Vucković, Ivan M.

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  • Vucković, Ivan M. (5)
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Author's Bibliography

Optimisation of isolation procedure for pyrrolizidine alkaloids from Rindera umbellata Bunge

Mandić, Boris M.; Vlajić, Marina D.; Trifunović, Snežana; Simić, Milena; Vujisić, Ljubodrag V.; Vucković, Ivan M.; Novaković, Miroslav; Nikolić-Mandić, Snežana D.; Tešević, Vele; Vajs, Vlatka; Milosavljević, Slobodan

(Taylor & Francis Ltd, Abingdon, 2015)

TY  - JOUR
AU  - Mandić, Boris M.
AU  - Vlajić, Marina D.
AU  - Trifunović, Snežana
AU  - Simić, Milena
AU  - Vujisić, Ljubodrag V.
AU  - Vucković, Ivan M.
AU  - Novaković, Miroslav
AU  - Nikolić-Mandić, Snežana D.
AU  - Tešević, Vele
AU  - Vajs, Vlatka
AU  - Milosavljević, Slobodan
PY  - 2015
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2412
AB  - Procedure for isolation of pyrrolizidine alkaloids (PAs) from Rindera umbellata Bunge plant species was optimised. Different extraction media (methanol, ethanol and sulphuric acid), concentration and volume of sulphuric acid, pH of PA solution for alkaline extraction, extraction time and techniques (maceration, ultrasonic and overhead rotary mixer assisted extraction) were investigated. The yields of six PAs (7-angeloyl heliotridane, 7-angeloyl heliotridine, lindelofine, 7-angeloyl rinderine, punctanecine and heliosupine) were monitored by GC-MS/FID. The best results for the isolation all of six PAs were obtained when the extraction was performed with 1M sulphuric acid (30mL per 1.00g of dried sample) by overhead rotary mixer during three days. Optimal pH value for alkaline extraction of PAs with CH2Cl2 was 9, and the extraction should be performed with four portions of 30mL of CH2Cl2. This procedure could be also useful for a plant sample preparation for GC and LC analyses of PAs.
PB  - Taylor & Francis Ltd, Abingdon
T2  - Natural Product Research
T1  - Optimisation of isolation procedure for pyrrolizidine alkaloids from Rindera umbellata Bunge
VL  - 29
IS  - 9
SP  - 887
EP  - 890
DO  - 10.1080/14786419.2014.991929
ER  - 
@article{
author = "Mandić, Boris M. and Vlajić, Marina D. and Trifunović, Snežana and Simić, Milena and Vujisić, Ljubodrag V. and Vucković, Ivan M. and Novaković, Miroslav and Nikolić-Mandić, Snežana D. and Tešević, Vele and Vajs, Vlatka and Milosavljević, Slobodan",
year = "2015",
abstract = "Procedure for isolation of pyrrolizidine alkaloids (PAs) from Rindera umbellata Bunge plant species was optimised. Different extraction media (methanol, ethanol and sulphuric acid), concentration and volume of sulphuric acid, pH of PA solution for alkaline extraction, extraction time and techniques (maceration, ultrasonic and overhead rotary mixer assisted extraction) were investigated. The yields of six PAs (7-angeloyl heliotridane, 7-angeloyl heliotridine, lindelofine, 7-angeloyl rinderine, punctanecine and heliosupine) were monitored by GC-MS/FID. The best results for the isolation all of six PAs were obtained when the extraction was performed with 1M sulphuric acid (30mL per 1.00g of dried sample) by overhead rotary mixer during three days. Optimal pH value for alkaline extraction of PAs with CH2Cl2 was 9, and the extraction should be performed with four portions of 30mL of CH2Cl2. This procedure could be also useful for a plant sample preparation for GC and LC analyses of PAs.",
publisher = "Taylor & Francis Ltd, Abingdon",
journal = "Natural Product Research",
title = "Optimisation of isolation procedure for pyrrolizidine alkaloids from Rindera umbellata Bunge",
volume = "29",
number = "9",
pages = "887-890",
doi = "10.1080/14786419.2014.991929"
}
Mandić, B. M., Vlajić, M. D., Trifunović, S., Simić, M., Vujisić, L. V., Vucković, I. M., Novaković, M., Nikolić-Mandić, S. D., Tešević, V., Vajs, V.,& Milosavljević, S.. (2015). Optimisation of isolation procedure for pyrrolizidine alkaloids from Rindera umbellata Bunge. in Natural Product Research
Taylor & Francis Ltd, Abingdon., 29(9), 887-890.
https://doi.org/10.1080/14786419.2014.991929
Mandić BM, Vlajić MD, Trifunović S, Simić M, Vujisić LV, Vucković IM, Novaković M, Nikolić-Mandić SD, Tešević V, Vajs V, Milosavljević S. Optimisation of isolation procedure for pyrrolizidine alkaloids from Rindera umbellata Bunge. in Natural Product Research. 2015;29(9):887-890.
doi:10.1080/14786419.2014.991929 .
Mandić, Boris M., Vlajić, Marina D., Trifunović, Snežana, Simić, Milena, Vujisić, Ljubodrag V., Vucković, Ivan M., Novaković, Miroslav, Nikolić-Mandić, Snežana D., Tešević, Vele, Vajs, Vlatka, Milosavljević, Slobodan, "Optimisation of isolation procedure for pyrrolizidine alkaloids from Rindera umbellata Bunge" in Natural Product Research, 29, no. 9 (2015):887-890,
https://doi.org/10.1080/14786419.2014.991929 . .
16
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16

