Topical Nonsteroidal Anti-Inflammatory Drugs in Uncomplicated Cataract Surgery: Effect of Sodium Naproxen

Russo, P.; Papa, V; Russo, Simona; Bella, A. Dl; Pabst, G; Milazzo, Giovanni; Balestrazzi, Angelo; Anselmetti, G.; Lorenzi, U.; Orsi, R.; Faletti, P.; Bindella, G.; Boccassini, G.; Kropp, B.; Calabria, G.; Campagna, P.; Ciurlo, C.; Caporossi, Aldo; Tasciotti, A.E.; Licignano, R.; Caprioglio, G.; Birattari, F.; Franch, A.; Darondeau, J.; Blanluet, G.; Ouen, Saint; Guerra, R.; Saccarola, P.; Lenz, W.; Schuff, O.; Lùpidi, G.; Coiràn, M.; Checcucci, M.; Burattini, L.; Foligno,; Mastropasqua, L.; Ciancaglini, M.; Ciafrè, M.; Cerulli, A.M.; Moretti, G.; Padovano, S.; Rotondo, S. Giovanni; Neuhann, T.; Okrafka, K.P.; Ratiglia, Roberto; Oldani, A.; Reiss, H.; Rochefort, J.Y.; Coulombe, Bois; Sborgia, Carlo; Lorusso, V.; Palmisano, C.; Moramarco, N.; Spinelli, D.; Curatola, M.R.; Maruccia, A.; Vaona, P.; Faraldi, Francesco; Villani, C.M.; Schiavone, M.; Gisoldi, R. Colabelli

doi:10.1177/112067210501500510

Cited by 5 publications

(4 citation statements)

References 27 publications

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“…Naproxen was also found to afford protection in rabbits against inflammatory response induced by anterior chamber paracentesis (81). In a comparative study, naproxen sodium (0.2%, wt/vol) drops were found to be as effective as diclofenac sodium (0.1%, wt/vol) drops in controlling post operative inflammation after uncomplicated cataract surgery (82). Naproxen (0.1%, wt/vol and 0.2%, wt/vol) eye drops were explored for controlling ocular inflammation in patients having phacoemulsification and intra ocular lens implantation (83).…”

Section: Naproxenmentioning

confidence: 99%

Topical Ocular Delivery of NSAIDs

Ahuja

Dhake²,

Sharma

et al. 2008

AAPS J

189

148

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Abstract. In ocular tissue, arachidonic acid is metabolized by cyclooxygenase to prostaglandins which are the most important lipid derived mediators of inflammation. Presently nonsteroidal anti-inflammatory drugs (NSAIDs) which are cyclooxygenase (COX) inhibitors are being used for the treatment of inflammatory disorders. NSAIDs used in ophthalmology, topically, are salicylic-, indole acetic-, aryl acetic-, aryl propionicand enolic acid derivatives. NSAIDs are weak acids with pKa mostly between 3.5 and 4.5, and are poorly soluble in water. Aqueous ophthalmic solutions of NSAIDs have been made using sodium, potassium, tromethamine and lysine salts or complexing with cyclodextrins/solubilizer. Ocular penetration of NSAID demands an acidic ophthalmic solution where cyclodextrin could prevent precipitation of drug and minimize its ocular irritation potential. The incompatibility of NSAID with benzalkonium chloride is avoided by using polysorbate 80, cyclodextrins or tromethamine. Lysine salts and α-tocopheryl polyethylene glycol succinate disrupt corneal integrity, and their use requires caution. Thus a nonirritating ophthalmic solution of NSAID could be formulated by dissolving an appropriate water-soluble salt, in the presence of cyclodextrin or tromethamine (if needed) in mildly acidified purified water (if stability permits) with or without benzalkonium chloride and polyvinyl alcohol. Amide prodrugs met with mixed success due to incomplete intraocular hydrolysis. Suspension and ocular inserts appear irritating to the inflamed eye. Oil drop may be a suitable option for insoluble drugs and ointment may be used for sustained effect. Recent studies showed that the use of colloidal nanoparticle formulations and the potent COX 2 inhibitor bromfenac may enhance NSAID efficacy in eye preparations.

