Dissolution Behaviours of Acetaminophen and Ibuprofen Tablet Influenced By L–HPC 21, 22, and Sodium Starch Glycolate as Disintegrant

Yoga Windhu Wardhana, D. Priambodo
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Abstract

The dissolution of tablets is one of a drug absorption determinant. Disintegrant agent has play an important role on determining the dissolution of tablets. In this experiment, the dissolution behaviours of Acetaminophen and Ibuprofen Tablet was studied using various disintegrant agent such as Low substituted – Hydroxypropyl Cellulose (L–HPC) 21, L–HPC 22 and Sodium Starch Glycolate (SSG) as comparator. Those disintegrant agents were used at three concentration (6%, 7% and 8%) for every tablets formula. Tablets were made by wet granulation method and pressed using single punch 13 mm flat E. Korsch machine. Evaluation of each tablets quality were conducted include for uniformity of weight and size (diameter and thickness), hardness, friability, disintegration time and dissolution. Physically standards from tablets were in good condition, the standards of the weight and thickness uniformity, hardness and friability met the requirement. The dissolution profile on Acetaminophen Tablets showed that only tablet with 6 % L–HPC 21 did not meet the requirement of FI V (Q = 80%, 30 minutes), but on Ibuprofen Tablets where met the requirement of  FI V (Q = 80%, 60 minutes) only tablet with 8%  L– HPC 21,  7% and 8% SSG. The conclusion of the study was the L–HPC has more disintegrant character at hydrophilic active ingredients. Key words:  Acetaminophen Tablet, Ibuprofen Tablet, SSG, L-HPC 21 and 22, Dissolution Profile
l - hpc21、22和乙醇酸淀粉钠对对乙酰氨基酚和布洛芬片溶出行为的影响
片剂的溶出度是决定药物吸收的因素之一。崩解剂对片剂溶出度有重要影响。本实验以低取代羟丙基纤维素(L-HPC) 21、L-HPC 22和乙醇酸淀粉钠(SSG)为比较剂,研究了对乙酰氨基酚和布洛芬片的溶出行为。崩解剂以3种浓度(6%、7%和8%)用于每片配方。采用湿法造粒法制备片剂,采用13 mm平板E. Korsch单孔压片机压片。对各片剂进行质量评价,包括重量、尺寸(直径、厚度)均匀性、硬度、脆性、崩解时间、溶出度等。所制片剂物理标准状况良好,质量、厚度均匀性、硬度、脆性等指标均符合要求。对乙酰氨基酚片溶出度曲线显示,只有6% L - HPC 21的片剂不符合FI V要求(Q = 80%, 30 min),而布洛芬片只有8% L - HPC 21、7%和8% SSG的片剂符合FI V要求(Q = 80%, 60 min)。研究结果表明,L-HPC对亲水性活性成分具有较强的崩解性。关键词:对乙酰氨基酚片,布洛芬片,SSG, l - hpc21和22,溶出度
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