口腔崩解片制备技术研究进展

Advances in preparation technology of orally disintegrating tablets

口腔崩解片无需水或仅需少量水即可在口腔内快速崩解,可满足口服困难或处于特殊情况下患者的医疗需求,顺应性高。由于其独特性能,近年来对于口腔崩解片的研究越来越多,并逐渐成为一大热点。制备技术也从传统的粉末直接压片、冷冻干燥、湿法制粒等进一步发展完善,出现许多新的技术:基于预混辅料的粉末直压、微波照射、3D打印技术、固态溶液技术等。通过查阅大量相关文献,并结合口腔崩解片的国内外发展情况,本文旨在综述口腔崩解片的制备新技术及掩味技术,着重介绍了制备工艺的新进展和新突破,提出目前亟需解决的问题以及口腔崩解片的口感改善技术,为口腔崩解片的进一步研发提供依据。口腔崩解片的良好性能不仅为药物速释提供了新的解决思路,也为老人、幼儿及吞咽困难的特殊疾病患者的临床用药开辟了一条有效途径,在医药领域具有巨大发展前景。

Oral disintegrating tablets can rapidly disintegrate in the oral cavity without water or only a small amount of water,which can meet the medical needs of patients with oral difficulties or in special circumstances with high compliance.Due to its unique properties,more and more studies have been conducted on orally disintegrating tablets in recent years,and gradually become a hot spot.The preparation technology has been further improved from the traditional powder direct compression,freeze-drying,wet granulation and so on.Many new technologies have emerged,including powder direct pressing based on premixed excipients,microwave irradiation,3 D printing technology,solid solution technology,etc.By consulting a large number of relevant literatures,combining with the development of orally disintegrating tablets at home and abroad,this paper aims to review the new preparation technology and taste masking technology of orally disintegrating tablets,emphatically introduces the new progress and breakthrough of preparation technology,and puts forward the problems to be solved and the taste improvement technology of orally disintegrating tablets,so as to provide the basis for the further research and development of orally disintegrating tablets.The good performance of orally disintegrating tablets not only provides a new solution for the rapid release of drugs,but also opens up an effective way for the clinical medication of the elderly,children and patients with special diseases of dysphagia,which has a great development prospect in the field of medicine.