Dave Vivek, Yadav Sachdev, Sharma Swapnil, Vishwakarma Pushpendra, Ali Nasir
Department of Pharmacy, Banasthali University, Rajasthan, India.
Sheffield Hallam University, Howard St, Sheffield, South Yorkshire S1 1WB, UK.
Pak J Pharm Sci. 2015 Jan;28(1):37-41.
Fast disintegrating tablets (FDTs) have received ever increasing demand during the last decade, and the field has become a hastily growing area in the pharmaceutical industry. Upon introduction into the mouth, these tablets dissolve or disintegrate in the mouth in the absence of additional water for easy administration of active pharmaceutical ingredients. Aceclofenac, an NSAID, has been recommended orally for the treatment of bone and connective tissue disorder and thus the formulation of the same resulted in development of several FDT technologies. The present aim is to formulate a tablet which disintegrate and dissolve rapidly and give its rapid onset of action: analgesic, antipyretic and anti-inflammatory action. Besides, the conventional tablets also show poor patient compliance an attempt had been made to formulate for FDT of aceclofenac by using various super disintegrants like sodium starch glycolate, croscarmellose sodium and crosspovidone (polyplasdone XL) and PEG 6000 followed by novel technique. The tablets were evaluated for friability, hardness, weight variation, disintegration time, wetting time, in vitro dissolution studies and drug content studies. It was concluded that the batch which was prepared by using combination of crosspovidone and sodium starch glycolate as a super disintegrant shows excellent disintegration time, enhance dissolution rate, taste masking and hence lead to improve efficacy and bioavailability of drug.
在过去十年中,口腔速崩片(FDTs)的需求不断增加,该领域已成为制药行业中迅速发展的领域。将这些片剂放入口中后,它们在无需额外用水的情况下即可在口腔中溶解或崩解,便于活性药物成分的给药。醋氯芬酸是一种非甾体抗炎药(NSAID),已被推荐口服用于治疗骨骼和结缔组织疾病,因此其制剂促成了多种FDT技术的发展。目前的目标是制备一种能够快速崩解和溶解并能迅速起效的片剂,即具有镇痛、解热和抗炎作用。此外,传统片剂还存在患者顺应性差的问题,因此尝试采用多种超级崩解剂,如羟丙甲纤维素、交联羧甲基纤维素钠和交联聚维酮(聚维酮XL)以及聚乙二醇6000,并采用新技术来制备醋氯芬酸口腔速崩片。对这些片剂进行了脆碎度、硬度、重量差异、崩解时间、湿润时间、体外溶出度研究和药物含量研究。得出的结论是,采用交联聚维酮和羟丙甲纤维素组合作为超级崩解剂制备的批次具有优异的崩解时间,提高了溶出速率,掩盖了味道,从而提高了药物的疗效和生物利用度。