title: Stability of an extemporaneously prepared thalidomide suspension.
abstract: OBJECTIVE
  The short-term physical and chemical stability of an oral suspension of thalidomide 20 mg/mL was studied.
  
  
  METHODS
  An oral suspension of thalidomide 20 mg/mL was prepared by emptying the contents of 12 100-mg thalidomide capsules into a glass mortar; 30 mL of Ora-Plus and 30 mL of Ora-Sweet were mixed and added to the thalidomide powder to make a final volume of 60 mL. Three identical samples of the formulation were prepared and placed in 2-oz amber plastic bottles with child-resistant caps and stored under refrigeration (3-5 °C). A 1-mL sample was withdrawn from each of the three samples with a micropipette immediately after preparation and at 7, 14, 21, 28, and 35 days. After further dilution to an expected concentration of 20 μg/mL with acetonitrile-methanol and then dilution with mobile phase, the samples were assayed in duplicate using stability-indicating high-performance liquid chromatography. Stability was determined by evaluating the percentage of the initial concentration remaining at each time point; stability was defined as the retention of at least 90% of the initial concentration of thalidomide.
  
  
  RESULTS
  At least 92% of the initial thalidomide concentration remained throughout the 35-day study period. There were no detectable changes in color, odor, or pH and no visible microbial growth in any sample.
  
  
  CONCLUSIONS
  An extemporaneously prepared suspension of thalidomide 20 mg/mL in a 1:1 mixture of Ora-Plus and Ora-Sweet was stable for at least 35 days when stored in 2-oz amber plastic bottles under refrigeration.
authors.affiliation: University of Michigan Health System, Ann Arbor, MI 48109, USA. svandeko@med.umich.edu
authors.forename: Shawna
authors.initials: S
authors.lastname: Kraft
authors.forename: Cary E
authors.initials: CE
authors.lastname: Johnson
authors.forename: Ryan P
authors.initials: RP
authors.lastname: Tyler
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D004355:Drug Stability; D004356:Drug Storage / Q000379:methods; D014677:Pharmaceutical Vehicles / Q000737:chemistry; D013535:Suspensions / Q000737:chemistry*; D013549:Sweetening Agents / Q000737:chemistry; D013792:Thalidomide / Q000737:chemistry*
chemical_list: D014677:Pharmaceutical Vehicles; D013535:Suspensions; D013549:Sweetening Agents; D013792:Thalidomide