Compounding HOTLINE

Q:Do you have a formula for compounding budesonide inhalation?

A:Budesonide suspension for inhalation (0.25 mg/2 mL and 0.5 mg/2 mL) is available as a commercially prepared, preserved, FDA-approved finished drug product. The compounding pharmacist should review and document factors that will support compounding of a similar formulation for each patient-specific order, request, or prescription. Examples of such factors include patient intolerance to an ingredient in the commercially prepared product, shortages or temporary unavailability, or discontinuance of the product.

Here is a formula:

Budesonide 200 mcg/3 mL Inhalation Solution, calculated to make 100 mL

Ingredients:

Supplies:

Graduated cylinders, 140-mL syringe, 0.2-micron sterile filter, sterile needles, sterile containers for injectable product, with stoppers, beakers, stirring rod, magnetic stirring device (optional)

Procedure:

1. Dissolve the budesonide in the ethyl alcohol.

2. Add the sterile water for injection to volume gradually, while stirring.

3. Add the benzalkonium chloride, and mix well.

4. Filter through a 0.2-micron sterile filter into sterile containers, using aseptic technique.

Notes:

This product must be prepared in compliance with US Pharmacopeia <797> Pharmaceutical Compounding? Sterile Preparations. No claims are made as to the uses, safety, efficacy, or bioavailability of this product.

The formula is for informational purposes only.

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