Welcome to Open Science
Contact Us
Home Books Journals Submission Open Science Join Us News
Preparation and Characterization of Low Dosage Omeprazole Tablets
Current Issue
Volume 5, 2017
Issue 5 (October)
Pages: 26-33   |   Vol. 5, No. 5, October 2017   |   Follow on         
Paper in PDF Downloads: 23   Since Dec. 20, 2017 Views: 1216   Since Dec. 20, 2017
Authors
[1]
Matija Gretić, Faculty of Chemical Engineering and Technology, University of Zagreb, Zagreb, Croatia.
[2]
Gordana Matijašić, Faculty of Chemical Engineering and Technology, University of Zagreb, Zagreb, Croatia.
[3]
Krunoslav Žižek, Faculty of Chemical Engineering and Technology, University of Zagreb, Zagreb, Croatia.
Abstract
Five different mixtures of seven components were prepared for tableting. Saccharose, a basic ingredient in each mixture for tableting, was pretreated by top-spray fluid-bed granulation process using polyvinylpyrrolidone as a binder. Microcrystalline cellulose (MCC), mannitol, lactose and PanExcea MC200G, original and granulated, were used as fillers in prepared mixtures. Magnesium stearate was added in each mixture as a glidant. Each component and mixtures for tableting were characterized by particle size distribution, bulk and tapped density, angle of repose, as well as calculated compressibility index and Hausner ratio. Tablets were characterized using standard tests on disintegration, hardness, dimensions and friability. Omeprazole was added to the mixture using the process of simple powder blending in a tumbling bed unit and by wet fluid-bed granulation process. Additionally, omeprazole content was determined in 10 randomly selected tablets. The results revealed a significant effect of particle size distribution on the properties of a mixture, and thus the characteristics of tablets. It was shown that granulated materials own suitable particle size distribution, better flowability, greater hardness of tablets and more uniform composition of omeprazole in tablets thus ensuring the targeted dosage content of the active ingredient in each tablet produced.
Keywords
Omeprazole, Tableting, Fluid-Bed Granulation, Particle Size Distribution, Uniformity of Content
Reference
[1]
Pilbrant A, Cederberg C. Development of an oral formulation of omeprazole. Scand J Gastroenterol 1985; 20: 113-120.
[2]
Bozdag S, Çalis S, Sumnu M. Formulation and stability evaluation of enteric-coated omeprazole formulations. S T P Pharm Sci 1999; 9: 321–327.
[3]
Senjković R. Osnove oblikovanja lijekova. Zagreb: Školska knjiga, 2003.
[4]
Gad SC, Pharmaceutical manufacturing handbook, Regulations and Quality, New Jersey: John Wiley & Sons Inc., 2008.
[5]
Allen LV, Popovich JrNG, Ansel HC. Ansel's Pharmaceutical dosage forms and drug delivery systems. Philadelphia: Lippincott Williams & Wilkins, 2011.
[6]
European Pharmacopoeia, 8th ed., EDQM, European Pharmacopoeia 01/2010:20936 Powder flow, Council of Europe, Strasbourg, France, 2013, 346.
[7]
Subhash Chougule A, Dikpati A, Trimbake T. Formulation development techniques of co-processed excipients. J Adv Pharm Sci 2012; 2: 231–249.
[8]
Jalšenjak I, Jalšenjak V, Filipović-Grčić J. Farmaceutika. Zagreb: Školska knjiga, 1998.
[9]
Migoha CO, Kaale E, Kagashe G. Formulation development of generic omeprazole 20 mg enteric coated tablets. Pharmacol Pharm 2015; 6: 293–301.
[10]
Tousey MD. The granulation process 101, Basic technologies for tablet making. Pharm Techn 2002; 8–13.
[11]
European Pharmacopoeia, 8th ed., EDQM, European Pharmacopoeia 01/2010:20907 Friability of uncoated tablets, Council of Europe, Strasbourg, France, 2013, 266.
[12]
European Pharmacopoeia, 8th ed., EDQM, European Pharmacopoeia 01/2010:20901 Disintegration of tablets and capsules, Council of Europe, Strasbourg, France, 2013, 2536.
[13]
Rowe RC, Sheskey PJ, Quinn ME. Handbook of pharmaceutical excipients, 6th ed., Pharmaceutical Press and American Pharmacists Association, 2009.
Open Science Scholarly Journals
Open Science is a peer-reviewed platform, the journals of which cover a wide range of academic disciplines and serve the world's research and scholarly communities. Upon acceptance, Open Science Journals will be immediately and permanently free for everyone to read and download.
CONTACT US
Office Address:
228 Park Ave., S#45956, New York, NY 10003
Phone: +(001)(347)535 0661
E-mail:
LET'S GET IN TOUCH
Name
E-mail
Subject
Message
SEND MASSAGE
Copyright © 2013-, Open Science Publishers - All Rights Reserved