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IRJET - Design and Evaluation of Albendazole Sustained Release Tablets
1.
International Research Journal
of Engineering and Technology (IRJET) e-ISSN: 2395-0056 Volume: 07 Issue: 03 | Mar 2020 www.irjet.net p-ISSN: 2395-0072 © 2020, IRJET | Impact Factor value: 7.34 | ISO 9001:2008 Certified Journal | Page 4310 Design and Evaluation of Albendazole Sustained Release Tablets Pranshu Tangri*, Ng Raghavendra Rao, Akshyay Chauhan, Piyush Chauhan, Tridev Kumar, Surbhi Verma Grd(pg)imt, dept of pharmaceutics, 214, rajpur road,dehradun -------------------------------------------------------------------***---------------------------------------------------------------- Abstract: The current research work deals with the development of sustained release tablets of albendazole using a blend of natural and synthetic polymers. Three formulations were prepared (A1-A3) by varying the composition of polymers in a ratio of 1:1 and alternating the polymer combinations. All the prepared formulations were evaluated for various parameters like hardness, weight variation, friability, content uniformity, disintegration time, in-vitro drug release study and also stability study. The study reveals optimum formulation blends and good in-vitro release profile showing rapid disintegration and rapid dissolution profile. Sustained release tablets are ideally suited for drug delivery of BCS class II drugs which have half life in the range of 2-8 hours. Albendazole is used for the treatment of infections caused by microbes in human intestine and the formulation can be used for effective germicidal treatment. The prepared formulations showed t50% of average 6-7 hours with t80% of 10-12 hours with zero order release profile in some formulations. All other parameters of the batches were found to be optimum and within acceptance criteria. The formulation AF3 was found to be the best formulation on the basis of evaluation parameters. The prepared formulations can be further developed and optimized to give better results. Key words: albendazole, sustained release, tablets. 1. Introduction Conventional drug delivery system has been characterized by immediate release and repeated dosing of the drug which might lead to the risk of dose fluctuation, this arises the need of a formulation with control release that maintain a near-constant or uniform blood level. The desire to maintain a near-constant or uniform blood level of a drug often translates into better patient compliance, as well as enhanced clinical efficacy of the drug for its intended use. [1,2] Sustained release, sustained action, prolong action, controlled release, extended action, depot are terms used to identify drug delivery systems that are designed to achieve prolong therapeutic effect by continuously releasing medication over an extended period of time after administration of single dose. In the case of orally administer this period is measured in hours while in the case of injectables this period varies from days to months. Advantages of sustained release dosage forms:- [3] 1. Control of drug therapy is achieved. 2. Rate and extent of drug absorption can be is modified 3. Frequency of drug administration is reduced. 4. Patient compliance can be improved. 5. Drug administration can be made convenient 6. Maximizing the availability of drug with minimum dose. 7. The safety margin of high potency drug can be increased. He oral route administration is mostly adopted route because of its comfortable dosage form, design and patient care. Several parameters should be kept in mind before formulating sustain release dosage form which includes various pH in GIT, the gastrointestinal motility, the enzyme system and its effect on the dosage form and the drug. Most of sustained release dosage form follows the mechanism of diffusion, dissolution or combination of both, to produce slow release of drug at predetermined
2.
International Research Journal
of Engineering and Technology (IRJET) e-ISSN: 2395-0056 Volume: 07 Issue: 03 | Mar 2020 www.irjet.net p-ISSN: 2395-0072 © 2020, IRJET | Impact Factor value: 7.34 | ISO 9001:2008 Certified Journal | Page 4311 rate. Hypothetically, a sustained release dosage form should release the drug by a zero-order mechanism which maintains drug plasma level time similar to intravenous infusion. [5,6,7] 2. Materials and methods 2.1 Materials All materials procured were of pharmaceutical grade and good quality. The drug was procured from tirupati pharmaceuticals pvt. Ltd. Paonta sahib. 2.2 Methods Standard curve of the drug was prepared in buffer 1.2, 7.4 and the beer lamberts range was established. Preformulation studies of the drug were also conducted including particle size, partition coefficient, solubility analysis. [8-11] The formulations were prepared by optimizing the formulation blends and finally three ratios of polymers were selected. Three polymers were identified including HPMCK4M, Carbopol 934 and hydroxyl ethyl cellulose. The ratio was 1:1 between polymers and the drug using varying polymer combinations as given in table no.. the tablets were prepared by direct compression methods. [12-15] The prepared formulations were evaluated for various parameters like hardness, weight variation, friability, content uniformity, disintegration time, in-vitro release and kinetics of release. [16-18] Table No. 1 Formulation Composition Formulation code Ingredient/quantity A1 A2 A3 Drug 100 100 100 MCC 50 50 50 HPMC K4M 50 - 50 Carbopol 934 - 50 50 Hydroxyl ethyl cellulose 50 50 - Lactose 50 50 50 Talc 1 1 1 Magnesium stearate 2 2 2 Results and discussion The results of the prepared formulations are given in table no:. the formulations showed optimum results with satisfactory release profile. The hardness was found to be in the range of 9.6-10.2kg/cm2, weight variation in the range of 1.2-2.8% which was well within the official limits, content uniformity was found to be from 96.4% - 98.4% which was within the acceptance criteria for tablets. Friability was within the limit of 1%. The disintegration time showed that the tablets show good sustained release profile with in-vitro release showing t 80% data of more than 12 hours. The release kinetics shows that the formulations follow zero order or higuchi kinetics with linear profile and also supercase II transport mechanism which suggests for swelling and erosion mechanism of srug release from the matrix tablets. [19-21] Table No.2 Evaluation Parameters Evaluation parameter Formulation code A1 A2 A3 Hardness (Kg/Cm2) 9.6 9.4 10.2
3.
