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The present research work was undertaken to formulate modified release tablets of lornoxicam using Compritol 888 ATO as a lipid matrixing agent and to evaluate the tablets for dissolution in hydro-alcoholic dissolution media to meet the requirement of regulators. The dissolution study was also conducted in aqueous medium containing alcohol and hydroxylpropyl methylcellulose to mimic the viscosity and pH after food and alcohol intake. The tablets were prepared by direct compression by adopting the concept of design of experiments and evaluated mainly for dissolution studies in aqueous dissolution media containing 10, 25 and 40% ethyl alcohol. The formulated tablets satisfied the USP requirements of drug release at 2, 6 and 10 hr. The drug release was insignificantly altered when the dissolution study was conducted in media containing increasing amount of alcohol probably due to higher solubility of the drug in alcohol. The drug release was suppressed when HPMC was used in the dissolution media. This may be due to rise in viscosity of the dissolution media. Dose dumping was not noticed under the experimental conditions. [ABSTRACT FROM AUTHOR]

The objective of the present study was to identify critical formulation parameters affecting the drug release from modified release wax matrix tablet of milnacipran hydrochloride employing the concept of design of experiments. The optimized amount of Compritol 888 ATO (intragranular) (X1), lactose (X2) and Compritol 888 ATO (extragranular) (X3) were determined employing simplex lattice design. The tablets were prepared using melt granulation technique. The in vitro drug release study was carried out in an acidic medium (pH 1.2) for 2 h and thereafter the dissolution study was conducted in phosphate buffer (pH 6.8). The selected dependent variables were the cumulative percentage of milnacipran hydrochloride dissolved at 1 (Y1), 8 (Y8), 16 (Y16) and 24 hr (Y24). Mathematical models, correlating the independent variables with dependent variables were evolved. Optimization was performed for the three independent variables using the stated target ranges; Y1=20%; Y8=45±5%; Y16=72±5%; Y24=100%. The optimized amounts of Compritol 888ATO (intragranular) (X1), lactose (X2) and Compritol 888 ATO (extragranular) (X3), were found to be 60, 55 and 30 mg, respectively. The optimized formulation showed a release profile that was close to the predicted values. The drug was released by anomalous diffusion from the optimized formulation. Compritol 888 ATO (intragranular) (X1), lactose (X2) and Compritol 888 ATO (extragranular) (X3) were identified as critical variables. [ABSTRACT FROM AUTHOR]