Design and evaluation of microwave-treated orally disintegrating tablets containing polymeric disintegrant and mannitol

作者：Sano Syusuke; Iwao Yasunori; Noguchi Shuji; Kimura Susumu; Itai Shigeru^*

来源：International Journal of Pharmaceutics, 2013, 448(1): 132-141.

DOI：10.1016/j.ijpharm.2013.03.023

• Orally disintegrating tablet
• Microwave
• Experimental design
• Multiple regression analysis

Microwave (MW) treatment was used to develop a formulation process for the preparation of wet molded orally disintegrating tablets (ODTs) consisting of mannitol and polymeric disintegrant with improved hardness and disintegration properties. The wet molded tablets were prepared in accordance with the conventional methods and subsequently heated by MW irradiation to induce the swelling of the tablet. Croscarmellose sodium, crospovidone, and low-substituted hydroxypropylcellulose (L-HPC) were evaluated for their use with this technology. NBD-020, which is a grade of L-HPC, provided the better hardness and disintegration results. In addition, the crystalline forms of mannitol impacted on hardness and disintegration properties of the ODT upon MW irradiation. The effects of the disintegrant ratio, delta and beta crystalline mannitol ratio, amount of water, and compression force on the ODT properties were evaluated using the design of experiment method. MW-induced swelling was enhanced by an increase in the disintegrant ratio. Although the hardness of the tablet increased following MW treatment, the disintegration time became less than that of the MW-untreated tablets as the beta-mannitol ratios increased. Taken together, the results indicated that the polymeric disintegrant greatly improved the properties of the molded tablets in combination with MW treatment.

• 出版日期2013-5-1