THE INFLUENCE OF HPC-L AND EUDRAGIT L30 D-55 ON DELAYED RELEASE OMEPRAZOLE MAGNESIUM MULTIPLE-UNIT PELLET SYSTEM
DOI:
https://doi.org/10.22159/ajpcr.2018.v11i7.25098Keywords:
Delayed release, Enteric coating, Fluid bed processor, Pellets, Omeprazole magnesiumAbstract
Objective: The objective of the study is to develop optimum, stable, delayed release pellets of omeprazole magnesium (20.6 mg dose). Omeprazole magnesium is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+ -ATPase at the secretory surface of the gastric parietal cell, which is orally administered drug, whereas omeprazole magnesium is degraded in stomach pH, so it is formulated as delayed release dosage form to absorb in intestinal pH.
Methods: The formulation of delayed release pellets of omeprazole magnesium was developed by enteric film coating process varying the compositions of drug loading, barrier coating, and enteric coating using fluid bed processor. The prepared multiple pellets were filled into hard gelatin capsules as a single unit dosage forms.
Results: The dissolution profile of formulation (F8) contains the efficient amount of hydroxypropyl cellulose-L and Eudragit L30 D55 leads to effective release of drug in 30 min. Fourier transform infrared and differential scanning colorimeter studies were conducted for the optimized formula to prove that the formula was not having incompatibility between the drug and excipients. The scanning electron microscopy studies were conducted to know the surface morphology of the pellets.
Conclusion: It was concluded that optimized formulation (F8) shown good similarity with innovator. The results of the accelerated stability of final formulation revealed that storage conditions were excellent.
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References
Dash SMurthy PNNath LChowdhury P1. McTavish D, Buckley MM, Heel RC. Omeprazole. An updated review of its pharmacology and therapeutic use in acid-related disorders. Drugs 1991;42:138-70.
The United States Pharmacopeial Convention, Official Monographs/ Omeprazole USP 35-NF 30; 2012. p. 4115-6.
Fang Y, Wang G, Zhang R, Liu Z, Liu Z, Wu X, et al. Eudragit L/ HPMCAS blend enteric-coated lansoprazole pellets: Enhanced drug stability and oral bioavailability. AAPS Pharm Sci Tech 2014;15:513 22.
de Oliveira HP, Albuquerque JJ Jr., Nogueiras C, Rieumont J. Physical chemistry behavior of enteric polymer in drug release systems. Int J Pharm 2009;366:185-9.
Missaghi S, Young C, Fegely K, Rajabi-Siahboomi AR. Delayed release film coating applications on oral solid dosage forms of proton pump inhibitors: Case studies. Drug Dev Ind Pharm 2010;36:180-9.
Rowe RC, Sheskey PJ, Qulnn ME. Hydroxypropyl Cellulose, Handbook of Pharmaceutical Excipients. 6th ed. Washington, DC: Pharmaceutical Press, An imprint of RPS (Royal Pharmaceutical Society of Great Britain) Publishing; 2009. p. 317-21.
Isaac GS, Axel K. Encyclopedia of Pharmaceutical Technology. 3rd ed., Vol. 1. New York: Informa Healthcare; 2007. p. 2651-63.
He W, Tian Z, Yang M, Fan J, Zhang S, Guan P, et al. A comparative study of the effect of different alkaline stabilizers on physicochemical properties of lansoprazole in formulation. Asian J Pharm Sci 2011;6:89 100.
He W, Yang M, Fan JH, Feng CX, Zhang SJ, Wang JX, et al. Influences of sodium carbonate on physicochemical properties of lansoprazole in designed multiple coating pellets. AAPS Pharm Sci Tech 2010;11:1287 93.
Melegari C, Bertoni S, Genovesi A, Hughes K, Rajabi-Siahboomi AR, Passerini N, et al. Ethylcellulose film coating of guaifenesin-loaded pellets: Amcomprehensive evaluation of the manufacturing process to prevent drug migration. Eur J Pharm Biopharm 2016;100:15-26.
Convention, Inc. US P32/NF27. Chapter 711: Dissolution, Chapter 786: Particle Size Distribution, Chapter 1174: Powder Flow, Rockville MD: Convention, Inc.; 2009. p. 263, 307, 688.
