采用32全因子设计以车前草黏液配制快速崩解多潘立酮片

S. Shahidulla, M. Khan, K. Jayaveera
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引用次数: 2

摘要

本文对车前草黏液的崩解特性进行了研究。目的:采用3²全因子设计,采用直接压缩法制备快速崩解片,以提高患者的药物依从性和溶出率。采用车前草黏液(2-10% w/w)作为天然超崩解剂,微晶纤维素(0-30% w/w)作为稀释剂,直接可压缩甘露醇增强口感。考察其硬度、脆度、厚度、含量均匀性、体外分散时间、润湿时间和吸水率。基于体外分散时间(约10s);该制剂含有10% w/w的车前草黏液和30%w/w的微晶纤维素,具有良好的体外释药模式(0.1 N HCl)、短期稳定性(400 /75% RH下3个月)和药物-赋形剂相互作用。表面响应图以图形化的方式表示独立变量(车前子黏液和微晶纤维素的浓度)对体外分散时间的影响。通过编制两个设计外检查点公式,验证了所生成数学模型的有效性。并将优化后的片剂与常规市售片剂进行了药物释放谱比较。该制剂的释药速度(50% 2.85 min)比常规片剂(50% 7.85 min)快近4倍。短期稳定性研究表明,制剂的药物含量和体外分散时间无明显变化(p < 0.05)。[3]张晓明,张晓明,张晓明,等。国际现代医药杂志,2015,4(8):415-419
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Formulation of fast disintegrating domperidone tablets using Plantago ovata mucilage by 3 2 full factorial design
The present work was carried out to study the disintegrant property of plantago ovata mucilage . The objective of the work was to formulate Fast disintegrating tablets of Domperidon with a view to enhance patient compliances and dissolution rate by direct compression method using 3² full factorial design. Plantago ovata mucilage (2-10% w/w) was used as natural superdisintegrant and microcrystalline cellulose (0-30% w/w) was used as diluent, along with directly compressible mannitol to enhance mouth feel. The tablets were evaluated for hardness, friability, thickness, drug content uniformity, in vitro dispersion time, wetting time and water absorption ratio. Based on in vitro dispersion time (approximately 10s); the formulation containing 10% w/w Plantago ovata mucilage and 30%w/w microcrystalline cellulose was found to be promising and tested for in vitro drug release pattern (in 0.1 N HCl), short-term stability (at 40o/75% RH for 3 month) and drug-excipient interaction. Surface response plots are presented to graphically represent the effect of independent variables (concentrations of Plantago ovata mucilage and microcrystalline cellulose) on the in vitro dispersion time. The validity of the generated mathematical model was tested by preparing two extra-design check point formulations. The optimized tablet formulation was compared with conventional commercial tablet formulation for drug release profiles. This formulation showed nearly four-fold faster drug release (t 50% 2.85 min) compared to the conventional commercial tablet formulation (t 50% 7.85 min). Short-term stability studies on the formulation indicated that there are no significant changes in drug content and in vitro dispersion time (p < 0.05). Shahidulla et al., International Current Pharmaceutical Journal, July 2015, 4(8): 415-419
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