A comprehensive quality control and cost comparison study of branded and generic angiotensin receptor blockers
Status PubMed-not-MEDLINE Language English Country Saudi Arabia Media print-electronic
Document type Journal Article
PubMed
38380162
PubMed Central
PMC10877430
DOI
10.1016/j.jsps.2024.101985
PII: S1319-0164(24)00035-5
Knihovny.cz E-resources
- Keywords
- Drugs, High-Performance Liquid Chromatography, Nuclear Magnetic Resonance, Pharmaceutical Quality Control,
- Publication type
- Journal Article MeSH
This study was designed to assess both the quality and cost aspects of various branded and generic formulations of angiotensin receptor blockers, specifically Irbesartan, Losartan Potassium, Olmesartan Medoxomil, Telmisartan, and Valsartan. The collected samples underwent distinct quality evaluations using the methods outlined in different global Pharmacopoeias (British Pharmacopoeia/European Pharmacopoeia, Indian Pharmacopoeia and United States Pharmacopoeia). These drugs were characterized using Fourier-Transform Infrared Spectroscopy and Nuclear Magnetic Resonance techniques, while their quality and concentration were analysed using High Performance Liquid Chromatography. The release profile of the drugs was examined through dissolution testing. Additionally, a cost comparison analysis was carried out by determining the prevailing market prices of the drugs. The evaluated branded and generic angiotensin receptor blockers were found to meet the established standards for impurities, active drug content, and dissolution as set by these Pharmacopoeias, indicating their optimal quality. Notably, the generic drugs exhibited significantly lower costs compared to their branded counterparts. This study confirms that the quality of generic angiotensin receptor blockers is equivalent to that of their branded counterparts. Consequently, these findings support the practicality of utilizing generic drugs as a more economically sustainable and cost-effective approach to managing diseases, especially those of chronic nature.
See more in PubMed
Aivalli P.K., et al. Perceptions of the quality of generic medicines: implications for trust in public services within the local health system in Tumkur, India. BMJ Glob. Health. 2018;2(Suppl 3):e000644. PubMed PMC
Al-Makki A, DiPette D, Whelton PK et., al, Hypertension Pharmacological Treatment in Adults: A World Health Organization Guideline Executive Summary. Hypertension. 2022 Jan;79(1):293-301. doi: 10.1161/HYPERTENSIONAHA.121.18192. Epub 2021 Nov 15. PMID: 34775787; PMCID: PMC8654104. PubMed PMC
Anand O., et al. Dissolution Testing for Generic Drugs: An FDA Perspective. AAPS J. 2011;13(3) doi: 10.1208/s12248-011-9272-y. PubMed DOI PMC
Andrew C., et al. Evaluating pharmaceuticals for health policy in low and middle income country settings. Wiley Online Library. 2004 doi: 10.1002/9780470994719.ch14. DOI
Dc S. Trends of generic substitution in community pharmacies. Pharm World Sci. 1999;260(6) doi: 10.1023/a:1008781619011. PubMed DOI
Fuchs FD, Whelton PK. High Blood Pressure and Cardiovascular Disease. Hypertension. 2020 Feb;75(2):285-292. doi: 10.1161/HYPERTENSIONAHA.119.14240. Epub 2019 Dec 23. PMID: 31865786; PMCID: PMC10243231. PubMed PMC
Gota V., Patial P. Toward better quality of anticancer generics in India. Indian J. Cancer. 2014;51(3):366. doi: 10.4103/0019-509x.146723. PubMed DOI
Gupta R., et al. Generic Drugs in the United States: Policies to Address Pricing and Competition. Clin. Pharmacol. Ther. 2019;105(2):329–337. doi: 10.1002/cpt.1314. PubMed DOI PMC
Heidari B., Avenatti E., Nasir K. Pharmacotherapy for essential hypertension: A brief review. Methodist DeBakey Cardiovasc J. 2022;18(5):5–16. doi: 10.14797/mdcvj.1175. PubMed DOI PMC
Hill Robert D, Vaidya Prabhakar N. Angiotensin II receptor blockers StatPearls Publishing Jan 2023 Angiotensin II Receptor Blockers (ARB) - StatPearls - NCBI Bookshelf (nih.gov) accessed 09th January 2024. PubMed
https://www.nhs.uk/conditions/high-blood-pressure-hypertension/treatment/accessed December 24, 2022.
Indian Pharmacopoeia Commission. Indian Pharmacopoeia. 9th ed. Sector 23, Raj Nagar Ghaziabad-201002: The Indian Pharmacopoeia Commission, 2022.
