COATING EFFICIENCY IN PREVENTING PHOTOLYTIC DEGRADATION OF TWO RANDOMLY SELECTED BRANDS OF METOPROLOL TARTRATE
Abstract
This research work was carried out to determine whether the film coating is effective to prevent the photolytic degradation of Metoprolol tartrate which is known to have photosensitivity. For this purpose, two randomly selected brands of two different pharmaceutical companies were chosen i.e. Brand A and Brand B. These two brands were exposed to different lighting conditions (normal light, direct sunlight as well as two incandescent lights i.e. 25 watt bulb, 40 watt bulb). Potency tests were performed using UV spectroscopy which showed gradual decline in potency of the tablets under aforesaid lighting conditions and the potency degradations were found 11.48%, 12.92%, 22.62%, 16.87% for Brand A and 14.74%, 14.24%, 10.88%, 18.10% for Brand B under 25 watt bulb, 40 watt bulb, direct sunlight and normal room light respectively. So this study reveals that the both brands containing metoprolol tartrate showed significant light sensitivity even though they are coated and protective opaque packaging is highly recommended for their protection.
Keywords:
Metoprolol Tartrate, Potency, Light, Incandescent, Photolytic Degradation, Photosensitivity, opaque packagingDOI
https://doi.org/10.25004/IJPSDR.2016.080203References
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2. Foody JM, Farrell MH, Krumholz HM. β-Blocker therapy in heart failure: scientific review. Jama 2002; 287(7):883-889.
3. Poole-Wilson PA, Swedberg K, Cleland JG, Di Lenarda A, Hanrath P, Komajda M, Lubsen J, Lutiger B, Metra M, Remme WJ, Torp-Pedersen C. Comparison of carvedilol and metoprolol on clinical outcomes in patients with chronic heart failure in the Carvedilol or Metoprolol European Trial (COMET): randomised controlled trial. The Lancet. 2003; 362(9377):7-13.
4. Lohse MJ, Engelhardt S, Eschenhagen T. What is the role of β-adrenergic signaling in heart failure. Circ. Res. 2003; 93(10):896-906.
5. Ogbru O. Metoprolol, Lopressor, Toprol XL: Drug Facts, Side Effects and Dosing. [online] Medicine Net. Available at: http://www.medicinenet.com/Metoprolol/article.htm [Accessed 03 May, 2015].
6. Helfand M, Peterson K, Christensen V, Dana T, Thakurta S. Drug Class Review. Oregon Health & Science University. 2009.
7. Lager I, Blohme G, Smith U. Effect of cardioselective and non-selective β-blockade on the hypoglycaemic response in insulin-dependent diabetics. The Lancet. 1979; 313(8114):458-462.
8. DiNicolantonio JJ, Lavie CJ, Fares H, Menezes AR, O'Keefe JH. Meta-analysis of carvedilol versus beta 1 selective beta-blockers (atenolol, bisoprolol, metoprolol, and nebivolol). The Am J Cardiol, 2013; 111(5):765-769.
9. Drugs.com. Metoprolol - FDA prescribing information, side effects and uses. [online] Available at: http://www.drugs.com/pro/Metoprolol.html [Accessed 03 May, 2015].
10. Kumar K, Kumar SP. Forced Degradation Studies – Practical Approaches and Overview of the Regulatory Guidance of Drug Products. IRJP. 2013; 4(5): 78-85.
11. Hotha KK, Reddy SPK, Raju VK, Ravindranath LK. Forced Degradation Studies: Practical Approach- Overview of Regulatory Guidance and Literature for the Drug Products and Drug Substances. IRJP. 2013; 4(5): 78-85.
12. Rosenberg JM, Schilit S, Nathan JP. Which oral medications should be protected from light and/or moisture? Drug Topics. 2008
13. Romero V, Marco P, Giménez J, Esplugas S. Adsorption and Photocatalytic Decomposition of the β-Blocker Metoprolol in Aqueous Titanium Dioxide Suspensions: Kinetics, Intermediates, and Degradation Pathways. Int. J. Photoenergy. 2013. [online] Available at: http://www.hindawi.com/journals/ijp/2013/138918/ [Accessed 16 February 2016].
14. Spring KR, Davidson MW. Sources of Visible light. Microscopy Resource Center. [Online] Available at: http://olympus.magnet.fsu.edu/primer/lightandcolor/lightsourcesintro.html [Accessed 16 February 2016].
15. U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER). Guidance for Industry Q1A (R2) Stability Testing of New Drug Substances and Products. USFDA. (ICH 2003), Revision 02 [Online] Available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073369.pdf [Accessed 16 February 2016].
16. Baertschi SW, Clapham D, Foti C, Jansen PJ, Kristensen S, Reed RA, Templeton AC, Tønnesen HH. Implications of In‐Use Photostability: Proposed Guidance for Photostability Testing and Labeling to Support the Administration of Photosensitive Pharmaceutical Products, Part 1: Drug Products Administered by Injection. J. Pharm. Sci., 2013; 102(11):3888-3899.
17. Koch-Weser J. Metoprolol. N Engl J Med. 1979; 301(13):698-703.
18. El-Ries MA, Attia FA, Ibrahim SA. AAS and spectrophotometric determination of propranolol HCl and metoprolol tartrate. J pharm biomed anal. 2000; 24(2):179-187.
Published
01-03-2016
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“COATING EFFICIENCY IN PREVENTING PHOTOLYTIC DEGRADATION OF TWO RANDOMLY SELECTED BRANDS OF METOPROLOL TARTRATE”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 8, no. 2, Mar. 2016, pp. 83-86, https://doi.org/10.25004/IJPSDR.2016.080203.
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How to Cite
“COATING EFFICIENCY IN PREVENTING PHOTOLYTIC DEGRADATION OF TWO RANDOMLY SELECTED BRANDS OF METOPROLOL TARTRATE”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 8, no. 2, Mar. 2016, pp. 83-86, https://doi.org/10.25004/IJPSDR.2016.080203.
