Qualitative and quantitative study of polymorphic forms in drug formulations by near infrared FT-Raman spectroscopy

Qualitative and quantitative study of polymorphic forms in drug formulations by near infrared FT-Raman spectroscopy

Near infrared FT-Raman spectroscopy was applied for the determination of polymorphic forms in a number of commercial drug products containing the polymorphic drug compounds sorbitol, mannitol, famotidine, acemetacin, carbamazepine, meprobamate and phenylbutazone. The crystal forms present in the dru...

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Bibliographic Details
Published in:Journal of molecular structure Vol. 661; pp. 307 - 317
Main Authors: Auer, Martin E., Griesser, Ulrich J., Sawatzki, Juergen
Format: Journal Article
Language:English
Published: Elsevier B.V 16-12-2003
Subjects:
Crystal forms
Drug products
Near infrared Raman spectroscopy
Polymorphism
Pseudopolymorphism
Quantitative analysis
Near infrared Raman spectroscopy
Drug products
Crystal forms
Pseudopolymorphism
Polymorphism
Quantitative analysis
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Summary:Near infrared FT-Raman spectroscopy was applied for the determination of polymorphic forms in a number of commercial drug products containing the polymorphic drug compounds sorbitol, mannitol, famotidine, acemetacin, carbamazepine, meprobamate and phenylbutazone. The crystal forms present in the drug products were identified based on the position, intensity and shape of characteristic bands. Quantitative analysis of a mixture of two crystal forms of mannitol in a drug product was carried out using a partial least-squares method. In drug products containing meprobamate, sorbitol, and carbamazepine, the thermodynamically stable form was found exclusively, whereas metastable polymorphs were found in solid dosage forms of acemetacin, phenylbutazone, famotidine and mannitol. A mixture of two polymorphic forms of mannitol in Lipobay tablets was determined to consist of 30.8±3.8% of the metastable modification I. The simple sample preparation, the occurrence of sharp bands in the spectra as well as the high reproducibility and accuracy qualifies FT-Raman spectroscopy for the identification and quantification of crystal forms in drug products. The method is perfectly suited to meet the regulatory requirements of monitoring crystal forms during processing and storage and often succeeds in detecting the present crystal form in drug products even when the used excipients are not known.
ISSN:0022-2860
1872-8014
DOI:10.1016/j.molstruc.2003.09.002