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Feasibility of an in vitro microbiological model as an alternative to the rabbit eye model
P V Devarajan1, C P Bhogte, A B Majali
1Department of Chemical Technology, University of Mumbai, Matunga, India.
Abstract:
Ocular inserts of gentamicin sulfate with polyvinyl alcohol (PVA) 1.5%, 2.0%, and 2.5% and a combination of methyl cellulose 2% and Eudragit NE 30D 30%, 35%, and 40% w/w of methyl cellulose were fabricated by a casting technique. The inserts were sterilized by gamma radiation at 25 kGy and tested for sterility. The microbiological efficacy of the ocular inserts against Staphylococcus aureus ATCC 6538P and Pseudomonas aeruginosa NCIM 2200 was evaluated by developing an in vitro microbiological model and an in vivo noninvasive rabbit eye model. Parameters of the in vitro microbiological model were varied, and the results correlated with a noninvasive rabbit eye model. The in vitro model proved to be a viable alternative to the rabbit eye model in evaluating the microbiological efficacy of gentamicin sulfate ocular inserts.
Insights
This study developed gentamicin sulfate ocular inserts using polyvinyl alcohol and methyl cellulose/Eudragit NE 30D. An in vitro model effectively predicted the efficacy of these antibiotic inserts, offering an alternative to animal testing.
Area of Science:
- Ophthalmology
- Pharmaceutics
- Microbiology
Background:
- Ocular infections require effective drug delivery systems.
- Gentamicin sulfate is a common antibiotic for eye infections.
- Developing reliable methods to test ocular drug efficacy is crucial.
Purpose of the Study:
- To fabricate and evaluate gentamicin sulfate ocular inserts.
- To develop and validate an in vitro microbiological model for assessing insert efficacy.
- To compare the in vitro model with an in vivo rabbit eye model.
Main Methods:
- Ocular inserts were prepared using polyvinyl alcohol (PVA) or methyl cellulose/Eudragit NE 30D via casting.
- Inserts were sterilized using gamma radiation (25 kGy) and tested for sterility.
- Microbiological efficacy was assessed using an in vitro model and an in vivo noninvasive rabbit eye model against Staphylococcus aureus and Pseudomonas aeruginosa.
Main Results:
- Various formulations of gentamicin sulfate ocular inserts were successfully fabricated.
- The in vitro microbiological model demonstrated a strong correlation with the in vivo rabbit eye model.
- Sterility testing confirmed the safety of gamma-irradiated inserts.
Conclusions:
- Gentamicin sulfate ocular inserts can be effectively prepared using PVA or methyl cellulose/Eudragit NE 30D.
- The developed in vitro model is a viable and potentially more efficient alternative to animal models for evaluating ocular insert efficacy.
- This research supports the development of novel ocular drug delivery systems.