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The objective of this study was to develop soft paracetamol gel using gellan gum as a gelling agent and sodium citrate as a source of cation. Different batches were prepared using three different concentrations of gellan gum (0.1, 0.3, and 0.5%), each with two different sodium citrate concentrations (0.3 and 0.5%). The consistency of the paracetamol gel was dependent on the concentration of gellan gum, sodium citrate and co-solute. The results of dissolution study of soft gel containing 0.3% gellan gum and 0.3% sodium citrate revealed that paracetamol was completely released in 30 min. Polyethylene glycol 400 worked as a solubilizer for paracetamol. All the gels possessed acceptable sensory characteristics when evaluated by human volunteers. Short term stability study carried out for four weeks at different temperatures revealed no considerable changes in performance characteristics of developed optimized formulation.

The aim of this investigation was to develop a novel multifunctional co-processed diluent consisting of microcrystalline cellulose (Avicel PH 102), crospovidone (Polyplasdone XL) and polyethylene glycol 4000. Colloidal silicon dioxide and talc were also incorporated as minor components in the diluent to improve tableting properties. Melt granulation was adopted for preparation of co-processed diluent. Percentage of Avicel PH 102, Polyplasdone XL and polyethylene glycol 4000 were selected as independent variables and disintegration time was chosen as a dependent variable in simplex lattice design. The co-processed diluent was characterised for angle of repose, bulk density, tapped density, Carr's index, percentage of fines and dilution potential study. Acetaminophen and metformin were used as poorly compressible model drugs for preparation of tablets. The blend of granules of drug and extra-granular co-processed diluent exhibited better flow as compared to the blend of drug granules and physical mixture of diluents blend. The diluent exhibited satisfactory tableting properties. The tablets exhibited fairly rapid drug release. In conclusion, melt granulation is proposed as a method of preparing co-processed diluent. The concept can be used to bypass patents on excipient manufacturing.

The objectives of present investigation were to achieve immediate release of paracetamol and tailored release of diclofenac sodium from bi-layer tablets. A 2(3) full factorial design was adopted using the amount of polyethylene glycol, microcrystalline cellulose and crospovidone as independent variables for fabricating paracetamol tablets. Diclofenac sodium tablets were prepared using hydroxypropyl methylcellulose as a matrixing agent. The results of analysis of variance showed that the friability of paracetamol was distinctly influenced by the formulation variables. The in vitro drug release behaviour of diclofenac tablets was compared with a marketed formulation. The optimized formulations of paracetamol and diclofenac sodium were used for manufacturing of bi-layer tablets. The bi-layer tablets showed immediate release of paracetamol and modified release of diclofenac.

The aim of the present investigation was to develop oral films of valdecoxib using Eudragit EPO and hydroxypropylmethylcellulose. Films of Eudragit EPO, hydroxypropylmethylcellulose and Eudragit EPO combined with hydroxypropylmethylcellulose were prepared by film casting method. Glycerol, menthol and aspartame were incorporated in the drug containing films as plasticizer, cooling agent and sweetener, respectively. The drug loading was 10 mg valdecoxib per 4 cm2 of the film. The films were evaluated for hydration study, folding endurance and in vitro drug dissolution in the distilled water. The films containing both Eudragit EPO and hydroxypropylmethylcellulose films showed neutral surface pH when prepared using 0.1 N HCl as a solvent. Glycerol played a critical role in imparting flexibility to the film and improving the drug release from film. The bitter taste of the drug was masked by using aspartame and menthol accompanied by the synergistic effect of Eudragit and glycerol. Water uptake by films was found to be dependant both on the amount of Eudragit EPO and glycerol. The films containing the higher proportion of glycerol showed higher water uptake and faster drug release at all the sampling time in the in vitro dissolution test. Optimum plasticity was obtained using the required concentration of hydroxypropylmethylcellulose and glycerol. The study revealed that taste masked valdecoxib films can be developed by the selection of appropriate film former and by the use of auxiliary excipients.

The objective of present work was to develop modified release tablets of isoniazid using hydroxylpropylmethylcellulose as a release-controlling agent. The low-viscosity grade hydroxylpropylmethylcellulose, medium-viscosity grade hydroxylpropylmethylcellulose, and high-viscosity grade hydroxylpropylmethylcellulose were used to prepare the matrix tablets. The tablets, prepared by direct compression, were subjected to physical characterization and in vitro drug release studies. The in vitro drug release was carried out using USP apparatus 1 at 50 rpm in 900 ml of acidic dissolution medium (pH 1.2) for 2 h, followed by 900 ml alkaline dissolution medium (pH 6.8). The polymer type did not affect the flow of powder blend and crushing strength of isoniazid tablets. The drug release rate was strongly influenced by the type of polymer and the concentration of polymer. The viscosity grade of hydroxylpropylmethylcellulose and the drug release was inversely correlated. To analyze the release mechanism Higuchi, zero-order, first-order, Hixson-Crowell, Weibull, and Korsmeyer-Peppas model were used. The optimized formulation followed the Weibull model. The use of simplified optimization methodology is demonstrated to evolve unified mathematical model.