Effect of Beneng Taro Starch (Xanthosoma undipes K. Koch) Concentration as Disintegrant on Active Ingredient and Microbial Limit Test of Paracetamol 500 mg Tablets

Pengaruh Variasi Konsentrasi Pati Talas Beneng (Xanthosoma undipes K. Koch) Sebagai Penghancur Terhadap Kadar Zat Aktif dan Uji Batas Mikroba Tablet Parasetamol 500 mg

Abstract

Tablet dosage form consist of active substances and excipients. Excipients or additives in tablet formulations may be fillers, binders and adhesives, disintegrants, lubricants, antiadherents, adsorbents, flavorings, and coloring agents. Excipients are physical, chemical and pharmacological inert substances which are added to tablet dosage formulations to help it meet the technological process requirements, technical specifications, physical appearance, and official quality requirements (pharmacopoeia). An important excipient for tablet dosage form is the disintegrants. Disintegrants affect the release of active medicinal substances from preparations and can then provide the desired therapeutic effect. One of the disintegrants is starch. Plants that have the potential to have high levels of starch are beneng taro. Xanthosoma undipes K. Koch tubers themselves have a starch content of 15.21%. This study aims to determine the effect of the concentration of taro beneng starch on active ingredient and microbial limit of paracetamol 500 mg tablets. Tablets are made by direct pressing method with variations in the concentration of beneng taro starch as a disintegrant, are 0% (FI), 5% (FII), 10% (FIII) and 15% (IV). The results of the determination of the content showed that all formulations met the requirements of the Pharmacopoeia of Indonesia, FI = 100.27%; FII = 99.95%; FIII = 100.06%; and FIV 99.85%. Microbial limit test showed that the Total Plate Count FI = 20 cfu/g; FII = 35 cfu/g; FIII = 10 cfu/g; FIV = 50 cfu/g. Total Yeast and Mold Count are FI = 110 cfu/g; FII = 100 cfu/g; FIII = 50 cfu/g; FIV = 150 cfu/g. Pathogenic bacterial tests show that all formulas are not contaminated with pathogenic bacteria.

Keywords: tablets, Xanthosoma undipes K. Koch, paracetamol, determination, microbes.