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Development and Evaluation of Mouth Dissolving Films of Amlodipine Besylate for Enhanced Therapeutic Efficacy

机译:苯磺酸氨氯地平口腔溶解膜增强治疗功效的开发和评价

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The present investigation was undertaken with an objective of formulating mouth dissolving films (MDFs) of Amlodipine Besylate (AMLO) to enhance convenience and compliance of the elderly and pediatric patients for better therapeutic efficacy. Film formers like hydroxy propyl methyl cellulose (HPMC) and methyl cellulose (MC) along with film modifiers like poly vinyl pyrrolidone K30 (PVP K30), and sodium lauryl sulphate (SLS) as solubilizing agents were evaluated. The prepared MDFs were evaluated forin vitrodissolution characteristics,in vitrodisintegration time, and their physicomechanical properties. All the prepared MDFs showed good mechanical properties like tensile strength, folding endurance, and % elongation. MDFs were evaluated by means of FTIR, SEM, and X-RD studies. MDFs with 7.5% (w/w) of HPMC E3 gave better dissolution properties when compared to HPMC E5, HPMC E15, and MC. MDFs with PVP K30 and SLS gave superior dissolution properties when compared to MDFs without PVP K30 and SLS. The dissolution properties of MDFs with PVP K30 were superior when compared to MDFs with SLS. In the case of F3 containing 7.5% of HPMC E3 and 0.04% of PVP K30, complete and faster release was observed within 60 sec when compared to other formulations. Release kinetics data reveals diffusion is the release mechanism.
机译:进行本研究的目的是配制苯磺酸氨氯地平(AMLO)的口溶膜(MDF),以增强老年人和儿科患者的便利性和依从性,从而获得更好的治疗效果。评价了成膜剂,如羟丙基甲基纤维素(HPMC)和甲基纤维素(MC),以及成膜剂,如聚乙烯吡咯烷酮K30(PVP K30)和十二烷基硫酸钠(SLS)作为增溶剂。评价了制备的MDF的体外溶解特性,体外崩解时间及其物理力学性能。所有制备的中密度纤维板均显示出良好的机械性能,如拉伸强度,耐折性和伸长率%。通过FTIR,SEM和X-RD研究评估了MDF。与HPMC E5,HPMC E15和MC相比,具有7.5%(w / w)HPMC E3的MDF具有更好的溶解性能。与不具有PVP K30和SLS的MDF相比,具有PVP K30和SLS的MDF具有更好的溶解性能。与带有SLS的MDF相比,带有PVP K30的MDF的溶出性能优越。如果F3包含7.5%的HPMC E3和0.04%的PVP K30,则与其他配方相比,在60?sec内可观察到完全,更快的释放。释放动力学数据表明扩散是释放机理。

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