METHOD OF PREPARATIONNote: This preparation should be prepared in an aseptic working envi-ronment, using aseptic technique, by a validated aseptic compounding phar-macist.1. Calculate the required quantity of each ingredient for the

total amount to be prepared.2. Accurately weigh/measure each ingredient.3. Dissolve the sodium chloride, edetate disodium, calcium chlo-

ride dihydrate and thimerosal in about 80 mL of sterile water for injection.

4. Add the hyaluronidase and stir until dissolved. 5. Add the sodium phosphate monobasic and stir until dissolved.6. Dropwise, adjust the pH using the sodium hydroxide 1% so-

lution until a pH in the range of 6.4 to 7.4 has been obtained.7. Add sufficient sterile water for injection to volume and mix well.8. Filter through a sterile 0.2-µm filter into a sterile container.9. Package and label.

PACKAGINGPackage in tight, light-resistant containers.

LABELINGFor professional use only. Store in a refrigerator. Do not use if

the solution is discolored or contains a precipitate.

STABILITYThe stabilized formula shown here has been assigned an "expi-

ration date" by the former manufacturer of up to 3 years when re-frigerated. For compounding purposes, a maximum of a six months"beyond use" date would be appropriate when stored in a refrig-erator.1

USEHyaluronidase is used to enhance the effectiveness of a number

of local anesthetic agents, especially in peribulbar anesthesia incataract surgery.2-5

QUALITY CONTROLSterility, pyrogenicity, pH, potency, visual observation.

DISCUSSIONHyaluronidase for injection is no longer commercially available.

It is a protein enzyme of unknown exact chemical structure. It iswidely distributed in nature but is currently derived primarily fromtesticular tissue.

References1. United States Pharmacopeia 25/National Formulary 20. Rockville, MD,

U.S. Pharmacopeial Convention, Inc., 2001, pp 2053-2057.2. Calenda E, Olle P, Muraine M, Brasseur G. Peribulbar anesthesia and sub-

Tenon injection for vitreoretinal surgery: 300 cases. Acta OphthalmolScand 78(2):196-199 (April) 2000.

3. Luchetti M, Magni G, Marraro G. A prospective randomized double-blind-ed controlled study of ropivacaine 0.75% versus bupivacaine 0.5%-mepi-vacaine 2% for peribulbar anesthesia. Reg Anesth Pain Med 25(2); 195-200,Mar-Apr 2000.

4. Corke PJ, Baker J, Cammack R. Comparison of 1% ropivacaine and a mix-ture of 2% lignocaine and 0.5% bupivacaine for peribulbar anaesthesia incataract surgery. Anaesth Intensive Care 27(3):249-252, Jun 1999.

5. Dempsey GA, Barrett PJ, Kirby IJ. Hyaluronidase and peribulbar block. BrJ Anaesth 78(6): 671-674, Jun 1997.

F O R M U L A T I O N S

RxHyaluronidase 15,000 unitsSodium chloride 850 mgEdetate disodium 100 mgCalcium chloride dihydrate 53 mgThimerosal 10 mgSodium phosphate monobasic, anhydrous 170 mgSterile water for injection qs 100 mLSodium hydroxide 1% solution qs to pH 6.4 to 7.4

Hyaluronidase Injection

International Journal of Pharmaceutical Compounding