1. OphthalMimic: A new alternative apparatus without animal tissue for the evaluation of topical ophthalmic drug products.
- Author
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Barbalho GN, Falcão MA, Alves Amaral V, Contarato JLA, Barbalho AM, Kaori Diógenes G, Mariana Gomes Silva M, Carvalho de Barros do Vale Rochelle B, Gelfuso GM, Cunha-Filho M, and Gratieri T
- Subjects
- Administration, Ophthalmic, Fluconazole administration & dosage, Printing, Three-Dimensional, Cornea drug effects, Cornea metabolism, Animals, Chitosan chemistry, Animal Testing Alternatives methods, Tears chemistry, Humans, Gelatin chemistry, Poloxamer chemistry, Ophthalmic Solutions chemistry
- Abstract
The necessity of animal-free performance tests for novel ophthalmic formulation screening is challenging. For this, we developed and validated a new device to simulate the dynamics and physical-chemical barriers of the eye for in vitro performance tests of topic ophthalmic formulations. The OphthalMimic is a 3D-printed device with an artificial lacrimal flow, a cul-de-sac area, a support base, and a simulated cornea comprised of a polymeric membrane containing poly-vinyl alcohol 10 % (w/v), gelatin 2.5 % (w/v), and different proportions of mucin and poloxamer, i.e., 1:1 (M1), 1:2 (M2), and 2:1 (M3) w/v, respectively. The support base is designed to move between 0° and 50° to replicate the movement of an eyelid. We challenged the model by testing the residence performance of poloxamer®407 16 % and poloxamer®407 16 % + chitosan 1 % (PLX16CS10) gels containing fluconazole. The test was conducted with a simulated tear flow of 1.0 mL.min
-1 for 5 min. The OphthalMimic successfully distinguished PLX16 and PLX16C10 formulations based on their fluconazole drainage (M1: 65 ± 14 % and 27 ± 10 %; M2: 58 ± 6 % and 38 ± 9 %; M3: 56 ± 5 % and 38 ± 18 %). In conclusion, the OphthalMimic is a promising tool for comparing the animal-free performance of ophthalmic formulations., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)- Published
- 2024
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