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

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.

Keywords:

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Order Reprints Request Corporate Permissions

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

Request Academic Permissions

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.

CHEMICAL AND FUNCTIONAL ANALYSIS OF GENERIC HYDROXYUREA FORMULATIONS

Information for

Open access

Opportunities

Help and information

CHEMICAL AND FUNCTIONAL ANALYSIS OF GENERIC HYDROXYUREA FORMULATIONS

Abstract

Reprints and Corporate Permissions

Academic Permissions

Related research

To cite this article:

Download citation

Information for

Open access

Opportunities

Help and information

Keep up to date

Your download is now in progress and you may close this window

Login or register to access this feature