EFFECT OF RELATIVE HUMIDITY ON ACETAMINOPHEN TABLET PROPERTIES PREPARED BY DIFFERENT TECHNIQUES USING POLYVINYLPYRROLIDINE DERIVATIVES AS BINDERAbstract
Amount of moisture content present in solid dosage forms plays a major role in influencing the physicochemical properties of tablets such as dissolution rate, disintegration time, hardness, etc. The aim of the current study was to investigate the effect of relative humidity (RH) exposure on various properties of acetaminophen tablets manufactured by direct compression and wet granulation methods. Microcrystalline cellulose was used as diluent and Plasdone™ K-29/32 and Kollidon® 90F as binder in different formulations. Wet granulation end point was determined using thermal effusivity measurements. Compressed tablets were exposed to 2%, 22%, 52% and 75% RH for 48 hours at room temperature (26 ± 10C). Powder rheometer was used to evaluate the flow properties of granules after RH exposure.USP dissolution apparatus II was used to study the in-vitro drug release profiles after humidity exposure compared to reference. Thermal properties of different humidity exposed granules were examined by modulated differential scanning calorimetry. Tablets were further analyzed for hardness and disintegration time. The observed results suggested that the initial drug release was retarded for the directly compressed tablets with increase in RH exposure compared to wet granulated tablets where no major difference was observed. Viscosity of binder solution also played a significant role in the moisture uptake. Hardness of the directly compressed tablets was higher and also decreased with humidity exposure. The results show a comparative aspect of the influence of relative humidity on tablets manufactured by various techniques and different excipients on the performance properties of tablets.
Rohit P. Dugar, Priyadarshi Gupta and Rutesh H. Dave*
Arnold and Marie Schwartz College of Pharmacy and Health Sciences, Division of Pharmaceutical Sciences, Long Island University, Brooklyn, NY, USA.
12 May, 2015
08 June, 2015
10 September, 2015
01 November, 2015