Analysis of Naproxen 500 mg Caplets from Different Brands Available in the Iraqi Market: A Comparative In-vitro Study

Authors

  • Amal F. Al-Dulaimi Department of Pharmaceutical Chemistry, College of Pharmacy, University of Mosul, Mosul, Iraq.
  • Zahraa Hussein Ali Department of Pharmaceutics, College of Pharmacy, University of Mosul, Mosul, Iraq.
  • Sarah Ahmed Waheed Department of Pharmaceutical Chemistry, College of Pharmacy, University of Mosul, Mosul, Iraq.

DOI:

https://doi.org/10.60988/p.v37i2.71

Keywords:

Content uniformity, Dissolution, Naproxen caplet, Similarity factor, Splitted caplets.

Abstract

Naproxen, a non-steroidal anti-inflammatory drug, has been used widely for its analgesic, antipyretic, and anti-inflammatory activities. Based on that, this medication has many brands available in the Iraqi market. These numerous brands confuse doctors and patients about which is the best in terms of good quality and the exact quantity of active ingredients. Accordingly, this research is conducted to perform an in-vitro comparative study to evaluate different brands of naproxen caplets available in Iraqi market (as whole and splitted caplets), with a price evaluation. With regard for the intact caplet investigations, the weight, size, friability, and content uniformity values of the caplets of all tested brands were acceptable, while the caplets’ hardness results were above the limits, especially for brands B and D. The disintegration times of these brands were within the limits, except for brand C that exceeded the limits with a large margin. Concerning the dissolution rate inspection, all brands fell within the pharmacopeial limits, but in the case of the 5-min drug release percentage comparison, which was linked straightly to the onset of action, brands A and B were superior. A similarity factor study revealed that brands A and B were similar regarding their dissolution profiles, while brands A and C were the most dissimilar. On the other hand, the splitted caplet investigation included weight, weight variation and uniformity, average accuracy percentage and content uniformity percentage analysis. The results of most of them occurred within acceptable limits. One of the most important parameters that directly affect patient compliance with the medication is the price and how it is linked with the effectiveness. On this matter, the best price: effectiveness ratio was found in brands E and B.

Author Biographies

Zahraa Hussein Ali, Department of Pharmaceutics, College of Pharmacy, University of Mosul, Mosul, Iraq.

Department of Pharmaceutics, College of Pharmacy, University of Mosul, Mosul, Iraq.

Sarah Ahmed Waheed, Department of Pharmaceutical Chemistry, College of Pharmacy, University of Mosul, Mosul, Iraq.

Department of Pharmaceutical Chemistry, College of Pharmacy, University of Mosul, Mosul, Iraq.

References

Alam S, Qamar F, Naveed S, Hamid F, Sadia H, Khan S. Formulation development and assessment of Naproxen sodium tablet (Anti rheumatic agent). RADS J Pharm Pharm Sci [Internet]. 2017;5(3):30–6. Available from: http://jpps.juw.edu.pk/index.php/jpps/article/view/146

Stoev SN, Gueоrguiev SR, Madzharov VG, Lebanova HV. Naproxen in Pain and Inflammation – A Review. Int J Pharm Phytopharm Res. 2021;11(1):142–8.

Al-Dulaimi AF, Al-Kotaji M, Abachi FT. Development of Novel Paracetamol/Naproxen co-crystals for Improvement in Naproxen Solubility. Iraqi J Pharm Sci. 2022;31(1):202–19.

Verma A, Gautam SP, Gautam T, Kaur S, Kanwar K. Recent Advancements in Tablet Technology : The need of hour. Int J Pharm Drug Anal. 2015;3(12):423–9.

Habib WA, Alanizi AS, Abdelhamid MM, Alanizi FK. Accuracy of tablet splitting: Comparison study between hand splitting and tablet cutter. Saudi Pharm J [Internet]. 2014;22(5):454–9. Available from: http://dx.doi.org/10.1016/j.jsps.2013.12.014

Mandour HI, Belal TS, Ramadan AA, Sharabi FM. Qualitative and quantitative analysis of some tramadol registered and illegitimate dosage forms in Egypt. 2024;1(January).

Alsawi S, Soliman A, Fadil S, Abdalkaream N, Hussein M. Evaluation of Quality and Antibacterial Activity of Four Brands of Ciprofloxacin Tablets Marketed in Libya. AlQalam J Med Appl Sci. 2024;7(1):192–9.

Abebe K, Beressa TB, Yimer BT. In-vitro evaluations of quality control parameters of paracetamol tablets marketed in Gondar City, Northwest Ethiopia. Drug Healthc Patient Saf. 2020;12:273–9.

Prakash G, Chandra SA, Sandhya P, Bidur C, Samir D. Pharmacopoeial comparison of in-process and finished product quality control test for pharmaceutical tablets. GSC Biol Pharm Sci. 2020;11(03):155–65.

Sharma S, Gupta S, Bhardwaj B, Sahu A. A Comparative Analysis of Metformin Hydrochloride Tablets , Both Branded and Generic. 2023;16(4).

Thummak S, Uppor W, Wannarit LO. Patient compliance: A concept analysis. Belitung Nurs J. 2023;9(5):421–7.

