THE EFFECT OF A NOVEL HYDROPHILIC BIOPOLYMER DERIVED FROM IPOMOEA BATATAS TUBER AS A GRANULATING AGENT IN PARACETAMOL TABLET FORMULATION

A novel hydrophilic biopolymer, I-polygel (IP) derived from the tubers of Ipomoea batatas was evaluated as a granulating agent at 2.50-5.50 % w/w in paracetamol tablets. Its compatibility with paracetamol was investigated using differential scanning calorimetry (DSC).  The micromeritic properties of the granules prepared by wet granulation method were considered.  They were compressed into tablets with a 12.5 mm flat-faced punch‎ fitted in a single punch tabletting machine. The weight uniformity, mechanical properties, disintegration time, dissolution profile, dissolution efficiency (DE) and the organoleptic properties of the tablets were studied. Gelatin (GT) was employed as a standard granulating agent. From the results, DSC thermograms showed that paracetamol was compatible with IP. Flowability and compressibility of the granules generally improved with increasing concentrations of the granulating agents with GT yielding better results (p > 0.05). The uniformity of weight of all the batches of tablets exhibited a variation in tablet weight ranging between 0.37 – 0.87 %. A consistent increase in the  mechanical properties of the tablets along the line of increasing concentrations of IP or GT with a corresponding decrease in friability was recorded, with GT indicating better outcomes at each concentration (p<0.05). The batches of tablets containing IP disintegrated within 3.76 -7.62 min whereas those of GT disintegrated between 10.89-20.92 min. All the batches of tablets containing IP and only 2.5 % w/w GT released up to 80 % of paracetamol within 30 min. The highest values of DE of 71.32- 74.17 % was obtained within 2.50-4.0 % w/w of IP only (p<0.05). Tablets with acceptable mechanical strength were obtained with either IP or GT, but lower disintegration time (<<< 15.00 min) and highest DEs of tablets were obtainable only with IP at the concentrations of 2.50-4.00 % w/w, showing that IP was better than GT as a granulating agent. Keywords: Hydrophilic biopolymer, I-polygel, Ipomoea batatas, granulating agent, paracetamol, tablet