Thermal behavior study and decomposition kinetics of amiodarone hydrochloride under isothermal conditions

Yoshida, María Irene; Gomes, Elionai Cassiana Lima; Soares, Cristina Duarte Vianna; Oliveira, Marcos Antônio de

doi:10.3109/03639045.2010.534099

Cited by 25 publications

(24 citation statements)

References 18 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Any change in the quality of a class II drug caused by stability problems directly influences the bioavailability of the drug (Yoshida et al, 2010(Yoshida et al, , 2011.…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

“…Thus, intrinsic stability and kinetic studies are key components in the discovery of potential drug degradation products, even though these products may not occur under normal medication storage conditions (Yoshida et al, 2010(Yoshida et al, , 2011.…”

Section: Introductionmentioning

confidence: 99%

“…The t 90 is often interpreted as the shelf-life of a drug. This is calculated through an extrapolation of the Arrhenius equation, and the value determines the drug lifetime at 298 K (Cides et al, 2006;Yoshida et al, 2010Yoshida et al, , 2011.The following equations can be used to describe the observed kinetics of degradation in solution:Arrhenius equation (1): (1) where: k = rate constant, Ea = activation energy, A = pre- Chemical degradation kinetics of fibrates: bezafibrate, ciprofibrate and fenofibrate 547 exponential factor, T = temperature in Kelvin, R = gas constant (8.314 J mol -1 K -1 ). The aim of this paper was to develop and optimize an analytical HPLC method for determination of fibrates and possible degradation products, to evaluate the intrinsic stability of these drugs under stress conditions, and to study the kinetics of degradation of these drugs that are so susceptible to chemical reactions.…”

mentioning

confidence: 99%

See 3 more Smart Citations

Chemical degradation kinetics of fibrates: bezafibrate, ciprofibrate and fenofibrate

Oliveira

Silva

Campos

2016

Braz. J. Pharm. Sci.

View full text Add to dashboard Cite

Fibrates are drugs used for the treatment of hypertriglyceridemia and for the prevention of atherosclerosis. Three drugs in the fibrate class, ciprofibrate, fenofibrate and bezafibrate, were chosen for this study because their raw materials are readily available and because scientific publications on these compounds is limited. To evaluate their intrinsic stability, the drugs were exposed to a test condition (temperature, oxidation, UV light exposure, hydrolysis at different pH values and metal ions in solution) and then were subjected to analysis by HPLC. The samples were run on a C18 column, with a flow rate of 1.0 mL min -1 in a mobile phase consisting of methanol: 0.01 % phosphoric acid v/v (80:20), with variable detection wavelengths in the UV spectra. The analysis methodology showed satisfactory performance parameters. The three drugs were very unstable, degrading in each of the conditions evaluated. The test conditions of acid and basic hydrolysis showed the most significant degradation. The results demonstrated that the drugs in this class are unstable. Based on these experimentally determined degradation kinetics, it is easy to understand and emphasize the importance of the lack of liquid dosage forms on the market for fibrates because of their instability.Uniterms: Hypertriglyceridemia/fibrates. Fibrates stability/study. Fibrates degradation products/High Perfomance Liquid Chromatography (HPLC). Fibrates/Degradation kinetics. INTRODUCTIONFibrates are drugs used for the treatment of hypertriglyceridemia and for the prevention of atherosclerosis, and are represented by the following compounds: clorfibrate, ciprofibrate, bezafibrate, fenofibrate and geozila. Fibrates decrease triglyceride levels and increase HDL-C levels, the latter effect is more pronounced in patients with hypertriglyceridemia. The effect on LDL-C levels varies. They may reduce LDL-C levels in patients with low triglycerides, but may paradoxically increase levels for patients with high triglyceride levels. Fibrates also significantly reduce the levels of highly atherogenic remnant lipoproteins, and are more efficient than statins in doing so (Schulz, 2006).Among the fibrates, three drugs were chosen for the execution of this project: ciprofibrate, fenofibrate and bezafibrate (Figure 1). The drugs were chosen based on the availability of raw materials and evidence of few scientific publications regarding the drugs on the subject of research.Some analytical methods have been developed for the analysis of ciprofibrate, fenofibrate and bezafibrate by HPLC/UV (Nascimento et al., 2011;Salama et al., 2011;Jain et al., 2012;Kumbhar et al., 2013;Wei et al., 2008). The vast majority of these analytical methodologies used reverse phase columns, mainly octadecyl silane, with a controlled acidic pH solution for the mobile phase and detection in the ultraviolet range.Few articles have been published on the stability of the chosen fibrates (Salama et al., 2011;Jain et al., 2012;Kumbhar et al., 2013), and none were found that identified degradation pro...

show abstract

“…Any change in the quality of a class II drug caused by stability problems directly influences the bioavailability of the drug (Yoshida et al, 2010(Yoshida et al, , 2011.…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

See 2 more Smart Citations

Chemical degradation kinetics of fibrates: bezafibrate, ciprofibrate and fenofibrate

Oliveira

Silva

Campos

2016

Braz. J. Pharm. Sci.

