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Pediatric Hematology and Oncology Volume 25, 2008 - Issue 5
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Articles

CHEMICAL AND FUNCTIONAL ANALYSIS OF GENERIC HYDROXYUREA FORMULATIONS

Virginia L. Harrod Department of Hematology, St. Jude Children's Research Hospital, Memphis, Tennessee, USA
, MD, PhD,
Thad Howard Department of Hematology, St. Jude Children's Research Hospital, Memphis, Tennessee, USA
, MS,
Miguel R. Abboud Department of Pediatrics, Children's Cancer Center of Lebanon, American University of Beirut Medical Center, Beirut, Lebanon
, MD,
Jane Hankins Department of Hematology, St. Jude Children's Research Hospital, Memphis, Tennessee, USA
, MD, MS,
Clarisse Lobo Hematology Institute of Rio de Janeiro (HEMORIO), Rio de Janeiro, Brazil
, MD &
Russell E. Ware Department of Hematology, St. Jude Children's Research Hospital, Memphis, Tennessee, USA
, MD, PhD
Pages 423-429 | Received 17 Nov 2007, Accepted 25 Mar 2008, Published online: 09 Jul 2009
 
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Abstract

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.

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