The stress stability of olanzapine: studies of interactions with excipients in solid state pharmaceutical formulations

Đorđević-Filijović, Nataša; Antonijević, Milan D.; Pavlović, Aleksandar; Vucković, Ivan M.; Nikolić, Katarina; Agbaba, Danica

(Informa Healthcare, London, 2015)

TY  - JOUR
AU  - Đorđević-Filijović, Nataša
AU  - Antonijević, Milan D.
AU  - Pavlović, Aleksandar
AU  - Vucković, Ivan M.
AU  - Nikolić, Katarina
AU  - Agbaba, Danica
PY  - 2015
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2415
AB  - Stress stability testing represents an important part of the drug development process. It is used as an important tool for the identification of degradation products and degradation pathways, as well as for the assessment of changes in physical form of drug molecules. The impact of excipients on the stability of olanzapine confirms that levels of impurities and degradants are limiting parameters and are therefore used for stability evaluation. The major degradation product of olanzapine was identified as 2-methyl-5,10-dihydro-4H-thieno[2,3-b][1,5] benzodiazepine-4-one (III). The structure of III was determined by using LC-MS, IR and NMR. Compatibility and stress stability results demonstrated that tablet formulations of olanzapine are sensitive to temperature and moisture. In samples protected from moisture, the increase in concentration of III was shown to be highly temperature dependent and the degradation followed zero-order kinetics. In addition, studies of olanzapine with excipients and in formulated tablets revealed polymorphic phase changes in some samples, influenced by a combination of stress temperature and humidity conditions. Polymorphic transitions were monitored using x-ray powder diffraction (XRPD) analysis and exhibited no correlation between the phase change (appearance of a new polymorph) and the degradation process.
PB  - Informa Healthcare, London
T2  - Drug Development and Industrial Pharmacy
T1  - The stress stability of olanzapine: studies of interactions with excipients in solid state pharmaceutical formulations
VL  - 41
IS  - 3
SP  - 502
EP  - 514
DO  - 10.3109/03639045.2014.884114
ER  - 
@article{
author = "Đorđević-Filijović, Nataša and Antonijević, Milan D. and Pavlović, Aleksandar and Vucković, Ivan M. and Nikolić, Katarina and Agbaba, Danica",
year = "2015",
abstract = "Stress stability testing represents an important part of the drug development process. It is used as an important tool for the identification of degradation products and degradation pathways, as well as for the assessment of changes in physical form of drug molecules. The impact of excipients on the stability of olanzapine confirms that levels of impurities and degradants are limiting parameters and are therefore used for stability evaluation. The major degradation product of olanzapine was identified as 2-methyl-5,10-dihydro-4H-thieno[2,3-b][1,5] benzodiazepine-4-one (III). The structure of III was determined by using LC-MS, IR and NMR. Compatibility and stress stability results demonstrated that tablet formulations of olanzapine are sensitive to temperature and moisture. In samples protected from moisture, the increase in concentration of III was shown to be highly temperature dependent and the degradation followed zero-order kinetics. In addition, studies of olanzapine with excipients and in formulated tablets revealed polymorphic phase changes in some samples, influenced by a combination of stress temperature and humidity conditions. Polymorphic transitions were monitored using x-ray powder diffraction (XRPD) analysis and exhibited no correlation between the phase change (appearance of a new polymorph) and the degradation process.",
publisher = "Informa Healthcare, London",
journal = "Drug Development and Industrial Pharmacy",
title = "The stress stability of olanzapine: studies of interactions with excipients in solid state pharmaceutical formulations",
volume = "41",
number = "3",
pages = "502-514",
doi = "10.3109/03639045.2014.884114"
}
Đorđević-Filijović, N., Antonijević, M. D., Pavlović, A., Vucković, I. M., Nikolić, K.,& Agbaba, D.. (2015). The stress stability of olanzapine: studies of interactions with excipients in solid state pharmaceutical formulations. in Drug Development and Industrial Pharmacy
Informa Healthcare, London., 41(3), 502-514.
https://doi.org/10.3109/03639045.2014.884114
Đorđević-Filijović N, Antonijević MD, Pavlović A, Vucković IM, Nikolić K, Agbaba D. The stress stability of olanzapine: studies of interactions with excipients in solid state pharmaceutical formulations. in Drug Development and Industrial Pharmacy. 2015;41(3):502-514.
doi:10.3109/03639045.2014.884114 .
Đorđević-Filijović, Nataša, Antonijević, Milan D., Pavlović, Aleksandar, Vucković, Ivan M., Nikolić, Katarina, Agbaba, Danica, "The stress stability of olanzapine: studies of interactions with excipients in solid state pharmaceutical formulations" in Drug Development and Industrial Pharmacy, 41, no. 3 (2015):502-514,
https://doi.org/10.3109/03639045.2014.884114 . .
8
5
7

