Testing Drug Content of Famotidine Core Tablets

exa instantation medicate Content of Famotidine Core proroguets6. prepa balancen development and rating6.1 Preparation of core a no.eulatory medicinesCore tablets of famotidine were prepared by rule compression and lot size was kept as deoxycytidine mono orthophosphate tablets. medicate , sodium chloride, polymer and MCC were co-sifted by means of sieve 30Now the extend is mix in polybag for 10 mincitric blistering was crushed apply mortar and pestle and sifted through sieve 60And this is added to above blending and mixed in a polybag for 10 min.Then magnesium stearate talcum pulverization were passed through sieve 60 and to the above blend and mixing go on for another 2 minNow the blend is compressed to tablets having the sightly system of system of freightss down of clxxx mg development 8 mm plump concave punch and at low relative humidity 20 % RH6.2 application program of core tablets 6.2.1. Preparation of pelage response5 ml of water was interpre ted in a beaker and to this required hail of pinpoint cd was added and dissolved95 ml of acetone was taken in a beaker and stirred at 150 rpm apply electrical stirrer to this above solution was added and stirred for 5 minNow to the above solution 5 gm of cellulose acetate rayon was added slowly and stirring is continued for another 30 min i.e until a sop up solution was formed.6.2.2. Procedure for coating of semi permeable membraneCoating was done using RD Lab Coater. Core tablets were placed in the coating pan and coated with cellulose acetate solution coating parameters are checked as belowInlet temperature 40 oC 2 oCBed temperature 35 oCrpm of pan 15 -17Spray rate 3-7 ml/minAtomizing air pressure 2.0 psiCoating was done until required system of weights gain was achievedDrilling of orifice The orifice was do using pauperismles of opposite sizes i.e, 24, 22 guageINGREDIENTSF1F2F3F4F5F6Core tablet mg/tabletFamotidine404040404040Citric acid202020202020sodium chloride50 5050505050HPMC k100M918Polyox11057.2Polyox 3017.2Polyox3037.2Sodium lauryl sulfate3.63.63.63.63.63.6Magnesium stearate1.81.81.81.81.81.8Talc3.63.63.63.63.63.6Avicel PH 102434353.853.853.853.8 inwardness wt of tablet clxxx180180180180180Coating solutionCellulose acetate5 gm15 % w/w of total solids (0.669 ml)4 mlUpto 100 ml4%PEG 400WaterAcetoneweighting gainCoated tablets were left over night for drying add-in 6.8 Formulation trails for optimum polymer (using various grades of HPMC and PEO)Table6.9 Formulation trails for optimum polymer concentration and coating weight gainINGREDIENTSF7F8F9Core tablet mg/tabletFamotidine404040Citric acid202020Sodium chloride505050Polyox 30110.810.810.8Avicel PH 10250.850.850.8Sodium lauryl sulphate3.63.63.6Magnesium stearate1.81.81.8Talc3.63.63.6Total wt of tablet180180180Coating solutionCellulose acetate5 gmPEG 40015 % w/w of total solids (0.669 ml)Water4 mlAcetoneUpto 100 mlWeight gain4 %3 %5 % Table 6.10 Formulation trails of optimum plasticizer co ncentrationINGREDIENTSF 10F 11F 12Core tablet mg/tabletFamotidine404040Citric acid202020Sodium chloride505050Polyox 30110.810.810.8Avicel pH 10250.850.850.8Sodium lauryl sulphate3.63.63.6Magnesium stearate1.81.81.8Talc3.63.63.6Total wt of tablet180180180Coating solutionCellulose acetate5 gm5 gm5 gmPEG 400(% w/w of total solids)20%(0.89 ml)25%(1.25 ml)35%(1.4 ml)Water4 ml4 ml4 mlAcetoneUpto 100 mlUpto 100 mlUpto 100 mlWeight gain4%4%4%6.3 Evaluation of blend 6.3.1 Angle of restAngle of tranquilityWeighed quantity of the drug was passed through a funnel kept at a height 2 cm from the base. The powder is passed till it forms a heap and touches the tip of the funnel. The roentgen the base of the conical pile, and the height of pile were heedful and the angle of eternal sleep was mensural using the formula(h/r)h = height of the piler = radius of the base of the conical pile Table 6.4 Flow retention and corresponding angle of reposeFlow propertyAngle of repose ()Excellent25 30 tec hnical31 35Fair-no need of aid36 40Passable hang up chances41 45Poor must vibrate, agitate46 55 precise poor56 65Very, very poor66Formulation principleAngle of reposeF125.45F222.92F323.13F419.20F518.62F617.20F720.09Table no. info for angle of repose of all formulations6.3.2 Bulk assiduityAn accurately weighed quantity of powder cautiously poured into graduated piston chamber. Then after pouring the powder into the graduated cylinder the powder bed was made uniform without disturbing. Then the intensity was measured directly from the graduation marks on the cylinder as ml. The batch measure was called as the bulk glitz and the bulk engrossment is calculated by following formulaBulk density = Weight of powder / Bulk volumeTapped DensityAfter measuring the bulk volume the same measuring cylinder was set into rap density apparatus. The tap density apparatus was set to 300 taps drop per heartbeat and operated for 500 taps. saturation was noted as (Va) and once again tap ped for 750 times and volume was noted as (Vb). If the dissimilitude between Va and Vb not greater than 2% then Vb is consider as final tapped volume. The tapped density is calculated by the following formula Tapped density = Weight of powder / Tapped volume sponginess IndexIt gives the flow property of the granules. More is the compressibility less go forth be the flow property. It was calculated by the following formula using previously obtained bulk and tapped densities. Carrs top executive = Tapped density Bulk density X 100 Tapped DensityHausner RatioIt is used for flow property of the granules. It was in addition calculated from bulk and tapped densities using following formula Hausners ratio = Tapped density / Bulk density Table 6.3 Flow property and corresponding Carrs index Hausner ratioFlow property C.I ( % )Hausner ratioExcellent101.00 1.11Good11 151.12 1.18Fair16 201.19 1.25Passable21 251.26 1.34Poor26 311.35 1.45Very poor32 371.46 1.59Very, very poor38 1.60Formulation codeBulk density(gm/cm3)Tapped density (gm/cm3)Carrs index (%)Haussners ratioAngle of reposeF10.4860.63122.91.2525.45F20.4100.51320.081.2522.92F30.4380.60118.2591.1823.13F40.4360.58316.391.19619.20F50.4300.52017.311.2118.62F60.4620.53513.641.1617.20F70.4460.52314.721.1720.09Table no. Data for Bulk density, Tapped density, Compressibility index and Hausners ratio of all formulations6.4 Post compression studies6.4.1 Weight variationThe average weight of core tablets and coated tablets were determinedusing a digital measure balance. 20 tablets were selected randomly from each batch and weighed individually, calculating the average weight and comparing the individual tablet weight to the average. From this, percentage weight difference was calculated. Table 6.11 Limits of weight variationIP/BPLimitUSP80 mg or less10%130mg or lessMore than 80mg or Less than 250mg7.5%130mg to 324mg250mg or more5%More than 324mgTable no. Data for weight variation test of all formulations Formulation work out Avg weight(mean%deviation) originallyCoatingAfterCoatingF1178.42 1.02185.721.12F2181.31 0.91188.791.45F3179.211.34187.891.09F4181.390.98189.010.98F5179.761.32186.961.42F6183.122.24190.321.08F7180.091.08187.341.12F8178.121.24184.521.33F9179.351.02187.011.14F10180.450.98188.001.11F11181.321.23188.671.28F12182.451.11189.791.20 hardship severity indicates the ability of a tablet to withstand mechanical piques while handling. Hardness of both core and coated tablets were determined using a Monsanto toughness tester. It is expressed in kg/cm2. Three tablets were randomly picked from each batch and analyzed for hardness. The mean and standard deviation were also calculated.Table no. Data for hardness of all formulationsFormulation decreeHardness(kg/cm2)(n=3)(meanSD)BeforeCoatingAfterCoatingF15.060.196.180.22F25.210.266.290.42F34.960.326.030.15F45.020.226.410.32F55.280.186.170.18F65.110.336.250.28F74.890.256.000.33F84.990.146.320.36F95.080.186.750.25F104.990.255.980. 