Bupivacaine is often administered by spinal injection prior to total hip arthroplasty. It is also commonly injected into surgical wound sites to reduce pain for up to 20 hours after surgery.

In comparison to other local anesthetics it has a long duration of action. It is also the most toxic to the heart when administered in large doses. This problem has led to the use of other long-acting local anaesthetics:ropivacaine and levobupivacaine. Levobupivacaine is a derivative, specifically an enantiomer, of bupivacaine.

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Hydromorphone Hydrochloride 20-mg/mL and Bupivacaine Hydrochloride 7.5-mg/mL Injection
From International Journal of Pharmaceutical Compounding, 3/1/04

METHOD OF PREPARATION

Note: This preparation should be prepared in a laminar airflow \ hood in a cleanroom or via isolation harrier technology by a validated aseptic compounding pharmacist using strict aseptic technique.

1. Calculate the required quantity of each ingredient for the total amount to be prepared.

2. Accurately weigh and/or measure each ingredient.

3. Dissolve the hydromorphone hydrochloride, bupivacaine hydrochloride and sodium chloride in sufficient sterile water for injection to volume.

4. Filter through an appropriate sterile 0.2-µm filter into a sterile container.

5. Package and label.

Note: Alternatively, 44 mL of 0.9% sodium chloride injection can be used to provide the 393 m.g of sodium, chloride.

PACKAGING

Package in tight, light-resistant containers.1

LABELING

Keep out of reach of children. Use only as directed.

STABILITY

A stability of at least 72 hours has been reported for this combination, when stored under fluorescent lighting and when stored in polyvinyl chloride containers at 24°C.2

USE

Hydromorphone hydrochloride and bupivacaine hydrochloride injection for intrathecal administration is used to treat chronic pain.

QUALITY CONTROL

Quality-control assessment can include weight/volume, physical observation, pH, specific gravity, osmolality, assay, color, clarity, particulate matter, sterility and pyrogenicity.3-4

DISCUSSION

This is a USP high-risk category preparation. This injection is designed for administration intrathecally via an implantable delivery system.

Hydromorphone hydrochloride (C^sub 17^H^sub 19^NO^sub 3^-HCl, MW 321.80) occurs as a fine, white or practically white, odorless, crystalline powder that is affected by light. It is freely soluble in water and sparingly soluble in alcohol. Hydromorphone is a semisynthetic phenanthrene-derivative opiate agonist. It is a strong analgesic that is used to relieve moderate-to-severe pain. It is also useful in the control of persistent, nonproductive cough.1,5

Bupivacaine hydrochloride (C^sub 18^H^sub 28^N2O-HCL.H2O, MW 342.90) occurs as a white, odorless, crystalline powder that melts at about 248°C, with decomposition. It is freely soluble in water and in alcohol. It is a long-acting, local amide-type anesthetic that is frequently used in combination with analgesics in pain-management situations.1

Sodium chloride (NaCl, MW 58.44) is available as a white crystalline powder or as colorless crystals. It has a saline taste and is used in a variety of parenteral and nonparenteral pharmaceutical formulations. The pH of a saturated solution is in the range of 6.7 to 7.3; and it is soluble in water (1 g in 2.8 mL), glycerin (1 g in 10 mL) and 95% ethanol (1 g in 250 mL). A 0.9% w/v aqueous solution is iso-osmotic with serum, and its solutions are stable.6

Sterile water for injection is water for injection that has been sterilized and suitably packaged; it contains no added substances. Water for injection is water purified by distillation or by reverse osmosis (RO) and contains no added substances. Note that water for injection is not prepared by an ion-exchange process. Water is used to describe potable water from a public water supply that is suitable for drinking and is the beginning point of the official waters. It is a clear, colorless, odorless and tasteless liquid. Purified water is water that is obtained by distillation, ion exchange, RO or some other suitable process. Water has a specific gravity of 0.9971 at room temperature, a melting point at 0°C and a boiling point at 100°CL It is miscible with most polar solvents and is chemically stable in all physical states (ice, liquid and steam).7

REFERENCES

1. US Pharmacopeial Convention, Inc. United States Pharmacopeia 26National Formulary 21. Rockville, MD:US Pharmacopeial Convention, lnc.;2003:276, 927-928, 2197-2201, 2551, 2564.

2. Christen C, Johnson CE, Walters JR. Stability of bupivacaine hydrochloride and hydromorphone hydrochloride during simulated epidural coadministration. Am J Health Syst Pharm 1996;53:170-173.

3. Alien LV Jr. Standard operating procedure for particulate testing for sterile products. /JPC 1998;2:78.

4. Alien LVJr. Standard operating procedure: Quality assessment for injectable solutions. /JPC 1999)3:406-407.

5. McEvoy GK. XlWfS Drug Information-2003. Bethesda, MD:American Society of Health-System Pharmacists;2003:2034-2035.

6. Owen SC. Sodium chloride. In: Rowe RC, Sheskey PJ, Weller PJ, eds. Handbook of Pharmaceutical Excipients. 4th ed. Washington, DC:American Pharmaceutical Association;2003:556-559.

7. Ellison A, Nash RA, Wilkin MJ. Water. In: Rowe RC, Sheskey PJ, Weller PJ, eds. Handbook of Pharmaceutical Excipients. 4th ed. Washington, DC:American Pharmaceutical Association;2003:672-676.

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