About: An improved thermoanalytical approach to quantifying trace levels of polymorphic impurity in drug powders

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About: An improved thermoanalytical approach to quantifying trace levels of polymorphic impurity in drug powders Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	An improved thermoanalytical approach to quantifying trace levels of polymorphic impurity in drug powders
Creator	Chan, John Chow, Albert Hung, Henry Mok, Cedric Shekunov, Boris Tong, Henry
Source	Elsevier; Medline; PMC
abstract	Abstract Accurate quantification of impurities existing as separate crystalline phases at trace levels in drug materials is an important issue in the pharmaceutical industry. In the present study, a thermoanalytical approach previously developed for quantifying trace levels of polymorphic impurity (form II metastable nuclei) in commercial salmeterol xinafoate powders has been successfully applied with slight modifications to ribavirin, an antiviral drug exhibiting roughly similar polymorph-dependent crystallization kinetics in melts to that of salmeterol xinafoate. Essentially, the approach involved modeling of the crystallization kinetics of both tested and reference drug materials in melts using the Avrami-Erofe’ev (AE) rate expression, derivation of a mathematical equation for relating the AE kinetic constant to the composition of reference polymorph mixtures, and the use of this derived equation (in the form of a calibration curve) to calculate the impurity contents of the tested samples from their computed AE constants. For ribavirin, modification of the latter equation by incorporation of an empirical exponent was found necessary to account for the composition-dependent changes in crystallization kinetics of the reference mixtures. Such modification has made possible the determination of polymorphic impurity content of as low as 0.004% (w/w) in ribavirin samples induced by different forms of grinding treatment.
has issue date	2005-05-13(xsd:dateTime)
bibo:doi	10.1016/j.ijpharm.2005.02.024
bibo:pmid	15848004
has license	els-covid
sha1sum (hex)	49e8d40d0a2de07dff651a40943120beb75cfd14
schema:url	https://doi.org/10.1016/j.ijpharm.2005.02.024
resource representing a document's title	An improved thermoanalytical approach to quantifying trace levels of polymorphic impurity in drug powders
has PubMed Central identifier	PMC7125510
has PubMed identifier	15848004
schema:publication	International Journal of Pharmaceutics
resource representing a document's body	covid:49e8d40d0a2de07dff651a40943120beb75cfd14#body_text
is schema:about of	named entity 'developed' named entity 'reference' named entity 'crystallization' named entity 'polymorphic' named entity 'impurity' named entity 'RATE' named entity 'LEVELS' named entity 'SLIGHT' named entity 'TO CALCULATE' named entity 'TESTED' named entity 'POWDERS' named entity 'ISSUE' named entity 'APPLIED' named entity 'QUANTIFICATION' named entity 'MODELING' named entity 'MATHEMATICAL' named entity 'TRACE' named entity 'THEIR' named entity 'DRUG' named entity 'LOW' named entity 'SIMILAR' named entity 'CRYSTALLIZATION' named entity 'SEPARATE' named entity 'LEVELS' named entity 'CONTENTS' named entity 'KINETICS' named entity 'POLYMORPH' named entity 'KINETIC CONSTANT' named entity 'TREATMENT' named entity 'IMPURITY' named entity 'NUCLEI' named entity 'STUDY' named entity 'PHARMACEUTICAL INDUSTRY' named entity 'ANTIVIRAL DRUG' named entity 'MODIFICATION' named entity 'POLYMORPHIC' named entity 'ACCOUNT' named entity 'APPROACH' named entity 'IMPURITY' named entity 'DRUG' named entity 'TRACE' named entity 'FORMS' named entity '004' named entity 'USING' named entity 'APPROACH' named entity 'IMPORTANT' named entity 'RIBAVIRIN' named entity 'CHANGES' named entity 'MIXTURES' named entity 'POWDERS' named entity 'IMPROVED' named entity 'SALMETEROL XINAFOATE' named entity 'SAMPLES' named entity 'COMMERCIAL' named entity 'NECESSARY' named entity 'PREVIOUSLY' named entity 'EXPRESSION' named entity 'EQUATION' named entity 'DIFFERENT' named entity 'EMPIRICAL' named entity 'COMPUTED' named entity 'DETERMINATION' named entity 'CRYSTALLINE' named entity 'DEPENDENT' named entity 'USE OF' named entity 'ACCURATE' named entity 'POSSIBLE' named entity 'REFERENCE' named entity 'FORM' named entity 'DERIVATION' named entity 'GRINDING' named entity 'PHASES' named entity 'INVOLVED' named entity 'EXHIBITING' named entity 'INDUCED' named entity 'MATERIALS'

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