Pharmaceutical Evaluation and Microbiological Properties of Three Brands of Tobramycin Eye Drops Marketed in Retail Pharmacies of Al-Bayda, Libya

Authors

  • Samia Alsawi Majeed Department of Pharmaceutics, Faculty of Pharmacy, Omar Al-Mukhtar University, Al Bayda, Libya Author
  • Ahmed Saeed Kabbashi Department of Biomedical Science, Faculty of Pharmacy, Omar Al-Mukhtar University, Al-Bayda, Libya. Author

DOI:

https://doi.org/10.54361/LJMR.19.1.29

Keywords:

Tobramycin, Eye drops, Pharmaceutical properties, Antimicrobial efficacy

Abstract

Background: Tobramycin (TBM) is a water-soluble aminoglycoside antibiotic in various formulations, including ophthalmic solutions. It has been demonstrated to be effective against numerous ocular pathogens. Objectives: This study aimed to determine the pharmaceutical and microbiological efficiency of three brands of tobramycin eye drops sold in retail pharmacies in Al-Bayda, Libya. Materials and Methods: Three sterile eye drops from different tobramycin brands sourced from the Al-Bayda market in Libya were analyzed. The physical appearance of each brand was assessed for packaging and closure integrity. Pharmaceutical analyses (color and clarity evaluation, pH), sterility testing, antibacterial activity, and antimicrobial effectiveness were conducted by inoculating nutrient agar and Sabouraud dextrose medium with each eye drop brand. Results: The findings showed that all brand packaging adheres to proper sealing standards with intact container closures. The labels complied with FIP guidelines for prescribed medicines. All brands were transparent and particle-free when examined against white and black backgrounds, respectively. The pH values for brands A, B, and C were 6.88, 6.91, and 6.90, respectively, matching the tear fluid's physiological pH. The refractive indices were 1.335, 1.334, and 1.334 for brands A, B, and C, respectively, consistent with tear fluid. Sterility tests indicated no microbial growth, and the preservatives were effective against Escherichia coli, Staphylococcus aureus, and Candida albicans. Conclusion: This preservative system confers resistance to microbial contamination during its utilization. Further clinical investigations are necessary to assess the safety and long-term effectiveness of these pharmaceutical agents.

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References

1. Boddu HS, Gupta H, Patel S. Drug delivery to the back of the eye following topical administration: an update on research and patenting activity. Recent patents on drug delivery & formulation. 2014;8(1):27-36.

2. Gibson M. Ophthalmic dosage forms. Pharmaceutical preformulation and formulation: CRC Press; 2016. p. 443-67.

3. Kurata M, Atsumi I, Yamagiwa Y, Sakaki H. Ocular instillation toxicity study: current status and points to consider on study design and evaluation. Fundamental Toxicological Sciences. 2016;3(5):217-32.

4. Patel P, Shastri D, Shelat P, Shukla A. Ophthalmic drug delivery system: challenges and approaches. Systematic Reviews in Pharmacy. 2010;1(2):113.

5. Ezenobi Nkechi O, Chinaka Chioma N, Obi Esther I. Assessment of the physicochemical and antimicrobial quality of some antibiotic and non-antibiotic eye drops marketed in different registered pharmacies in port harcourt, rivers state. European Journal of Biomedical. 2018;5(3):4-10.

6. Raghad A, Ebtihal N, Hanan I. Microbial contamination of eye drops. Iraqi J Pharm Sci. 2011;20(2):91-5.

7. Iskandar K, Marchin L, Kodjikian L, Rocher M, Roques C. Highlighting the microbial contamination of the dropper tip and cap of in-use eye drops, the associated contributory factors, and the risk of infection: a past-30-years literature review. Pharmaceutics. 2022;14(10):2176.

8. Tsegaw A, Tsegaw A, Abula T, Assefa Y. Bacterial contamination of multi-dose eye drops at ophthalmology department, University of Gondar, Northwest Ethiopia. Middle East African journal of ophthalmology. 2017;24(2):81-6.

9. Hasegawa A, Gulmezian-Sefer M, Cheng Y, Srikumar R. Microbiological Considerations for Ophthalmic Products: Sterility, Endotoxin Limits, and Preservatives. Ophthalmic Product Development: From Bench to Bedside: Springer; 2022. p. 199-227.

10 .Bennett NH, Chinnery HR, Downie LE, Hill LJ, Grover LM. Material, immunological, and practical perspectives on eye drop formulation. Advanced Functional Materials. 2020;30(14):1908476.

