Stability of Preoperative Cataract Surgery Gel in Polycarbonate Syringes

Bailey, Caroline; Aloumanis, Vasileios; Walker, Brian; Ben, Michel; McGuire, Jason; Vu, Nicole

Abstract

Stability of Preoperative Cataract Surgery Gel in Polycarbonate Syringes

Author(s): Bailey Caroline, Aloumanis Vasileios, Walker Brian, Ben Michel, McGuire Jason, Vu Nicole

Issue: Nov/Dec 2009 - Geriatric Compounding

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Page(s): 564-568

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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

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