International Research Journal
of Engineering and Technology (IRJET) e-ISSN: 2395-0056 Volume: 07 Issue: 03 | Mar 2020 www.irjet.net p-ISSN: 2395-0072 © 2020, IRJET | Impact Factor value: 7.34 | ISO 9001:2008 Certified Journal | Page 4312 Friability (%) 0.5 0.3 0.46 Weight Variation (%) ±1.3 ±2.5 ±2.8 Content Uniformity (%) 98.4% 96.4% 97.8% Disintegration Time (Sec) More than 2 hours More than 2 hours More than 2 hours T 80% (Mins) >12 hours >12 hours >12 hours Figure No:1 Hardness Of Formulations Figure No:2 % Weight Variation Of Formulations Figure No:3 % Content Uniformity Of Formulations 9 9.2 9.4 9.6 9.8 10 10.2 10.4 A1 A2 A3 HARDNESS(KG/CM2) HARDNESS 0 0.5 1 1.5 2 2.5 3 A1 A2 A3 %WEIGHTVARIATION % WEIGHT VARIATION
4.
International Research Journal
of Engineering and Technology (IRJET) e-ISSN: 2395-0056 Volume: 07 Issue: 03 | Mar 2020 www.irjet.net p-ISSN: 2395-0072 © 2020, IRJET | Impact Factor value: 7.34 | ISO 9001:2008 Certified Journal | Page 4313 Figure No:4 % Friability Of Formulations Figure no:5 % in-vitro drug release 95 95.5 96 96.5 97 97.5 98 98.5 99 A1 A2 A3 %CONTENTUNIFORMITY % CONTENT UNIFORMITY 0 0.1 0.2 0.3 0.4 0.5 0.6 A1 A2 A3 %FRIABILITY % FRIABILITY
5.
International Research Journal
of Engineering and Technology (IRJET) e-ISSN: 2395-0056 Volume: 07 Issue: 03 | Mar 2020 www.irjet.net p-ISSN: 2395-0072 © 2020, IRJET | Impact Factor value: 7.34 | ISO 9001:2008 Certified Journal | Page 4314 Table No. 3 Release Kinetics Of Formulations A1 Model Fitting R2 k Zero order 0.9917 0.1077 1st order 0.9853 -0.0019 Higuchi Matrix 0.9350 9.2553 Peppas 0.9835 0.3396 Hix.Crow. 0.9962 0.0005 Parameters for Korsmeyer-Peppas Equation n = 1.0567 k = 0.3396 Best fit model= Hixon-Crowell Mechanism of release▼ Supercase II Transport 0 10 20 30 40 50 60 70 80 90 0 100 200 300 400 500 600 700 800 %DRUGRELEASE TIME (MINS) % IN-VITRO DRUG RELEASE A1 A2 A3
6.
International Research Journal
of Engineering and Technology (IRJET) e-ISSN: 2395-0056 Volume: 07 Issue: 03 | Mar 2020 www.irjet.net p-ISSN: 2395-0072 © 2020, IRJET | Impact Factor value: 7.34 | ISO 9001:2008 Certified Journal | Page 4315 Table No.4 Release Kinetics Of Formulations A2 Model Fitting R2 k Zero order 0.9955 0.1057 1st order 0.9248 -0.0019 Higuchi Matrix 0.9266 9.1213 Peppas 0.9830 0.2555 Hix.Crow. 0.9608 0.0005 Parameters for Korsmeyer-Peppas Equation n = 1.1460 k = 0.2555 Best fit model= Zero order Mechanism of release▼ Supercase II Transport Table No. 5 Release Kinetics Of Formulations A3 Model Fitting R2 k Zero order 0.9958 0.1082 1st order 0.9811 - 0.0019 Higuchi Matrix 0.9376 9.1902 Peppas 0.9889 0.2708 Hix.Crow. 0.9941 0.0005 Parameters for Korsmeyer-Peppas
7.
