Your Compounding Questions Answered

Question:

Do you have a formulation for hydrocortisone 100 mg suppositories?

Answer:

Hydrocortisone is a white to almost-white bitter-tasting crystalline powder. It is only very slightly soluble in water (~0.28 mg/mL). Its solubility is less than 25 mg/mL at the most in ethanol and 12.7 mg/mL in propylene glycol. In nonsterile suspension, hydrocortisone’s pH is 5.5 to 7.0. The pKa of hydrocortisone when titrated with NaOH is 11.05 at 25°C.

Products and preparations containing hydrocortisone or its salts or esters are stored in tight containers at controlled room temperature and protected from light. Hydrocortisone acetate suppositories are available as the commercial product Anusol-HC, Anucort-HC, and other generic forms. The formulation for this product (which was on the market pre—Durham-Humphrey, and therefore a “grandfathered” product without NDA) is a fatty acid blend. Using professional judgment, pharmacists can compound the formulation or a variation when the commercially manufactured product is unavailable or not available in time.

One formulation employs hydrocortisone free base rather than hydrocortisone acetate. Patient response to compounded preparations is the usual clinical determinant of efficacy.

Suggested Formulation

Hydrocortisone suppositories 100 mg Calculated to make 12 each (2-mL mold)

Ingredients

Hydrocortisone USP 1.200 g

Silica gel (fumed silica USP/NF) 0.120 g

Fatty acid blend 20.520 g

Supplies

Suppository molds, 2 mL

Hot plate (with a stir bar option)

Water bath; thermometer

Beaker

Stirring rod

Ceramic or Wedgwood mortar and pestle

Suggested Method

1. Weigh or measure ingredients accurately.

2. Combine the powders in the mortar and comminute to fine, uniform consistency.

3. Heat the fatty acid blend in the water bath until completely melted and temperature is 55°C to 60°C.

4. Stir the melted fatty acid blend to form a vortex and sprinkle the powders slowly into the vortex until thoroughly dispersed and the mixture is homogeneous.

5. Reduce heat and allow the mixture to cool to 45°C to 50°C.

6. Pour into room temperature molds, allow to cool, remove from molds, package, and dispense. Label: Refrigerate, do not freeze.

Note: Fatty acid blend weighs approximately 1.82 g/2 mL. This formulation is for informational purposes only. No claims are made as to the uses, efficacy, safety, or bioavailability of this preparation.

Mr. Erickson is director of professional affairs and director of professional services at Gallipot, a Fagron company.