A comparative evaluation of furosemide tablet marketed in Libya

Abstract :

Furosemide is a widely potent diuretic drug used in the management of edema and hypertension. Various brands of furosemide are available in the Libyan market and should be subjected to different quality control tests to assess their pharmaceutical equivalence. This study aimed to assess and compare the quality and the pharmaceutical equivalence of some generic brands of furosemide 40 mg tablets marketed in Libya. The pharmaceutical quality of four brands of furosemide tablets was investigated using official and unofficial compendia standards including uniformity of weight, friability, thickness, hardness, drug content and dissolution rate. The results obtained showed acceptable external features as well as the thickness, diameter and uniformity of weight for all the furosemide tablets. The tested brands complied with the official specifications of friability, hardness and drug content. In conclusion, all four brands can be considered as bioequivalence and thus can be pharmaceutically substituted in clinical practice.

References

1. Cooper-DeHoff RM, Pepine CJ (2010) The use of diuretics plus calcium channel blockers for hypertension may be associated with a higher risk of myocardial infarction but not stroke compared with the combination of diuretics plus β blockers. Evidence Based Medicine. 15 (3): 92-93. doi: 10.1136/ebm1067
2. Katzung BG (2012) Basic and clinical pharmacology. 14th ed. Mc Graw Hill. ISBN: 978-1259641152.
3. British Pharmacopeia (2009) The stationery office/TSO, London. 1st ed., vol. 1-4. ISBN: ‎ 9780113227990.
4. Aulton ME (2007) The design and manufacture of medicines, third edition. Elsevier limited, UK. ISBN: 9780443101083.
5. Ansel HC (1981) Introduction to pharmaceutical dosage forms. 3rd ed., Lea & Febiger, Philadelphia, USA. ISBN: 0812107713.
6. Perumalla SR, Sun CC (2014) Enabling tablet product development of 5-fluorocytosine through integrated crystal and particle engineering. Journal of Pharmaceutical Sciences. 103 (4): 1126-1132. doi: 10.1002/jps.23876
7. Kumare MM, Marathe RP, Kawade RM, Ghante MH, Shendarkar GR (2013) Design of fast dissolving tablet of atenolol using novel co processed superdisintegrant. Asian Journal of Pharmaceutical and Clinical Research. 6 (3): 81-85. Corpus ID: 11257135.
8. Banker GS, Rhodes CT (2002) Modern pharmaceutics. 4th ed. Marcel Dekker Inc, New York. ISBN: 9780824706746.
9. Kesselheim AS, Misono AS, Lee JL (2008) Clinical equivalence of generic and brand-name drugs used in cardiovascular diseases: a systemic review and meta-analysis. JAMA. 300: 2514-2526. doi: 10.1001/jama. 2008.758
10. Strom BL (1987) Generic drug substitution revisited. The New England Journal of Medicine. 316 (23): 1456-1462. doi: 10.1056/NEJM198706043162306
11. Food and Drug Administration (2004) Center for Drug Evaluation and Research (CDER). http//www.fda. gov/cder /reports/rtn/2004/rtn2004. (Accessed on 1/6/2023).
12. Gackson G, Arver S, Banks I, Stecher J (2010) Review article: counterfeit phosphodiesterase type 5 inhibitors pose significant safety risks. International Journal of Clinical Practice. 64 (4): 497-504. doi: 10.1111/j.1742-1241. 2009.02328.x
13. Khuluza F (2014) In vitro evaluation of the quality of paracetamol and cotrimoxazole tablets used in Malawi based on pharmacopeial standards. Malawi Medical Journal. 26 (2): 38-41. PMID: 25157315; PMCID: PMC4141240.
14. Olayemi SO, Akinleye MO, Awodele EO, Idris O, Oladimeji-Salami J (2012) The physicochemical equivalence of eight brands of amlodipine in Logos, Nigeria. West Africain Journal of Medicine. 31 (3): 154-159. PMID: 23310934.
15. Nguyen TA, Knight R, Roughead EE, Brooks G, Mant A (2015) Policy options for pharmaceutical pricing and purchasing: issues for low- and middle-income countries. Health Policy and Planning. 30 (2): 267-280. doi: 10.1093/heapol/czt105
16. Abebe S, Ketema G, Kassahun H (2020) In vitro comparative quality assessment of different brands of furosemide tablets marketed in Northwest Ethiopia. Drug Design Development and Therapy. 14: 5119-5128. doi: 10.2147/ DDDT.S280203
17. Abozaid DM, Saleh WM (2022) Evaluation of some metformin hydrochloride brands available in Libyan market. Mediterranean Journal of Pharmacy and Pharmaceutical Sciences. 2 (4): 6-12. doi: 10.5281/zenodo.7479690