Pyrrolizidine Alkaloids and Fatty Acids from the Endemic Plant Species Rindera umbellata and the Effect of Lindelofine-N-oxide on Tubulin Polymerization

Mandić, Boris M.; Simić, Milena; Vucković, Ivan M.; Vujisić, Ljubodrag V.; Novaković, Miroslav; Trifunović, Snežana; Nikolić-Mandić, Snežana D.; Tešević, Vele; Vajs, Vlatka; Milosavljević, Slobodan

(MDPI, Basel, 2013)

TY  - JOUR
AU  - Mandić, Boris M.
AU  - Simić, Milena
AU  - Vucković, Ivan M.
AU  - Vujisić, Ljubodrag V.
AU  - Novaković, Miroslav
AU  - Trifunović, Snežana
AU  - Nikolić-Mandić, Snežana D.
AU  - Tešević, Vele
AU  - Vajs, Vlatka
AU  - Milosavljević, Slobodan
PY  - 2013
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1894
AB  - The examination of the aerial parts, roots, and seeds of the endemic plant Rindera umbellata is reported in this paper for the first time. Phytochemical investigation of R. umbellata led to the isolation and characterization of ten pyrrolizidine alkaloids and eleven fatty acids in the form of triglycerides. Pyrrolizidine alkaloids 1-9 were found in the aerial parts, 7 and 8 in the roots, and 6-10, together with eleven fatty acids, in the seeds of this plant species. The structures of compounds 1-10 were established based on spectroscopic studies (H-1- and C-13-NMR, 2D NMR, IR and CI-MS). After trans-esterification, methyl esters of the fatty acids were analyzed using GC-MS. The effect of lindelofine-N-oxide (7) on tubulin polymerization was determined.
PB  - MDPI, Basel
T2  - Molecules
T1  - Pyrrolizidine Alkaloids and Fatty Acids from the Endemic Plant Species Rindera umbellata and the Effect of Lindelofine-N-oxide on Tubulin Polymerization
VL  - 18
IS  - 9
SP  - 10694
EP  - 10706
DO  - 10.3390/molecules180910694
ER  - 
@article{
author = "Mandić, Boris M. and Simić, Milena and Vucković, Ivan M. and Vujisić, Ljubodrag V. and Novaković, Miroslav and Trifunović, Snežana and Nikolić-Mandić, Snežana D. and Tešević, Vele and Vajs, Vlatka and Milosavljević, Slobodan",
year = "2013",
abstract = "The examination of the aerial parts, roots, and seeds of the endemic plant Rindera umbellata is reported in this paper for the first time. Phytochemical investigation of R. umbellata led to the isolation and characterization of ten pyrrolizidine alkaloids and eleven fatty acids in the form of triglycerides. Pyrrolizidine alkaloids 1-9 were found in the aerial parts, 7 and 8 in the roots, and 6-10, together with eleven fatty acids, in the seeds of this plant species. The structures of compounds 1-10 were established based on spectroscopic studies (H-1- and C-13-NMR, 2D NMR, IR and CI-MS). After trans-esterification, methyl esters of the fatty acids were analyzed using GC-MS. The effect of lindelofine-N-oxide (7) on tubulin polymerization was determined.",
publisher = "MDPI, Basel",
journal = "Molecules",
title = "Pyrrolizidine Alkaloids and Fatty Acids from the Endemic Plant Species Rindera umbellata and the Effect of Lindelofine-N-oxide on Tubulin Polymerization",
volume = "18",
number = "9",
pages = "10694-10706",
doi = "10.3390/molecules180910694"
}
Mandić, B. M., Simić, M., Vucković, I. M., Vujisić, L. V., Novaković, M., Trifunović, S., Nikolić-Mandić, S. D., Tešević, V., Vajs, V.,& Milosavljević, S.. (2013). Pyrrolizidine Alkaloids and Fatty Acids from the Endemic Plant Species Rindera umbellata and the Effect of Lindelofine-N-oxide on Tubulin Polymerization. in Molecules
MDPI, Basel., 18(9), 10694-10706.
https://doi.org/10.3390/molecules180910694
Mandić BM, Simić M, Vucković IM, Vujisić LV, Novaković M, Trifunović S, Nikolić-Mandić SD, Tešević V, Vajs V, Milosavljević S. Pyrrolizidine Alkaloids and Fatty Acids from the Endemic Plant Species Rindera umbellata and the Effect of Lindelofine-N-oxide on Tubulin Polymerization. in Molecules. 2013;18(9):10694-10706.
doi:10.3390/molecules180910694 .
Mandić, Boris M., Simić, Milena, Vucković, Ivan M., Vujisić, Ljubodrag V., Novaković, Miroslav, Trifunović, Snežana, Nikolić-Mandić, Snežana D., Tešević, Vele, Vajs, Vlatka, Milosavljević, Slobodan, "Pyrrolizidine Alkaloids and Fatty Acids from the Endemic Plant Species Rindera umbellata and the Effect of Lindelofine-N-oxide on Tubulin Polymerization" in Molecules, 18, no. 9 (2013):10694-10706,
https://doi.org/10.3390/molecules180910694 . .
17
9
15

Streptomyces sp JS520 produces exceptionally high quantities of undecylprodigiosin with antibacterial, antioxidative, and UV-protective properties

Stanković, Nada; Radulović, Vanja; Petković, Miloš; Vucković, Ivan M.; Jadranin, Milka; Vasiljević, Branka; Nikodinović-Runić, Jasmina

(Springer, New York, 2012)

