Pharmacy Times

COMPOUNDINGHOTLINE

Author: Martin A. Erickson, III, RPh

Q Can you provide a formulation for compounding meloxicam oral suspension?

A Meloxicam oral suspension recently was released as a commercially available product. It should not be extemporaneously compounded unless the manufacturer has discontinued the product, the pharmacist cannot obtain it, or a patient medical need is present (eg, documented allergy, specific base or salt requirements, etc). Officially, the use of a compounded product to replace a commercially manufactured product is "allowed" where the compounding is not in violation of FDA Compliance Policy Guide Sec. 460.200, Pharmacy Compounding.

  1. Calculate the number of tablets needed for the preparation. Calculate the quantity of 1% methylcellulose and syrup or SyrSpend SF product needed for the preparation.
  2. Crush the meloxicam tablets, triturate to a fine powder in a ceramic or Wedgwood mortar with the pestle.
  3. Add a small amount of propylene glycol to the powdered tablets with trituration to wet the powder and make a paste, or use a small amount of SyrSpend SF or SyrSpend SF Cherry to wet and make a smooth paste.
  4. Add a small amount of 1% methylcellulose to the paste, and continue to triturate to make a smooth mixture.
  5. Geometrically add the rest of the 1% methylcellulose with trituration.
  6. Transfer the suspension to a graduated cylinder.
  7. Add aliquots of the syrup or SyrSpend SF or SyrSpend SF Cherry to the mortar, and swirl with the pestle to rinse the remaining suspension into the graduated cylinder.
  8. Use a spatula to transfer all of the remaining material from the mortar and pestle to the graduated cylinder.
  9. Add flavoring to taste, if needed.
  10. Add sufficient syrup to the graduated cylinder to bring to the calculated final volume desired.
  11. Transfer to a tight, light-resistant bottle to dispense.

Label: "Shake Well,""Keep in Refrigerator." Stability: No information found. Use USP Compounding Monograph <795> information: 14 days beyond-use dating, refrigerated.

No claims are made as to the uses, safety, efficacy, or bioavailability of this product. The formula is for informational purposes only.

E-mail your compounding questions to compounding@pharmacytimes.com

Mr. Erickson is director of professional affairs at Gallipot Inc.