Politi MC, Housten AJ, Forcino RC, Jansen J, Elwyn G. Discussing Cost and Value in Patient Decision Aids and Shared Decision Making: A Call to Action. MDM Policy Pract. 2023;8(1):1–8.

Kvarnström K, Westerholm A, Airaksinen M, Liira H. Factors contributing to medication adherence in patients with a chronic condition: A scoping review of qualitative research. Pharmaceutics. 2021;13(7):1–41.

British Pharmacopia, Medicinal and Pharmaceutical Substances. volIII. London: The Stationary Office; 2020.

United States Pharmacopoeia (USP) 41, NF 36. USA: The United States Pharmacopeial Convention; 2018.

Sahu SB, Shende HR, Kamde KD. A Review on Tablets: Its Formulation and Evaluation. Int J Nov Res Dev [Internet]. 2024;9(2):440–51. Available from: www.ijnrd.org

Al-Dulaimi A, Al-kotaji M, Abachi F. Paracetamol/ naproxen co-crystals; a simple way for improvement of flowability, tableting and dissolution properties. Iraqi J Pharm. 2021;18(1):1–19.

Asrade B, Tessema E, Tarekegn A. In vitro comparative quality evaluation of different brands of carbamazepine tablets commercially available in Dessie town, Northeast Ethiopia. BMC Pharmacol Toxicol [Internet]. 2023;24(1):1–8. Available from: https://doi.org/10.1186/s40360-023-00670-1

Shuma ML, Jahan A, Halder S. Assessment of drug release kinetics and quality of naproxen generic tablets in Bangladesh. Dissolution Technol. 2021;28(2):30–5.

Mandloi M, Singh G, Gupta MK. Development and validation of various spectrophotometric methods for naproxen as anti arthritis. J Drug Deliv Ther. 2018;8(6-A):33–42.

United States Pharmacopeia (USP) 26, NF 21. 26th ed. Rockville, MD: The United States Pharmacopeial Convention; 2002.

Zaid AN, Al-Ramahi RJ, Ghoush AA, Qaddumi A, Zaaror YA. Weight and content uniformity of lorazepam half-tablets: A study of correlation of a low drug content product. Saudi Pharm J [Internet]. 2013;21(1):71–5. Available from: http://dx.doi.org/10.1016/j.jsps.2011.12.009

Kasahun AE, Joseph NM, Belete A. Practices of tablet splitting and dose uniformity of fragments at public hospitals in Ethiopia: A cross-sectional study supported by experimental findings. PLoS One [Internet]. 2022;17(12 December):1–17. Available from: http://dx.doi.org/10.1371/journal.pone.0279135

Gharaibeh SF, Tahaineh L. Effect of different splitting techniques on the characteristics of divided tablets of five commonly split drug products in Jordan. Pharm Pract (Granada). 2020;18(2):1–7.

Van Riet-Nales DA, Doeve ME, Nicia AE, Teerenstra S, Notenboom K, Hekster YA, et al. The accuracy, precision and sustainability of different techniques for tablet subdivision: Breaking by hand and the use of tablet splitters or a kitchen knife. Int J Pharm [Internet]. 2014;466(1–2):44–51. Available from: http://dx.doi.org/10.1016/j.ijpharm.2014.02.031

Hummler H, Stillhart C, Meilicke L, Grimm M, Krause E, Mannaa M, et al. Impact of Tablet Size and Shape on the Swallowability in Older Adults. Pharmaceutics. 2023;15(4):1–20.

Ahmed W, El-Gogary RI, Nasr M, Sammour OA. Development and in Vitro/In Vivo Evaluation of Itopride Hydrochloride Expanding Tablets. J Pharm Innov [Internet]. 2023;18(3):1350–61. Available from: https://doi.org/10.1007/s12247-023-09729-2

Weiss M. Relationship Between Dissolution Rate in Vitro and Absorption Rate in Vivo of Ketamine Prolonged-Release Tablets. Eur J Drug Metab Pharmacokinet [Internet]. 2023;48(2):133–40. Available from: https://doi.org/10.1007/s13318-022-00812-6

Upadhyay P, . K, Chaudhary P, Upadhyay S. A Review on Formulation and Evaluation Approaches for Fast Release Tablet. Mathews J Pharm Sci. 2023;7(1):1–10.

Muselík J, Komersová A, Kubová K, Matzick K, Skalická B. A critical overview of FDA and EMA statistical methods to compare in vitro drug dissolution profiles of pharmaceutical products. Pharmaceutics. 2021;13(10).

Akter A, Begh MZA, Parvez A, Islam F. Quality analysis of different marketed brands of carbamazepine available in Bangladesh. Pharmacologyonline. 2019;2(August):105–12.

Downloads

Published

25-06-2025

How to Cite

[1]
Al-Dulaimi, A.F. et al. 2025. Analysis of Naproxen 500 mg Caplets from Different Brands Available in the Iraqi Market: A Comparative In-vitro Study. Pharmakeftiki . 37, 2 (Jun. 2025). DOI:https://doi.org/10.60988/p.v37i2.71.