Formulation and in vitro Evaluations of Paracetamol Orally Disintegrating Tablets

Azmiera Azimuddin, Mohamad Farhan bin Roslan, Riyanto Teguh Widodo
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Abstract

Orally disintegrating tablets are a solid dosage form compromising medicinal substances which disintegrate rapidly, generally within a matter of seconds, when placed on the tongue. In this study, paracetamol orally disintegrating tablets was formulated and evaluated. Direct compression was used to prepare 350 mg tablets of five formulations (F1- F5) by using a single punch manual tableting machine. Pre-formulation studies were performed on the powder mixture of each formulation to obtain information regarding their flow properties. The tablets from each formulation were also evaluated for weight uniformity, drug content uniformity, thickness, hardness, friability, disintegration and dissolution. The disintegration tests carried out revealed that tablets from F2 showed the shortest disintegration time of 32.67 ± 3.14 seconds followed by tablets from F5, F3, F4 and F1. However, the dissolution results illustrated that tablets from F5 have the best dissolution profile, releasing 84.70 ± 5.31% of drugs within 4 minutes. Hence the most optimized formulation of a paracetamol orally disintegrating tablet in this study.
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对乙酰氨基酚口腔崩解片的处方及体外评价
口腔崩解片是一种固体剂型的药物,当放在舌头上时,通常在几秒钟内迅速崩解。本研究配制了扑热息痛口腔崩解片并对其进行了评价。采用单冲式手动压片机,直接压缩制备5种配方(F1- F5) 350 mg片剂。对每种配方的粉末混合物进行配方前研究,以获得有关其流动特性的信息。并对各制剂的重量均匀度、药含量均匀度、厚度、硬度、脆性、崩解度和溶出度进行了评价。崩解试验结果显示,F2片剂崩解时间最短,为32.67±3.14 s,其次为F5、F3、F4和F1片剂。溶出度结果表明,F5片的溶出度最佳,4 min内释药率为84.70±5.31%。由此得出了本研究中对乙酰氨基酚口腔崩解片的最佳配方。
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