Instrumental investigations of promestriene: first report regarding the solid-state characterization and compatibility with pharmaceutical excipients

Bengescu, Cosmina; Ledeţi, Adriana; Olariu, Tudor Rareș; Circioban, Denisa; Muntean, Cornelia; Vlase, Gabriela; Vlase, Titus; Tomoroga, Carmen; Dragomirescu, Anca; Dascălu, Daniela; Suta, Lenuta-Maria; Ledeți, Ionuț; Murariu, Marius

doi:10.1007/s10973-023-11942-7

Cited by 2 publications

(1 citation statement)

References 12 publications

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“…Pharmaceutical formulations are obtained by conditioning APIs along excipients, which have a significant impact on the biopharmaceutical profile of the drug molecule [9]. The stability of the drugs can be evaluated using thermoanalytical tools, which lead to crucial information on its stability under thermal stress and decomposition under different conditions (in non-isothermal and/or isothermal conditions), based on irreversible mass loss [10] and phase transitions, including polymorphic shift [11]. Additionally, in the field of pharmaceuticals, thermal analysis can provide essential data on interactions between APIs and excipients [12,13], the formation and stability of supramolecular adducts such as guest-host complexes with cyclodextrins [14][15][16][17], salts and cocrystals [18][19][20][21][22], or even semisolid formulations, such as medicated jellies [23] or gels [24].…”

Section: Introductionmentioning

confidence: 99%

Thermal Stability and Kinetics of Degradation of Moxonidine as Pure Ingredient vs. Pharmaceutical Formulation

Baul,

Ledeţi,

Cîrcioban

et al. 2023

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The stability of active pharmaceutical ingredients (APIs) and the corresponding pharmaceutical formulations are nowadays of great importance in pharmaceutical research and technology. The quality of an API or of finished pharmaceutical products (FPPs) is time dependent under the influence of several parameters, such as light and air exposure, temperature, and humidity. Additionally, the stability profile of an API is influenced by the formulation composition, due to the presence of excipients or by the characteristic of the packaging materials. In this sense, the main objective of this study was to analyze the degradation kinetics of the antihypertensive drug moxonidine as a pure ingredient (MOX) and in two different solid mixtures, one corresponding to a pharmaceutical formulation (MOXTAB) and the other to an enriched pharmaceutical formulation in MOX (MOXMIX). As investigation techniques, FTIR (Fourier transform infrared) spectroscopy and TG/DTG/HF analysis were employed, while the thermoanalytical data were processed according to the ASTM E698 kinetic method and the isoconversional methods of Flynn–Wall–Ozawa (FWO) and Friedman (FR). The kinetic methods revealed that the excipients have a stabilizing effect on MOX (in terms of Ea values), but the decomposition mechanism of the samples is complex, according to the results suggested by the analysis of Ea vs. α values.

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Section: Introductionmentioning

confidence: 99%

Thermal Stability and Kinetics of Degradation of Moxonidine as Pure Ingredient vs. Pharmaceutical Formulation

Baul,

Ledeţi,

Cîrcioban

et al. 2023

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Study of thermally induced interactions between active substances from the sartans class and various excipients

Cernușcă,

Bradu,

Pahomi

et al. 2024

J Therm Anal Calorim

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Sartans, also known as angiotensin receptor blockers, comprise a category of antihypertensive medications designed to inhibit the actions of angiotensin II (Ang II) in the body, ultimately reducing blood pressure levels. This class of compounds is derived from 2-(1-benzyl-1H-imidazol-5-yl)-acetic acid, with its origin characterized by an imidazole core that underwent various substitutions at specific positions within the heterocyclic nucleus. We investigated the behavior of Losartan, Valsartan and Irbesartan and their compatibility with various excipients used in pharmaceutical tablet formulations by FTIR spectroscopic studies, thermal behavior by thermogravimetry and differential scanning calorimetry. The aim of the study was to determine the excipients to be used in pharmaceutical formulations containing drugs from the class of sartans as active ingredients. Our study concludes by recommending precautionary measures in elaborating new solid formulations containing lactose in the case of Losartan.

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Instrumental investigations of promestriene: first report regarding the solid-state characterization and compatibility with pharmaceutical excipients

Cited by 2 publications

References 12 publications

Thermal Stability and Kinetics of Degradation of Moxonidine as Pure Ingredient vs. Pharmaceutical Formulation

Thermal Stability and Kinetics of Degradation of Moxonidine as Pure Ingredient vs. Pharmaceutical Formulation

Study of thermally induced interactions between active substances from the sartans class and various excipients

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