Bromfenac Sodium

Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID), which has anti-inflammatory activity and may block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2.

Topical 0.1% Bromfenac Sodium for Intraoperative Miosis Prevention and Prostaglandin E2 Inhibition in Femtosecond Laser-Assisted Cataract Surgery.[Pubmed:28106471]

J Ocul Pharmacol Ther. 2017 Apr;33(3):193-201.

PURPOSE: The purpose of this study was to evaluate the effect of topical 0.1% Bromfenac Sodium, a nonsteroidal anti-inflammatory drug (NSAID), on intraoperative pupil dilation maintenance and prostaglandin E2 (PGE2) inhibition during femtosecond laser-assisted cataract surgery. METHODS: Sixty patients (30 each in study and control groups) were included in this study. The patients received 0.1% bromfenac ophthalmic solution or control placebo twice a day for 3 days before surgery. Pupil size was measured at the initiation of femtosecond laser pretreatment and phacoemulsification. Aqueous humor was collected at the beginning of routine cataract surgery. PGE2 levels were measured with an enzyme-linked immunoassay. Laser flare photometry was measured preoperatively and at 1 day postoperatively. RESULTS: Compared with untreated patients, the change in pupil size and postoperative day 1 aqueous flare were significantly reduced throughout the operation in the patients treated with 0.1% bromfenac (P < 0.001). Mean PGE2 concentrations were also significantly decreased by treatment with 0.1% bromfenac (P < 0.001). The reduction of the pupil area and postoperative day 1 aqueous flare were significantly correlated with PGE2 levels (P < 0.001). CONCLUSION: NSAID treatment, when administered before femtosecond laser-assisted cataract surgery, was effective in maintaining intraoperative pupil dilation, preventing miosis, and reducing PGE2 levels.

Development and Validation of a New Stability-Indicating RP-UPLC Method for the Quantitative Determination of Bromfenac Sodium and Its Impurities in an Ophthalmic Dosage Form.[Pubmed:27270417]

J Chromatogr Sci. 2016 Jun 6. pii: bmw089.

A new rapid stability-indicating reversed-phase UPLC method was developed and validated for the determination of Bromfenac Sodium and its impurities in Bromfenac ophthalmic solution. During literature search, only a few publications were found about Bromfenac Sodium. There is no official monograph in the pharmacopoeias about Bromfenac Sodium. Chromatographic separation has been achieved on a polar-embedded Waters Acquity BEH Shield RP18 (100 mm x 2.1 mm, 1.7 mum) column under gradient elution by using a binary mixture of potassium dihydrogen phosphate (0.01 M, pH 3.3) and acetonitrile (ACN) at a flow rate of 0.5 mL/min. Chromatogram was monitored at 265 nm using a photodiode array detector (PDA). The drug and its related impurities are eluted within 13 min. Resolution of Bromfenac Sodium and all eight potential impurities have been achieved greater than 4.0 for all pairs of compounds. To prove the stability-indicating power of the method, the drug was subjected to hydrolytic (acid, alkaline and water), oxidative, photolytic and thermal stress, and the major degradation products were identified based on LC-MS analysis. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantification, precision, accuracy and robustness.

[Comparison of the effects of 0.1% bromfenac sodium eye drops and corticosteroids after small incision lenticule extraction].[Pubmed:28162195]

Zhonghua Yan Ke Za Zhi. 2017 Jan 11;53(1):18-22.

