title: Stability of lenalidomide suspension after preparation by a simple suspension method for enteral tube administration.
abstract: OBJECTIVE
  A simple suspension method has been developed for tube administration, in which tablets (and capsules) are disintegrated in hot water (55℃) without grinding (or opening) them. In the present study, we evaluated the feasibility of this simple suspension method for the preparation of lenalidomide (Celgene, Summit, New Jersey and USA) suspension by testing the stability of this drug at 55℃ and its adsorbability on the tube.
  
  
  METHODS
  We examined, by high-performance liquid chromatography, the time-dependent changes in the concentration of lenalidomide in suspensions of the drug prepared by the simple suspension method. The high-performance liquid chromatography analyses of lenalidomide were performed on Prominence LC-20AB/SPD-20 A (Shimadzu, Kyoto, Japan) with a ZORBAX SB-C18 RR analytical column (Agilent Technologies, Santa Clara, California, USA; particle size: 2.1 × 100 mm, 3.5 µm) at a flow rate of 0.4 mL/min. A solvent system consisting of 10 mM ammonium acetate (pH 7.0)/acetonitrile was used as the eluent and the eluate was detected by UV at 254 nm.
  
  
  RESULTS
  Lenalidomide was confirmed to remain stable in hot water at 55℃ for 24 h in the prepared suspension by the simple suspension method, and more than 99% of the drug could be recovered from the suspension. In addition, 94.5-98.0% of the drug amount could pass through a percutaneous endoscopic gastrostomy tube. Lenalidomide was scarcely adsorbed on to the percutaneous endoscopic gastrostomy tube made of polyurethane or polyvinyl chloride.
  
  
  CONCLUSIONS
  Lenalidomide was found to be stable even in hot water and was not adsorbed on to the percutaneous endoscopic gastrostomy tube.
authors.affiliation: Division of Pharmacy, National Cancer Center Hospital East, Chiba, Japan toogawa@east.ncc.go.jp.
authors.forename: Tomoko O
authors.initials: TO
authors.lastname: Morita
authors.affiliation: Division of Pharmacy, National Cancer Center Hospital East, Chiba, Japan.
authors.forename: Ayumi
authors.initials: A
authors.lastname: Yamaguchi
authors.affiliation: Division of Functional Imaging, Research Cancer for Innovation Oncology, National Cancer Center Hospital East, Chiba, Japan.
authors.forename: Sadaaki
authors.initials: S
authors.lastname: Kimura
authors.affiliation: Division of Functional Imaging, Research Cancer for Innovation Oncology, National Cancer Center Hospital East, Chiba, Japan.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Fujii
authors.affiliation: Department of Drug Safety Management, Meiji Pharmaceutical University, Tokyo, Japan.
authors.forename: Kazushi
authors.initials: K
authors.lastname: Endo
authors.affiliation: Division of Pharmacy, National Cancer Center Hospital East, Chiba, Japan.
authors.forename: Keishiro
authors.initials: K
authors.lastname: Izumi
authors.affiliation: Division of Pharmacy, National Cancer Center Hospital East, Chiba, Japan.
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Saito
authors.affiliation: Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Hospital and Graduate School of Medicine, Hyogo, Japan.
authors.forename: Hironobu
authors.initials: H
authors.lastname: Minami
mesh_terms: D000327:Adsorption; D020533:Angiogenesis Inhibitors / Q000032:analysis / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid; D003680:Deglutition Disorders / Q000150:complications; D004339:Drug Compounding; D004355:Drug Stability; D005240:Feasibility Studies; D000077269:Lenalidomide; D010316:Particle Size; D012997:Solvents; D013056:Spectrophotometry, Ultraviolet; D013535:Suspensions; D013607:Tablets; D013696:Temperature; D013792:Thalidomide / Q000031:analogs & derivatives* / Q000032:analysis / Q000737:chemistry
chemical_list: D020533:Angiogenesis Inhibitors; D012997:Solvents; D013535:Suspensions; D013607:Tablets; D013792:Thalidomide; D000077269:Lenalidomide
keywords: Lenalidomide; dysphagia; the simple suspension method