Document Detail

Pharmaceutical development, quality control, stability and compatibility of a parenteral lyophilized formulation of the investigational polymer-conjugated platinum antineoplastic agent AP5346.
MedLine Citation:
PMID:  17069422     Owner:  NLM     Status:  MEDLINE    
AP5346 is a low molecular weight polymer-conjugated platinum antineoplastic agent. The lyophilized drug product has completed a phase I clinical trial. In order to guarantee a constant quality of AP5346 pharmaceutical products, quality control and analysis of the drug substance and final product were performed. The identity of AP5346 was confirmed using 1H NMR, 195Pt NMR and IR spectroscopy. Furthermore, the free platinum content, platinum release characteristics, molecular size and size distribution were established. With the selected analytical techniques, AP5346 could be distinguished very well from its polymeric analogues, such as AP5280 and AP5279. Stability experiments revealed that AP5346 final product is stable for 12 months at 5 degrees C, in the dark. For administration to patients, AP5346 final product is reconstituted with 5% w/v dextrose and diluted in infusion containers. To investigate the influence of container materials, the stability of AP5346 after reconstitution and dilution in infusion containers was determined. The infusion containers investigated were composed of glass, polyvinyl chloride (PVC, intraflex) and low density polyethylene (LD-PE, Ecoflac). AP5346 was shown to be stable after reconstitution and dilution with 5% w/v dextrose in these infusion containers for at least 96 h at 2-8 degrees C in the dark and at room temperature with ambient light conditions.
S C Van der Schoot; B Nuijen; P Sood; K B Thurmond; D R Stewart; J R Rice; J H Beijnen
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Die Pharmazie     Volume:  61     ISSN:  0031-7144     ISO Abbreviation:  Pharmazie     Publication Date:  2006 Oct 
Date Detail:
Created Date:  2006-10-30     Completed Date:  2006-12-05     Revised Date:  2007-01-29    
Medline Journal Info:
Nlm Unique ID:  9800766     Medline TA:  Pharmazie     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  835-44     Citation Subset:  IM    
Department of Pharmacy and Pharmacology, Slotervaart Hospital/The Netherlands Cancer Institute, Amsterdam, The Netherlands.
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MeSH Terms
Antineoplastic Agents / administration & dosage,  chemistry*
Calorimetry, Differential Scanning
Chemistry, Pharmaceutical
Chromatography, Gel
Cross-Linking Reagents / chemistry
DNA / chemistry
Drug Compounding
Drug Incompatibility
Freeze Drying
Magnetic Resonance Spectroscopy
Organoplatinum Compounds / administration & dosage,  chemistry*
Pharmaceutical Solutions
Platinum / analysis
Quality Control
Spectrophotometry, Atomic
Spectrophotometry, Infrared
Reg. No./Substance:
0/AP5346; 0/Antineoplastic Agents; 0/Cross-Linking Reagents; 0/Organoplatinum Compounds; 0/Pharmaceutical Solutions; 7440-06-4/Platinum; 9007-49-2/DNA

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

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