Granisetron: Developing oral liquid from tablets
(Editor’s note: This is a follow-up to an article that appeared in the September 1997 Drug Utilization Review, p. 140, "Pharmacists assess oral granisetron use.")
Following a successful trial to replace IV granisetron with a tablet dosage to counter emesis for cancer patients on emetogenic chemotherapy, pharmacists at Hartford (CT) Hospital have advanced their antiemetic program. They have completed a stability study on turning the granisetron tablets into an oral liquid aimed at patients who cannot swallow the tablets or are on a nasogastric feeding tube.
The study found that a solution of 0.2 mg of granisetron per mL remained stable for a 14-day period, as detailed in the American Journal of Health-System Pharmacy.1
This follows an eight-month trial that has since become hospital policy: Pharmacists replaced IV granisetron for highly emetogenic chemotherapy patients with a once-daily 2 mg oral tablet. Of those patients, 80.7% had a "complete response," meaning no bouts of ausea or vomiting. Moderately emetogenic patients received a 1 mg dose resulting in a complete response rate of 98.3%, which decreased patient emesis overall. The hospital reported drug cost savings of $27,600 a year under the program.
With tablet dosage firmly in place but with no liquid granisetron currently on the market, Hartford pharmacists came up with the liquid dosage solution by crushing 12 1 mg tablets in 30 mL of distilled water, which was then diluted in cherry flavored syrup for total solution of 60 mL. The solution was divided into bottles stored at 5 and 24 degrees Celsius. Samples were drawn for chromatography analysis after being centrifuged for 10 minutes at 3,000 rpm.
The high performance liquid chromatography (HPLC) used for analysis matched the method already established to evaluate the stability of granisetron hydrochloride in syringes, with the HPLC setup consisting of a pump, autosampler, variable wavelength ultraviolet light detector, cyano column, and integrator.
Along with a standard pH meter, samples were studied for nine of the 14-day stability time frame. Researchers noted no change in the solution’s color, consistency, or pH (which ranged from 2.7 to 2.8 when stored in both 5 and 24 degree Celsius bottles). More importantly, concentration levels remained stable throughout, with a concentration change of 10% or less considered stable at either temperature.
Quercia, supervisor for drug information services at Hartford Hospital, says the liquid solution is being used on both adult and pediatric floors, aimed at patients with nasogastric tubes. "It’s been very successful, very useful," he says of the administering and results to date, stressing that a low number of patients are requiring and receiving the liquid doses.
[For more information, contact Robert A. Quercia, MS, BCNSP, Supervisor, Drug Information Services, Department of Pharmacy Services, Hartford Hospital, 80 Seymour Street, Hartford, CT 06102. Telephone: (860) 545-2003.]
Reference
1. Quercia RA., et. al. "Stability of granisetron hydrochloride in an extemporaneously prepared oral liquid." Am J Health-Syst Pharm 1997; 54:1,404-1,406.
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