Objective: To study the safety, efficacy and tolerability of the usage of 0.1% Bromfenac Sodium eye drops in small incision lenticule extraction (SMILE). Methods: Prospective case control study. Three groups were observed, including 60 patients (60 eyes) undergoing SMILE for myopia. After surgery, 20 patients (20 eyes) were treated with 0.1% Bromfenac Sodium eye drops twice daily for 10 days, 20 patients (20 eyes) were treated with topical compound tobramycin eye drops 4 times daily for 10 days, and 20 patients (20 eyes) were treated with topical compound tobramycin eye drops 4 times daily for 3 days and 0.1% Bromfenac Sodium eye drops twice daily thereafter for 7 days. All of the patients were examined preoperatively and at 1 day, 10 days, 1 month and 3 months postoperatively, including visual acuity, intraocular pressure, topography and adverse reactions. The differences among the 3 groups were analyzed by the single factor analysis of variance. Results: There was no significant difference among the 3 groups in the uncorrected visual acuity at 10 days, 1 month and 3 months postoperatively (F=0.77, 0.30, 0.36. P=0.47, 0.75, 0.69) . The intraocular pressure in the dexamethasone group at 10 days, 1 month and 3 months postoperatively was higher than the other two groups with no significant difference (F=0.56, 0.98, 0.63. P=0.57, 0.38, 0.54) . The surface asymmetry index of patients was 0.33+/-0.10, 0.50+/-0.17 and 0.55+/-0.21 in the Bromfenac Sodium group, 0.33+/-0.08, 0.49+/-0.16 and 0.60+/-0.37 in the dexamethasone-Bromfenac Sodium group, and 0.31+/-0.12, 0.52+/-0.23 and 0.55+/-0.19 in the dexamethasone group; preoperatively and at 1 and 3 months, respectively. There was no significant difference among the 3 groups in the surface asymmetry index at 1 and 3 months postoperatively (F=0.09, 0.21. P=0.91, 0.81) . The surface regularity index of patients was 0.15+/-0.12, 0.34+/-0.18 and 0.40+/-0.18 in the Bromfenac Sodium group, 0.18+/-0.17, 0.33+/-0.26 and 0.33+/-0.26 in the dexamethasone-Bromfenac Sodium group, and 0.30+/-0.25, 0.41+/-0.28 and 0.34+/-0.29 in the dexamethasone group preoperatively and at 1 and 3 months, respectively. There was no significant difference among the 3 groups in the surface regularity index at 1 and 3 months postoperatively (F=0.74, 0.39. P= 0.48, 0.68) . In the Bromfenac Sodium group, one patient complained of binocular visual fatigue at 10 days, and one patient complained of dryness in one eye at 1 and 3 months. Conclusion: Bromfenac Sodium eye drops can be used to replace corticosteroids after SMILE procedure with high safety and good tolerance. Satisfactory recovery of visual acuity, intraocular pressure and ocular surface could be achieved. (Chin J Ophthalmol, 2017, 53: 18-22).

Chondroitin sulfate-chitosan nanoparticles for ocular delivery of bromfenac sodium: Improved permeation, retention, and penetration.[Pubmed:27051629]

Int J Pharm Investig. 2016 Apr-Jun;6(2):96-105.

INTRODUCTION: Superiority of topical instillation of drug into the cul-de-sac for the treatment of various ophthalmic complications can be validated with commercial availability of a large number of conventional formulations even though this mode of instillation still elicits limitations owing to poor ocular bioavailability. To overcome the drawbacks of conventional formulations, a large number of novel carriers have been investigated. In this perspective, a new novel nanocarrier, chondroitin sulfate (ChS)-chitosan (CS)-nanoparticles (NPs) are being evaluated for improved delivery of Bromfenac Sodium. MATERIALS AND METHODS: Formulation was developed and optimized for CS, chondroitin, and initial drug concentration. Optimized formulation was evaluated for various in vitro aspects i.e., particles' size, size distribution, zeta potential, shape and morphology, in vitro release profile, corneal permeation, corneal retention, corneal uptake, and ocular tolerance test. RESULTS: The mean particle size, polydispersity index, zeta potential, and entrapment efficiency of optimized formulation were found to be 245.6 +/- 14.22 nm, 0.187 +/- 0.016, +37.59 +/- 4.05 mV, and 71.72 +/- 4.43%, respectively. Transmission electron microscopic analysis revealed a spherical shape of developed formulation. Further, formulation exhibited biphasic release profile and Korsmeyer-Peppas model was found to be the best fit model. Significantly high transcorneal permeation (1.62-fold) and corneal retention (1.92-fold) of bromfenac was observed through ChS-CS-NPs when compared with marketed eyedrops (P < 0.01). Furthermore, high corneal uptake of CHS-CS-NPs was confirmed by confocal laser scanning microscopy (CLSM). Safety profile of the developed formulation was established by hen's egg test-chorioallantoic membrane test. CONCLUSION: Encouraging outcomes of in vitro and ex vivo studies indicated that CHS-CS-NPs could be a potential substitute for improved ocular delivery.

Bromfenac Sodium is a nonsteroidal anti-inflammatory drug (NSAID), which has anti-inflammatory activity and may block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2.

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