COMPATIBILITY STUDY PERFORMANCE OF OPHTHALMIC NANOEMULSION FOR REDUCING OCULAR HYPERTENSION

Reshu Gupta*, Tejal G. Soni and B. N. Suhagia

ABSTRACT

The objective of present study was to develop a stable ophthalmic nanoemulsion for reducing ocular hypertension using Brinzolamide (BRZ) 10 mg/mL which is therapeutically equivalent to marketed reference drug product. Pre-formulation study was performed to evaluate the compatibility of product with materials which come in contact with the product during manufacturing. Compatibility study was carried out with metal, silicon tubes, filters and plastic containers. Thermal cycling and Photostability study were also performed to ensure the stability of the product. Brinzolamide ophthalmic nanoemulsion was formulated by dissolving the API in Kollisolv MCT 70 in a S.S vessel under continuous stirring. Stability studies at different conditions were also performed. Compatibility study results indicate that drug product was compatible with the product contact materials. Thermal cycling and photostabilty data indicates that there was no significant degradation in the formulation. As a part of aseptic filtration by sterilizing grade filter validation study was performed to challenge Brevundimonas diminuta at level of ≥ 1 x 107 CFU/cm2. A stable ophthalmic nanoemulsion of Brinzolamide was developed and evaluated for compatibility and stability studies at different conditions were performed and it can be concluded that the product is compatible with product contact materials, thermal and photostable.

Keywords: Brinzolamide, Compatibility Study, Thermal Cycling, Freeze thaw, Stability Study.