Ocular allergy is one of the most common disorders of the eye surface. The conventional eye drops lack of therapeutic efficacy due to low ocular bioavailability and decreased drug residence time on eye surface. Hence, the present research work aimed to formulate, optimize, and evaluate the in situ gel for ophthalmic drug delivery. The prepared in situ gel formulations were evaluated for clarity, pH, gelling capacity, viscosity, osmolality, in vitro release study, and kinetic evaluation. ex vivo corneal permeation/penetration study using goat and in vivo studies on rabbits were also performed. Fourier‐transformed infrared spectroscopy was also applied to study possible interactions between drug and polymers. The formulations found to be stable, nonirritant, and showed sustained release of the drug for a period of up to 24 hr with no ocular damage. The developed in situ gels loaded with tetrahydrozoline are alternative and promising ocular candidates for the treatment of allergic conjunctivitis.
The aim of the present study was to develop and validate a High-Performance liquid Chromatography (HPlC) method for the determination of voriconazole in drug substances and in situ gel. a mixture of acetonitrile and ultrapure water (50:50) (v/v) was used as mobile phase. The column was a C18 column (150x4.6mm with 5µm particles). The eluent was monitored with uV detection at 256 nm and flow rate was set to 1 ml/ min. The method was validated partially with respect to system suitability, linearity, limits of detection (lOd) and quantitation (lOQ), precision, accuracy, specificity, selectivity and stability. Obtained results showed that the analytical method had good linearity, accuracy, precision, selectivity and stability. analytical method development results indicated that the lOd was 0.022 µg/ml; lOQ was 0.065 µg/ml and assay exhibited a linear range of 1-30 µg/ml.
Objective: This study was aimed to prepare, characterize and evaluate in situ gel formulation for a sustained ocular delivery of voriconazole. Material and Method: In situ gels were prepared with three different hydrophilic co-polymers: Poloxamer 188, 407 and 388. The formulations were characterized in terms of their clarity, pH, viscosity drug content uniformity and mechanical/rheological properties. Moreover, in vitro drug release and stabilitystudies were performed. Result and Discussion: The results showed that the optimized in situ gel formulation had desired in vitro properties and a good stability over the period of 3 months. Texture profile analysis presented that formulations offered suitable adhesive and mechanical properties. P2-V formulation exhibited pseudoplastic flow and typical gel-type mechanical spectra (G′ > G″) at different frequecy values and at different temperatures. Moreover, all formulations showed a sustained drug release for 24 hours. In conclusion, voriconazole loaded in situ gel could be offered as an encouraging strategy as ocular systems for ocular infections treatment.
The purpose of this work was the development of an alternative ocular tetrahydrozoline hydrochloride (THZ) microemulsion for the management of allergic conjunctivitis. Pseudo‐ternary phase diagrams were used to produce the microemulsions. For the formulation of the microemulsions, isopropyl myristate was selected as oil. Furthermore, various surfactants were applied for the determination of their suitability; ME‐1 and ME‐4 were developed using Sorbitan monolaurate 80 and Polysorbate 80, for ME‐2 and ME‐5 Sorbitan monolaurate 80 and macrogolglycerol ricinoleate while for ME‐3 and ME‐6 Sorbitan monolaurate 80 and Polysorbate 20. For ME‐1, ME‐2, and ME‐3 propylene glycol and ethanol, for ME‐4, ME‐5, and ME‐6 ethanol and polyethylene glycol were used as co‐surfactants. Various characterization parameters of microemulsions were evaluated such as droplet size, conductivity, zeta potential, viscosity, and pH. In addition, the drug release, stability, sterility, safety, ex vivo, and in vivo experiments were studied. The characterization showed that the formulations can act as suitable carriers for eye application. In addition, it was revealed that microemulsions were found stable and sterile. The formulations released the drug in a sustained manner. Ex vivo diffusion studies exhibited that the microemulsions can be used for topical delivery to the eye. Assessment of in vitro ocular irritation was conducted by an in vivo prediction model, EpiOcular™ eye irritation test. Based on the in vivo studies, the chosen ideal microemulsion showed longer contact time to the cornea than the commercial product. Moreover, the developed ocular carrier was found to be safe from the viewpoint of in vitro ocular irritancy and mutagenicity. In conclusion, according to characterization results, the THZ microemulsions can act as a hopeful approach for topical eye application.
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