18. Afifi SA, Ahmadeen S (2012) A comparative study for evaluation of different brands of metformin hydrochloride 500 mg tablets marketed in Saudi Arabia. Life Science Journal. 9 (4): 4260-4266. doi: 10.7537/marslsj090412.636
19. Gennaro AR (1995) Remington: the science and practice of pharmacy. 19th edition, Williams & Wilkins Publishing, Easton. ISBN: 978-0912734040.
20. British Pharmacopoeia (2002) Appendix: XII. Stationery Office, UK. ISBN: 9780113225750.
21. Khan LG, Razvi N, Anjum F, Siddiqui SA, Ghayas S (2014) Effects of various excipients on tizanidine hydrochloride tablets prepared by direct compression. Pakistan Journal of Pharmaceutical Sciences. 27 (5): 1249-1254. PMID: 25176379.
22. Khan MQ, Razvi N, Anjum F, Ghazal L, Siddiqui SA, Ghayas S (2014) Evaluation and comparison of different brands of domperidone tablets available in Karachi, Pakistan. Pakistan Journal of Pharmaceutical Sciences. 27 (4): 935-938. PMID: 25015463.
23. Muselik J, Franc A, Dolezel P, Goněc R, Krondiová A, Lukášová I (2014) Influence of process parameters on content uniformity of a low dose active pharmaceutical ingredient in a tablet formulation according to GMP. Acta Pharmaceutica. 64 (3): 355-367. doi: 10.2478/acph-2014-0022
24. Troy DB (2006) Remington: the science and practice of pharmacy. 21st ed. Philadelphia, PA: Lippincott, Williams & Wilkins. ISBN: 9780781746731.
25. Yau MK, Meyer MC (1981) In-vivo in-vitro correlation with a commercial dissolution simulator 1, methenamine, nitrofurantion and chlorothiazide. Journal of Pharmaceutical Sciences. 70 (9): 1017-1024. doi: 10.1002/jps. 2600700913
26. Hambisa S, belew S, Suleman S (2019) In vitro comparative quality assessment of different brands of norfloxacin tablets available in Jimma, Southwest Ethiopia. Drug Design, Development and Therapy. 13: 1241-1249. doi: 10.2147/DDDT.S189524
27. Morshed N (2015) Comparative evaluation of prednisolone 5mg tablets marketed in Bangladesh. World Journal of Pharmaceutical Research. 4 (5): 277-289. Corpus ID: 73747781.
28. Baig A, Quraishi AR, Zahir F (2013) Post-market in-vitro comparative evaluation of quality control parameters of paracetamol compressed tablets manufactured in local industrial zones of Kpk Pakistan. The Pharma Innovation Journal. 2 (3, Part A): 11-15. doi: Nil.
29. The United States Pharmacopeia (2015) The United States pharmacopeia: The national formulary. ISBN: 9781936424443.
30. Tuli BM (2014) Evaluation of pharmaceutical equivalence of two different brands (Limaryl and Dactus) of Glimepiride tablets (2mg) available in Bangladesh. Department of Pharmacy, East West University. Aftabnagar, Dhaka, Bangladesh. Thesis. Corpus ID: 111263809.
31. Allen L, Ansel HC (2013) Ansel’s pharmaceutical dosage forms and drug delivery systems. 10th ed. Wolters Kluwer Health. ISBN: 978-1451188769.
32. Melia CD, Davis SS (1989) Review article: mechanisms of drug release from tablets and capsules. 2: Dissolution. Alimentary Pharmacology and Therapeutics. 3 (6): 513-25. doi: 10.1111/j.1365-2036.1989.tb00243.x
33. Hammarlund MM, Paalzow LK, Odlind B (1984) Pharmacokinetics of furosemide in man after intravenous and oral administration. Application of moment analysis. European Journal of Clinical Pharmacology. 26: 197-207. doi: 10.1007/BF00630286
34. Patel RC, Keraliya RA, Patel MM, Patel NM (2010) Formulation of furosemide solid dispersion with micro-crystalline cellulose for achieve rapid dissolution. Journal of Advanced Pharmaceutical Technology and Research. 1 (2): 180-189. PMID: 22247844; PMCID: PMC3255424.
35. Gupta MM (2019) quality control testing of different brands of conventional tablets of ibuprofen available in Trinidad & Tobago, West Indies: an in-vitro testing. Faculty of Medical Sciences, Research Day; March 2019. ID: biblio-1025491.
36. Almdaaf MA, Altriki MS, Elnekaib MA (2023) Post-marketing quality assessment of paracetamol brands in the Libyan market. Mediterranean Journal of Pharmacy and Pharmaceutical Sciences. 3 (4): 73-79. doi: 10.5281/ zenodo.10289340

Citation :

Eteer et al. (2023) A comparative evaluation of furosemide tablet marketed in Libya. Mediterr J Pharm Pharm Sci. 3 (4):83-89. https://doi.org/10.5281/zenodo.10389843