11. Shaqra QMA, Al-Groom RM, Shaqra AQA. Antimicrobial Effectiveness in Eye Drops: Limited Sterility versus Reduction in Microbial Count. PDA Journal of Pharmaceutical Science and Technology. 2020;74(3):309-17.

12. Harland D, Define A. Course Category. Infection. 2024.

13. Olorode OA, Ofonime OM, Orowo AE. Evaluation of Antimicrobial Effectiveness of Ophthalmic Drops Sold in Nigeria Pharmacy Stores and Market Places. Medico Research Chronicles. 2017;4(01):109-22.

14. Rosasco MA, Segall AI. Determination of the chemical stability of various formulations of tobramycin eye-drops by HPLC method and data analysis by R-GUI stability software. 2015.

15. Saka R, Chella N. Nanocarriers as tools for delivery of nature derived compounds and extracts with therapeutic activity. Sustainable Agriculture Reviews 44: Pharmaceutical Technology for Natural Products Delivery Vol 2 Impact of Nanotechnology. 2020:73-114.

16. Yang X, Goswami S, Gorityala BK, Domalaon R, Lyu Y, Kumar A, et al. A tobramycin vector enhances synergy and efficacy of efflux pump inhibitors against multidrug-resistant Gram-negative bacteria. Journal of medicinal chemistry. 2017;60(9):3913-32.

17. Serio AW, Keepers T, Andrews L, Krause KM. Aminoglycoside revival: review of a historically important class of antimicrobials undergoing rejuvenation. EcoSal Plus. 2018;8(1):10.1128/ecosalplus. ESP-0002-2018.

18. Bulitta JB, Ly NS, Landersdorfer CB, Wanigaratne NA, Velkov T, Yadav R, et al. Two mechanisms of killing of Pseudomonas aeruginosa by tobramycin assessed at multiple inocula via mechanism-based modeling. Antimicrobial agents and chemotherapy. 2015;59(4):2315-27.

19. Thomas RK, Melton R, Asbell PA. Antibiotic resistance among ocular pathogens: Current trends from the ARMOR surveillance study (2009–2016). Clinical Optometry. 2019:15-26.

20. Chojnacki M, Philbrick A, Wucher B, Reed JN, Tomaras A, Dunman PM, Wozniak RA. Development of a broad-spectrum antimicrobial combination for the treatment of Staphylococcus aureus and Pseudomonas aeruginosa corneal infections. Antimicrobial agents and chemotherapy. 2019;63(1):10.1128/aac. 01929-18.

21. Mah FS, Karpecki PM. Review of Loteprednol Etabonate 0.5%/Tobramycin 0.3% in the treatment of Blepharokeratoconjunctivitis. Ophthalmology and Therapy. 2021;10(4):859-75.

22. Martínez-Pulgarín DF, Ávila MY, Rodríguez-Morales AJ. Interventions for Demodex blepharitis and their effectiveness: a systematic review and meta-analysis. Contact Lens and Anterior Eye. 2021;44(6):101453.

23. Kobayashi K, Hayashi I, Kouda S, Kato F, Fujiwara T, Kayama S, et al. Identification and characterization of a novel aac (6′)-Iag associated with the bla IMP-1–integron in a multidrug-resistant Pseudomonas aeruginosa. PloS one. 2013;8(8):e70557.

24. Perin N, Babić D, Kassal P, Čikoš A, Hranjec M, Vianello R. Spectroscopic and Computational Study of the Protonation Equilibria of Amino-Substituted benzo [b] thieno [2, 3-b] pyrido [1, 2-a] benzimidazoles as Novel pH-Sensing Materials. Chemosensors. 2022;10(1):21.

25. Rosalia M, Chiesa E, Tottoli EM, Dorati R, Genta I, Conti B, Pisani S. Tobramycin nanoantibiotics and their advantages: a minireview. International journal of molecular sciences. 2022;23(22):14080.

26. Thacharodi A. The genetic basis of aminoglycoside resistance in Pseudomonas aeruginosa. University of Otago; 2022.

27. Jodh R, Tawar M, Kachewar A, Ingole Y, Deshmukh T, Ijapure V. Pharmacological Review on Tobramycin. 2022.

28. Miles AA, Misra S, Irwin J. The estimation of the bactericidal power of the blood. Epidemiology & Infection. 1938;38(6):732-49.

