Shirsand S B, Suresh Sarasija, Para M S, Swamy P V, Kumar D Nagendra
Department of Pharmaceutical Technology, H.K.E. Society's College of Pharmacy, Sedam Road, Gulbarga-585 105, India.
Indian J Pharm Sci. 2009 Jan;71(1):41-5. doi: 10.4103/0250-474X.51952.
In the present work, fast disintegrating tablets of prochlorperazine maleate were designed with a view to enhance patient compliance by direct compression method. In this method mucilage of Plantago ovata and crospovidone were used as superdisintegrants (2-8% w/w) along with microcrystalline cellulose (20-60% w/w) and directly compressible mannitol (Pearlitol SD 200) to enhance mouth feel. The prepared batches of tablets were evaluated for hardness, friability, drug content uniformity, wetting time, water absorption ratio and in vitro dispersion time. Based on in vitro dispersion time (approximately 8 s), the two formulations were tested for the in vitro drug release pattern (in pH 6.8 phosphate buffer), short-term stability (at 40 degrees /75% relative humidity for 3 mo) and drug-excipient interaction (IR spectroscopy). Among the two promising formulations, the formulation prepared by using 8% w/w of Plantago ovata mucilage and 60% w/w of microcrystalline cellulose emerged as the overall best formulation (t(50%) 3.3 min) based on the in vitro drug release characteristics compared to conventional commercial tablets formulation (t(50%) 17.4 min). Short-term stability studies on the formulations indicated that there are no significant changes in drug content and in vitro dispersion time (p<0.05).
在本研究中，设计了马来酸氯丙嗪快速崩解片，旨在通过直接压片法提高患者的顺应性。在该方法中，车前子黏液和交联聚维酮用作超级崩解剂（2 - 8% w/w），同时加入微晶纤维素（20 - 60% w/w）和可直接压片的甘露醇（Pearlitol SD 200）以改善口感。对制备的片剂批次进行硬度、脆碎度、药物含量均匀度、润湿时间、吸水率和体外分散时间的评估。基于体外分散时间（约8秒），对两种制剂进行体外药物释放模式（在pH 6.8磷酸盐缓冲液中）、短期稳定性（在40℃/75%相对湿度下放置3个月）和药物 - 辅料相互作用（红外光谱）测试。在两种有前景的制剂中，基于体外药物释放特性，与传统市售片剂制剂（t(50%) 17.4分钟）相比，使用8% w/w车前子黏液和60% w/w微晶纤维素制备的制剂成为总体最佳制剂（t(50%) 3.3分钟）。制剂的短期稳定性研究表明，药物含量和体外分散时间没有显著变化（p<0.05）。