TY  - JOUR
AU  - Stanković, Nada
AU  - Radulović, Vanja
AU  - Petković, Miloš
AU  - Vucković, Ivan M.
AU  - Jadranin, Milka
AU  - Vasiljević, Branka
AU  - Nikodinović-Runić, Jasmina
PY  - 2012
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1683
AB  - A Gram-positive, red-pigment-producing bacterial strain, designated JS520 was isolated from the pristine sediment from the cave on mountain Miroc in Serbia. Strain was confirmed to belong to Streptomyces genus based on phenotypic and genetic analysis. Streptomyces sp. JS520 has the ability to produce exceptionally high amounts of deep red pigment into both solid and liquid media. Liquid chromatography and mass spectroscopy of the purified pigments revealed the major component to be undecylprodigiosin (93 %) with minor component being oxidatively cyclized derivative. The pigment production was affected by medium composition, temperature, pH, and the aeration rate. By medium optimization, yields of undecylprodigiosin of 138 mg l(-1) were achieved, what is the highest level of undecylprodigiosin production reported for the members of Gram-positive Streptomyces genus. Purified pigment had antimicrobial properties against bacterial Bacillus and Micrococcus species (50 mu g ml(-1)) and against Candida albicans species (100-200 mu g ml(-1) range). The ability to affect auto-oxidation of the linoleic acid was demonstrated for the purified undecylprodigiosin, suggesting antioxidative properties of this pigment. Multiple ecophysiological roles of the pigment were revealed by comparing cultures grown under pigment-producing and pigment-nonproducing conditions. Cells grown under undecylprodigiosin-producing conditions could tolerate presence of hydrogen peroxide exhibiting three times smaller zones of inhibition at 100 mM H2O2. Undecylprodigiosin-producing cells were also less susceptible to tetracycline, kanamycin, chloramphenicol, and 8-hydroxyquinoline. While the growth of the cells not producing pigment was completely inhibited by 15 min of exposure to ultraviolet light (254 nm), cells producing undecylprodigiosin and cells supplied with purified pigment in vitro showed survival rates at 22 and 8 %, respectively.
PB  - Springer, New York
T2  - Applied Microbiology and Biotechnology
T1  - Streptomyces sp JS520 produces exceptionally high quantities of undecylprodigiosin with antibacterial, antioxidative, and UV-protective properties
VL  - 96
IS  - 5
SP  - 1217
EP  - 1231
DO  - 10.1007/s00253-012-4237-3
ER  - 
@article{
author = "Stanković, Nada and Radulović, Vanja and Petković, Miloš and Vucković, Ivan M. and Jadranin, Milka and Vasiljević, Branka and Nikodinović-Runić, Jasmina",
year = "2012",
