PHOTOLYTIC DEGRADATION STUDY ON FILM COATED ATENOLOL TABLET AVAILABLE IN MARKET
Objective: Despite its sensitivity to light, atenolol has been manufactured as a film-coated tablet with normal blister packaging by several pharmaceutical companies in Bangladesh. The aim of this study was to investigate the extent of light-induced potency degradation of a randomly selected film coated brand of atenolol.
Methods: Atenolol tablets were exposed to different lighting conditions such as normal room light, direct sunlight and different incandescent lights (25W and 40W). Subsequently, UV spectroscopy technique was employed to determine the relative reduction of light absorbance compared to their respective controls. Thereafter, photolytic degradation was calculated by means of the potency reduction of tablets.
Results: In all lighting conditions, atenolol tablets underwent exposure dependent gradual decrease in potency. Except for normal room light condition, a significant decrease in potency was found even after 4 to 6 h of exposure to all lighting conditions. After 6 h, potency reduction was found at 40-47%, 26-38% and 34-36% in the samples exposed to direct sunlight, 25 W bulb, and 40 W bulb respectively. Although the shelf life of the film coated tables was 2 y, surprisingly, statistically significant reduction in potency was observed within only 30 d in room light condition.
Conclusion: In order to protect from light, blister packaging is not sufficient for film coated atenolol tablets. Photo-stability of all brands of atenolol must be ensured either by protective packaging materials or by optimizing the formulations.
2. Lim SS, Vos T, Flaxman AD, Danaei G, Shibuya K, Adair-Rohani H, et al. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990â€“2010:a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012;380:2224â€“60.
3. Andros V, Egger A, Dua U. Blood pressure goal attainment according to JNC 7 guidelines and utilization of antihypertensive drug therapy in MCO patients with type 1 or type 2 diabetes. J Manag Care Pharm 2006;12:303-9.
4. Dwivedi S, Gonmei Z, Toteja G, Srivastava N. Assessment of risk factors of hypertension among adults residing in an urban slum of Delhi. Asian J Pharm Clin Res 2018;11:405-7.
5. Moore J. Hypertension: catching the silent killer. J Pract Nurs 2005;30:16-35.
6. Sharma S, Sawhney V. Awareness, stress, anxiety, and depression among hypertensive patients attending cardiac outpatient department in a super specialty hospital. Asian J Pharm Clin Res 2016;9:62-4.
7. Missiriya S, John J. Assess the prevalence of hypertension and knowledge regarding the prevalence of stroke. Asian J Pharm Clin Res 2017;10:177-80.
8. Santhanasamy PMC. The effectiveness of cardiac walking on blood pressure among patients with hypertension at a selected hospital in Kancheepuram district. Asian J Pharm Clin Res 2017;10:171-4.
9. Santhanasamy PJJ. Effectiveness of laughter therapy on blood pressure among patients with hypertension. Asian J Pharm Clin Res 2017;10:246-50.
10. Makridakis S, DiNicolantonio JJ. Hypertension: empirical evidence and implications in 2014. Open Heart 2014; 1:e000048.
11. Shukla R, Omray LK. Formulation characterization of diltiazem transdermal system for the treatment of hypertension. Int J Curr Pharm Res 2016;8:12-5.
12. Agarwal S, Zamil F, Singh L, Saxena A. Formulation and evaluation of floating beads of diltiazem HCL. Int J Curr Pharm Res 2016;8:38-42.
13. Das M, Sahu B, Hazarika J. Development of bilayer tablets for the immediate and controlled release of allicin. Int J Curr Pharm Res 2017;9:153-60.
14. Agon P, Goethals P, Van Haver D, Kaufman JM. Permeability of the blood-brain barrier for atenolol studied by positron emission tomography. J Pharm Pharmacol 1991;43:597-600.
15. Medical Research Council trial of treatment of hypertension in older adults: principal results. MRC Working Party. Br Med J 1992;304:405-12.
16. Andrisano V, Gotti R, Leoni A, Cavrini V. Photodegradation studies on atenolol by liquid chromatography. J Pharm Biomed Anal 1999;21:851-7.
17. Thoma K, Klimek R. Photostabilization of drugs in dosage forms without protection from packaging materials. Int J Pharm 1991;67:169-75.
18. Matsuda Y, Itooka T, Mitsuhashi Y. Photo-stability of indomethacin in model gelatin capsules: effects of film thickness and concentration of titanium dioxide on the coloration and photolytic degradation. Chem Pharm Bull (Tokyo) 1980;28:2665-71.
19. Albini A, Fasani E. editors. Drugs, photochemistry and photostability. Cambridge: Royal Society of Chemistry; 1998.
20. El-Didamony A, Hafeez S, Saad A. Extraction-spectrophotometric determination of some antihypertensive drugs in a pharmaceutical and biological fluid using two sulphonphthalein dyes. Int J Appl Pharm 2015;7:10-7.
21. Tonnesen HH. Formulation and stability testing of photolabile drugs. Int J Pharm 2001;225:1-14.
22. Bakshi M, Singh S. Development of validated stability-indicating assay methods-- a critical review. J Pharm Biomed Anal 2002;28:1011-40.
23. 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. Int Res J Pharm 2013;4:78â€“85.