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Thesis _Rinda Devi Bachu.pdf (2.07 MB)

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Development and Evaluation of a Novel Microemulsion of Dexamethasone and Tobramycin for Topical Ocular Administration

Bachu, Rinda Devi
http://rave.ohiolink.edu/etdc/view?acc_num=mco1512562325333526

Abstract Details

2017, Master of Science (MS), University of Toledo, Pharmaceutical Sciences (Industrial Pharmacy).
Objective: The drug absorption from an ophthalmic suspension dosage form is highly unpredictable. Identical formulations with similar concentrations of active and inactive ingredients tend to exhibit differences in absorption. These differences in absorption could be due to varying physicochemical properties such as pH, particle size, zeta potential, size distribution and viscosity. These properties affect the precorneal residence time, drug release and ocular drug absorption [1, 2]. Drug delivery to the eye using microemulsions has drawn significant attention due to their intrinsic properties and ability to solubilize both hydrophilic and lipophilic drugs. They offer several advantages including thermodynamic stability combined with improved dose uniformity [3], ocular retention, permeation and absorption of drugs [4]. The present study involves the development and evaluation of a novel dexamethasone (0.1%) and tobramycin (0.3%) loaded microemulsion with potential for treating anterior segment eye inflammation and bacterial infection. Methods: The microemulsion was evaluated for pH, particle size, zeta potential, light transmittance, morphology, and in vitro drug release. Sterility of microemulsion was evaluated by direct as well as plate inoculation methods. Anti-inflammatory activity of dexamethasone, bactericidal activity of tobramycin, and cytotoxicity of the microemulsion were evaluated and compared with that of marketed eye drop suspension (Tobradex®). Histological evaluation was performed in bovine corneas in order to assess the safety of microemulsion in comparison to Tobradex® suspension. In-addition, the stability of the microemulsion was also studied at 4°C, 25°C and 40°C. Results: The pH of microemulsion was close to the pH of tear fluid. The microemulsion displayed average globule size under 20 nm with light transmittance around 95-100%. Aseptically prepared microemulsion remained sterile for up to 14 days. The cytotoxicity of microemulsion in bovine corneal endothelial cells was comparable to that of Tobradex® suspension. Anti-inflammatory activity of dexamethasone and anti-bacterial activity of tobramycin from the microemulsion were significantly higher than those of Tobradex® suspension (p<0.05). Histological evaluation showed intact corneal epithelium without any signs of toxicity and the developed microemulsion was found to be stable at 4°C and 25°C for 3 months. Conclusions: In conclusion, the microemulsion developed could be a suitable alternative to the currently marketed Tobradex® suspension for treating anterior segment infection and inflammation. Further in vivo studies in animals are warranted to evaluate the clinical utility of the microemulsion. References: 1. Saettone, M.F., Progress and problems in ophthalmic drug delivery. Business Briefing: Pharmatech, 2002. 1: p. 167-71. 2. Schoenwald, R. and P. Stewart, Effect of particle size on ophthalmic bioavailability of dexamethasone suspensions in rabbits. Journal of pharmaceutical sciences, 1980. 69(4): p. 391-394. 3. Stringer, W. and R. Bryant, Dose uniformity of topical corticosteroid preparations: difluprednate ophthalmic emulsion 0.05% versus branded and generic prednisolone acetate ophthalmic suspension 1%. Clin Ophthalmol, 2010. 4: p. 1119-1124. 4. Hegde, R.R., A. Verma, and A. Ghosh, Microemulsion: new insights into the ocular drug delivery. ISRN pharmaceutics, 2013.
Sai Hanuman Sagar Boddu, PhD (Advisor)
89 p.
Pharmacy Sciences
Ocular Microemulsion; Dexamethasone; Tobramycin; Topical administration; Anterior segment inflammation

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Citations

  • Bachu, R. D. (2017). Development and Evaluation of a Novel Microemulsion of Dexamethasone and Tobramycin for Topical Ocular Administration [Master's thesis, University of Toledo]. OhioLINK Electronic Theses and Dissertations Center. http://rave.ohiolink.edu/etdc/view?acc_num=mco1512562325333526

    APA Style (7th edition)

  • Bachu, Rinda Devi. Development and Evaluation of a Novel Microemulsion of Dexamethasone and Tobramycin for Topical Ocular Administration. 2017. University of Toledo, Master's thesis. OhioLINK Electronic Theses and Dissertations Center, http://rave.ohiolink.edu/etdc/view?acc_num=mco1512562325333526.

    MLA Style (8th edition)

  • Bachu, Rinda Devi. "Development and Evaluation of a Novel Microemulsion of Dexamethasone and Tobramycin for Topical Ocular Administration." Master's thesis, University of Toledo, 2017. http://rave.ohiolink.edu/etdc/view?acc_num=mco1512562325333526

    Chicago Manual of Style (17th edition)

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This open access ETD is published by University of Toledo Health Science Campus and OhioLINK.