Thermal analysis study of amlodipine as pure compound and in binary mixture

Duda-Seiman, Corina; Vlase, Gabriela; Duda-Seiman, Daniel; Albu, Paul; Doca, N.

doi:10.1007/s10973-011-1431-y

Cited by 10 publications

(4 citation statements)

References 14 publications

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“…Since the presence of excipients can affect thermal stability, potential interactions between amlodipine besylate and the excipients were investigated in the 175–220 °C and no such interaction was observed. Hence, neither the decomposition process or the interaction with the excipients affects the thermal stability of amlodipine besylate [ 61 ]. A similar investigation was carried out by Tomasseti et al, in which the thermal stability of acetominophen was investigated [ 62 ].…”

Section: Introductionmentioning

confidence: 99%

Thermal Stability of Amorphous Solid Dispersions

Jelić¹

2021

Molecules

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Amorphous solid dispersion drug delivery systems (ASD DDS) were proved to be efficient for the enhancement of solubility and bioavailability of poorly water-soluble drugs. One of the major keys for successful preparation of ASD is the selection of appropriate excipients, mostly polymers, which have a crucial role in improving drug solubility and its physical stability. Even though, excipients should be chemically inert, there is some evidence that polymers can affect the thermal stability of active pharmaceutical ingredients (API). The thermal stability of a drug is closely related to the shelf-life of pharmaceutical products and therefore it is a matter of high pharmaceutical relevance. An overview of thermal stability of amorphous solids is provided in this paper. Evaluation of thermal stability of amorphous solid dispersion is perceived from the physicochemical perspective, from a kinetic (motions) and thermodynamic (energy) point of view, focusing on activation energy and fragility, as well all other relevant parameters for ASD design, with a glance on computational kinetic analysis of solid-state decomposition.

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Section: Introductionmentioning

confidence: 99%

Thermal Stability of Amorphous Solid Dispersions

Jelić¹

2021

Molecules

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“…The physicochemical characterization of commercial drugs is important for standardization and evaluation of purity, making it suitable for the study of preformulation [12], interactions with excipients [13], decomposition kinetics [14], polymorphism [15], etc. The use of evolved gas analysis (EGA) regarding the products derived from the thermal decomposition of the active ingredients is important because these products may appear as impurities in commercial drugs [16,17] which makes the use of coupled TG-EGA-MIR a valuable tool, and it is currently employed in the study of thermal degradation of different materials [18,19].…”

Section: Plakogiannis and Mccauleymentioning

confidence: 99%

“…The EGA data provided important information about the volatile compounds that evolved during the thermal decomposition of the sulindac. The study of the degradation products of active ingredients is of utmost importance because they may appear as impurities in the active ingredients [16,17]. Figure 1S (see supplementary material) shows the infrared spectra in three dimensions that were collected in nitrogen and air atmospheres with a sample mass of approximately 10 mg and a heating rate of 10°C min -1 .…”

Section: Thermal Studiesmentioning

confidence: 99%

Solid-state thermal and spectroscopic studies of the anti-inflammatory drug sulindac using UV–Vis, MIR, NIR, DSC, simultaneous TG–DSC, and the coupled techniques TG-EGA-MIR and DSC–optical microscopy

Guerra

Gálico

Holanda

et al. 2016

J Therm Anal Calorim

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Simultaneous thermogravimetry-differential scanning calorimetry (TG-DSC), differential scanning calorimetry-optical microscopy (DSC-optical microscopy), online coupled thermogravimetry-infrared spectroscopy evolved gas analyses (TG-EGA-MIR), and spectroscopic techniques were used to study the non-steroidal anti-inflammatory drug sulindac in polymorphic form II. The TG-DSC curves, which were performed with the aid of DSCoptical microscopy, provided information concerning the thermal stability and decomposition profiles of the compound. From the TG-EGA-MIR coupled technique, it was possible to identify formaldehyde as a volatile compound that was released during thermal decomposition. A complete spectroscopic characterization in the ultraviolet, visible, near-and middle-infrared regions was performed in order to understand the spectroscopic properties of sulindac form II.

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“…A typical application is the use of non-isothermal thermogravimetric (TG) runs for estimating the thermal stability and shelf-life of a material (drug) at a specific temperature [12,13]. Moreover, these techniques alerted compatibility problems and indicated the most favorable directions for a successful formulation [14,15]. In the present study, we focused our attention on the thermal stability of the commercial pharmaceutical tablet formulation (Flavamed ® ) (FT), in which ambroxol hydrochloride (AMB) is an active component.…”

Section: Introductionmentioning

confidence: 99%

Thermo-Analytical and Compatibility Study with Mechanistic Explanation of Degradation Kinetics of Ambroxol Hydrochloride Tablets under Non-Isothermal Conditions

et al. 2021

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Ambroxol hydrochloride (AMB), used as a broncho secretolytic and an expectorant drug, is a semi-synthetic derivative of vasicine obtained from the Indian shrub Adhatoda vasica. It is a metabolic product of bromhexine. The paper provides comprehensive and detailed research on ambroxol hydrochloride, gives information on thermal stability, the mechanism of AMB degradation, and data of practical interest for optimization of formulation that contains AMB as an active compound. Investigation on pure AMB and in commercial formulation Flavamed® tablet (FT), which contains AMB as an active compound, was performed systematically using thermal and spectroscopic methods, along with a sophisticated and practical statistical approach. AMB proved to be a heat-stable and humidity-sensitive drug. For its successful formulation, special attention should be addressed to excipients since it was found that polyvinyl pyrrolidone and Mg stearate affect the thermal stability of AMB. At the same time, lactose monohydrate contributes to faster degradation of AMB and change in decomposition mechanism. It was found that the n-th order kinetic model mechanistically best describes the decomposition process of pure AMB and in Flavamed® tablets.

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Thermal analysis study of amlodipine as pure compound and in binary mixture

Cited by 10 publications

References 14 publications

Thermal Stability of Amorphous Solid Dispersions

Thermal Stability of Amorphous Solid Dispersions

Solid-state thermal and spectroscopic studies of the anti-inflammatory drug sulindac using UV–Vis, MIR, NIR, DSC, simultaneous TG–DSC, and the coupled techniques TG-EGA-MIR and DSC–optical microscopy

Thermo-Analytical and Compatibility Study with Mechanistic Explanation of Degradation Kinetics of Ambroxol Hydrochloride Tablets under Non-Isothermal Conditions

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