The Disintegrant Property of a Hydrophilic Cellulose Polymer Derived from the Tubers of Ipomoea batatas in Paracetamol Tablet Formulation

Abstract

Aims: A new hydrophilic cellulose polymer (I-hydrocel) derived from the tubers of Ipomoea batatas was assessed as a tablet disintegrant in paracetamol tablet formulation in comparison with maize starch. Methods: I-hydrocel was incorporated intragranularly at 5, 10 and 15% w/w to prepare granules containing paracetamol (80.65% w/w), gelatin (3.50% w/w) and lactose as a filler by wet granulation alongside those containing maize starch. The micromeritic evaluations of the granules were carried and later, they were lubricated with 0.5% w/w magnesium stearate and compressed at 4.50 kg into tablets using a single punch tablet press fitted with a 12.50 mm punch. The uniformity of weight/content and disintegration time tests for tablets were accomplished using the British Pharmacopoeia, BP methods. Tablet hardness, friability and tensile strength were also evaluated. A 30 min dissolution rate studies were conducted using the rotating paddle at 50 rpm (United States Pharmacopoeia, USP) in 900 ml of phosphate buffer (pH 5.8) at 37 ± 0.5°C. The absorbance of the respective samples were determined in an ultraviolet (UV) spectrophotometer at 245 nm.  Results: The granules were flowable and the tablets compressed from them complied with BP acceptable limit for uniformity of weight, drug content and disintegration time (≤ 15 min). However, tablets containing 5% w/w corn starch disintegrated significantly more quickly (P= 0.000) than those containing 5% w/w I-Hydrocel but at 10 and 15% w/w of I-hydrocel and maize starch, there was no significant difference (P= 0.296 and 0.543 respectively) in disintegration times of tablets. The tablets prepared with maize starch generally had higher values of hardness, tensile strength and hardness-friability-ratio (HFR) than those containing I-hydrocel (P = 0.000) while the friability obtained for the tablets from either disintegrant were less than 1%. In dissolution rate studies, all the batches of tablets containing either maize starch or I-hydrocel released their drug content above 80% and maximally within 15 min. Conclusion: At 5% w/w, paracetamol tablets prepared with maize starch disintegrated earlier than those of I-hydrocel while at 10 and 15% w/w, there was no significant difference in disintegration time for both samples. Therefore, at 10 or 15% w/w, either maize starch or I-hydrocel could be used to achieve a similar disintegration outcome. However, the disintegration time obtained at 5, 10 and 15 % w/w of either disintegrant complied with BP specifications of ≤ 15 min for uncoated tablets.