COMPOUNDING HOTLINE

Q I have a patient with encephalopathy and a tracheotomywho is unable to swallow tablets. Do you have a suggestionfor oral suspension of glycopyrrolate 1 mg/5 mL?

A Glycopyrrolate is soluble 1:4.2 in water. It is available as ashelf-stable aqueous injection. The drug is shelf-stable atpH below 6. This information supports the conclusion that anextemporaneously compounded oral solution could be shelf-stable.

Beyond-use dating is a matter for professional judgment,based on guidance in USP 27 <795>, Pharmaceutical Compounding:Nonsterile Preparations. The monograph stipulatesthat, in the absence of applicable stability and beyond-use informationfor a specific drug and preparation, water-containingcompounds from ingredients in solid form may be assigned abeyond-use date not later than 14 days from the date of compoundingwhen stored at cold temperatures.

Here is a suggestion for your compound: Dilute the glycopyrrolatepowder in water, or use the injectable form, and combineit with flavored syrup.

For a nasogastric, gastrostomy, or jejunostomy tube, theaqueous, unflavored form would suffice. Adjust to pH 6 with sodiumhydroxide or hydrochloric acid.

E-mail your compounding questions [email protected]

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