Characterization of degradation products of amorphous and polymorphic forms of clopidogrel bisulphate under solid state stress conditions

Raijada, Dhara; Prasad, Bhagwat; Paudel, Amrit; Shah, Ravi P.; Singh, Saranjit

doi:10.1016/j.jpba.2009.05.001

Cited by 41 publications

(43 citation statements)

References 15 publications

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“…No previous reports were found in the literature regarding the degradation behavior of ECD. The main issues addressed in this study were modified according to the procedures outlined by Shah et al Raijada et al, 2010). The overall scheme in this degradation investigation (Fig.…”

Section: Study Of Degradation Products and Degradation Pathways Of Ecmentioning

confidence: 99%

Study of Degradation Products and Degradation Pathways of ECD and Its Drug Product, ECD Kit

Liu¹,

Lin²,

Hsia³

et al. 2011

Wide Spectra of Quality Control

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Section: Study Of Degradation Products and Degradation Pathways Of Ecmentioning

confidence: 99%

Study of Degradation Products and Degradation Pathways of ECD and Its Drug Product, ECD Kit

Liu¹,

Lin²,

Hsia³

et al. 2011

Wide Spectra of Quality Control

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“…Its amorphous form has also been patented (3,4). In our previous study (5), we observed a typical difference in the drug's stability in solution and in the solid state. While only one degradation product was formed in solution, almost eight were detected in the solid state.…”

Section: Introductionmentioning

confidence: 86%

“…The amorphous form was generated in-house by solvent evaporation method by dissolving polymorph II in ethanol (5). HPLC grade acetonitrile was purchased from J.T.…”

Section: Experimental Materialsmentioning

confidence: 99%

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Influence of Microenvironment pH, Humidity, and Temperature on the Stability of Polymorphic and Amorphous Forms of Clopidogrel Bisulfate

2010

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Abstract. The effect of microenvironment pH, humidity, and temperature was evaluated on the stability of polymorphic and amorphous forms of clopidogrel bisulfate, when present alone or in combinations. Oxalic acid and sodium carbonate were used as solid stressors to create acidic and alkaline pH, respectively. The samples without and with stressors were subjected for 3 months to (1) 0% RH, 25% RH, 75% RH, and 85% RH at 40°C and also to (2) 60°C, 80°C, and 100°C at 0% RH. In case of solid samples without stressors, the mixture of polymorphic and amorphous forms showed more degradation than the individual forms above critical relative humidity (85% RH). Similar higher degradation was observed between 75% RH and 85% RH in case of acid-stressed samples. In alkaline microenvironment, all the samples showed identical decomposition attributed to conversion of bisulfate salt to free base. Thermal studies indicated that polymorphic forms of clopidogrel bisulfate and also its glassy amorphous form were highly resistant to temperature, whereas the rubbery state of the drug degraded significantly at temperatures of ≥80°C.

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“…Because clopidogrel bisulphate polymorphs comprise an enantiotropic system, and Form II is the thermodynamically more stable at room temperature [1,9], there is potential for the transformation of Form I into Form II, both in the production stage and during storage [10,11]. This fact requires a suitable analytical technique for the detection and quantification of the stable form within the metastable form.…”

Section: Introductionmentioning

confidence: 99%

X-ray diffraction characterization of different polymorphyc forms of clopidogrel bisulphate in substance and pharmaceutical dosage form

Klisurića¹,

Rakića²,

Cvetinov³

et al. 2013

Journal of Research in Physics

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The present study deals with the application of X-ray powder diffraction (XRPD) analysis as a technique for identification of the forms of clopidogrel bisulphate (CLP) present in both the active pharmaceutical ingredients (API) and tablets, specifically addressing the question of whether API converts to another form after 12 months of storage. The investigation of the possibility of phase transitions occurring over a temperature range spanning from room temperature to the melting point, both in tablets and pure CLP, were also performed. Tablet samples were observed for the changes in their structure using polarizing optical microscopy, which was also used to determine the melting points of tablet samples. The results gained during this work confirm that XRPD is applicable for API and tablets testing. This is particularly important if we take into account that the method can be used during stability studies, i.e. in order to test the quality of tablets during the validity period.

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Characterization of degradation products of amorphous and polymorphic forms of clopidogrel bisulphate under solid state stress conditions

Cited by 41 publications

References 15 publications

Study of Degradation Products and Degradation Pathways of ECD and Its Drug Product, ECD Kit

Study of Degradation Products and Degradation Pathways of ECD and Its Drug Product, ECD Kit

Influence of Microenvironment pH, Humidity, and Temperature on the Stability of Polymorphic and Amorphous Forms of Clopidogrel Bisulfate

X-ray diffraction characterization of different polymorphyc forms of clopidogrel bisulphate in substance and pharmaceutical dosage form

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