盐酸小檗碱薄膜包衣片的处方及评价

Q3 Pharmacology, Toxicology and Pharmaceutics
Manju Koli, Lipi Nogai, Maulshree Bhandari, Riya Mishra, Rashmi Pathak, Himanshu Sharma
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引用次数: 0

摘要

本研究旨在制备盐酸黄连素薄膜包衣片并对其进行评价。对API进行了预配方研究。薄膜包衣片与传统口服剂型相比具有优势,薄膜包衣片也影响药物压缩后的释放。薄膜包衣也有助于使片剂具有良好的味觉掩蔽性能和优异的机械强度。研究表明,纤维素涂层材料无法抵抗压缩力,而羟丙基-甲基纤维素共聚物则能抵抗压缩力。此外,羟丙基-甲基纤维素共聚物的水分散体显示出与纤维素材料一样的高柔性,从而提供了对破坏性压缩力的抵抗力。预配方特征按照药典规范进行。采用红外光谱法对药物和辅料的配伍性进行了研究。研究了各种压缩前参数,如堆积密度、振实密度、压缩指数和Hausner比,以及压缩后参数,如重量变化、厚度、硬度、脆性、崩解时间和药物释放。光谱表明药物和赋形剂之间没有相互作用。为了获得最佳的优化产品,使用稀释剂、粘合剂、助粘剂、润滑剂和不同浓度的超级崩解剂开发了五种不同的配方。采用湿法制粒法制备片剂。进行了优化,发现Crospovidone和Enhance DT的超级崩解剂的释放特性最好。Protectab HP-1包衣在盐酸黄连素片上进行。在pH6.8的磷酸盐缓冲液中进行体外释放。制剂F-5表现出较好的药物释放性,并被选为最佳制剂。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Formulation And Evaluation Of Berberine Hydrochloride Film Coated Tablet
The purpose of the present study was to formulate and evaluate Berberine HCl Film coated tablet. Preformulation studies of API were done. The film coated tablets have advantages over conventional oral dosage forms, film coated tablet also influences the release of drug after compression. Film coating also help in making the tablet with good taste masking properties and excellent mechanical strength. It was revealed in the study that cellulosic coating materials were unable to resist the compression forces whereas hydroxypropyl methyl cellulose co-polymers resist the forces. Furthermore, aqueous dispersions of hydroxypropyl methyl cellulose co-polymers showed high flexibility as that of cellulosic materials thereby providing resistance from destructive compressional forces. The Preformulation characteristics were done as per the Pharmacopeial specifications. The drugs and excipients compatibility studies were carried out by FT-IR spectroscopy. Various pre-compressional parameters like bulk density, tapped density, compressibility index and Hausner’s ratio and post-compressional parameters like weight variation, thickness, hardness, friability, disintegration time and drug release were studied. The spectra elucidate that there was no interaction between Drug and excipients. In order to achieve the best optimized product, five different formulations were developed using diluents, binder, glidant, lubricant, and different concentrations of super-disintegrant. The tablets were prepared by using wet granulation method. Optimization was done and it was found that release profile was found to be best with super-disintegrant that is Crospovidone and Enhance DT. Protectab HP-1 coating was done on Berberine HCl tablets. In-vitro release was carried out in medium 6.8 pH Phosphate buffer. The formulation F-5 was showed better drug release and selected as an optimized formulation.
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