30DEC

Libyan International Conference for Health Sciences

The First Libyan International Conference for Health Sciences (2024): Open University, Tripoli, Libya
Mediterranean Journal of Pharmacy and Pharmaceutical Sciences
https://app.periodikos.com.br/journal/medjpps/article/doi/10.5281/zenodo.10289340

Mediterranean Journal of Pharmacy and Pharmaceutical Sciences

Original article

Post-marketing quality assessment of paracetamol brands in the Libyan market

Mostafa A. Almdaaf, Mohammed S. Altriki, Mohamed A. Elnekaib

Downloads: 1
Views: 364

Abstract

Paracetamol is one of the most found over-the-counter drugs worldwide. It is widely used as an analgesic and antipyretic drug. Many commercial types of paracetamol tablets are available under different brand names in the Libyan drug market. The present study was conducted to evaluate post-marketing quality parameters for three brands of paracetamol tablets marketed in Libya. All three brands were evaluated for weight variation, hardness, friability, disintegration time and uniformity of content following British pharmacopeia guidelines. The outcomes of this study showed all tested brands complied with the British pharmacopeia specifications for the weight variation test, friability test (0.05%-0.17%), and hardness test (171.3N-197.6 N). In addition, two brands passed the British pharmacopeia requirements for the disintegration time test, whereas one brand exceeded the allowed disintegration time by about five minutes. Furthermore, High-performance liquid chromatography was used to determine paracetamol content. Although the average amount of paracetamol drug available in these brands is not very close to 100%, where one brand achieved the lowest value (438.1 mg), the loaded dose of paracetamol in selected tablets in the three brands was within the British pharmacopeia standard specifications for the uniformity content test. Therefore, it can be concluded that almost all the three tested brands of paracetamol tablets that are available in the Libyan drug market meet the British pharmacopeia specification for quality control analysis.

Keywords

Brand, paracetamol, post-marketing, quality control

References

  1. Binega G, Wondimisgegne D, Tsega B (2013) Analysis and comparison of paracetamol tablets dispensed in legal dispensaries and non-pharmaceutical shops in Gondar town, North West Ethiopia. International Journal of Pharmacy and Industrial Research. 03 (02): 144-151. doi: Nil.
  2. Nsimba SED (2008) Problems associated with substandard and counterfeit drugs in developing countries: a review article on global implications of counterfeit drugs in the era of anti-retroviral (ARVS) drugs in a free market economy. East African Journal of Public Health. 5 (3): 205-210. doi: 10.4314/eajph.v5i3.39004
  3. Counterfeit drugs: guidelines for the development of measures to combat counterfeit drugs (1999) Geneva; World Health Organization (WHO): 1-60. doi: Nil.
  4. Taylor RB, Shakoor O, Behrens RH, Everard M, Low AS, Wangboonskul J, Reid RG, Kolawole JA (2001) Pharmaopoeial quality of drugs supplied by Nigerian pharmacies. Lancet. 357 (9272): 1933-1936. doi: 10.1016/ s0140-6736(00)05065-0
  5. Technical report on counterfeit medicines: Counterfeit medicines Fact Sheet No 275.Geneva; World Health Organization (WHO): 2006. doi: Nil.
  6. Kaur H, Goodman C, Thompson E, Thompson KA, Masanja I, Kachur SP, Abdulla S (2008) A nationwide survey of the quality of antimalarial in retail outlets in Tazania. PloS One. 3 (10): 3403. doi: 10.1371/journal. pone.0003403
  7. Mehuys E, Crombez G, Paemeleire K, Adriaens ELs, Van Hees T, Demarche S, Christiaens T, Van Bortel L, Van Tongelen I, Remon J-P, Boussery K (2019) Self-medication with over-the-counter analgesics: a survey of patient characteristics and concerns about pain medication. The Journal of Pain. 20 (2): 215-223. doi: 10.1016/ j.jpain.2018.09.003
  8. Chung VC, Ma PH, Tang TS, Lau CH, Kim JH, Griffiths SM (2011) Do patients tell their clinicians they are using both prescribed and over the counter allopathic and traditional medicines? European Journal Integrative Medicine. 3 (4): 289-298. doi: 10.1016/j.eujim.2011.09.008
  9. Teklu L, Adugna E, Ashenef A (2014) Quality evaluation of paracetamol tablets obtained from the common shops (KIOSKS) in Addis Ababa, Ethiopia. International Journal of Pharmaceutical Sciences and Research. 5 (8): 3502-3510. doi: 10.13040/IJPSR.0975-8232.5(9).3502-10
  10. Jozwiak-Bebenista M, Nowak JZ (2014) Paracetamol: mechanism of action, applications and safety concern. Acta Poloniae Pharmaceutica-Drug Research. 71 (1): 11-23. PMID: 24779190.
  11. Khan AD, Baranwal PK, Ali MA, Kumar S, Sharma S (2019) Comparative quality evaluation of two brands of paracetamol tablets obtained from the market. International Journal of Pharmaceutical Education and Research. 1 (1): 14-18. doi: 10.37021/IJPER.V111.14
  12. Abozaid DA, Saleh WM (2022) Evaluation of some metformin hydrochloride brands available in the Libyan market. Mediterranean Journal of Pharmacy and Pharmaceutical Sciences. 2 (4): 6-12. doi: 10.5281/zenodo. 7479690
  13. Akasha AA, Ahdeya EA, Bsebsu ZA (2019) Comparative study between five brands of metformin hydrochloride available in Libyan drug market. Mintage Journal of Pharmaceutical and Medical Sciences. 8 (3) 37-41. doi: Nil.
  14. Islam M, Gupta V, Mahalwal VS, Achalu T (2019) Physico-chemical evaluation of four brands of paracetamol 500 mg tablets by using quality control techniques. The Pharmaceutical and Chemical Journal. 6 (4): 89-96. doi: Nil.
  15. Alsaifi1 A, Alyahawi A (2018) Quality assessment of different brands of paracetamol tablets in Yemeni market. Universal Journal of Pharmaceutical Research. 3 (4): 42-46. doi: 10.22270/ujpr.v3i4.182
  16. Sahle SB, Ayane AT, Wabe NT (2012) Comparative quality evaluation of paracetamol tablet marketed in Somali region of Ethiopia. International Journal of Pharmaceutical Sciences and Research. 3 (2): 545-550. doi: 10.13040/IJPSR.0975-8232.3(2).545-50
  17. Khreit OIG, Alkailani HAM, Alqathafi WSK (2017) A comparative study of physical and chemical parameters of selected paracetamol tablets available in the pharma market of Libya. Der Pharma Chemica. 9 (2): 1-6. doi: Nil.
  18. Rwaiha O, Sarar O, Jwaili M, Alshowaigi M, Mtawa A, Alsabri S (2020) Post-marketing in-vitro comparative studies of different brands of paracetamol tablets available in Misurata market, Libya. Research and Reviews: Journal of Pharmacy and Pharmaceutical Sciences. 9 (1): 1-10. Corpus ID: 235806211.

Submitted date:
11/11/2023

Reviewed date:
12/06/2023

Accepted date:
12/08/2023

Publication date:
12/07/2023

657245fba9539576c216c534 medjpps Articles
Links & Downloads

Mediterr J Pharm Pharm Sci

Share this page
Page Sections