Pharmacy Times

Compounding terbutaline solution

Author:

What is the formula for compounding terbutaline solution for inhalation in unit-dose vials for a nebulizer?
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Terbutaline sulfate is a crystalline powder, white to gray-white in color. One gram is soluble in 4 mL of water, slightly soluble in alcohol (ethanol) and methanol, and practically insoluble in chloroform and ether. The US Pharmacopeia (USP) specifies that the injection have a pH of 3 to 5. It has been reported that the drug is stable in solutions at pH 1 to 7. Storage conditions include protecting it from light at 15?C to 30?C in containers with tight-fitting lids. Discolored solutions of terbutaline sulfate should not be used. Sterile products must be prepared according to USP <1206>, Sterile Drug Products for Home Use.

Terbutaline sulfate, as a direct-acting sympathomimetic agent, has actions and uses similar to those of albuterol. It may be used as an aerosol, dosed at 1 to 2 inhalations of 250 mcg every 4 hours to a maximum of 8 inhalations in 24 hours; it is given on an as-needed basis.

Here is a formulation for Terbutaline 0.1% Inhalation Solution calculated to make 1000 mL.

Ingredients:

  • Terbutaline sulfate 5-mg tablets, 200 tablets Citric acid 1 g Benzalkonium chloride, 50% solution, 1 drop
  • Sterile water for irrigation or sterile normal saline, qs ad 1000 mL

Procedure:
Triturate the terbutaline sulfate tablets to a fine powder, and triturate them with the citric acid. Add the powder mixture and the benzalkonium chloride solution to the sterile irrigation or normal saline solution. Allow it to stand for 24 hours. Filter the solution through a 0.22-micron filter into clean unit-dose containers. Use a Cornwall handheld syringe gun with a 0.2-micron filter to transfer the solution into sterile unit-of-use dispensing containers.

Store the compound in the refrigerator, protect it from light, and observe aseptic technique. No claims are made as to the uses, safety, efficacy, or bioavailability of this product. The formula is for informational purposes only.