OCTOBER 01, 2004
Martin A. Erickson, III, RPh

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

A Glycopyrrolate is soluble 1:4.2 in water. It is available as a shelf-stable aqueous injection. The drug is shelf-stable at pH below 6. This information supports the conclusion that an extemporaneously 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 stipulates that, in the absence of applicable stability and beyond-use information for a specific drug and preparation, water-containing compounds from ingredients in solid form may be assigned a beyond-use date not later than 14 days from the date of compounding when stored at cold temperatures.

Here is a suggestion for your compound: Dilute the glycopyrrolate powder in water, or use the injectable form, and combine it with flavored syrup.

For a nasogastric, gastrostomy, or jejunostomy tube, the aqueous, unflavored form would suffice. Adjust to pH 6 with sodium hydroxide or hydrochloric acid.

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