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2. Powder X-ray diffraction analysisM. N. Karemore* et al. /International Journal Of Pharmacy&TechnologyPowder X-ray diffraction patterns of telmisartan, β-cyclodextrin and telmisartan-β-cyclodextrin inclusioncomplex were determined using powder X-ray diffractometer.3. SolubilityThe solubility of telmisartan and telmisartan-β-cyclodextrin complex was checked in various solvent atroom temperature using rotary/mechanical shaker. Solubility of drug was determined by saturation method. In 100ml of solvent 100 mg of drug was added so 1000 µg/ml of solution was prepared. Drug was saturated because ofinsolubility in the solvent out of that 25 ml taken into 50 ml volumetric flask with the help of mechanical shakerand after shaking was completed solution was filtered through whatman filter paper and after suitable dilutionabsorbance was recorded and concentration of drug in solution was determined. From this concentration amountdissolved in the solvent i.e solubility was determined.4. Dissolution studyDissolution study of telmisartan and its complex with β-cyclodextrin was performed to evaluate drugrelease profile. Dissolution where performed on USP type II dissolution apparatus with 900 ml 6.8 phosphatebuffer at 37 o C at 50 rpm. 5ml aliquots were withdrawn at specific time interval and filtered using Whatman filterpaper. Equal volume of fresh medium was replaced into dissolution medium to maintain constant volumethroughout dissolution medium. Absorbance of filtered solution was checked by UV spectrophotometer at 296 nm.5. Determination of dug content of Telmisartan-β-cyclodextrin complexTelmisartan-β-cyclodextrin complex was evaluated for the drug content. Telmisartan-β-cyclodextrincomplex equivalent to 20 mg drug was stirred with 100 ml of phosphate buffer for 60 min, then the solution wasfiltered and treated as stock solution containing 100 mg/ml drug. From this stock solution the concentration of 10µg/ml was prepared and drug content was determined using calibration curve of pure telmisartanspectrophotometrically at 296 nm using phosphate buffer as blank.Preparation of tablets containing complex of Telmisartan with β-cyclodextrin by direct compression methodThe amounts of complex equivalent to 20 mg of drug was taken and then mixed with directly compressible diluentand superdisintegrants in a mortar. Magnesium stearate and talc were passed through sieve no. 80, mixed andIJPT | April-2012 | Vol. 4 | Issue No.1 | 4000-4010 Page 4003

M. N. Karemore* et al. /International Journal Of Pharmacy&Technologyand calculate percentage release. The results are listed in Table No.4. and the dissolution profile are shown in Fig.No. 1, 2 and 3Stability StudyStability studies of the selected formulated tablets were carried out by keeping the tablets at roomtemperature and at 40 ° C ± 2 ° C / 75 ± 5% RH (stability chamber) for 30days and evaluated for physical properties,drug release and drug content during the testing period. All the parameters were compared with initial formulation.Table No. 4: In vitro drug released study of formulation F1-F9.% of Drug ReleaseSr. TimeFormulation No.No. (min)F1 F2 F3 F4 F5 F6 F7 F8 F91 0 0 0 0 0 0 0 0 0 02 1 49.86 48.73 45.72 36.72 37.48 41.80 38.25 35.59 32.983 2 79.74 76.36 73.55 65.81 66.58 71.46 69.01 63.73 58.094 3 95.57 93.30 91.78 84.53 86.25 90.98 89.64 81.90 75.885 4 96.46 94.35 93.41 87.07 89.70 92.25 91.08 84.97 79.676 5 97.17 95.28 94.98 88.49 91.54 93.12 92.15 86.74 81.237 6 97.92 95.98 95.34 89.52 92.22 94.49 92.99 88.34 81.868 7 98.64 96.68 96.08 90.59 92.90 94.67 93.72 89.58 82.84Fig. No. 1: In Vitro Dissolution profiles formulation F1-F3Showing relationship between Time Vs % Drugs Release.IJPT | April-2012 | Vol. 4 | Issue No.1 | 4000-4010 Page 4006