International Research Journal
of Engineering and Technology (IRJET) e-ISSN: 2395-0056 Volume: 07 Issue: 03 | Mar 2020 www.irjet.net p-ISSN: 2395-0072 © 2020, IRJET | Impact Factor value: 7.34 | ISO 9001:2008 Certified Journal | Page 4316 Equation n = 1.1326 k = 0.2708 Best fit model= Zero order Mechanism of release▼ Supercase II Transport Conclusion The prepared formulations show good release profile with good evaluation parameters. The formulation need to be further optimized and evaluated to show even better results. The polymeric combinations selected are ideal for sustained release profile of many drugs and can be used as a set formula for formulating sustained and controlled release products. All formulation are found to be consistent, stable and within the acceptance criteria. References 1] Gwen MJ, Joseph RR. In: Banker GS and Rhodes, CT, (editors). Modern pharmaceutics. 3rd ed. Vol 72. New York: Marcel Dekker Inc., 1996; p. 575. [2] Chein YW. Novel drug delivery systems. 2nd ed. New York: Marcel Dekker Inc., 1997; pp.1-42. [3] Ritchel WA. Biopharmaceutic and pharmacoki-netic apects in the design of controlled release per-oral drug deliver system. Drug Dev Ind Pharm 1989; 15: 1073-103. [4] Reddy KR, Mutalik S, Reddy S. Once daily sustained release matrix tablets of nicorandinal formulation in vitro evaluation. AAPS Pharm Sci Tech 2003; 4: 1-9. [5] Mohammed AD, James LF, Michael HR, John EH, Rajabi-Siahboomi AR. Release of propranolol hydrochloride from matrix tablets containing sodium carboxymethylcellulose and hydrox-ypropylmethylcellulose. Pharm Dev Tech 1999; 4: 313-24. [6] Verma RK, Garg S. Development and evaluation of osmotically controlled oral drug delivery system of glipizide. Eur J Pharm Biopharm 2004; 57: 513-25. [7] Jamzad S, Fassihi R. Development of controlled release low dose class II drug-glipizide. Int J Pharm 2006; 312: 24-32. [8] Rodriguez L, Caputo O, Cini M, Cavallari C, Grecchi R. In vitro release of theophylline from directly-compressed matrices containing methacrylic acid copolymers and/or dicalcium phosphate dihydrate. Ill Farmaco 1993; 48: 1597- 604. [9] Sweetman SC. Martindale, the complete drug reference. 34th ed. London: Pharmaceutical Press, 2005; pp. 324-48. [10] Patel JK, Patel RP, Amin AF, Patel MM. Formulation and evaluation of glipizide microspheres. AAPS Pharm Sci Tech 2005; 6: 49-55. [11] Chowdary KPR, Rao YS. Design and in vitro and in vivo evaluation of mucoadesive microcapsules of glipizide for oral controlled release. AAPS Pharm Sci Tech 2003; 4: 1-6. [12] Cooper J, Gunn C. Powder flow and compaction. In: Carter SJ, (editor). Tutorial pharmacy. New Delhi: CBS Publishers and distributors, 1986; pp. 211-33. [13] Lachman L, Lieberman HA, Kanig JL. The theory and practice of industrial pharmacy. Philadelphia: Lea & Febieger, 1970; pp. 68-9. [14] The Pharmacopoeia of India. New Delhi: Controller of Publication, 1996; pp.736.
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International Research Journal
of Engineering and Technology (IRJET) e-ISSN: 2395-0056 Volume: 07 Issue: 03 | Mar 2020 www.irjet.net p-ISSN: 2395-0072 © 2020, IRJET | Impact Factor value: 7.34 | ISO 9001:2008 Certified Journal | Page 4317 [15] Rawlins EA. Bentley's text book of pharmaceutics. London: Cassell and Colloer Macmillian, 1977. [16] Hadjioannou TP, Christain GD, Koupparis MA. Quantitative calculations in pharmaceutical practice and research. New York: VCH Publishers Inc., 1993; pp. 345-8. [17] Bourne DW. Pharmacokinetics. In: Banker GS, Rhoides CT, (editors). Modern pharmaceutics. 4th ed. New York: Marcel Dekker Inc. 2002; 67-92. [18] Aulton ME, Wells TL. Pharmaceutics, the science of dosage form design. London: Churchill, Livingstone, 1988. [19] Martin A. Physical pharmacy. Baltimore: Lippincott Williams and Wilkins, 2001; p. 423. [20] Lachman L, Lieberman HA, Kanig JL. The theory & practice of industrial pharmacy. Mumbai: Varghese Publishing House, 1987; p. 293. [21] Sanchez-Lafuente C, Faucci MT, Fernandez-Arevels M, Alvarez FJ, Rabasco AM, Mura P. Development of sustained release matrix tablets of didanosine contain is methacyclic and ethyl cellulose polymers. Int J Pharm 2002; 234: 213-21.
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