COMPOUNDINGHOTLINE

Pharmacy Times, Volume 0, 0

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.

  • 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.
  • Crush the meloxicam tablets, triturate to a fine powder in a ceramic or Wedgwood mortar with the pestle.
  • 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.
  • Add a small amount of 1% methylcellulose to the paste, and continue to triturate to make a smooth mixture.
  • Geometrically add the rest of the 1% methylcellulose with trituration.
  • Transfer the suspension to a graduated cylinder.
  • 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.
  • Use a spatula to transfer all of the remaining material from the mortar and pestle to the graduated cylinder.
  • Add flavoring to taste, if needed.
  • Add sufficient syrup to the graduated cylinder to bring to the calculated final volume desired.
  • 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.