M. N. Karemore* et al. /International Journal Of Pharmacy&TechnologyFig. No. 2: In Vitro Dissolution profiles of formulation F4-F6.Showing relationship between Time Vs % drug releaseFig. No. 3: In Vitro Dissolution profiles of formulation F7-F9.Result and DiscussionShowing relationship between Time Vs % drug releaseThe rate of dissolution can be increased by increasing the surface area of available drug by complexation with β-cyclodextrin using various methods and it was found that complex of telmisartan-β-cyclodextrin prepared withkneading method in 1:2 molar ratio showed increase in solubility of telmisartan. Powder X-ray diffractionspectroscopy showed decrease in degree of crystallinity in the given sample when complex of drug andcyclodextrin are formed and increases in amorphousness and consequently increase in solubility of drug wasobserved.The dissolution of a drug can also be influenced by disintegration time of the tablets. Fasterdisintegration of tablets delivers a fine suspension of drug particles resulting in a higher surface area and fasterdissolution. In the present work direct compression was employed to prepare tablets. Using telmisartan-βcyclodextrincomplex, Micro crystalline cellulose and directly compressible mannitol was selected as diluent.Croscarmellose sodium, crospovidone and sodium starch glycolate were selected as superdisintegrants.IJPT | April-2012 | Vol. 4 | Issue No.1 | 4000-4010 Page 4007

M. N. Karemore* et al. /International Journal Of Pharmacy&TechnologyMagnesium stearate and talc were selected as lubricant and glidant respectively. Aspartame was added as asweetening agent. Tablets were compressed individually using 8 station rotary compression machine.Precompressional parameters, angle of repose, bulk density, tapped density, % compressibility and hausnerratio studies indicated that most of the formulation showed fair and good flow properties.Postcompressional parameters, hardness, friability, disintegration time, wetting time, drug content anddissolution studies were studied. Friability of tablets ranged between 0.53% to 0.85%. Drug content of tabletsranged between 95.80% to 99.50%. Stability studies of the selected formulated tablets were carried out by keepingthe tablets at room temperature and at 40 ° C ± 2 ° C / 75 ± 5% RH (stability chamber) for 30days. From the stabilitystudies it was found that formulation were stable at room temperature and at 40 ° C ± 2 ° C / 75 ± 5% RH for a periodof 30 days. There was no appreciable change in physical properties, drug release and drug content during thetesting period.Tablets prepared by Croscarmellose sodium (5% concentration) as a superdisintegrant showed leastdisintegration time as compared with other tablets prepared by crospovidone and sodium starch glycolate. FT-IRstudies revealed that, there was no interaction of the drug with the excipients used.ConclusionFrom this study, it was concluded that dissolution rate of poorly soluble drug, Telmisartan could be enhanced bypreparing fast dissolving tablets by direct compression with β-cyclodextrin complex prepared by kneading method.Among all the formulations, formulation F1 which was prepared by direct compression with β-cyclodextrincomplex using croscarmellose sodium 5% yielded better results in terms of dissolution rate.AcknowledgementThe authors are thankful to Zydus Cadila. Ltd. Ahamadabad for providing gift sample of Telmisartan. Theauthors thank Gangwal chemicals Ltd. Mumbai for providing β-cyclodextrin and Maple Biotech Ltd. Pune forproviding superdisintegrants.References1. Chein YW, Novel Drug Delivery System, 2 nd edition, Marcel Dekker Inc; New York,1992, p 2.IJPT | April-2012 | Vol. 4 | Issue No.1 | 4000-4010 Page 4008