View full text Add to dashboard Cite

show abstract

“…Kinetic studies were conducted under acid and basic conditions, according to the model adjustments reported in the literature [14]. Given the analytical results, the order of the degradation reactions was established according to the models of zero, first, and second orders, calculated by applying the linear correlation coefficient (r).…”

Section: Methodsmentioning

confidence: 99%

Degradation Kinetics of Atorvastatin under Stress Conditions and Chemical Analysis by HPLC

Oliveira¹,

Yoshida

Belinelo³

et al. 2013

Molecules

View full text Add to dashboard Cite

Atorvastatin is an antilipemic drug belonging to the statins class, whose reference drug is Pfizer’s Lipitor®. It is used to reduce the levels of lipoproteins rich in cholesterol and reduce the risk of coronary artery disease. It is well-known that calcium atorvastatin (ATV), C66H68CaF2N4O10•3H2O, presents polymorphism. The drug in question is commonly sought after by pharmaceutical industries that produce generic drugs, due to the fact that the drug has a high value price, it is consumed globally, and its patent expired in late 2010. Many questions concerning this drug’s pharmaceutical scope demonstrate its importance regarding stability studies and the identification of degradation products of drugs and pharmaceutical formulations. ATV has been found to degrade under acid and basic conditions, including a first order kinetic degradation under acid conditions, as compared to a zero order kinetic degradation under basic conditions, which tends to be less stable when studied within acid mediums. The rate constant (k) for degradation in acid medium was 1.88 × 10−2 s−1 (first order), while for basic medium k = 2.35 × 10−4 mol L−1 s−1 (zero order), demonstrating a lower stability of the drug within acid mediums.

show abstract

Pharmakologische Eigenschaften von Notfallmedikamenten unter Extrembedingungen

Schäfer

Schmidt

Sareban³

et al. 2019

Notfall Rettungsmed

View full text Add to dashboard Cite

Zusammenfassung Notfallmedikamente kommen an nahezu allen Orten dieser Erde zum Einsatz. Damit werden sie unterschiedlichsten Umweltbedingungen (Kälte, Hitze, direkte Sonneneinstrahlung) ausgesetzt. Sämtliche Daten zur Pharmakokinetik, Pharmakodynamik, Medikamentensicherheit und -haltbarkeit werden jedoch unter standardisierten Bedingungen erhoben, die sich von den Anwendungsbedingungen in der Notfallmedizin erheblich unterscheiden können. Durch die Kälte bei Wintereinsätzen im Gebirge können ebenso wie bei Einsätzen in großer Hitze und bei direkter Sonnenexposition chemische Reaktionen entstehen, welche die Eigenschaften der Medikamente bis hin zur kompletten Wirkungslosigkeit verändern können. Zusätzlich können Unterkühlung oder Überhitzung des Patienten zu einer Zentralisation bzw. Vasodilatation führen und damit das pharmakologische Verteilungsvolumen erheblich verändern, woraus Unter- bzw. Überdosierungen resultieren können. Gleichzeitig kann durch einen temperaturbedingt veränderten Metabolismus die Konjugation und Elimination von Medikamenten beeinflusst sein und zu einer unvorhersehbaren Verlängerung der Medikamentenwirkung führen. Trotz der erheblichen klinischen Relevanz dieser Thematik existieren bisher kaum Daten zu den konkreten Effekten extremer Umweltbedingungen auf die pharmakologischen Eigenschaften von Notfallmedikamenten. Diese Übersicht soll dazu dienen, den aktuellen Kenntnisstand der notfallmedizinischen Pharmakotherapie unter Extrembedingungen darzustellen.

show abstract

Thermal behavior study and decomposition kinetics of amiodarone hydrochloride under isothermal conditions

Cited by 25 publications

References 18 publications

Chemical degradation kinetics of fibrates: bezafibrate, ciprofibrate and fenofibrate

Chemical degradation kinetics of fibrates: bezafibrate, ciprofibrate and fenofibrate

Degradation Kinetics of Atorvastatin under Stress Conditions and Chemical Analysis by HPLC

Pharmakologische Eigenschaften von Notfallmedikamenten unter Extrembedingungen

Contact Info

Product

Resources

About