compounding HOTLINE

Martin A. Erickson III, RPh
Published Online: Sunday, April 1, 2007
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Q. I am a pharmacist in Mexico. A patient is allergic to most oils and wants injectable estradiol. I tried saline, polyethylene glycol 400, benzyl alcohol, and polysorbate 80, but the suspended particles were too large for injection.

A. Estradiol is "...practically insoluble in water; soluble 1 in 28 of alcohol [ethanol], 1 in 435 of chloroform, and 1 in 150 of ether; soluble in acetone, dioxan, and solutions of fixed alkali hydroxides; sparingly soluble in vegetable oils" (Martindale. The Extra Pharmacopoeia. 29th ed. London, England: Pharmaceutical Press; 1989:1407). Estradiol salts follow a similar pattern; they are practically insoluble in water. Here are a few suggestions: If parenteral administration is required, try patch testing the patient for allergy to oils, seeking one yielding no reaction. If you can, switch the patient to either transdermal administration (pluronic lecithin organogel gel vehicle) or oral capsules or troches for buccal or sublingual absorption of the estradiol.

Estradiol 5 mg/mL in oil injection,calculated to make 100 mL

Ingredients:

Estradiol 0.5 g

Benzyl alcohol 5 mL

Sesame oil qs ad 100 mL

Supplies:

Sterile 0.2-μm filter (oil-compatible) or dry heat sterilizer

Procedure:

1. Accurately weigh/measure each ingredient.

2. Add the estradiol to the benzyl alcohol and mix well.

3. Add sufficient sesame oil to the mixture in (1) to bring to total final volume and mix well.

4. Sterilize the solution either by filtration or in dry heat.*

5. Package in sterile, tight, light-resistant containers.

Notes:

This preparation should be compounded only in accordance with USP <795> and <797>. This preparation is for intramuscular injection.

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

*Oil-based solutions cannot be sterilized by autoclaving.


Estradiol cypionate in oil injection 5 mg/mL, calculated to make 100 mL

Ingredients:

Estradiol cypionate 0.5 g

Chlorobutanol anhydrous 0.54 g

Cottonseed NF qs ad 100 mL

Supplies:

Sterile vials

Dry heat sterilizer

Procedure:

1. Accurately weigh/measure each ingredient.

2. Add the estradiol cypionate to the chlorobutanol and mix well.

3. Add sufficient cottonseed oil to the mixture in (1) to bring to total final volume and mix well.

4. Sterilize the solution either by filtration or in dry heat.*

5. Package in sterile containers and label.

Packaging:

Package in sterile, tight, light-resistant containers.

Notes:

This preparation should be compounded only in accordance with USP <795> and <797>. This preparation is for intramuscular injection.

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

*Oil-based solutions cannot be sterilized by autoclaving.

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

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




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