M. N. Karemore* et al. /International Journal Of Pharmacy&Technology2. Debjit Bhowmik, Chiranjib.B, Krishnakanth, Pankaj, R.Margret Chandira Fast Dissolving Tablet : AnOverview Journal of Chemical and Pharmaceutical Research, 2009, 1(1): p.163-1773. Bhupendra G. Prajapati and Nayan Ratnakar : A Review on Recent patents on Fast dissolving drug deliverySystem. International Journal of Pharm Tech Research.Vol.1, No.3, July-Sept 2009, p. 790-7984. S.Jeevanandham, D.Dhachinamoorthi, KB Chandra Sekhar : Formulation and evaluation of Naproxen sodiumorodispersible tablet by sublimation method. Asian Journal of Pharmaceutics. Jan-March 2010, Vol 4, p. 48-51.5. NG Raghavendra Rao, T.Patel, S.Gandhi : Development and evaluation of carbamazepine fast dissolving tabletprepared with a complex by direct compression technique. Asian Journal of Pharmaceutics. Vol.3, p. 97-103.6. www.wikipedia.com7. www.drugbank.com8. Dali Shukla, Subhashis Chakraborty, Sanjay Singh : Mouth dissolving tablet I : An overview of formulationtechnology. Sci. Pharm. 2009 ;77; p.309-3269. Patil J.S, Kadam D.V, Marapur S.C : Inclusion complex system: A novel technique to improve the solubilityand bioavailability of poorly soluble drugs. A review. International Journal of Pharmaceutical Sciences Reviewand Research; Vol. 2, Issue 2, May-June 2010; article 006, p. 29-3410. P.P.Sawarikar, B.K.Sridhar, S.Shivkumar : Formulation and evaluation of fast disintegrating/dissolving tabletsof Isoxspurine HCL. Journal of Current Pharmaceutical Research 2010; 3(1); p. 41-4611. Pratikkumar A.Patel and Vandana B.Patravale: Commercial Telmisartan Tablets: A comparative evaluationwith innovator brand micardis. IJPSR, Vol.1(8), 2010, p.282-29212. B.S.Venkateswarlu, R.Margret Chandira, Talele Ajay : Formulation developement and evaluation of fastdissolving tablets of Carvedilol. Journal of Chemical and Pharmaceutical Research, 2010, 2(1) : p.196-21013. Kulkarni Ajit Shankarrao, Ghadge Dhairysheel Mahadeo, Kokate Pankaj Balavantrao : Formulation and invitroevaluation of orally disintegrating tablet of Olanzapine-2-hydroxypropyl-beta-cyclodextrin Inclusioncomplex. Iranian Journal of Pharmaceutical Research (2010), 9(4)IJPT | April-2012 | Vol. 4 | Issue No.1 | 4000-4010 Page 4009

M. N. Karemore* et al. /International Journal Of Pharmacy&Technology14. Marzia Cirri, Claudia Rangoni, Francesca Maestrelli : Development of fast dissolving tablets of Flurbiprofencyclodextrin complexes. Drug Development and Industrial Pharmacy, 31: 2005, p. 697-707.15. Tejash Serasiya, Shailesh koradia, Subhash Vaghani, N.P.Jivanil : Design, optimizization and in vitroevaluation of orodispersible tablets of Pheniramine malate. International Journal of Pharmaceutical Researchand Development-Online. Vol-1/ Issue-10 / Dec / 004. p. 1-1816. Assessment Report Telmisartan Actavis, European Medicines Agency, 2010. p. 1-1417. New medicines on the market : Telmisartan. UK Drug Information Pharmacist Group, Jan 2000, p. 1-618. Leon Lachman, Herbert A. Liberman, Joseph L. Kanig, “The Theory and Practice of Industrial Pharmacy”,3 rd edition. p. 295-30219. Sathesh Kumar E, Senthil kumar B, Gopalakrishna B : Formulation and evaluation of fast dissolving tablets ofAceclofenac. International Journal of Pharmceutical Sciences. May-August 2010; 2(3): p. 810-82120. Kibbe AH, Hand book of Pharmaceutical Excipients, 3 rd edition, Pharmaceutical Press, London. 199921. US Pharmacopoeia 30-NF 2007, p. 1174.Corresponding Author:Megha N. Karemore*,Plot no. 1202, Behind M.I.G. Colony,K.D.K. College Road, Nandanwan,Nagpur. Dist: Nagpur (M.S.) 440 009, India.Email: meghakaremore0687@gmail.comIJPT | April-2012 | Vol. 4 | Issue No.1 | 4000-4010 Page 4010