OphthalMimic: A new alternative apparatus without animal tissue for the evaluation of topical ophthalmic drug products

Barbalho, Geisa N.; Falcão, Manuel A.; Alves Amaral, Venâncio; Contarato, Jonad L.A.; Barbalho, Aliucha M.; Kaori Diógenes, Gabriela; Mariana Gomes Silva, Melyssa; Carvalho de Barros do Vale Rochelle, Beatriz; Gelfuso, Guilherme M.; Cunha-Filho, Marcilio; Gratieri, Tais

doi:10.1016/j.ymeth.2024.05.005

Methods

2024

DOI: 10.1016/j.ymeth.2024.05.005

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OphthalMimic: A new alternative apparatus without animal tissue for the evaluation of topical ophthalmic drug products

Geisa N. Barbalho,

Manuel A. Falcão,

Venâncio Alves Amaral

et al.

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2024

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Cited by 2 publications

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Hydrogel-based hybrid membrane enhances in vitro ophthalmic drug evaluation in the OphthalMimic device

Barbalho,

Falcão,

Amaral

et al. 2024

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Hydrogel-based hybrid membrane enhances in vitro ophthalmic drug evaluation in the OphthalMimic device

Barbalho,

Falcão,

Amaral

et al. 2024

Methods

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Applying Different Conditions in the OphthalMimic Device Using Polymeric and Hydrogel-Based Hybrid Membranes to Evaluate Gels and Nanostructured Ophthalmic Formulations

Contarato,

Barbalho,

Cunha-Filho

et al. 2024

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The OphthalMimic is a 3D-printed device that simulates human ocular conditions with artificial lacrimal flow, cul-de-sac area, moving eyelid, and a surface to interact with ophthalmic formulations. All tests with such a device have used a continuous artificial tear flow rate of 1 mL/min for 5 min. Here, we implemented protocol variations regarding the application time and simulated tear flow to increase the test’s discrimination and achieve reliable performance results. The new protocols incorporated the previously evaluated 0.2% fluconazole formulations containing or not chitosan as a mucoadhesive component (PLX16CS10 and PLX16, respectively) and novel moxifloxacin 5% formulations, either in a conventional formulation and a microemulsion (CONTROL and NEMOX, respectively). The flow rate was reduced by 50%, and a pre-flow application period was also included to allow formulation interaction with the membrane. The OphthalMimic model was used with both polymeric and hydrogel-based hybrid membranes, including a simulated eyelid. Lowering the flow made it feasible to prolong the testing duration, enhancing device discrimination potential. The hydrogel membrane was adequate for testing nanostructure formulations. The OphthalMimic device demonstrated once again to be a versatile method for evaluating the performance of ophthalmic drug formulations with the potential of reducing the use of animals for experimentation.

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OphthalMimic: A new alternative apparatus without animal tissue for the evaluation of topical ophthalmic drug products

Cited by 2 publications

References 36 publications

Hydrogel-based hybrid membrane enhances in vitro ophthalmic drug evaluation in the OphthalMimic device

Hydrogel-based hybrid membrane enhances in vitro ophthalmic drug evaluation in the OphthalMimic device

Applying Different Conditions in the OphthalMimic Device Using Polymeric and Hydrogel-Based Hybrid Membranes to Evaluate Gels and Nanostructured Ophthalmic Formulations

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