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Effect of pH on absorption of sufentanil citrate in a portable pump reservoir during storage and administration under simulated epidural conditions
Authors:P. J. Roos   J. H. Glerum   J. W. Meilink  L. Zwang
Affiliation:(1) Department of Pharmacy, Academic Medical Centre, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands;(2) Department of Pharmacy, University Hospital Utrecht, Heidelberglaan 100, 3584 CX Utrecht, the Netherlands;(3) Department of Pharmaceutics, Faculty of Pharmacy, University of Utrecht, Sorbonnelaan 16, 3584 CA Utrecht, the Netherlands;(4) Department of Pharmacy, University Hospital Rotterdam-Dijkzigt, Dr. Molewaterplein 40, 3015 GD Rotterdam, the Netherlands;(5) Department of Clinical Chemistry, University Hospital Rotterdam-Dijkzigt, the Netherlands
Abstract:Sufentanil (5mgrg/ml as citrate) was investigated for its stability when diluted with sodium chloride 0.9%, in 100 ml polyvinyl chloride portable pump reservoirs during administration under simulated epidural conditions at 32°C for 48 h. Sufentanil was absorbed into the polyvinyl chloride, resulting in a reduction of 10.9% of the concentration after 48 h. The absorption of sufentanil (5mgrg/ml as citrate), alone and in combination with bupivacaine hydrochloride (2 mg/ml), was investigated when diluted with sodium chloride 0.9% in combination with a citrate buffer (pH 4.6), in the same reservoirs under similar conditions. There was no loss of sufentanil after 48 h in both experiments. The effect of the pH on the absorption of sufentanil in polyvinyl chloride was investigated at different pH values. After storage for 21 days at 32°C there was 5.1% loss of sufentanil at pH 4 and 80.6% loss at pH 6. The citrate buffer at the optimum pH (4.6) has a low, acceptable buffer capacity for epidural administration.
Keywords:Absorption  Buffer capacity  Epidural administration  Polyvinyl chloride  Stability  Storage  Sufentanil
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