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B. A. Aird, J. D. Dahlstrom, G. A. Baklayan, J. A. Gow; Stability of Vitrase® Solutions After Dilution in Anesthetics. Invest. Ophthalmol. Vis. Sci. 2009;50(13):2907.
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Current United States Pharmacopeia section <797> on compounding sterile preparations allow for storage of refrigerated (2-8°C) admixtures ≤3 days (72 hrs) and room temperature storage ≤1 day (24 hrs). We determined the stability of Vitrase [(hyaluronidase injection) ovine, 200 USP units/mL)] and anesthetic admixtures of lidocaine and bupivacaine prepared and stored in sterile glass vials upon storage at 5°C through 72 hrs.
Control and sample vials were prepared in sterile 10 mL vials using volumetric pipettes, mixed by repeated inversion and swirling of the re-capped vials, and stored in a 5°C stability chamber between the testing time points. At t = 0, 24, 48, and 72 hrs, the control and sample vials were removed from the stability chamber and equilibrated to room temperature prior to sampling. Control and sample vials were returned to the 5°C stability chamber for storage. The initial hyaluronidase activity assay was conducted immediately upon completion of sample dilutions. Theoretical hyaluronidase concentration in the vials was 25 USP U/mL.
Almost every lidocaine and lidocaine/bupivacaine paired controls and samples yielded activity values with ≤ 6% RE. The calculated hyaluronidase activity at t = 0 hr, 24 hrs, 48 hrs, and 72 hrs (USP U/mL) for the Vitrase control was respectively 7.8, 6.8, 6.3, 5.8; Vitrase-lidocaine 8.8, 8.8, 8.7, 8.6; and Vitrase-lidocaine-bupivacaine 8.7, 8.6, 8.5, 8.4. For percentage of remaining hyaluronidase activity relative to t = 0 levels, Vitrase control was respectively 100, 87.2, 80.8, 74.4; Vitrase-lidocaine 100, 100, 98.9, 97.7; and Vitrase-lidocaine-bupivacaine 100, 98.9, 97.7, 86.6.
Hyaluronidase activity loss in the Vitrase controls was by an apparent first-order process while that of the Vitrase-anesthetic admixtures occurred at a much slower rate. Hyaluronidase activity of Vitrase [(hyaluronidase injection) ovine, 200 USP units/mL)] and Vitrase-anesthetic admixtures of lidocaine and bupivacaine preparations were stable through 72 hrs when prepared in glass and maintained at 5°C.
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