NDLI: A novel 6-mercaptopurine oral liquid formulation for pediatric acute lymphoblastic leukemia patients

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Hanff, Lidwien M. Mathot, Ron A. A. Smeets, Oscar Postma, Doerine J. Ramnarain, Satianand Vermes, Andras Pieters, Rob Zwaan, C. Michel
Abstract	OBJECTIVE: Pediatric patients with acute lymphoblastic leukemia (ALL) are treated with oral 6-mercaptopurine (6MP) for nearly 2 years, but no pediatric formulation has been available. In this study, an oral 6MP liquid suitable for pediatric use was developed and tested in the target population. METHOD: A randomized cross-over study was performed in 20 pediatric ALL patients (age 1.9 - 14.6 years), comparing pharmacokinetics and pharmacodynamics of a newly developed 6MP liquid formulation to 6MP capsules, both taken orally for 4 weeks. RESULTS: Based upon trough levels of the principal active metabolite,6-thioguanine nucleotides (6-TGN),a relative bioavailability of the liquid vs. capsules of 1.01 was found (90% CI 0.86 - 1.20), demonstrating bioequivalence. This was supported by the similarly observed 6MP dosages needed for leucocyte depletion, for both formulations (35 mg/day (range 10 - 115 mg)). 75% of the parents/patients (p = 0.005) preferred the oral liquid over the capsules because of the ease of administration. CONCLUSION: We conclude that the novel 6MP liquid is a promising treatment for ALL.
File Format	HTM / HTML
ISSN	09461965
Issue Number	8
Volume Number	52
Journal	Int. Journal of Clinical Pharmacology and Therapeutics
Language	English
Publisher	Dustri-Verlag
Publisher Date	2014-08-01
Publisher Place	Germany
Access Restriction	Subscribed
Subject Keyword	Discipline Pharmacology 6-mercaptopurine Therapeutic Use Antimetabolites, Antineoplastic Guanine Nucleotides Blood Precursor Cell Lymphoblastic Leukemia-lymphoma Drug Therapy Thionucleotides Administration & Dosage Pharmacokinetics Administration, Oral Adolescent Biological Availability Child Child, Preschool Cross-over Studies Female Humans Infant Leukocytes Metabolism Male Therapeutic Equivalency Young Adult Comparative Study Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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