Stability of dolasetron in two oral liquid vehicles.
The stability of dolasetron 10 mg/mL over 90 days when prepared as an oral liquid formulation from commercially available tablets in both strawberry syrup and a sugar-free vehicle was studied. A liquid suspension of dolasetron mesylate 10 mg/mL was prepared from commercially available dolasetron tablets, OraPlus, and Ora-Sweet or strawberry syrup. Six samples of each formulation were prepared and stored in amber plastic bottles. Three samples of each formulation were refrigerated (3-5 degrees C) and three were stored at room temperature (23-25 degrees C). A 1-mL sample was withdrawn from each of the 12 bottles immediately and after 7, 14, 30, 60, and 90 days. After further dilution to an expected concentration of 10 micrograms/mL with sample diluent, the solutions were assayed in duplicate using high-performance liquid chromatography. The samples were also inspected for color and odor changes, and the pH of each sample was determined. The stability-indicating capability of the dolasetron assay was determined by forced degradation of four separate 10-mg/mL samples exposed to direct sunlight for 90 days. There were no detectable changes in color, odor, or taste and no visible microbial growth in any sample. At least 98% of the initial dolasetron concentration remained throughout the 90-day study period for all samples. An extemporaneously compounded oral liquid preparation of dolasetron mesylate 10 mg/mL in a 1:1 mixture of Ora-Plus and strawberry syrup or Ora-Sweet was stable for at least 90 days when stored at 3-5 or 23-25 degrees C.
Johnson
Cary E
CE
College of Pharmacy, University of Michigan, University of Michigan Hospitals and Health Centers, Ann Arbor, MI, USA.
Wagner
Deborah S
DS
Bussard
Wendy E
WE
D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D004356:Drug Storage; D007211:Indoles / Q000008:administration & dosage / Q000737:chemistry*; D019999:Pharmaceutical Solutions; D014677:Pharmaceutical Vehicles / Q000737:chemistry*; D011807:Quinolizines / Q000008:administration & dosage / Q000737:chemistry*; D012034:Refrigeration; D013535:Suspensions; D013607:Tablets
D007211:Indoles; D019999:Pharmaceutical Solutions; D014677:Pharmaceutical Vehicles; D011807:Quinolizines; D013535:Suspensions; D013607:Tablets; C060344:dolasetron