Evaluation of tablets Pre compression parameters Angle of repose Angle of repose was determined by funnel method Accurately weighed 10 g granules were taken in the funnel Height of the funnel was adjusted such that the tip of the funnel just touches the apex of the heap of powder The powder was allowed to flow through funnel freely onto the surface The diameter of the powder cone was measured and angle of repose was calculated using the following equation 12 tan Ɵ h r where Ɵ angle of repose h height of cone r radius of cone base Bulk density Take about 100 gm of lansoprazole microparticles into a dry 250 ml cylinder and note the unsettled apparent volume Vo Bulk density was calculated in g ml 13 By using the formula Bulk density M Vo Where M weight of the sample taken Vo bulk volume of the drug Tapped density Take about 100 gm of lansoprazole microparticles into a dry 250 ml cylinder and tap the cylinder upto 500 times and note the tapped volume Va 12 Then the tapped density was calculated using the following formula Tapped density M Va Where M weight of the sample taken Va final tapped volume of drug Carr s index The compressibility index of granules was determined using carr s index Carr s index Tapped density Bulk density Tapped density X 100 Hausner s ratio The Hausner s ratio was determined by formula Hausner s ratio Tapped density Bulk density Evaluation of Post compression parameters of lansoprazole microsphere compressed tablets 1 Tablets thickness 13 Tablets thickness was measured by using Vernier calliper Five tablets was taken and placed between the two arms of the Vernier calliper 2 Tablet hardness 14
The crushing strength of tablets was measured by Pfizer hardness tester 3 Friability 13 14 Roche friabilator was used for testing the friability Twenty tablets was weighed accurately and placed in the tumbling apparatus that revolves at 25 rpm After 4 min the tablets were weighed and percentage loss in tablet weight was determined 4 Weight Variation 15 16 Twenty tablets were weighed individually and the average weight was determined Then percentage deviation from the average weight was calculated 5 Estimation of drug content 10 tablets were finely powdered and quantity of the powder equivalent to 30 mg of lansoprazole was accurately weighed and transferred to 250 ml volumetric flask containing 50 ml of pH 6 8 phosphate buffer and allowed to stand for 8 hour with intermittent shaking to ensure complete solubility of the drug The solution was then made up to 100ml volume with pH 6 8 phosphate buffer and mixed thoroughly The solution was filtered diluted and drug content was estimated by UV spectrophotometer at 260nm The drug concentration was calculated from the calibration curve 17 6 In vitro drug release studies 18 Lansoprazole tablets were subjected to in vitro drug release studies in simulated gastric and intestinal fluids Drug release studies were carried out using USP dissolution test apparatus I at 100 rpm 37 0 5 C and pH 1 2 phosphate buffer for 2 hours
The dissolution medium was replaced with pH 7 4 Phosphate buffer and experiment continued for upto 12 hours 5ml sample was withdrawn and replaced with fresh medium at different time intervals The samples withdrawn were analysed after suitable dilutions for drug release release kinetics and cumulative percentage of the drug release was calculated against time using UV spectrophotometer Stability studies 19 Stability of a drug has been defined as the ability of a particular formulation in a specific container to remain within its physical chemical therapeutic and toxicological specifications stability studies are carried out as per ICH guidelines The selected batch was sealed in aluminium packaging and kept in humidity chamber maintained at 40 2 75 5 RH for 3 months During this span the tablets was analysed in terms of their drug content and in vitro drug dissolution and other physicochemical properties viz hardness friability etc RESULT AND DISCUSSION PREFORMULATION STUDIES Melting point of lansoprazole was found to be 180 Melting point of the drug sample complied with the melting point of pore drug as per literature survey 178 182 thus indicated the purity of the drug sample The solubility of the lansoprazole was determined by adding excess amount of drug in the solvent It was found that lansoprazole is freely soluble in DMF soluble in methanol and buffer pH 6 8 and sparingly soluble in ethanol Hence DMF methanol and phosphate buffer pH 6 8 were selected for the further characterization studies Wavelength of drug was found to be 282nm which complies with the literature Preparation of Calibration curve Standard curve of Lansoprazole in phosphate Buffer pH 6 8 and 0 1N HCL were made for in vitro release studies which are tabulated in Table 3 and graphically represented in Figure 1and 2
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