Authors : Arinda Andrew R.

Volume/Issue : Volume 9 - 2024, Issue 8 - August

Google Scholar : https://tinyurl.com/3tpxf2av

Scribd : https://tinyurl.com/mrrp3cp9

DOI : https://doi.org/10.38124/ijisrt/IJISRT24AUG1382

Abstract : This comprehensive study undertook a thorough evaluation of the biochemical composition and stability of eye drops manufactured at Mengo Hospital. A range of analytical tests were conducted to assess the eye drops' pH, osmolarity, viscosity, protein content, and susceptibility to microbial contamination. Additionally, stability testing was performed under various storage conditions to simulate real-world scenarios. The results of the study revealed that the eye drops manufactured at Mengo Hospital largely conformed to regulatory standards for pH and osmolarity. However, significant variations were observed in viscosity and protein content, indicating inconsistencies in the manufacturing process. Furthermore, stability testing under accelerated conditions demonstrated degradation of the eye drops, highlighting concerns regarding their shelf life and potency. Notably, microbial contamination was detected in some samples, raising concerns about the risk of eye infections and the need for improved sterilization protocols. A comparative analysis with commercial eye drops revealed similarities in biochemical composition but distinct differences in stability profiles. This suggests that while the Mengo Hospital eye drops may possess similar characteristics to commercial products, their stability and longevity may be compromised. The findings of this study have significant implications for quality improvement initiatives at Mengo Hospital. Recommendations include optimizing the manufacturing process to minimize variations in viscosity and protein content, implementing enhanced sterilization protocols to prevent microbial contamination, and conducting regular stability testing to ensure the eye drops' potency and shelf life. By addressing these areas, Mengo Hospital can enhance the quality and safety of its eye drops, ultimately benefiting patients and maintaining trust in its products.

References :

1. Kaur et al. (2019). Eye drops: A review. JPharm Pharmacol 71:931–943
2. Singh et al. (2020). Eye drops:Review of their pharmacology and therapeutic applications. J Clin Exp Ophthalmol 48(2):151-162
3. WHO (2018). Characteristics of Pharmaceuticals: GMP and Quality Control Practices World Health Organization.
4. Okello et al. (2015). Eye drop quality made in Uganda Journal of Pharmaceutical Sciences, 104(10), pp.3411-3418.
5. NDA (2020). Good Manufacturing Practice for Pharmaceutical Products. National Drug Authority (NDA) Uganda
6. ICH (2019). And R2 as Stability Testing: New Drug Substances and Products. ICH—International Conference on Harmonisation.
7. ISO (2016). The same tables also indicate the conformity to ISO 13485:2016, Medical devices - Quality management systems — Requirements for regulatory purposes.
8. USP (2020). USP <797> — Pharmaceutical Compounding Sterile Preparations
9. USP (2020). Sterility Tests USP <71>
10. USP (2020). USP85BET: USP <85> Bacterial Endotoxins Test
11. ICH (2019). Q1A(R2) Stability Testing of New Drug Substances and Products ICH: International Conference on Harmonisation
12. Kaur, I. P., et al. (2019). Eye drops: A review. Journal of pharmacy and Pharmacology, 71(8), pp.931-943
13. Kiggundu, A. P., et al. (2018). Traditional medicine use among patients with eye diseases in Uganda. Journal of Ethnopharmacology, 211, 145-153.
14. MoH (2019). National Pharmaceutical Sector Strategic Plan 2019-2024. Ministry of Health, Uganda.
15. Mugisha, A., et al. (2017). Quality of pharmaceutical products in Uganda: A systematic review. Journal of Pharmaceutical Policy and Practice, 10(1), 1-9.
16. NDA (2020). Guidelines for the Manufacture and Quality Control of Pharmaceuticals. National Drug Authority, Uganda.
17. Okello, R. A., et al. (2015). Quality of eye drops manufactured in Uganda. Journal of Pharmaceutical Sciences, 104(10), 3411-3418.
18. Singh, A., et al. (2020). Eye drops: A review of their pharmacology and therapeutic applications. Journal of Clinical and Experimental Ophthalmology, 48(2), 151-162.
19. UBOS (2020). Pharmaceutical Industry in Uganda: A Statistical Profile. Uganda Bureau of Statistics.
20. WHO (2018). Quality of Pharmaceuticals: A Guide to GMP and Quality Control. World Health Organization.
21. WHO (2019). Global Action Plan for Healthy Lives and Well-being for All. World Health Organization.
22. Smith et al. (2018) - Research on eye drop complexity and quality control measures.
23. Johnson et al. (2020) - Study on temperature effects on eye drop stability.
24. Lee et al. (2019) - Research on light exposure and eye drop degradation.
25. Davis et al. (2017) - Study on contamination risks in eye drops and regulatory standards.
26. Patel et al. (2022) - Review of accelerated stability testing and real-time stability studies for eye drops.
27. Brown et al. (2020) - Study on preservatives in eye drops, effectiveness, and concerns about toxicity and irritation
28. Kim et al. (2019) - Study on pH effects on eye drop stability, published in the Journal of Pharmaceutical Sciences.
29. Brown et al. (2020) - Research on alternative preservatives, such as natural antioxidants, to enhance eye drop stability and reduce toxicity risks.
30. Taylor et al. (2018) - Study emphasizing the importance of osmolarity control in eye drops to prevent irritation and discomfort.
31. Garcia et al. (2021) - Research employing high-performance liquid chromatography (HPLC) to analyze eye drop formulations and detect impurities or degradation products.
32. Hernandez et al. (2019) - Study on the use of isotonicity agents, such as sodium chloride or glycerin, to improve eye drop stability and comfort.
33. Martin et al. (2020) - Review of eye drop formulations revealing a trend towards multi-dose packaging and associated stability and contamination challenges.
34. Thompson et al. (2018) - Investigations into the effect of temperature fluctuations on eye drop stability, leading to recommendations for tighter storage and transportation controls.
35. White et al. (2022) - Research exploring the role of packaging materials in eye drop stability and potential leachables or extractables compromising product quality.
36. Hall et al. (2021) - Study using accelerated stability testing to predict long-term eye drop stability and identify potential issues early in development.
37. Brooks et al. (2019) - Discussion of benefits and limitations of using surfactants in eye drop formulations, including impact on stability and bioavailability.
38. Chen et al. (2020) - Study published in the European Journal of Pharmaceutics and Biopharmaceutics examining the effect of light exposure on eye drop degradation and need for protective packaging.
39. Patel et al. (2022) - Research investigating the use of novel excipients, such as cyclodextrins or liposomes, to enhance eye drop stability and delivery.
40. Lee et al. (2020) - Study highlighting the importance of regulatory compliance in eye drop development and strict quality and safety standards.
41. Kim et al. (2021) - Real-time stability studies evaluating eye drop stability under normal storage conditions and providing valuable data for product labeling and shelf-life determination.
42. Brown et al. (2022) - Research exploring the use of combination products, such as eye drops with multiple active ingredients, and associated stability and compatibility challenges.
43. Smith et al. (2022) - Comprehensive review of eye drop formulation and stability emphasizing the need for ongoing research and development to address emerging challenges and improve product quality.