Formulation and Evaluation of Captopril Sustained Release Pellet Containing Tablet by Fluidized Bed Processing

Ujwala N. Pagar, R. K. Surawase
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Abstract

A novel compression of coated pellets formulation of captopril was developed in order to improve the efficacy of antihypertensive therapy considering the half-life of drug. The sustained release pellets containing tablet were prepared by using 32 factorial design by employing 2 polymers i.e., HPMC k4M and eudragit RS 30D at 3 levels. As captopril having short half-life (2 hrs) there is need to formulate the modified release formulation. sustained release pellets containing tablet is the best approach to reduce the dose frequency of captopril tablet, by using the single polymer (eudragit RS 30D). The release retardant layer over a drug loaded pellets was achieved by 3% eudragit RS 30D polymer solution by using fluidized bed processor and then the pellets were mixed with other excipients and compress into the tablets and it showed the good sustained release pattern.
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卡托普利缓释片的流化床制备及评价
考虑到药物的半衰期,为提高卡托普利抗高血压的疗效,研制了一种新型的卡托普利压缩包衣微丸制剂。采用32因子设计,以HPMC k4M和eudragit RS 30D两种聚合物为3个水平制备了含片剂的缓释微丸。由于卡托普利半衰期短(2小时),有必要研制改良释放制剂。单聚合物(eudragit RS 30D)缓释微丸是降低卡托普利片给药频率的最佳方法。采用流化床处理技术,以3%苦楝酸RS 30D聚合物溶液为缓释剂,在载药微丸表面形成缓释层,再与其他辅料混合压入片剂中,获得良好的缓释效果。
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