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Abstract:  The stability of preoperative cataract surgery gel packaged in 1-mL polycarbonate syringes, stored protected from light under controlled temperatures for a period of 60 days, was studied. Preoperative cataract surgery gel is a mixture of cyclopentolate hydrochloride 0.51 mg/mL, phenylephrine hydrochloride 5.1 mg/mL, and tropicamide 0.51 mg/mL in preservative-free lidocaine hydrochloride 2% gel. Stability was defined as the maintenance of initial physical and chemical characteristics during storage under controlled ambient (25°C/60% relative humidity) or refrigerated (2°C to 4°C) conditions. Evaluation parameters were appearance, pH, sterility, endotoxin level, and potency of each active ingredient. The specificity and stability-indicating characteristics of an assay method using high-performance liquid chromatography were validated through forced degradation studies. Samples were tested at predefined time intervals over a period of 60 days. Preoperative cataract surgery gel maintained the appearance of a clea

Related Keywords: Caroline Bailey, MSc, RPh, Vasileios Aloumanis, MSFS, Brian Walker, Michel Ben, MS, Jason McGuire, BS, Nicole Vu, PhD, preoperative cataract surgery gel, cyclopentolate hydrochloride, phenylephrine hydrochloride, tropicamide, lidocaine hydrochloride gel, eye disorders, ocular surgery, ophthalmic preparations, anticholinergic agents, sympathetic agonists, local anesthetics, pupil dilation, mydriatics, sympathomimetics, stability, cycloplegics

Related Categories: OPHTHALMICS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, STERILE PREPARATIONS, DOSAGE FORMS/DRUG CARRIERS, STORAGE

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