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Ann Pharmacother. 2010 Mar;44(3):462-5. doi: 10.1345/aph.1M647. Epub 2010 Feb 11.

Stability of extemporaneously prepared rufinamide oral suspensions.

Author information

1
Wegmans School of Pharmacy, St. John Fisher College, Rochester, NY 14618, USA. dhutchinson@sjfc.edu

Abstract

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 A 1-mL sample was withdrawn from each of the 6 bottles with a micropipette immediately after preparation and at 7, 14, 28, 56, and 90 days.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.

PMID:
20150505
DOI:
10.1345/aph.1M647
[Indexed for MEDLINE]
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