Comparative study of the quality of atorvastatin tablet brands obtained from Lagos, Nigeria
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Abstract
Background: The quality of any pharmaceutical product significantly affects its effectiveness and safety. Atorvastatin, a widely used medication for managing cholesterol level, relies on meeting established standard for optimal clinical response.
Objective: This research aimed at evaluation of the quality of the leading atorvastatin tablets brands marketed in Lagos, Nigeria.
Methods: The assessments of the quality of eight atorvastatin brands (ATRO1, ATRO2, ATRO3, ATRO4, ATRO5, ATRO6, ATRO7, and ATRO8) were done using British Pharmacopoeia (BP) and United States Pharmacopeia (USP) methods. Physicochemical parameters (thickness, weight uniformity, diameter, friability, and hardness) were evaluated using British Pharmacopoeia (BP) methods, the active ingredient content was quantified using ultraviolet-visible spectrometry, and the dissolution profiles were analyzed using a USP dissolution apparatus II.
Results: All brands met BP specifications for uniformity of weight and thickness. However, ATRO 2, ATRO 6, ATRO 7, and ATRO 8 had larger diameters than BP standard. ATRO1 exceeded the BP specification for friability. The hardness generally fell within acceptable ranges. Regarding percentage purity, only ATRO 1 and ATRO 7 met BP standards. Dissolution profile analysis revealed variations among the brands. Only ATRO 1 and ATRO 7 met the BP requirement of releasing 80% of atorvastatin within 30 minutes.
Conclusion: There are observed variations in physicochemical parameters, percentage purity, and dissolution profiles among the eight brands of atorvastatin tablets and these could potentially impact the clinical effectiveness and safety of the medication. Strict quality control is essential to maintain consistency and efficacy of pharmaceuticals.
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References
1. Stavrova-Hristova RP (2019). The Role of Cholesterol in Assessing the Condition of the Surgical Patients. Journal of Biomedical and Clinical Research 12(2):87-93.
2. Centonze G, Natalini D, Piccolantonio A, Salemme V, Morellato A, Arina P, Riganti C, Defilippi P (2022). Cholesterol and its derivatives: multifaceted players in breast cancer progression. Frontiers in Oncology 12:906670.
3. Schade DS, Shey L, Eaton RP (2020). Cholesterol review: a metabolically important molecule. Endocrine Practice 26(12):1514-23.
4. De Smet E, Mensink RP, Plat J (2012). "Effects of plant sterols and stanols on intestinal cholesterol metabolism: suggested mechanisms from past to present". Molecular Nutrition & Food Research 56(7): 1058-1072.
5. Christie WW (1982). Lipid Analysis: Isolation, separation, identification and structural analysis of lipids. 2nd Ed; Pergamon Press New York, NY.
6. Murphy K (2011). Cholesterol: The good, the bad, and the ugly. Nursing Made Incredibly Easy 9(3):26-34.
7. Durrington P (2003). "Dyslipidaemia". The Lancet 362(9385): 717-731.
8. Brunzell JD, Davidson M, Furberg CD, Goldberg RB, Howard BV, Stein JH, Witztum JL (2008). "Lipoprotein management in patients with cardiometabolic risk: consensus statement from the American Diabetes Association and the American College of Cardiology Foundation". Diabetes Care 31(4): 811-822.
9. Lewington S, Whitlock G, Clarke R, Sherliker P, Emberson J, Halsey J, Qizilbash N, Peto R, Collins R (2008). Blood cholesterol and vascular mortality by age, sex, and blood pressure: a meta-analysis of individual data from 61 prospective studies with 55000 vascular deaths (vol 370, pg 1829, 2007). The Lancet 372(9635).
10. Thompson PD, Buchner D, Piña IL, Balady GJ, Williams MA, Marcus BH, Berra K, Blair SN, Costa F, Franklin B, Fletcher GF (2003). Exercise and physical activity in the prevention and treatment of atherosclerotic cardiovascular disease: a statement from the Council on Clinical Cardiology (Subcommittee on Exercise, Rehabilitation, and Prevention) and the Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity). Circulation 107(24):3109-16.
11. Crismaru I, Pantea Stoian A, Bratu OG, Gaman MA, Stanescu AM, Bacalbasa N, Diaconu CC (2020). Lowdensity lipoprotein cholesterol lowering treatment: the current approach. Lipids in Health and Disease 19:1-0.
