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NEUROLOGY

Stability of Extemporaneously Prepared Rufinamide Oral Suspensions

Assistant Professor of Pharmacy Practice, Wegmans School of Pharmacy, St. John Fisher College, Rochester, NY

Yayin Liou, BS

PharmD student, Wegmans School of Pharmacy, St. John Fisher College

Robert Best, BS

chemistry student, St. John Fisher College; now, graduate student, College of Arts and Sciences, University at Buffalo; Buffalo, NY

Fang Zhao, PhD

Associate Professor of Pharmaceutical Sciences, Wegmans School of Pharmacy, St. John Fisher College

Reprints: Dr. Hutchinson, Wegmans School of Pharmacy, St. John Fisher College, 3690 East Avenue, Rochester, NY 14618, fax 585/385-5295, dhutchinson{at}sjfc.edu

BACKGROUND: Rufinamide is an oral antiepileptic drug indicated for adjunctive therapy in treating generalized seizures associated with Lennox-Gastaut syndrome. Currently, rufinamide is available as 200-mg and 400-mg tablets. A liquid dosage form does not exist at the present time. Lack of a suspension formulation may present an administration problem for many children and adults who are unable to swallow tablets. The availability of a liquid dosage form will provide an easy and accurate way to measure and administer the medication.

OBJECTIVE: To determine the stability of both sugar-containing and sugar-free rufinamide suspensions over a 90-day period.

METHODS: A suspension of rufinamide 40 mg/mL was prepared by grinding twelve 400-mg tablets of rufinamide tablets in a glass mortar. Sixty milliliters of Ora-Plus and 60 mL of either Ora-Sweet or Ora-Sweet SF (sugar free) were mixed and added to the powder to make a final volume of 120 mL. Three identical samples of each formulation were prepared and placed in 60-mL amber plastic bottles and were stored at room temperature. A 1-mL sample was withdrawn from each of the 6 bottles with a micropipette immediately after preparation and at 7, 14, 28, 56, and 90 days. After further dilution to an expected concentration of 0.4 mg/mL, the samples were assayed using high-performance liquid chromatography. Stability was defined as the retention of at least 90% of the initial concentration.

RESULTS: At least 90% of the initial rufinamide concentration remained throughout the 90-day study period in both preparations. There were no detectable changes in color, odor, taste, and pH and no visible microbial growth.

CONCLUSIONS: Extemporaneously compounded suspensions of rufinamide 40 mg/mL in a 1:1 mixture of Ora-Plus and Ora-Sweet or Ora-Sweet SF were stable for at least 90 days when stored in 59-mL amber polypropylene plastic bottles at room temperature.

Key Words: pediatrics, rufinamide, stability, suspension

Published Online, February 11, 2010. www.theannals.com, DOI 10.1345/aph.1M647