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

Auer, Martin; Griesser, Ulrich J.; Sawatzki, J.

doi:10.1016/j.molstruc.2003.09.002

Cited by 84 publications

(85 citation statements)

References 22 publications

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“…Raman vibrational spectroscopy is sensitive to any small bond environmental changes, and thus can be useful in distinguishing most crystal polymorphic forms. A major Raman spectroscopy advantage over IR is that due to the minor contribution of overtone vibrations in Raman spectra, the Raman peaks are sharp, wellresolved bands, compared to IR spectra [24]. Raman is also a quantitative spectroscopy method and has many applications as solid dosage forms quantitative analysis techniques.…”

Section: Discussionmentioning

confidence: 99%

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Quantifying Solid-State Mixtures of Crystalline Indomethacin by Raman Spectroscopy Comparison with Thermal Analysis

Atef

Chauhan

Prasad

et al. 2012

ISRN Chromatography

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This paper investigates Raman spectroscopy as a quick and reliable method to quantify the alpha (α) and gamma (γ) polymorphic forms of indomethacin compared to differential scanning calorimetry (DSC). Binary mixtures with different ratios of α and γ indomethacin were prepared and analyzed by Raman and DSC. The Raman method was found to be more reliable and superior compared to DSC. The partial conversion of the alpha to gamma polymorphic form during the DSC measurement was the major limitation for the use of full DSC as a quantitative method and resulted in difference between the calculated and measured enthalpy of both polymorphic forms.

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Section: Discussionmentioning

confidence: 99%

“…Thus rapid and reliable quantification of polymorphic forms of active drug ingredients (API) is essential during drug manufacturing [8][9][10].…”

Section: Introductionmentioning

confidence: 99%

Quantifying Solid-State Mixtures of Crystalline Indomethacin by Raman Spectroscopy Comparison with Thermal Analysis

Atef

Chauhan

Prasad

et al. 2012

ISRN Chromatography

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“…B. für die quantitative Analyse, Bestimmung der Konzentration aktiver Wirkstoffe, [42] des amorphen Anteils, [43] der quantitativen Bestimmung des Anteils verschiedener Polymorphe und deren Umwandlung in Abhängigkeit von der Zeit genutzt. [44] In Kombination mit Insitu-Röntgenbeugung an einer Synchrotronquelle konnten beispielsweise unterschiedliche Feststofftransformationen unter nicht ambienten Bedingungen mit recht guter zeitlicher Auflösung untersucht werden. [45] Bisher wurde jedoch nur über wenige Untersuchungen mit In-situ-Raman-Spektroskopie an nicht pharmazeutisch relevanten Stoffen berichtet.…”

Section: Röntgenabsorptionsspektroskopie (Xas)unclassified

In‐situ‐Verfolgung der Bildung kristalliner Feststoffe

Pienack

Bensch

2011

Angewandte Chemie

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Die Prozesse, die in den frühen Stadien der Bildung kristalliner Feststoffe ablaufen, sind nur wenig verstanden, sodass eine rationale Synthese neuer Feststoffe weitgehend ausgeschlossen ist. Die Untersuchung der strukturbildenden Prozesse ist eine Herausforderung an analytische und theoretische Methoden, da vor und während einer Nukleation sehr kleine Teilchen oder Aggregate unterschiedlicher chemischer Zusammensetzung und Größe in komplexen und dynamischen Gleichgewichten untersucht werden müssen. Dieser Aufsatz gibt einen Überblick über die Methoden zur In‐situ‐Untersuchung der frühen Kristallisationsstadien von Feststoffen, die helfen können, eine gezieltere Synthese metastabiler Polymorphe, kurzlebiger Intermediate und von Präkursoren mit neuen oder verbesserten Eigenschaften zu erreichen. Beispiele aus aktuellen Forschungsarbeiten sollen die Notwendigkeit und die Potentiale, aber auch die Grenzen der In‐situ‐Verfolgung von Kristallisationsprozessen verdeutlichen.

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“…Mannitol can exist in three different forms: α, β and δ hemihydrate from which the β form is used for the database. [29,30] The crystalline solid state of sorbitol consists of five different polymorphic forms called A, B, , and E sorbitol. [30,31] The polymorphic A-form is the most stable form of sorbitol and is presented in Fig.…”

Section: Polyalcoholsmentioning

confidence: 99%

Reference database of Raman spectra of pharmaceutical excipients

Veij

Vandenabeele

Beer

et al. 2008

J Raman Spectroscopy

200

100

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Raman spectroscopy has evolved into an important fast, direct and nondestructive technique in pharmaceutical analysis. Usually, the focus in this field is mainly on the active ingredients and not on the excipients present in the drugs. A collection of Raman spectra of widely used pharmaceutical excipients is presented in this article, which can serve as a reference for the interpretation of Raman spectra during drug analysis (including classical qualitative and quantitative pharmaceutical analysis, counterfeit tracing and process analytical technology (PAT) applications). The 43 analyzed excipients can be classified into seven categories: mono-and disaccharides (dextrose, lactitol, maltitol, lactose and sucrose), polysaccharides (microcrystalline cellulose, methylcellulose (MC), carboxymethylcellulose (CMC), hydroxypropyl cellulose (HPC), hydroxypropyl methylcellulose (HPMC), wheat starch, maltodextrin, primojel, tragacanth and pectin), polyalcohols (propylene glycol, erythritol, xylitol, mannitol and sorbitol), carboxylic acids and salts (alginic acid, glycine, magnesium stearate, sodium acetate and sodium benzoate), esters (arachis oil, lubritab, dibutyl sebacate, triacetin, Eudragit E100 and Eudragit RL100), inorganic compounds (calcium phosphate, talc, anatase and rutile (TiO 2 ), calcium carbonate, magnesium carbonate, sodium bicarbonate and calcium sulfate) and some unclassified products [gelatin, macrogol 4000 (polyethylene glycol (PEG), polyvinyl pyrrolidone and sodium lauryl sulfate].

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

Cited by 84 publications

References 22 publications

Quantifying Solid-State Mixtures of Crystalline Indomethacin by Raman Spectroscopy Comparison with Thermal Analysis

Quantifying Solid-State Mixtures of Crystalline Indomethacin by Raman Spectroscopy Comparison with Thermal Analysis

In‐situ‐Verfolgung der Bildung kristalliner Feststoffe

Reference database of Raman spectra of pharmaceutical excipients

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