Evaluation of the Stability of Mercaptopurine Suspension Compounded in a Commercial Vehicle and the Determination of an Appropriate Beyond-use Date

Mercaptopurine is commonly used to treat acute lymphoblastic leukemia and has historically been commercially available only in tablet form. Since tablets may be difficult for children and elderly patients to swallow, many pharmacists have compounded mercaptopurine suspensions. The U.S. Food and Drug...

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Bibliographic Details
Published inInternational journal of pharmaceutical compounding Vol. 20; no. 1; p. 81
Main Authors Peacock, Gina F, Sauvageot, Jurgita, Hill, Ashley, Killian, Alyssa
Format Journal Article
LanguageEnglish
Published United States 01.01.2016
Subjects
Antimetabolites, Antineoplastic - administration & dosage
Antimetabolites, Antineoplastic - chemistry
Chemistry, Pharmaceutical - methods
Chromatography, High Pressure Liquid - methods
Drug Compounding - methods
Drug Packaging
Drug Stability
Drug Storage
Excipients - chemistry
Humans
Mercaptopurine - administration & dosage
Mercaptopurine - chemistry
Suspensions
Tablets
Time Factors
Viscosity
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Summary:Mercaptopurine is commonly used to treat acute lymphoblastic leukemia and has historically been commercially available only in tablet form. Since tablets may be difficult for children and elderly patients to swallow, many pharmacists have compounded mercaptopurine suspensions. The U.S. Food and Drug Administration recently approved a commercial suspension, but it is not widely available at this time. Therefore, pharmacists may still need to compound mercaptopurine suspension for use in areas where it is not available or if the commercial suspension is in short supply. Stability studies must be conducted in order to assign appropriate beyond-use dates for compounded preparations. The objective of this study was to evaluate the stability of extemporaneously compounded suspensions using commercially available mercaptopurine tablets, as well as active pharmaceutical ingredient in a vehicle of Ora-Sweet and Ora-Plus (1:1) stored in plastic and glass containers at room temperature. Each mercaptopurine preparation was analyzed using a validated stability-indicating high-performance liquid chromatography method at the following time points: 0, 7, 14, 21, 30, 60, and 90 days. Suspensions were also observed for changes in appearance or odor, and pH was tested at each time point. The suspension compounded from Roxane generic tablets was extremely viscous and was therefore eliminated from the study. All other suspensions showed no observed physical changes and maintained greater than 93% of initial concentration of mercaptopurine for the entire study period.
ISSN:1092-4221