29. Kusuma SAF, Abdassah M, Maryati F. Comparison of perservatives efficacy of benzalkonium chloride, thimerosal, and benzyl alcohol in eye drop products containing chloramphenicol. Int J Appl Pharm. 2020;12:100-5.

30. Pharmacopeia U, editor The United States Pharmacopeia, USP 41/The National Formulary. Rockville, MD: US Pharmacopeial Convention; 2018.

31. Pharmacopoeia J. Preservative Effectiveness Test. Pharmaceuticals and Medical Devices Agency: Tokyo, Japan. 2016.

32. Commission BP. Appendix II F: X-ray fluorescence spectrometry. British Pharmacopoeia. 2021;5.

33. Kavanagh D. Political culture: Macmillan International Higher Education; 1972.

34. Wroblewska KB, Jadach B, Muszalska-Kolos I. Progress in drug formulation design and delivery of medicinal substances used in ophthalmology. International journal of pharmaceutics. 2021;607:121012.

35. Nair A, Strauch S, Lauwo J, Jähnke RW, Dressman J. Are counterfeit or substandard anti‐infective products the cause of treatment failure in Papua New Guinea? Journal of pharmaceutical sciences. 2011;100(11):5059-68.

36. Ezenobi NO, Chinaka CN. Microbiological and physicochemical assessment of some brands of gentamicin eye drops marketed in registered retail pharmacies in Port Harcourt, Nigeria. Journal of Pharmacy & Bioresources. 2018;15(1):27-36.

37. Mohamed-Ahmed AH, Kuguminkiriza D. Local production of eye drops in the hospital or pharmacy setting: considerations and safety tips. Community Eye Health. 2023;36(118):17.

38. Awwad S, Mohamed Ahmed AH, Sharma G, Heng JS, Khaw PT, Brocchini S, Lockwood A. Principles of pharmacology in the eye. British journal of pharmacology. 2017;174(23):4205-23.

39. Bachu RD. Development and Evaluation of a Novel Microemulsion of Dexamethasone and Tobramycin for Topical Ocular Administration: University of Toledo; 2017.

40. Simmons PA, Vehige JG. Clinical performance of a mid-viscosity artificial tear for dry eye treatment. Cornea. 2007;26(3):294-302.

41. Scherer D, Alvarez-Gonzalez E, Pettigrew T. EyeSol: a novel topical ocular drug delivery system for poorly soluble drugs. Drug Development and Delivery. 2013;13(1):40-4.

42. Rajab R, AlAhmad Y. EVALUATION OF PRESERVATIVE EFFECTIVENESS IN SOME EYE DROPS IN SYRIAN MARKET BY ANTIMICROBIAL EFFECTIVENESS TEST ACCORDING TO DIFFERENT PHARMACOPEIAS. Bulletin of Pharmaceutical Sciences Assiut University. 2022;45(2):1155-63.

43. Kharb S, Thompkinson DK, Kumari H. Stability study of fortified low-fat spreads with preservatives. Food Quality and Safety. 2022;6:fyac027.

44. Chang DF. Tackling the challenge of needless surgical waste in ophthalmology. Journal of Cataract & Refractive Surgery. 2023;49(4):333-8.

45. Figus M, Agnifili L, Lanzini M, Brescia L,Sartini F, Mastropasqua L, Posarelli C. Topical preservative-free ophthalmic treatments: an unmet clinical need. Expert Opinion on Drug Delivery. 2021;18(6):655-72.

46. Sutton SV, Geis PA. Antimicrobial preservative efficacy and microbial content testing. Cosmetic microbiology: CRC Press; 2020. p. 67-93.

47. Freeman PD, Kahook MY. Preservatives in topical ophthalmic medications: historical and clinical perspectives. Expert Review of Ophthalmology. 2009;4(1):59-64.

48. Al-Rubaye IMM. A review of the literature on antimicrobial preservatives: Definition, properties, classification, safety, side effects and antimicrobial effectiveness testing. Atena Journal of Public Health. 2022;4:7-.

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Published

01-01-2025

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How to Cite

1.
Majeed S, Kabbashi A. Pharmaceutical Evaluation and Microbiological Properties of Three Brands of Tobramycin Eye Drops Marketed in Retail Pharmacies of Al-Bayda, Libya. LJMR [Internet]. 2025 Jan. 1 [cited 2025 Jun. 1];19(1):201-13. Available from: http://ljmr.ly/index.php/ljmr/article/view/357

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