Hardy Ian J, Fitzpatrick Shaun, Booth Steven W
Pharmaceutical Research & Development, Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK.
J Pharm Pharmacol. 2003 Dec;55(12):1593-9. doi: 10.1211/0022357022610.
Tamp filling processes are widely used for the filling of powders into hard gelatin capsules, whereby capsule fill weight is controlled by the formation of a loosely packed plug of material that is dispensed into the capsule shell. To rationally design formulations for tamp filling processes the formulator must have an intimate knowledge of the synergy between machine parameters and powder properties and the corresponding effect on product quality. However, despite ubiquitous use throughout the pharmaceutical industry, relatively little is understood about the design of powders for tamp filling processes. The aim of the following review is to summarize the published literature to date from a formulation design perspective and to provide a framework for future scientific research.
压塞填充工艺广泛用于将粉末填充到硬明胶胶囊中,通过形成一个松散堆积的物料塞来控制胶囊填充重量,该物料塞被分配到胶囊壳中。为了合理设计用于压塞填充工艺的制剂,配方设计师必须深入了解机器参数与粉末特性之间的协同作用以及对产品质量的相应影响。然而,尽管在整个制药行业中广泛使用,但对于用于压塞填充工艺的粉末设计却了解甚少。以下综述的目的是从制剂设计的角度总结迄今为止已发表的文献,并为未来的科学研究提供一个框架。