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Section: Naproxenmentioning

confidence: 99%

Topical Ocular Delivery of NSAIDs

Ahuja

Dhake²,

Sharma

et al. 2008

AAPS J

189

148

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“…Mean postoperative anterior chamber flare and cell scores and postoperative corneal edema and descemet membrane folds were comparable in both groups at all follow-up times [35]. A double-masked trial in 328 patients comparing diclofenac and naproxen 0.2% for post-cataract surgery inflammation control showed no difference in anterior chamber inflammation between the two groups [36]. This trial also demonstrated that NSAIDs can be used without concurrent corticosteroids to treat patients with mild-to-moderate inflammation after uncomplicated cataract surgery.…”

Section: Conjunctival Inflammation ‡mentioning

confidence: 66%

Diclofenac sodium 0.1% ophthalmic solution: update on pharmacodynamics, clinical interest and safety profile

Bodaghi

2008

Expert Review of Ophthalmology

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Diclofenac sodium 0.1% ophthalmic solution has a long, well-proven track record as a potent, efficacious, topical, ocular anti-inflammatory agent, especially in the control of miosis during surgery, postsurgical inflammation of the anterior segment, cystoid macular edema and inflammation owing to noninfectious conjunctivitis such as allergic conjunctivitis. Owing to its analgesic properties, it is also widely used for short-duration treatment in pain associated with photorefractive keratectomy and corneal erosion. Therefore, it has been approved by health authorities for a wide range of indications, depending on each country. It has been shown to be at least as effective as other nonsteroidal anti-inflammatory drugs and corticosteroids. Diclofenac is a well-tolerated product and the few serious corneal adverse events that do occur could be avoided by good prescriptive practice and careful follow-up of patients at-risk. This review summarizes the available data on pharmacokinetics and pharmacodynamics, as well as the efficacy, safety and regulatory aspects related to diclofenac.

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“…Although PAA are excellent pH sensitive polymers but the amount required to form a stiff gel upon instillation in the eye is not easily neutralized by the buffering action of tear fluid or may require higher PAA concentration that may irritate the ocular tissue; therefore, combination PAA with a suitable hydrophilic cellulose viscosity-enhancing polymer allows a reduction in the PAA concentration without comprising the in situ gelling properties [8], and will improve mucoadhesion. Naproxen is a non-steroidal antiinflammatory drug NSAID propionic acid derivative; which inhibits both Cyclooxygenase enzymes COX 1 and COX 2 [9], which function is to promote prostaglandin production; hence, providing both analgesic and anti-inflammatory activities and when naproxen at a concentration of 0.2% [10], is given topically to the eye surface, it is effective in decreasing aqueous levels of proteins and the rate of miosis, and the maintenance of mydriasis during cataract surgery.…”

Section: Introductionmentioning

confidence: 99%

PREPARATION AND IN VITRO EVALUATION OF NAPROXEN AS A pH SENSITIVE OCULAR IN-SITU GEL

DAWOOD,

KASSAB

2019

Int J App Pharm

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Objective: The aim of this study was to prepare and evaluate a pH sensitive ocular in-situ gel of Naproxen, to increase the ocular residence time. Methods: pH sensitive in situ gel formulations were prepared using different concentrations of Carbomer CB [0.5%, 0.6%, 0.7%] in combination with hydroxypropyl methylcellulose HPMC K40 [0.75%, 1%, 1.5%] or HPMC K100 [0.5%, 0.75%, 1%, 1.5%]. The prepared in situ gels were evaluated for appearance, pH, gelling capacity [sol-to-gel transition/in vitro], tonicity, viscosity, in vitro release studies, release kinetic analysis, and the selected formulas were subjected to rheological studies, and the finally selected formula was subjected to drug content, FT-IR studies, and ocular irritancy tests. Results: Increasing the concentration of the carbomer polymer improved the gelling capacity and gelation time, also the higher the viscosity and concentration of the hydrophilic HPMC polymer, the higher the viscosity of the formula, which affected the release, gelation capacity and time. The overall results showed that formula F10 [CB 0.7%, HPMC K100 0.75%] exhibited excellent pH-triggered in-situ gelation time, sustained the release of naproxen for 3 h’ time with a release rate of more than 90%. Conclusion: Ocular in situ gel of naproxen offers a potential dosage form to increase the residence time in the ocular cul de sac, decreasing the drug drainage, and increasing the effectiveness of the drug.

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Topical Nonsteroidal Anti-Inflammatory Drugs in Uncomplicated Cataract Surgery: Effect of Sodium Naproxen

Abstract: NSAIDs can effectively be used without concurrent administration of corticosteroids to control postoperative inflammation after uncomplicated cataract surgery. In addition, naproxen ophthalmic solution may be considered a suitable alternative to the currently available NSAIDs.

Cited by 5 publications

References 27 publications

Topical Ocular Delivery of NSAIDs

Topical Ocular Delivery of NSAIDs

Diclofenac sodium 0.1% ophthalmic solution: update on pharmacodynamics, clinical interest and safety profile

PREPARATION AND IN VITRO EVALUATION OF NAPROXEN AS A pH SENSITIVE OCULAR IN-SITU GEL

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