A review of analytical applications of calorimetry

Ferguson, Hugh; Frurip, D. J.; Pastor, Adrián; Peerey, Linda; Whiting, L. F.

doi:10.1016/s0040-6031(00)00498-6

Cited by 42 publications

(21 citation statements)

References 65 publications

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“…The presence of small amounts of impurities in a substance may decrease the melting point and increase its melting range (Donnelly et al, 1990). In the literature, authors have also used DSC to determine the purity of a given substance (Ferguson et al, 2000;Schnitzler et al, 2001). However, this technique should not be used for this purpose when the analyte decomposes during its fusion (Dooren, Muller, 1984), such as for prednisone (Farmacopeia Brasileira, 2010).…”

Section: Differential Scanning Calorimetry (Dsc)mentioning

confidence: 99%

Prednisone raw material characterization and formulation development

Toehwé¹,

Prado

Rocha

2018

Braz. J. Pharm. Sci.

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Solid dosage forms for oral use, particularly tablets, are the most highly used dosage forms in therapy because they are easily administered, have high productivity and relatively low cost and provide a more stable drug to form a semi-solid net. Numerous parameters influence the quality of the final dosage form. In this study, the dissolution profile of 20-mg prednisone tablets bioequivalent to the reference product and three test formulations were evaluated using stability testing. During the study, prednisone tablets and the active pharmaceutical ingredient (API) prednisone from two different manufacturers were characterized with respect to their physical and physicochemical properties. The results showed that the dissolution profiles of the test batches and the reference product did not retain pharmaceutical equivalence throughout all the stability study. Notably, both samples of API prednisone were of the same crystal form, and any phase transition that occurred during the study could not be attributed to dissolution variation during stability.

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Section: Differential Scanning Calorimetry (Dsc)mentioning

confidence: 99%

Prednisone raw material characterization and formulation development

Toehwé¹,

Prado

Rocha

2018

Braz. J. Pharm. Sci.

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“…Giron, Brittain e Craig e Reading relataram aplicações da análise térmica na área farmacêutica e apresentaram alguns exemplos. 9,12,20,25 …”

Section: Relevânciaunclassified

Análise térmica aplicada a fármacos e formulações farmacêuticas na indústria farmacêutica

Oliveira¹,

Yoshida²,

Gomes³

2011

Quím. Nova

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Recebido em 16/10/10; aceito em 11/2/11; publicado na web em 15/4/11 THERMAL ANALYSIS APPLIED TO DRUGS AND PHARMACEUTICAL FORMULATIONS IN PHARMACEUTICAL INDUSTRY. Several matters of the pharmaceutical demonstrate the great importance of thermal analysis application, especially TG and DSC for the pharmaceutical industry future, namely: characterization of the drugs with the thermal events definition, in studies of drug purity, in the polymorphs identification, in compatibility studies of solid dosage pharmaceutical formulations, in drugs and pharmaceutical formulations thermal stability, and in determination of shelf life for isothermal degradation kinetics by extrapolation using the Arrhenius equation. Thus, the test results obtained from thermal analysis are directly related to the quality of a pharmaceutical product, whether the stability or bioavailability of the pharmaceutical product.Keywords: thermal analysis; pharmaceutical industry; characterization. INTRODUÇÃOVários estudos relacionados à aplicação da termogravimetria (TG) e calorimetria exploratória diferencial (DSC) na caracterização, avaliação de pureza, compatibilidade de formulação farmacêutica, identificação de polimorfismo, estabilidade e decomposição térmica de fármacos e medicamentos encontram-se descritos na literatura. A TG é utilizada para medir a variação de massa em função da temperatura em uma atmosfera controlada sob um programa de aquecimento. Para fins farmacêuticos, seu uso é descrito na caracterização, determinação de pureza e de umidade, identificação de pseudopolimorfismo, na avaliação da estabilidade de fármacos e medicamentos e em estudos de cinética de degradação. A DSC é utilizada para medir a diferença de fluxo de calor entre uma substância e um material de referência em função de um programa de aquecimento ou resfriamento. Na área farmacêutica é utilizada na caracterização térmica e determinação da pureza de fármacos, estudos de compatibilidade entre os constituintes da formulação e identificação de polimorfismo com determinação das entalpias de cada forma cristalina.Recentemente, muitos trabalhos em análise térmica têm sido publicados na área aplicada à indústria farmacêutica. Desta forma, as indústrias brasileiras estão, cada vez mais, demonstrando o interesse neste âmbito. Os artigos publicados demonstram que os dados obtidos por análise térmica estão diretamente relacionados com a qualidade final de um produto farmacêutico, seja quanto à eficácia terapêutica do medicamento ou à estabilidade do mesmo ao longo do prazo de validade. Além disso, muitos órgãos regulamentadores de insumos e produtos farmacêuticos já descrevem a importância da análise térmica e dos parâmetros de qualidade dela provenientes. 1-7 APLICAÇÕESA Farmacopeia Japonesa, JP XIV, foi a primeira a descrever os métodos de análise térmica, mas sem nenhuma exigência em monografias. 6 A TG foi descrita apenas como um método alternativo para o teste de perda por dessecação em matérias-primas e ainda foi citada como suporte para aplicações do tipo estudo de purez...

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“…Reaction calorimetry is a common tool based on heat flows and heat balance measurements. It finds most of its applications in the determination of kinetics parameters, in the evaluation of data for process safety analysis and process optimization3 as well as phase equilibrium and phase transition studies 4. The reaction calorimeter is composed of a 1.3 L high pressure reactor coupled to a Mettler‐Toledo RC1 e thermostat.…”

Section: Introductionmentioning

confidence: 99%

Reaction Calorimetry in Supercritical Carbon Dioxide

Fortini

Lavanchy

Meyer

2004

Macro Materials & Eng

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Summary: Reaction calorimetry is an efficient tool used to obtain kinetic, thermodynamic and safety data. A reaction calorimeter, RC1e‐HP350, developed in collaboration with Mettler‐Toledo GmbH, allows investigating chemical reactions under supercritical conditions. The main technical difference, compared with a classical liquid system, is that the whole reactor volume is occupied by the media. Heat transfer analysis in supercritical carbon dioxide (scCO2) by the Wilson plot method shows that the behavior of the internal heat transfer coefficient in scCO2 is the opposite of the one observed for classical liquid. In scCO2 the lower the temperature (above the critical point) the better the internal heat transfer coefficient. The evolution of scCO2 thermodynamical and transport properties near the critical point are responsible for this behavior. The dispersion polymerization of methyl methacrylate in scCO2, with the polydimethylsiloxane monomethacrylate as stabilizer, is used as a model reaction. A polymerization reaction enthalpy of −56.9 ± 2.2 kJ · mol−1 is determined, being in good agreement with previously reported data. The results presented illustrate the accuracy of the heat balance model used and emphasize the potential of reaction calorimetry for the promotion of supercritical fluids technologies.Technical comparison between liquid and supercritical reaction calorimetry.magnified imageTechnical comparison between liquid and supercritical reaction calorimetry.

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A review of analytical applications of calorimetry

Cited by 42 publications

References 65 publications

Prednisone raw material characterization and formulation development

Prednisone raw material characterization and formulation development

Análise térmica aplicada a fármacos e formulações farmacêuticas na indústria farmacêutica

Reaction Calorimetry in Supercritical Carbon Dioxide

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