Oxycodone Hydrochloride 1 mg/mL Oral Liquid

Method of Preparation: Calculate the quantity of each ingredient for the amount to be prepared. Accurately weigh or measure each ingredient. Place the oxycodone hydrochloride (HCl) powder in a mortar. If tablets are used, place them in a mortar and comminute to a fine powder. Add the vehicle in portions while mixing to final volume. Package and label.

Use: Oxycodone HCl is used in the treatment of moderate-to-severe pain.

Packaging: Package in tight, light-resistant containers.¹

Labeling: Shake well before taking. Keep out of the reach of children. Store in a refrigerator. Discard after ____ [time period].

Stability: A beyond-use date of 14 days when stored in a refrigerator may be used for this preparation.¹

Quality Control: Quality-control assessment can include weight/volume, pH, specific gravity, active drug assay, color, clarity, rheologic properties/pourability, physical observation, and physical stability (discoloration, foreign materials, gas formation, mold growth).²

Discussion: Oxycodone Immediate-Release Solution is in short supply. Mallinckrodt and Xanodyne have discontinued their products. Lannett and VistaPharm products are unavailable owing to their Drug Enforcement Administration supply quotas. Other products either are not approved by the FDA or are pending production and marketing. Until then, pharmacists may need to compound this preparation. Numerous vehicles may be used; the beyond-use date is the default date provided in USP General Chapter <795>.

Oxycodone HCl (C₁₈H₂₁NO₄.HCl.3H₂O, MW 405.9) occurs as white to off-white, odorless, crystalline hygroscopic crystals or powder. It melts at about 275°C and is soluble 1 g in 6 mL water and 1 g in 60 mL alcohol. A solution in water is neutral to litmus. Oxycodone HCl is incompatible with alkalis, iodides, and tannic acid.³

Oxycodone HCl Oral Solution USP has a pH between 1.4 and 4.0 and may contain alcohol. It should be preserved in tight, light-resistant containers.

If the bulk powder is used, this preparation will be a solution; if a tablet is used as the drug source, the preparation will be a suspension.

Ora-Sweet syrup vehicle is a flavoring vehicle for oral extemporaneous preparations. It is flavored with a citrus-berry flavor blend and contains glycerin and sorbitol to prevent “cap lock.” It is buffered to a pH of approximately 4.2 and has an osmolality of about 3,240 mOsm/kg. Ora-Sweet contains purified water, sucrose, glycerin, sorbitol (5%), flavoring, sodium phosphate, and citric acid as buffering agents and potassium sorbate and methylparaben as preservatives.⁴

Ora-Sweet SF syrup vehicle, a flavoring vehicle for oral extemporaneous preparations, is a sugar-free, alcohol-free syrup flavored with a citrus-berry flavor blend. It is buffered to a pH of approximately 4.2 and may be used alone or in combination with other vehicles. It will tolerate a dilution to 50% with dissolved actives in water or suspending agents and still retain an acceptable taste. Ora-Sweet SF, which has an osmolality of 2,150 mOsm/kg, contains water, sodium saccharin, xanthan gum, glycerin, sorbitol, citric acid, and sodium citrate as buffers; methylparaben, propylparaben, and potassium sorbate as preservatives; and flavoring agents.⁵

Ora-Blend is a sweetened oral suspending vehicle used to simplify the process involved in the extemporaneous compounding of oral suspensions. It is an aqueous-based, sweetened vehicle consisting of a synergistic blend of suspending agents that have a high degree of colloidal activity. It is buffered to a slightly acidic pH of approximately 4.2 and has a viscosity of approximately 700 cps at 25°C and an osmolality of 2,107 mOsm/kg. Ora-Blend occurs as an opaque, pinkish liquid with a sweet citrus-berry flavor. It contains purified water, sucrose, glycerin, sorbitol, flavoring, microcrystalline cellulose, carboxymethylcellulose sodium, xanthan gum, carrageenan, citric acid, and sodium phosphate as buffers and simethicone as an antifoaming agent; it is preserved with methylparaben and potassium sorbate.⁶

Ora-Blend SF is a flavored oral suspending vehicle used in the extemporaneous compounding of oral suspensions. It is an aqueous-based, sweetened vehicle consisting of a synergistic blend of suspending agents with a high degree of colloidal activity. The suspending agents form a structured, gel-like matrix that suspends particles and allows for little settling. It is buffered to a pH of approximately 4.2 and has a viscosity of approximately 1,000 cps at 25°C and an osmolality of 1,073 mOsm/kg. Ora-Blend SF occurs as an opaque, pinkish liquid with a sweet citrus-berry flavor. It contains purified water, sorbitol, glycerin, flavoring, microcrystalline cellulose, carboxymethylcellulose sodium, xanthan gum, carrageenan, and sodium saccharin; citric acid and sodium citrate as buffers; and simethicone as an antifoaming agent. Ora-Blend SF is preserved with methylparaben, propylparaben, and potassium sorbate.⁷

REFERENCES

1. U.S. Pharmacopeia 34/National Formulary 29. Rockville, MD: US Pharmacopeial Convention, Inc; 2011:330-336,3773-3774.
2. Allen LV Jr. Standard operating procedure for performing physical quality assessment of oral and topical liquids. IJPC. 1999;3:146-147.
3. Reynolds JEF, ed. Martindale: The Extra Pharmacopeia. 28th ed. London, England: Pharmaceutical Press; 1982:1022-1023.
4. Ora-Sweet product information. Minneapolis, MN: Paddock Laboratories, Inc; 2010.
5. Ora-Sweet SF product information. Minneapolis, MN: Paddock Laboratories, Inc; 2010.
6. Ora-Sweet Blend product information. Minneapolis, MN: Paddock Laboratories, Inc; 2010.
7. Ora-Sweet Blend SF product information. Minneapolis, MN: Paddock Laboratories, Inc; 2010.

To comment on this article, contact rdavidson@uspharmacist.com.