abstract = "A Gram-positive, red-pigment-producing bacterial strain, designated JS520 was isolated from the pristine sediment from the cave on mountain Miroc in Serbia. Strain was confirmed to belong to Streptomyces genus based on phenotypic and genetic analysis. Streptomyces sp. JS520 has the ability to produce exceptionally high amounts of deep red pigment into both solid and liquid media. Liquid chromatography and mass spectroscopy of the purified pigments revealed the major component to be undecylprodigiosin (93 %) with minor component being oxidatively cyclized derivative. The pigment production was affected by medium composition, temperature, pH, and the aeration rate. By medium optimization, yields of undecylprodigiosin of 138 mg l(-1) were achieved, what is the highest level of undecylprodigiosin production reported for the members of Gram-positive Streptomyces genus. Purified pigment had antimicrobial properties against bacterial Bacillus and Micrococcus species (50 mu g ml(-1)) and against Candida albicans species (100-200 mu g ml(-1) range). The ability to affect auto-oxidation of the linoleic acid was demonstrated for the purified undecylprodigiosin, suggesting antioxidative properties of this pigment. Multiple ecophysiological roles of the pigment were revealed by comparing cultures grown under pigment-producing and pigment-nonproducing conditions. Cells grown under undecylprodigiosin-producing conditions could tolerate presence of hydrogen peroxide exhibiting three times smaller zones of inhibition at 100 mM H2O2. Undecylprodigiosin-producing cells were also less susceptible to tetracycline, kanamycin, chloramphenicol, and 8-hydroxyquinoline. While the growth of the cells not producing pigment was completely inhibited by 15 min of exposure to ultraviolet light (254 nm), cells producing undecylprodigiosin and cells supplied with purified pigment in vitro showed survival rates at 22 and 8 %, respectively.",
publisher = "Springer, New York",
journal = "Applied Microbiology and Biotechnology",
title = "Streptomyces sp JS520 produces exceptionally high quantities of undecylprodigiosin with antibacterial, antioxidative, and UV-protective properties",
volume = "96",
number = "5",
pages = "1217-1231",
doi = "10.1007/s00253-012-4237-3"
}
Stanković, N., Radulović, V., Petković, M., Vucković, I. M., Jadranin, M., Vasiljević, B.,& Nikodinović-Runić, J.. (2012). Streptomyces sp JS520 produces exceptionally high quantities of undecylprodigiosin with antibacterial, antioxidative, and UV-protective properties. in Applied Microbiology and Biotechnology
Springer, New York., 96(5), 1217-1231.
https://doi.org/10.1007/s00253-012-4237-3
Stanković N, Radulović V, Petković M, Vucković IM, Jadranin M, Vasiljević B, Nikodinović-Runić J. Streptomyces sp JS520 produces exceptionally high quantities of undecylprodigiosin with antibacterial, antioxidative, and UV-protective properties. in Applied Microbiology and Biotechnology. 2012;96(5):1217-1231.
doi:10.1007/s00253-012-4237-3 .
Stanković, Nada, Radulović, Vanja, Petković, Miloš, Vucković, Ivan M., Jadranin, Milka, Vasiljević, Branka, Nikodinović-Runić, Jasmina, "Streptomyces sp JS520 produces exceptionally high quantities of undecylprodigiosin with antibacterial, antioxidative, and UV-protective properties" in Applied Microbiology and Biotechnology, 96, no. 5 (2012):1217-1231,
https://doi.org/10.1007/s00253-012-4237-3 . .
66
46
65

