Chemical and functional analysis of generic hydroxyurea formulations.
Hydroxyurea has documented laboratory and clinical efficacy for children with sickle cell anemia (SCA), and has potential to become an effective and inexpensive treatment option for patients in countries with limited resources. Concerns exist, however, regarding product quality and manufacturing variability among different international vendors, particularly for generic formulations. To address these concerns, hydroxyurea capsules from 8 different pharmaceutical sources were analyzed using quantitative chemical and functional assays. All samples had measured values within 20% of expected results, with no significant differences observed among vendors. Generic hydroxyurea formulations represent a potent yet inexpensive therapeutic option for children with SCA worldwide.
Department of Hematology, St. Jude Children's Research Hospital, Memphis, Tennessee 38105, USA.
Virginia L
VL
Harrod
Thad
T
Howard
Miguel R
MR
Abboud
Jane
J
Hankins
Clarisse
C
Lobo
Russell E
RE
Ware
D000755:Anemia, Sickle Cell / Q000188:drug therapy; D000986:Antisickling Agents; D016568:Drugs, Generic / Q000032:analysis* / Q000592:standards; D006801:Humans; D006918:Hydroxyurea / Q000032:analysis* / Q000592:standards; D004364:Pharmaceutical Preparations / Q000032:analysis / Q000592:standards; D013057:Spectrum Analysis
D000986:Antisickling Agents; D016568:Drugs, Generic; D004364:Pharmaceutical Preparations; D006918:Hydroxyurea