昂丹司琼口腔崩解片的研制与评价

Anil R Gadhe, Bipin D Pustake, M. Shinde, R. Korhale, V. Gharge
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引用次数: 0

摘要

口腔崩解片具有起效快、给药方便、崩解快等优点。采用超崩解剂可溶亲水性基质和甜味剂对制剂的影响两种方法制备昂丹司琼口腔崩解片。采用直接压片法制备口腔崩解片。所配制的口腔崩解片具有快速崩解的特性,可提高患者的依从性。对制剂的湿化时间、崩解时间、药物含量、体外溶出度等物理参数进行了评价。在第一种方法中,发现含有10 mg的批F7含crosspovidone (Polyplasdone XL 10)的崩解时间最短(即约为10 mg)。7.00秒),最大药物释放。F7批次的润湿时间最短(即12秒)。在第二种选择方法中,发现含糖精钠的f10批次在杂质研究(相对物质研究)方面表现较好。与其他两种甜味剂相比,杂质含量在规定范围内。对最佳配方进行了稳定性研究。整个批次含有10毫克的crosspovidone (Polyplasdone XL 10)和糖精钠,在物理和化学上都是稳定的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development and Evaluation of Ondansetron Orally Disintegrating Tablets
Orally disintegrating tablet (ODT) has number of advantages like faster onset of action, ease of administration, rapid disintegration and dissolution etc. A novel attempt has been made to develop orally disintegrating tablets of Ondansetron by using two approaches, one is soluble hydrophilic matrix by superdisintegrant and other is effect of sweetener on the formulation. Direct compression method was employed for making orally disintegrating tablets. The formulated orally disintegrating tablets have rapid disintegration property for better patient compliance. Formulated tablets were evaluated for physical parameters along with wetting time, disintegration time, drug content and “in vitro” dissolution. In first approach it was found that batch F7 containing Crospovidone (Polyplasdone XL 10) 10 mg showed minimum disintegration time (i.e. approx. 7.00 seconds) with maximum drug release. Wetting time for batch F7 was found to beminimum (i.e. 12 seconds). In second approach of selection of sweetener batch F 10 containing Sodium saccharin was found better in terms of Impurity study (Relative Substances study).Impurity was found within the specified limit compared to other two sweeteners. Stability study was carried out on optimized formulation. Overall batch containing 10 mg Crospovidone (Polyplasdone XL 10) along with Sodium Saccharin was foundstable both physically and chemically.
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