12. Mangat S, Agarwal S, Rosendorff C (2007). Do statins lower blood pressure?. Journal of cardiovascular pharmacology and therapeutics 12 (2): 112-123.
13. Adams SP, Tsang M, Wright JM (2015). Atorvastatin for lowering lipids. Cochrane Database of Systematic Reviews. doi:10.1002/14651858.cd008226.pub3
14. Black AE, Sinz MW, Hayes RN, Woolf TF (1998). Metabolism and excretion studies in mouse after single and multiple oral doses of the 3-hydroxy-3-methylglutar yl-CoA reduc tase inhibitor atorvastatin. Drug Metabolism and Disposition 26 (8): 755-763.
15. Soni V, Pandey V, Asati S, Tekade RK (2018). Impact of Pharmaceutical Product Quality on Clinical Efficacy. In Dosage Form Design Considerations pp. 731-771). Academic Press.
16. Colhoun HM, Betteridge DJ, Durrington PN, Hitman GA, Neil HAW, Livingstone SJ, Thomason MJ, Mackness MI, Charlton-Menys V, Fuller JH (2004). Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. The Lancet 364(9435): 685-696.
17. Benet LZ (2013). The Role of BCS (Biopharmaceutics Classification System) and BDDCS (Biopharmaceutics Drug Disposition Classification System) in Drug Development. Journal of Pharmaceutical Sciences 102(1): 34-42.
18. Cardot JM, Beyssac E, Alric M (2007). In Vitro-In Vivo Correlation: Importance of Dissolution in IVIVC. Dissolution Technologies 14(1):15-19.
19. Chiba Y, Kohri N, Iseki K, Miyazaki K (1991). Improvement of dissolution and bioavailability for mebendazole, an agent for human echinococcosis, by preparing solid dispersion with polyethylene glycol. Chemical and Pharmaceutical Bulletin 39: 2158-2160.
20. Maggio RM, Castellano PM, Kaufman TS (2008). A new principal component analysis-based approach for testing "similarity" of drug dissolution profiles. European Journal of Pharmaceutical Sciences 34 (1): 66-77.
21. British Pharmacopoeia Commission (2013). British Pharmacopoeia. London: Her Majesty Stationery Office, p. 1324
22. Bonfilio RB, De Araujo MB, Salgado HR (2010). Recent applications of analytical techniques for quantitative pharmaceutical analysis: a review. WSEAS Transactions on Biology and Biomedicine 7(4):316-38.
23. Singhal A, Saini U, Chopra B, Dhingra AK, Jain A, Chaudhary J (2024). UV-Visible Spectroscopy: A Review on its Pharmaceutical and Bio-allied Sciences Applications. Current Pharmaceutical Analysis 20 (3):161-77.
24. Alwadi AY, Arafeh GM, Almehlesi MS, Maswadeh HM, Salman IM, Ameer OZ (2022). Comparative Analysis of Commercially Available Acetaminophen Tablets in Saudi Arabia. Dissolution Technologies 29 (3): GC1-12.
25. United States Pharmacopeial Convention (2018). Committee of Revision (Dissolution). United States Pharmacopeia, the National Formulary. United States Pharmacopeial Convention, Incorporated.
26. United States Pharmacopeial Convention (2020). General Test Chapter Ultraviolet-Visible Spectroscopy. United States Pharmacopeia, the National Formulary. United States Pharmacopeial Convention, Incorporated.
27. AlBratty M, Alhazmi HA, Alam MS, Alam MI, Javed SA, Alam N (2020). Assessment of physicochemical properties and comparison of dissolution profiles of metformin hydrochloride tablets in Saudi Arabia. Dissolution Technologies 27 (1):36-44.
28. Safila Naveed (2014). Development of a simple and sensitive method for the determination of paracetamol in pharmaceutical formulations using UV-Visible spectrophotometry. Journal of Applied Pharmaceutical Science, 4(03), 051-055.
29. Akinleye MO, Idris O, Nwachukwu PN, Oyetunde OO (2012). Quality of brands of atorvastatin calcium tablets marketed in Lagos, Nigeria. International Journal of Pharmacy and Pharmacology, 1(1):001-007.