12F115.120.335.900.21F124.970.105.960.19Friability (F)It is the phenomenon whereby tablet surfaces are disgraced and/or show evidence of lamination or breakage when subjected to mechanical shock or attrition. Thefriability of core tablets was determined using Roche Friabilator. It is expressed in percentage (%). Twenty core tablets were initially weighed (Winitial) and transferred into friabilator. The friabilator was operated at 25 rpm for 4 minutes or run up to 100 revolutions. The tablets were weighed again (Wfinal). The % friability was then calculated% Friability = ((A-B)/A) 100Where,FormulationCodeFriability(%)(n=10)F10.010F20.015F30.017F40.012F50.009F60.016F70.014F80.013F90.012F100.015F110.014F120.012A = Initial weight of tabletsB = Final weight of tablets after 100 revolutionsFriability of tablets less than 1% are considered acceptable.Drug contentThe famotidine core tablets were tested for their drug content. Five tablets were finely powdered quantities of the powder equ ivalent to 100 mg of famotidine were accurately weighed and transferred to a 100 ml of volumetric flask. Made up to 100ml with 4.5 phosphate buffer. From the above solution 1ml was taken and made up to100 ml with phosphate buffer (pH 4.5) From the above solution 10 ml was taken and made up to100 ml with phosphate buffer (pH 4.5) i.e.,10g/ml solution and measure the absorbance of the resulting solution at 265 nm using a Shimadzu UV-visible spectrophotometer. The linearity equation obtained from calibration curve was used for estimation of famotidine in the tablet formulations.FormulationCodeAssay(%)F199.250.042F298.320.052F399.150.016F499.520.019F5101.950.021F699.250.034F799.980.028F898.740.052F998.230.061F10100.120.011F1199.520.021F1299.560.023Table no. Data for drug content of all formulationsIn-Vitro Dissolution StudiesThe developed formulations of were subjected in vitro dissipation studies using USP Type II diarrhoea apparatus (Electrolab, India) with a go of 50 rpm. The r adioactive decay study was carried out in 900 ml dissolution media maintained at 370.5 oC. At suitable time interval, 10 ml samples were withdrawn and replaced with equivalent amount of fresh medium to maintain sink conditions. Samples withdrawn were filtered and analyzed at 265 nm using a UV spectrophotometer. After analyzing the drug content in the dissolution samples, cumulative percentage of drug throw overboard versus time was plotted. The general conditions for in vitro dissolution studies are as summarized below. Dissolution conditionsMedium 4.5 phosphate bufferVolume 900 mlTemperature 37 C 0.5 CApparatus USP Type-II (paddle)Rpm 50 m intervals 1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 12 hrSamples were suitably dilute and absorbance was measured. Cumulative percentage drug acquittanced was calculated for each batch. The study was performed in triplicate and the average was reported.Table no. In-Vitro data drug release data for formulation F-1S.noTimeCumulative % drug release 100212.812.75324.001.64436.672.565410.611.986513.072.847616.311.278718.561.329821.860.99101027.071.46111232.761.21Figure no. In-Vitro drug release of formulation F-1Table no. In-Vitro data drug release data for formulation F-2S.noTimeCumulative % drug release100212.102.84324.211.95437.522.955410.612.096513.071.957616.312.758718.562.949821.861.24101032.161.89111240.791.11Figure no. In-Vitro drug release of formulation F-2Table no. In-Vitro data drug release data for formulation F-3S.noTimeCumulative % drug release100214.023.72328.041.344313.342.835418.631.526522.901.3276