OphthalMimic: A new alternative apparatus without animal tissue for the evaluation of topical ophthalmic drug products.
Methods
; 228: 1-11, 2024 Aug.
Article
in En
| MEDLINE
| ID: mdl-38759909
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., 11 (M1), 12 (M2), and 21 (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.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Ophthalmic Solutions
/
Poloxamer
Limits:
Animals
/
Humans
Language:
En
Journal:
Methods
Journal subject:
BIOQUIMICA
Year:
2024
Type:
Article
Affiliation country:
Brazil