School of Science, University of Greenwich (Medway Campus) , Central Avenue, Chatham Maritime, Chatham, Kent , UK.
Drug Dev Ind Pharm. 2014 Feb;40(2):145-56. doi: 10.3109/03639045.2013.804833. Epub 2013 Jun 13.
The majority of active pharmaceutical ingredients (APIs) found in oral dosage forms have a bitter taste. Masking the unpleasant taste of bitter, APIs is a major challenge in the development of such oral dosage forms. Taste assessment is an important quality-control parameter for evaluating taste-masked formulations of any new molecular entity. Hot-melt extrusion (HME) techniques, have very recently, been accepted from an industrial compliance viewpoint in relation to both manufacturing operations and development of pharmaceuticals. HME achieves taste masking of bitter APIs via various mechanisms such as the formation of solid dispersions and inter-molecular interactions and this has led to its wide-spread use in pharmaceutical formulation research. In this article, the uses of various taste evaluation methods and HME as continuous processing techniques for taste masking of bitter APIs used for the oral delivery of drugs are reviewed.
大多数在口服剂型中发现的活性药物成分（APIs）具有苦味。掩盖 APIs 的不良苦味是开发此类口服剂型的主要挑战。味道评估是评估任何新分子实体的掩味配方的重要质量控制参数。热熔挤出（HME）技术最近已从工业合规的角度被接受，涉及制造操作和药物开发。HME 通过形成固体分散体和分子间相互作用等各种机制实现苦味 API 的掩味，这导致其在药物制剂研究中得到广泛应用。本文综述了各种味道评估方法和 HME 作为苦味 API 的掩味的连续处理技术在药物口服递送中的应用。
