Sipos Emese, Oltean Andrea Ramona, Szabó Zoltán-István, Rédai Emőke-Margit, Nagy Gabriella Dónáth
.
Acta Pharm. 2017 Jun 27;67(2):237-246. doi: 10.1515/acph-2017-0017.
Pediatric, ibuprofen containing orodispersible tablets (ODTs) were prepared using the SeDeM expert system methodology. In order to facilitate formulation, directly compressible ibuprofen was employed (Ibuprofen DC 8TM) and characterized using its SeDeM profile. The mannitol based superdisintegrant Ludiflash® was characterized by the SeDeM-ODT expert system, which also allowed calculation of the optimal excipient concentration in order to obtain suitable tablet hardness and disintegration time. After adding a sweetener and a standard combination of lubricants, the optimized formulation was directly compressed into tablets and evaluated in terms of tablet hardness, friability, disintegration time and dissolution profile. The SeDeM method was applied to determine the amount of corrective excipient (Ludiflash®) required for the compression of Ibuprofen DC 85TM in order to achieve suitable ODTs. Adequate tablet hardness, disintegration time, friability and dissolution profiles were found during tablet evaluation.
采用SeDeM专家系统方法制备了含布洛芬的儿科口腔崩解片（ODT）。为便于制剂成型，使用了可直接压片的布洛芬（Ibuprofen DC 8TM），并通过其SeDeM曲线进行表征。基于甘露醇的超级崩解剂Ludiflash®通过SeDeM-ODT专家系统进行表征，该系统还可计算最佳辅料浓度，以获得合适的片剂硬度和崩解时间。添加甜味剂和标准润滑剂组合后，将优化后的配方直接压制成片，并对片剂硬度、脆碎度、崩解时间和溶出曲线进行评估。应用SeDeM方法确定压制布洛芬DC 85TM以获得合适口腔崩解片所需的校正辅料（Ludiflash®）用量。在片剂评估过程中发现了足够的片剂硬度、崩解时间、脆碎度和溶出曲线。
