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Received December 25, 2015 Accepted February 12, 2016 EBRANTIL Capsules are a drug product of urapidil, an alpha-1 adrenergic receptor antagonist, in the form of enteric/sustained-release granule filled capsules. This product can be administered as a solution prepared by the simple suspension method (SSM) to patients with gastrostomy through tubes; however, there is no information on the elution behavior of the drug administered by SSM. In this study, one EBRANTIL Capsules 15 mg was put in 20 mL of purified water or Japanese Pharmacopoeia (JP) 1st fluid for the dissolution test (pH 1.2) of 55 and 37°C. The test container was left for 10 minutes, then the content was suspended. The dissolution test was carried out in JP 1st fluid. The elution of urapidil from EBRANTIL Capsules untreated by SSM was 30% or less in 60 minutes. Ninety percent or greater of urapidil eluted in 30 minutes treated with water of 55°C. The elution rate of urapidil treated with water of 37°C was relatively slower than that; however, 60% or greater urapidil eluted in 60 minutes. The elution behavior of urapidil from the capsule treated with JP 1st fluid was almost the same as that of the untreated EBRANTIL Capsules. These data suggest that the granules in the capsules were slightly dissolved in JP 1st fluid, but they dissolved immediately in water of 55 and 37°C. In conclusion, EBRANTIL Capsules should not be administered by SSM to avoid lowering blood pressure when treating patients.

Changes in Elution of Urapidil Sustained Release Capsules Prepared by Simple Suspension Method