Cooper J, Gun C, Carter SJ. Powder Flow and Compaction. Tutorial Pharmacy. New Delhi: CBS Publishers; 1986. p. 211-33.
Khan KA. The concept of dissolution efficiency. J Pharm Pharmacol 1975;27:48.
Dash S, Murthy PN, Nath L, Chowdhury P. Kinetic modeling on drug release from controlled drug delivery system. Acta Pol Pharm 2010;67:217-23.
Lokhandwala H. Kinetic modeling and dissolution profiles comparison: An overview. Int J Pharm Biosci 2013;4:728-37.
Chuong MC, Palugan L, Su TM, Busano C, Lee R, Di Pretoro G, et al. Formulation of controlled-release capsules of biopharmaceutical classification system i drugs using niacin as a model. AAPS Pharm Sci Tech 2010;11:1650-61.
Moore JW, Flanner HH. Mathematical comparison of dissolution profiles. Pharm Tech 1996;20:64-74.
Hu Y, Wu G, Gu P, Yang W, Wang C, Ding Z, et al. Thermodynamic models for determination of the solubility of omeprazole in pure and mixture organic solvents from T = (278.15 to 333.15) K. J Chem Thermodynamics 2016;94:177-85.
Ravella VN, Nadendla RR, Kesari NC. Design and evaluation of sustained release pellets of aceclofenac. J Pharm Res 2013;6:525-31.
Friesen DT, Shanker R, Crew M, Smithey DT, Curatolo WJ, Nightingale JA. Hydroxypropyl methylcellulose acetate succinate-based spray-dried dispersions: An overview. Mol Pharm 2008;5:1003 19.
Siepmann F, Siepmann J, Walther M, MacRae RJ, Bodmeier R. Blends of aqueous polymer dispersions used for pellet coating: importance of the particle size. J Control Release. 2005;105(3):226–39.
Priya YD, Chowdary YA, Murthy TE, Seshagiri B. Design and evaluation of atomoxetine HCl pellets by MUPS technology. Int J Pharm Pharm Sci 2014;6:110-5.
Lecomte F, Siepmann J, Walther M, MacRae RJ, Bodmeier R. Polymer blends used for the aqueous coating of solid dosage forms: Importance of the type of plasticizer. J Control Release 2004;99:1-13.
Laboulfie F, Hmati M, Lamure A, Diguet S. Effect of the plasticizer on permeability, mechanical resistance and thermal behaviour of composite coating films. Powder Technol 2012;23:14-9.
Agnes EJ, Ortega GG. Mathematical models and physicochemistry of diffusion. Cad Farm 2003;19:9-19.
de Souza DF, Goebel K, Andreazza IF. Development of enteric coated sustained release minitablets containing mesalamine. Braz J Pharm Sci 2013;49:529-36.
Bussemer T, Bodmeier RA. Drug delivery: Pulsatile systems. Encyclopedia of Pharmaceutical Technology. New York: Marcel Dekker 2007;1:1287-97.
Shah VP, Tsong Y, Sathe P, Liu JP. In vitro dissolution profile comparison statistics and analysis of the similarity factor, f2. Pharma Res 1998;15:889-95.
Siepmann F, Siepmann J, Walther M, MacRae RJ, Bodmeier R. Polymer blends for controlled release coatings. J Control Release 2008;125:1 15.
Stroyer A, McGinity JW, Leopold CS. Solid-state interactions between the proton pump inhibitor omeprazole and various enteric coating polymers. J Pharm Sci 2006;95:1342-53.
He W, Yang M, Fan JH, Feng CX, Zhang SJ, Wang JX, et al. Influences of sodium carbonate on physicochemical properties of lansoprazole in designed multiple coating pellets. AAPS Pharm Sci Tech 2010;11:1287 93.
Emara LH, Abdelfattah FM, Taha NF, El-Ashmawy AA, Mursi NM. In vitro evaluation of ibuprofen hot-melt extruded pellets employing different designs of the flow through cell. Int J Pharm Pharm Sci 2014;6:192-7.
Jyothi BJ, Doniparthi J. Multiparticulate drug delivery systems using natural polymers as release retardant materials. Int J Pharm Pharm Sci 2014;6:61-5.
Vishwas SS, Satish VS, Rupali NK. Formulation optimization of promethazine theoclate immediate release pellets by using extrusion spheronization technique. Int J Appl Pharm 2018;10:30-5.
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