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Note: This preparation should be prepared in a laminar airflow hood in a cleanroom or via isolation barrier technology by a validated aseptic compounding pharmacist using strict aseptic technique. This is a high-risk preparation.

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

3. Dissolve the tramadol hydrochloride and sodium acetate in sufficient sterile water for injection to volume and mix well.

4. Filter through sterile 0.220 -µm filters into sterile single-use vials or syringes.

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PACKAGING

Package in tight, light-resistant containers.1

LABELING

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

STABILITY

If not sterility tested: A beyond-use date of up to 24 hours at room temperature, up to 3 days at refrigerated temperature (2 to 8°C), or up to 45 days if frozen can be used for this preparation.1

Tf sterility tested: A beyond-use date of up to 14 days stored in a refrigerator can be used for this preparation.1

USE

Tramadol injection has been used in the treatment of moderate to moderately severe pain.

QUALITY CONTROL

Quality-control assessment can include weight/volume, physical observation, pH, specific gravity, osmolality, assay, color, clarity, particulate matter, sterility and pyrogenicity.2,3

DISCUSSION

Tramadol is an opioid analgesic with noradrenergic and serotonergic properties that may contribute to its analgesic activity. It is a centrally active analgesic acting apparently by selective activity at the µ-receptor. Tt is used in the treatment of moderate-to-scvere pain. It can be administered orally, reetally, intravenously and intramuscularly.4

Tramadol hydrochloride (C^sub 16^H^sub 25^NO^sub 2^, MW 299.84) occurs as an odorless, white to off-white crystalline powder that is readily soluble in water and ethanol. It has a pKa of 9.41 and has a water: octanol partition coefficient of 1.35 at pH 7.

Sodium acetate (CH^sub 3^CO^sub 2^Na, MW 82.03, anhydrous; CH^sub 3^CO^sub 2^Na3H^sub 2^O, MW 136.08, trihydrate) occurs as colorless, transparent crystals or as a granular, crystalline powder. It is either odorless or may have a faint, acetous odor. The trihydrate will effloresce in warm, dry air and it melts at about 60°C. It is soluble in water (1 g in 0.8 mL) and alcohol (l g in 19 mL). It is often used as a component in a sodium acetatc:acetic acid buffer.

Sterile water for injection is water for injection that has been sterilized and suitably packaged; it contains no added substance. Water for injection is water purified by distillation or by reverse osmosis 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, reverse osmosis 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°C. It is miscible with most polar solvents and is chemically stable in all physical states (ice, liquid and steam).1'6

REFERENCES

1. United States Pharmacopeial Convention, Inc. United States Pharmacopeia 27-NationalFormulary22. Rockville, MD: US Pharmacopeial Convention, Inc.; 2004: 1950,2345-2349.

2. Alien LV Jr. Standard operating procedure for paniculate testing for sterile products. IJPC1998; 2(1): 78.

3. Alien LV Jr. Standard operating procedure: Quality assessment for injectable solutions. IJPC1999; 3(5): 406-407.

4. Sweetman SC, ed. MAHTINDALE: The Complete Drug Reference. 33rd ed. London: The Pharmaceutical Press; 2002: 89-99.

5. Callahan KS. Blood, fluids, electrolytes and hematologie drugs. In: Gennaro AR, ed. Remington: The Science and Practice of Pharmacy. 19th ed. Easton, PA: Mack Publishing Company; 1995:931.

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

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