 2014;84(4):123-30.
The number of tablets marketed with a score line to aid divisibility is increasing. The subdivision of scored tablets in order to ensure dose flexibility may be an easier and cheaper solution from the aspect of production. However, to ensure the appropriate mechanical properties and divisibility of tablets so as to guarantee consequent dosing is a difficult problem, which is influenced by many properties of the applied materials, such as the physicochemical behaviour, the plasticity, the degree of elasticity, the mechanism of compression, etc. These exert a significant influence on the postcompressional properties of tablets, and hence on the subdivision of tablets. Despite the considerable difficulties, the increasing importance in paediatrics and the ever stricter requirements of the drug authorities, the subdivision of scored tablets is a poorly studied field. This paper deals with the influence of physico-chemical properties of materials on the postcompressional parameters of tablets, and especially on the subdivision of tablets. For measurement of the force required to break tablets into halves, a laboratory-constructed hardness tester was utilized.
带有刻痕以方便分割的片剂数量正在增加。从生产角度来看，对有刻痕片剂进行再分割以确保剂量灵活性可能是一种更简便且成本更低的解决方案。然而，要确保片剂具有适当的机械性能和可分割性以保证后续给药是一个难题，这受到所用材料的许多特性影响，如物理化学行为、可塑性、弹性程度、压缩机制等。这些对片剂的压后性能有重大影响，进而影响片剂的分割。尽管存在相当大的困难，鉴于其在儿科领域日益重要以及药品监管机构的要求日益严格，但有刻痕片剂的分割仍是一个研究较少的领域。本文探讨了材料的物理化学性质对片剂压后参数的影响，特别是对片剂分割的影响。为测量将片剂掰成两半所需的力，使用了实验室自制的硬度测试仪。
