Document Detail


Stability of irinotecan-loaded drug eluting beads (DC Bead) used for transarterial chemoembolization.
MedLine Citation:
PMID:  19617306     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: The aim of this study was to determine the loading efficiency, physicochemical stability, and release of irinotecan-loaded DC Beads (bead size 100-300 microm, 300-500 microm) before and after mixing with nonionic contrast medium (Accupaque 300, Imeron 300, Ultravist 300) during a prolonged period of time (28 days) when stored at room temperature or refrigerated. METHODS: DC Beads were loaded with 50 mg irinotecan (Campto) per milliliter beads in a 2 h loading period. Drug loading efficiency and stability were determined by measuring the irinotecan concentration in the excess solution. A free-flowing in vitro elution method for a period of 2 h and phosphate buffered solution (PBS, pH 7.2) as elution medium were used to analyze the integrity of the irinotecan-loaded. Stability of irinotecan-loaded beads after mixing with an equal volume of three different nonionic contrast agents was determined by measuring irinotecan concentrations in the excess solutions. Vials with loaded beads were stored protected from light at room temperature. Mixtures with contrast media were stored protected from light under refrigeration (2-8 degrees C). Samples were taken periodically over a 4 week period (day 0, 1, 3, 7 and 28). A reversed phase HPLC assay with ultraviolet detection was utilized to analyze the concentration and purity of irinotecan. RESULTS: The loading procedure of DC Beads with irinotecan drug solution resulted in a loading percentage of 96% (bead size 100-300 microm) independent of the storage time. No differences in loading levels and no irinotecan degradation products were observed over the period of 28 days, while the test vials were stored light protected at room temperature. Integrity of loaded irinotecan was also given over that same period of time according to the purity and concentration of irinotecan measured after intentional elution with PBS. Mixing of irinotecan-loaded beads (bead size 100-300 microm, 300-500 microm) with nonionic contrast media decreased the irinotecan loading efficiency by approximately 5-10% during a maximum period of 24 h. However, no further elution or degradation was observed during a 4-week period when stored protected from light under refrigeration. CONCLUSIONS: Irinotecan-loaded DC Beads are shown to have adequate physicochemical stability over a period of at least 28 days when stored light protected at room temperature. Due to concerns of microbiological overgrowth refrigeration should always be considered. The preparation of admixtures of irinotecan-loaded beads with contrast medium in centralized cytotoxic preparation units is not recommended, because of rapid elution of 5-10% of irinotecan from the loaded beads. Furthermore, physicians see no advantages of admixtures due to the wide variation of mixing ratios of drug-loaded beads with contrast medium. In addition varying volumes of 0.9% sodium chloride solution are to be admixed during the chemoembolization procedure.
Authors:
Jeanette Kaiser; Judith Thiesen; Irene Kr?mer
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Publication Detail:
Type:  Comparative Study; Journal Article     Date:  2009-07-17
Journal Detail:
Title:  Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners     Volume:  16     ISSN:  1477-092X     ISO Abbreviation:  J Oncol Pharm Pract     Publication Date:  2010 Mar 
Date Detail:
Created Date:  2010-02-23     Completed Date:  2010-05-25     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9511372     Medline TA:  J Oncol Pharm Pract     Country:  England    
Other Details:
Languages:  eng     Pagination:  53-61     Citation Subset:  IM    
Affiliation:
Department of Pharmacy, University Medical Center, Johannes Gutenberg-University, Langenbeckstrasse 1, 55131 Mainz, Germany.
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MeSH Terms
Descriptor/Qualifier:
Antineoplastic Agents, Phytogenic / administration & dosage,  analysis,  chemistry*
Camptothecin / administration & dosage,  analogs & derivatives*,  analysis,  chemistry
Chemoembolization, Therapeutic*
Chromatography, High Pressure Liquid
Contrast Media / chemistry*
Drug Compounding / methods
Drug Delivery Systems*
Drug Stability
Drug Storage
Infusions, Intra-Arterial
Microspheres*
Particle Size
Solubility
Temperature
Time Factors
Chemical
Reg. No./Substance:
0/Antineoplastic Agents, Phytogenic; 0/Contrast Media; 100286-90-6/irinotecan; 7689-03-4/Camptothecin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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