Prajapati Shailesh T, Mehta Anant P, Modhia Ishan P, Patel Chhagan N
Department of Pharmaceutics and Pharmaceutical Technology, Shri Sarvajanik Pharmacy College, Gujarat, India.
Int J Pharm Investig. 2012 Oct;2(4):176-82. doi: 10.4103/2230-973X.106988.
The purpose of this research work was to formulate raft-forming chewable tablets of H2 antagonist (Famotidine) using a raft-forming agent along with an antacid- and gas-generating agent.
Tablets were prepared by wet granulation and evaluated for raft strength, acid neutralisation capacity, weight variation, % drug content, thickness, hardness, friability and in vitro drug release. Various raft-forming agents were used in preliminary screening. A 2(3) full-factorial design was used in the present study for optimisation. The amount of sodium alginate, amount of calcium carbonate and amount sodium bicarbonate were selected as independent variables. Raft strength, acid neutralisation capacity and drug release at 30 min were selected as responses.
Tablets containing sodium alginate were having maximum raft strength as compared with other raft-forming agents. Acid neutralisation capacity and in vitro drug release of all factorial batches were found to be satisfactory. The F5 batch was optimised based on maximum raft strength and good acid neutralisation capacity. Drug-excipient compatibility study showed no interaction between the drug and excipients. Stability study of the optimised formulation showed that the tablets were stable at accelerated environmental conditions.
It was concluded that raft-forming chewable tablets prepared using an optimum amount of sodium alginate, calcium carbonate and sodium bicarbonate could be an efficient dosage form in the treatment of gastro oesophageal reflux disease.
本研究工作的目的是使用一种增稠剂以及抗酸剂和产气剂来制备H2拮抗剂（法莫替丁）的漂浮型咀嚼片。
采用湿法制粒制备片剂，并对其漂浮强度、酸中和能力、重量差异、药物含量百分比、厚度、硬度、脆碎度和体外药物释放进行评估。在初步筛选中使用了各种增稠剂。本研究采用2(3)全因子设计进行优化。海藻酸钠的用量、碳酸钙的用量和碳酸氢钠的用量被选为自变量。选择漂浮强度、酸中和能力和30分钟时的药物释放作为响应指标。
与其他增稠剂相比，含有海藻酸钠的片剂具有最大的漂浮强度。所有因子批次的酸中和能力和体外药物释放均令人满意。基于最大漂浮强度和良好的酸中和能力对F5批次进行了优化。药物-辅料相容性研究表明药物与辅料之间无相互作用。优化制剂的稳定性研究表明，该片剂在加速环境条件下是稳定的。
得出结论，使用最佳量的海藻酸钠、碳酸钙和碳酸氢钠制备的漂浮型咀嚼片可能是治疗胃食管反流病的一种有效剂型。
