Effect of gamma radiation on amlodis and its potential for radiosterilization

Işınlama Dozunun ve Depolama Süresinin Gama ile Işınlanmış Sülfapridinin Sinyal Şiddeti Üzerine Etkisi

“…Considering the Fig.1, the signal intensity of the sample increased significantly depending on increase in irradiation doses. This proves that the increase in amount of radiation absorbed by sample also increases the number of free radicals formed in the sample [12][13]. In the calculations, although the dose of irradiation has reached up to 15 kGy, g spectroscopic splitting factor and ΔH linewidth of the sample were determined to remain approximately same.…”

Electron Paramagnetic Resonance Investigation of Radiation Effect on Certain Types of Drug Powders

“…Despite the increasing dose of radiation, no change was observed in the form of spectra, but signal intensities appeared to increase significantly. The increases in the peak-to-peak distance of the EPR spectra signals reveal that the number of the free radicals increases in the samples after the irradiation [21,22]. When each spectrum was examined separately, a significant change in g and ∆H values was not determined despite the increased dose of radiation.…”

Dissolution, Nucleation, Crystal Growth, Crystal Aggregation, and Particle Breakage of Amlodipine Salts: Modeling Crystallization Kinetics and Thermodynamic Equilibrium, Scale-up, and Optimization

“…Amlodipine (( RS )-3-ethyl 5-methyl 2-[(2-aminoethoxy)­methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate) salts such as besylate, mesylate, or maleate belong to the group of dihydropyridine calcium channel blockers . Amlodipine maleate (AM) is the calcium channel antagonist of the dihydropyridine class and is used for the treatment of hypertension and coronary artery disease. , The radiation sensitivity of this active ingredient in a wide dose range is low, thus exhibiting the potential for radio-sterilization …”

“…Although amlodipine is produced and consumed in large quantities worldwide, the mechanisms of its crystallization and dissolution, pertinent to both its downstream processing and drug release, were not extensively investigated, at least not in a quantitative manner. Most of the research of amlodipine precipitation is closely related to liquid chromatography, that is the development of analytical procedures for its determination in a mixture of components. − On the other hand, the physical and chemical characteristics and solid phase composition of the hydrated and anhydrous crystal forms of amlodipine salts (besylate and saccharinate) have been examined in several studies, for example, by Rollinger and Burger, Banerjee et al, and Koradia et al Additionally, the resolution, chelation, and binding of amlodipine besylate by tartrate, cyclodextrin, and cytochromes and the corresponding influence on the crystal structure were presented by Gotrane et al, Bradea et al, and Shah et al While this binding promotes structural stability, γ radiation and elevated temperature cause its degradation. Considering quite a few studies elucidating the crystal structure and properties, very little is known about the mechanisms of the crystallization and dissolution of amlodipine salts, and some aspects of the processes are presented by Koradia et al, Boetker et al, and Qu et al…”

“…1,2 The radiation sensitivity of this active ingredient in a wide dose range is low, thus exhibiting the potential for radiosterilization. 3 Crystallization, precipitation, dissolution, and related phenomena play an important role both in the production process of amlodipine in the pharmaceutical industry as well as in its end-user application in drug delivery systems. Crystallization and dissolution are mainly governed by several parallel processes, which finally lead to chemical and physical equilibrium.…”