Effect of Cryogrinding on Chemical Stability of the Sparingly Water-Soluble Drug Furosemide View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2011-12

AUTHORS

Karolina Adrjanowicz, Kamil Kaminski, Katarzyna Grzybowska, Lukasz Hawelek, Marian Paluch, Irena Gruszka, Daniel Zakowiecki, Wieslaw Sawicki, Przemyslaw Lepek, Wojciech Kamysz, Lukasz Guzik

ABSTRACT

PURPOSE: To investigate the effect of cryogrinding on chemical stability of the diuretic agent furosemide and its mixtures with selected excipients. METHODS: Furosemide was ground at liquid nitrogen temperature for 30, 60, 120 and 180 min. Mixtures of furosemide-PVP and furosemide-inulin (1:1) were milled under cryogenic conditions. Materials were analyzed by XRD, UPLC, MS and NMR. RESULTS: Upon increasing the milling time, a significant build-up of an unidentified impurity 1, probably the main degradation product, was noticed. Cogrinding of furosemide with PVP and inulin worsened chemical stabilization of the pharmaceutical. The main degradation product formed upon cryomilling was subsequently identified as 4-chloro-5-sulfamoylanthranilic acid (CSA). Based on some theoretical considerations involving specific milling conditions, the milling intensity and an expected specific milling dose have been calculated. Results indicate that cryogenic grinding is capable to initiate mechanically induced decomposition of furosemide. CONCLUSIONS: Cryogenic grinding can activate and accelerate not only structural changes (solid state amorphization) but also chemical decomposition of pharmaceuticals. A cryogenic milling device should be considered as a chemical reactor, where under favourable conditions chemical reactions could be mechanically initiated. More... »

PAGES

3220-3236

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s11095-011-0496-4

DOI

http://dx.doi.org/10.1007/s11095-011-0496-4

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1047079674

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/21706267


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