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Therapeutic delivery · 2026

Soluble ocular insert of brinzolamide and timolol maleate: in-vitro, ex-vivo and in-vivo characterization.

СтатьяНазвание и аннотация: Перевод в очереди
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Prajapati Nikunj, Vaghela Priyal, Thakkar Hetal

Аннотация

AIMS: The present study aimed to formulate and evaluate a novel transparent and soluble ocular insert containing a fixed-dose combination of Brinzolamide (210 µg) and Timolol maleate (105 µg).

MATERIALS AND METHODS: The soluble ocular inserts were formulated using hydroxypropyl methylcellulose (HPMC) and polyvinyl alcohol (PVA) as film-forming polymers. Optimization of the parameters was done using a D-optimal design.

RESULTS AND CONCLUSIONS: The optimized soluble ocular inserts were found to be transparent, homogeneous, flexible and demonstrated acceptable surface pH (7.21 ± 0.12), bioadhesive strength (11.88 ± 0.89 g), and tensile strength (1.016 ± 0.13 MPa). In-vitro studies demonstrated sustained drug release up to 24 h following Higuchi kinetics. Ex-vivo permeation across goat cornea and in-vivo pharmacodynamic studies demonstrated enhanced and prolonged intraocular pressure reduction compared to the marketed suspension. The short-term stability testing indicated that the ocular insert retained the characteristics of %Transmittance, pH, Assay and % drug release. Overall, the results suggest that for better therapeutic efficacy and adherence in glaucoma treatment, the dual-drug loaded ocular insert provides a new, patient-friendly substitute for traditional ophthalmic dosage forms.

ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

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