Methylprednisolone and its related substances in freeze-dried powders for injections

Solomun, Ljiljana; Ibrić, Svetlana; Vajs, Vlatka; Vucković, Ivan M.; Vujić, Zorica

(Srpsko hemijsko društvo, Beograd, 2010)

TY  - JOUR
AU  - Solomun, Ljiljana
AU  - Ibrić, Svetlana
AU  - Vajs, Vlatka
AU  - Vucković, Ivan M.
AU  - Vujić, Zorica
PY  - 2010
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1426
AB  - In this work, the behavior of the active pharmaceutical substances methylprednisolone (in a form of methylprednisolone sodium succinate) in finished pharmaceutical dosage form, i.e., freeze-dried powder for injections, was examined. The goal was to evaluate the chemical stabilities of methylprednisolone sodium succinate packaged in a dual chamber vial, as a specific container closure system. The effect of different parameters: temperature, moisture and light were monitored. The method proposed by United States Pharmacopeia was used to determine concentrations of methylprednisolone, as the sum of the concentration of methylprednisolone esters (17-hydrogen succinate and 21-hydrogen succinate) and free methylprednisolone. The HPLC method was used for stability evaluation of the active substance and determination of related substances. Four main degradation products were registered. Temperature has a major impact on the degradation process with the appearance of 3 degradation products (impurities B, C and D), while the presence of light caused an increasing content of impurity A. Identification of impurity B, C and D has been realized using mass and NMR spectroscopy. All three substances are substances related to methylprednisolone.
AB  - U ovom radu ispitivane su osobine farmakološki aktivne supstance metilprednizolona (u obliku metilprednizolon-natrijum-sukcinata) u gotovom proizvodu - liofilizatu za rastvor za injekcije. Cilj rada je ispitivanje hemijske stabilnosti metilpredni-zolon-natrijum-sukcinata u dvokomornoj bočici, kao specifičnom sistemu kontaktnog pakovanja. Ispitan je efekat različitih parametara: temperature, vlage i svetlosti. Za određivanje koncentracije metilprednizolona, kao zbirne koncentracije metilprednizolon estara (17-hidrogen-sukcinata i 21-hidrogen-sukcinata) i slobodnog metilprednizolona, korišćena je metoda opisana u Američkoj farmakopeji. Za ispitivanje srodnih supstanci primenjena je HPLC metoda. Uočena su 4 degradaciona proizvoda. Dokazano je da povećanje temperature ima najveći značaj na proces degradacije i utiče na povećanje sadržaja nečistoća B, C i D, dok prisustvo svetlosti dovodi do povećanja sadržaja nečistoće A. Nečistoće B, C i D su identifikovane primenom masene i NMR spektroskopije. Sve tri nečistoće su identifikovane kao srodne supstance metilprednizolona.
PB  - Srpsko hemijsko društvo, Beograd
T2  - Journal of the Serbian Chemical Society
T1  - Methylprednisolone and its related substances in freeze-dried powders for injections
T1  - Metilprednizolon i njegove srodne supstance u liofilizatu za rastvor za injekcije
VL  - 75
IS  - 10
SP  - 1441
EP  - 1452
DO  - 10.2298/JSC100115087S
ER  - 
@article{
author = "Solomun, Ljiljana and Ibrić, Svetlana and Vajs, Vlatka and Vucković, Ivan M. and Vujić, Zorica",
year = "2010",
