Formulation Development and Evaluation of Fast Disintegrating Sustained Release Pellets Containing Verapamil Hydrochloride Tablets by Fluidized Bed Processor

Jagruti J. Pansare, R. K. Surawase
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Abstract

This study aimed to developed novel fast disintegrating sustained release pellets containing tablet by using Fluidized Bed processor. Verapamil HCl used as a model drug for the formulation. Fluidized bed processor was used for coating of drug and polymer on the sugar spheres. To overcome the problem of swallowing for paediatric, geriatric, psychiatric, bedridden patients, uncooperative patients or for active patients who are busy and travelling and may not access to we aim to formulate the fast-disintegrating tablet. The superdisintigrant are commonly use like cross povidone, sodium starch glycolate which disintegrate tablet rapidly. It is assumed that, after the disintegration of tablets, pellets within tablets which are reside in GIT for several hours and gradually released a drug in controlled way. Eudragit RS 30D and ethyl cellulose were used as a sustained release polymer. Coating of spheres with sustained release film is achieved by bottom spray processor of FBP. Proper pellets coating film thickness, and concentration of polymers’, ensure obtaining desirable VH release profile for extended period of time, was defined. X composition of tablet with pellets were examined in order to obtained formulation, from which VH release would mostly appropriate pellets before compressing. Compression of pellets into tablet, being a modern technological process than enclosing them into hard gelatine capsule. The optimized batch evaluated by studied the effect of compression force, tablet hardness and friability and drug release from the pellets by sustained release manner.
盐酸维拉帕米片快崩解缓释微丸的流化床工艺研究与评价
本研究旨在利用流化床处理技术制备新型快速崩解的片剂缓释微丸。盐酸维拉帕米用作配方的模型药物。采用流化床处理技术在糖球表面包衣药物和聚合物。为克服小儿、老年、精神科、卧床不起、不配合的患者或因工作繁忙、旅行不便而活动频繁的患者的吞咽困难,我们研制了快速崩解片。常用的强力崩解剂有交叉聚维酮、乙醇酸淀粉钠等,崩解速度快。假设片剂崩解后,片内微球在GIT中停留数小时,并以可控的方式逐渐释放药物。以芡实RS 30D和乙基纤维素为缓释聚合物。采用FBP底喷处理机对微球进行涂膜。确定了适当的微丸涂膜厚度和聚合物浓度,以确保在较长时间内获得理想的VH释放曲线。考察了片剂与微丸的X组分,得到了在压缩前VH释放最适宜微丸的配方。将颗粒压缩成片剂是一种现代技术过程,而不是将它们包裹在坚硬的明胶胶囊中。通过考察压缩力、片剂硬度、脆度及缓释释药的影响来评价优化后的颗粒剂。
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