Jambhekar S.S., Breen P.J. Drug dissolution: significance of physicochemical properties and physiological conditions. Drug Discov. Today. 2013;18(23–24):1173–1184. doi: 10.1016/j.drudis.2013.08.013. PubMed DOI
Kashyap A., et al. Cost analysis of various branded versus generic chemotherapeutic agents used for the treatment of early breast cancer- a deep insight from India. Expert Rev. Pharmacoecon. Outcomes Res. 2019;20(4):355–361. doi: 10.1080/14737167.2019.1637735. PubMed DOI
Kesselheim A.S. Clinical Equivalence of Generic and Brand-Name Drugs Used in Cardiovascular Disease. JAMA. 2008;300(21):2514. doi: 10.1001/jama.2008.758. PubMed DOI PMC
Kingori P., et al. Poor-quality medical products: social and ethical issues in accessing “quality” in global health. BMJ Glob. Health. 2019;4(6):e002151. PubMed PMC
Kovacs S et al. Technologies for Detecting Falsified and Substandard Drugs in Low and Middle-Income Countries. Sullivan DJ, ed. PLoS ONE 2014; 9(3): e90601. 10.1371/journal.pone.0090601. PubMed PMC
Kumar GR. An analysis of generic medicines in India 2017. Available at: https://www.thehansindia.com/posts/index/Hans/2017-05-09/An-analysis-of-generic-medicines-in-India/298834.
Manzoli L., et al. Generic versus brand-name drugs used in cardiovascular diseases. Eur. J. Epidemiol. 2015;31(4):351–368. doi: 10.1007/s10654-015-0104-8. PubMed DOI PMC
Meredith P.A. Generic Drugs. Drug-Safety. 1996;15:233–242. doi: 10.2165/00002018-199615040-0000. PubMed DOI
Mills K.T., Stefanescu A., He J. The global epidemiology of hypertension. Nat. Rev. Nephrol. 2020;16(4):223–237. doi: 10.1038/s41581-019-0244-2. PubMed DOI PMC
Newton P.N., et al. Impact of poor-quality medicines in the “developing” world. Trends Pharmacol. Sci. 2010;31(3):99–101. doi: 10.1016/j.tips.2009.11.005. PubMed DOI PMC
Oparil S., Acelajado M.C., Bakris G.L., et al. Hypertension. Nat. Rev. Dis. Primers. 2019;4(4):1–48. doi: 10.1038/nrdp.2018.14. PubMed DOI PMC
Patterson J.H., Angiotensin I.I. Receptor Blockers in Heart Failure. Pharmacotherapy. 2003;23(2):173–182. doi: 10.1592/phco.23.2.173.32095. PubMed DOI
Pharmaceuticals & Medical Devices Bureau of India (janaushadhi.gov.in) accessed June 14, 2023.
Rahman M.S., et al. A comprehensive analysis of selected medicines collected from private drug outlets of Dhaka city, Bangladesh in a simple random survey. Sci. Rep. 2022;12(1) doi: 10.1038/s41598-021-04309-1. PubMed DOI PMC
Rajput G., Patel P., Singh D., Asati V., Kurmi B.D. Quality by design assisted high-performance liquid chromatography parameters for simultaneous estimation of simvastatin and fenofibrate. Sep Sci plus. 2022;5:566–578. doi: 10.1002/sscp.202200078. DOI
Shafie A.A., Hassali M.A. Price comparison between innovator and generic medicines sold by community pharmacies in the state of Penang. Malaysia. Journal of Generic Medicines. 2008;6(1):35–42. doi: 10.1057/jgm.2008.25. DOI
Sharma A.K., et al. Impurities Present in Cardiovascular Active Substances and Medicinal Products: A Pharmacopoeial Perspective. Current Chromatography. 2022;9(1) doi: 10.2174/2213240609666220728091253. e280722207051. DOI
Taylor A.A., Helmy S. Journal of Clinical Hypertension n. 2011;Vol 13(9)
Unger T., Borghi C., Charchar F., et al. 2020 International society of hypertension global hypertension practice guidelines. Hypertension. 2020;75(6):1334–1357. doi: 10.1161/hypertensionaha.120.15026. PubMed DOI
United States Pharmacopeial Convention. The United States Pharmacopoeia-National Formulary., 43rd–38th ed. Rockville, Md: United States Pharmacopoeial Convention, 2023. Available at: https://online.uspnf.com/uspnf.
Whelton P.K., Carey R.M., Aronow W.S., et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults. J. Am. Coll. Cardiol. 2018;71(19):e127–e248. doi: 10.1016/j.jacc.2017.11.006. PubMed DOI
World Health Organization. Guideline for the pharmacological treatment of hypertension in adults. Geneva. 2021. Licence: CC BY-NC-SA 3.0 IGO. PubMed
World Health Organization. Hypertension. World Health Organization. Published March 16, 2023. https://www.who.int/news-room/fact-sheets/detail/hypertension.