abstract = "In this work, the behavior of the active pharmaceutical substances methylprednisolone (in a form of methylprednisolone sodium succinate) in finished pharmaceutical dosage form, i.e., freeze-dried powder for injections, was examined. The goal was to evaluate the chemical stabilities of methylprednisolone sodium succinate packaged in a dual chamber vial, as a specific container closure system. The effect of different parameters: temperature, moisture and light were monitored. The method proposed by United States Pharmacopeia was used to determine concentrations of methylprednisolone, as the sum of the concentration of methylprednisolone esters (17-hydrogen succinate and 21-hydrogen succinate) and free methylprednisolone. The HPLC method was used for stability evaluation of the active substance and determination of related substances. Four main degradation products were registered. Temperature has a major impact on the degradation process with the appearance of 3 degradation products (impurities B, C and D), while the presence of light caused an increasing content of impurity A. Identification of impurity B, C and D has been realized using mass and NMR spectroscopy. All three substances are substances related to methylprednisolone., U ovom radu ispitivane su osobine farmakološki aktivne supstance metilprednizolona (u obliku metilprednizolon-natrijum-sukcinata) u gotovom proizvodu - liofilizatu za rastvor za injekcije. Cilj rada je ispitivanje hemijske stabilnosti metilpredni-zolon-natrijum-sukcinata u dvokomornoj bočici, kao specifičnom sistemu kontaktnog pakovanja. Ispitan je efekat različitih parametara: temperature, vlage i svetlosti. Za određivanje koncentracije metilprednizolona, kao zbirne koncentracije metilprednizolon estara (17-hidrogen-sukcinata i 21-hidrogen-sukcinata) i slobodnog metilprednizolona, korišćena je metoda opisana u Američkoj farmakopeji. Za ispitivanje srodnih supstanci primenjena je HPLC metoda. Uočena su 4 degradaciona proizvoda. Dokazano je da povećanje temperature ima najveći značaj na proces degradacije i utiče na povećanje sadržaja nečistoća B, C i D, dok prisustvo svetlosti dovodi do povećanja sadržaja nečistoće A. Nečistoće B, C i D su identifikovane primenom masene i NMR spektroskopije. Sve tri nečistoće su identifikovane kao srodne supstance metilprednizolona.",
publisher = "Srpsko hemijsko društvo, Beograd",
journal = "Journal of the Serbian Chemical Society",
title = "Methylprednisolone and its related substances in freeze-dried powders for injections, Metilprednizolon i njegove srodne supstance u liofilizatu za rastvor za injekcije",
volume = "75",
number = "10",
pages = "1441-1452",
doi = "10.2298/JSC100115087S"
}
Solomun, L., Ibrić, S., Vajs, V., Vucković, I. M.,& Vujić, Z.. (2010). Methylprednisolone and its related substances in freeze-dried powders for injections. in Journal of the Serbian Chemical Society
Srpsko hemijsko društvo, Beograd., 75(10), 1441-1452.
https://doi.org/10.2298/JSC100115087S
Solomun L, Ibrić S, Vajs V, Vucković IM, Vujić Z. Methylprednisolone and its related substances in freeze-dried powders for injections. in Journal of the Serbian Chemical Society. 2010;75(10):1441-1452.
doi:10.2298/JSC100115087S .
Solomun, Ljiljana, Ibrić, Svetlana, Vajs, Vlatka, Vucković, Ivan M., Vujić, Zorica, "Methylprednisolone and its related substances in freeze-dried powders for injections" in Journal of the Serbian Chemical Society, 75, no. 10 (2010):1441-1452,
https://doi.org/10.2298/JSC100115087S . .
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