Iurian Sonia, Dinte Elena, Iuga Cristina, Bogdan Cătălina, Spiridon Iuliana, Barbu-Tudoran Lucian, Bodoki Andreea, Tomuţă Ioan, Leucuţa Sorin E
Department of Pharmaceutical Technology and Biopharmacy, Faculty of Pharmacy, University of Medicine and Pharmacy,''Iuliu Haţieganu", 41 Victor Babes Street, 400012 Cluj-Napoca, Romania.
Department of Drug Analysis, Faculty of Pharmacy, University of Medicine and Pharmacy "Iuliu Haţieganu", 6 Louis Pasteur Street, 400349 Cluj-Napoca, Romania.
Saudi Pharm J. 2017 Dec;25(8):1217-1225. doi: 10.1016/j.jsps.2017.09.006. Epub 2017 Sep 17.
The aim of the present study was to evaluate the funtion of fenugreek seed mucilage (FSM) as potential matrix forming agent for orodispersible pharmaceutical lyophilisates. The FSM was isolated and characterized. FSM colloidal dispersions were prepared and the rheological evaluation was performed. Oral lyophilisates (OLs) with different FSM concentrations, containing meloxicam as model drug were prepared by freeze drying method. The OLs were characterized and compared to gelatin containing tablets, prepared under the same conditions. The FSM dispersions revealed shear thinning flow type. Based on colloidal dispersions' rheological properties, five FSM concentrations were taken forward to the lyophilization step. Completely dry and elegant tablets were obtained. Texture analysis indicated highly porous structures, confirmed by SEM analysis, which explain the fast disintegration properties. All the prepared tablets disintegrated in less than 47 s. The disintegration process was prolonged by the increase in FSM content, due to the high viscosity the polymer creates in aqueous media. FSM tablets presented longer disintegration times, as compared to gelatin tablets, but also higher crushing strength. Considering the fast disintegration and the high crushing strength, FSM is a good candidate as matrix forming agent for fast disintegrating dosage forms or other freeze-dried preparations.
本研究的目的是评估胡芦巴籽黏液(FSM)作为口腔崩解药物冻干制剂潜在基质形成剂的功能。对FSM进行了分离和表征。制备了FSM胶态分散体并进行了流变学评估。采用冷冻干燥法制备了含不同FSM浓度、以美洛昔康为模型药物的口腔冻干制剂(OLs)。对OLs进行了表征,并与在相同条件下制备的含明胶片剂进行了比较。FSM分散体呈现剪切变稀流动类型。基于胶态分散体的流变学性质,选取了五种FSM浓度进行冻干步骤。获得了完全干燥且外观良好的片剂。质地分析表明片剂具有高度多孔的结构,扫描电子显微镜分析证实了这一点,这解释了其快速崩解的特性。所有制备的片剂在不到47秒内崩解。由于聚合物在水性介质中产生的高粘度,FSM含量的增加延长了崩解过程。与明胶片剂相比,FSM片剂的崩解时间更长,但抗压强度也更高。考虑到其快速崩解和高抗压强度,FSM是作为快速崩解剂型或其他冻干制剂的基质形成剂的良好候选材料。