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.
Harrod
Virginia L
VL
Department of Hematology, St. Jude Children's Research Hospital, Memphis, Tennessee 38105, USA.
Howard
Thad
T
Abboud
Miguel R
MR
Hankins
Jane
J
Lobo
Clarisse
C
Ware
Russell E
RE
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