Cvetković, Nebojša

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  • Cvetković, Nebojša (9)
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Author's Bibliography

In vitro/in silico investigation of the drug substance and telmisartan tablets

Homšek, Irena; Cvetković, Nebojša; Marić, Ljiljana; Spasić, Aleksandra; Ivić, Branka; Erić, Slavica

(Savez farmaceutskih udruženja Srbije, Beograd, 2012)

TY  - JOUR
AU  - Homšek, Irena
AU  - Cvetković, Nebojša
AU  - Marić, Ljiljana
AU  - Spasić, Aleksandra
AU  - Ivić, Branka
AU  - Erić, Slavica
PY  - 2012
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1812
AB  - Telmisartan acts as antagonist of angiotensin II type-1 (AT1) receptor and is indicated in the treatment of essential hypertension. In order to rationalize the pharmacokinetic characteristics, pharmacological activity, as well as the optimal method of administration of this drug, knowledge of its physico-chemical properties is needed. The assessment of the drug physico-chemical parameters on the basis of its chemical structure at different pH values, which are characteristic for physiological conditions, enables the prediction of its behaviour in the body before the drug is synthesized. Such assessment of its physico-chemical parameters during the preformulation phase is important for the development of a safe, efficient and stable dosage form. Based on the calculated pKa values, this paper is focused on the prediction of distribution of the ionized and nonionized drug species in the pH gradient of 1 to 8 and the calculation of physico-chemical parameters such as telmisartan lipophilicity (log P) and intrinsic solubility (log S0). On the basis of the calculated physicochemical parameters, the pH-dependent solubility and lipophilicity curves of this medicinal substance have been constructed. The assessment of intrinsic dissolution rate and dissolution rate of telmisartan from tablets was used to investigate the influence of medium pH values applied on the model substance behavior. The results obtained from predicting the physico-chemical properties and from experimental evaluation of the model substance intrinsic dissolution rate and telmisartan dissolution rate from tablets, indicate the importance of physico-chemical characterization of the active substance during the preformulation investigation for predicting the drug behaviour in the body (absorption, bioavailability, tissue penetration, elimination). .
AB  - Telmisartan deluje kao antagonista angiotenzinskog II tipa-1 (AT1) receptora i indikovan je u terapiji esencijalne hipertenzije. Da bi se razjasnile farmakokinetičke osobine, farmakološka aktivnost, kao i optimalni način primene ove lekovite supstance, potrebno je poznavanje njenih fizičko-hemijskih osobina. Određivanje fizičko-hemijskih parametara lekovite supstance na osnovu hemijske strukture pri različitim pH vrednostima koje su karakteristične za fiziološke uslove omogućava predviđanje njenog ponašanja u organizmu pre nego što se lekovita supstanca sintetiše. Određivanje fizičko-hemijskih parametara u toku preformulacionih ispitivanja značajno je za razvijanje bezbednog, efikasnog i stabilnog farmaceutskog oblika. U ovom radu je, na osnovu izračunatih pKa vrednosti, izvršeno predviđanje raspodele jonizovanih i nejonizivanog oblika lekovite supstance u pH gradijentu od 1 do 8 i izračunavanje fizičko-hemijskih parametara telmisartana kao što su lipofilnost (log P) i osnovna rastvorljivost (log S0). Na osnovu izračunatih fizičko-hemijskih parametara konstruisane su krive pH-zavisne rastvorljivosti i lipofilnosti ove lekovite supstance. Određivanjem osnovnih brzina rastvaranja i brzina rastvaranja telmisartana iz tableta ispitan je uticaj pH vrednosti primenjenog medijuma na ponašanje model supstance. Rezultati dobijeni predviđanjem fizičko-hemijskih osobina, kao i eksperimentalnim određivanjem osnovne brzine rastvaranja model supstance i brzine rastvaranja telmisartana iz tableta ukazuju na značaj fizičko-hemijske karakterizacije aktivne supstance tokom preformulacionih ispitivanja za predviđanje njenog ponašanja u organizmu (resorpcije, biološke raspoloživosti, penetracije u tkiva, eliminacije).
PB  - Savez farmaceutskih udruženja Srbije, Beograd
T2  - Arhiv za farmaciju
T1  - In vitro/in silico investigation of the drug substance and telmisartan tablets
T1  - In vitro/in silico ispitivanje lekovite supstance i tableta telmisartana
VL  - 62
IS  - 6
SP  - 548
EP  - 561
UR  - https://hdl.handle.net/21.15107/rcub_farfar_1812
ER  - 
@article{
author = "Homšek, Irena and Cvetković, Nebojša and Marić, Ljiljana and Spasić, Aleksandra and Ivić, Branka and Erić, Slavica",
year = "2012",
abstract = "Telmisartan acts as antagonist of angiotensin II type-1 (AT1) receptor and is indicated in the treatment of essential hypertension. In order to rationalize the pharmacokinetic characteristics, pharmacological activity, as well as the optimal method of administration of this drug, knowledge of its physico-chemical properties is needed. The assessment of the drug physico-chemical parameters on the basis of its chemical structure at different pH values, which are characteristic for physiological conditions, enables the prediction of its behaviour in the body before the drug is synthesized. Such assessment of its physico-chemical parameters during the preformulation phase is important for the development of a safe, efficient and stable dosage form. Based on the calculated pKa values, this paper is focused on the prediction of distribution of the ionized and nonionized drug species in the pH gradient of 1 to 8 and the calculation of physico-chemical parameters such as telmisartan lipophilicity (log P) and intrinsic solubility (log S0). On the basis of the calculated physicochemical parameters, the pH-dependent solubility and lipophilicity curves of this medicinal substance have been constructed. The assessment of intrinsic dissolution rate and dissolution rate of telmisartan from tablets was used to investigate the influence of medium pH values applied on the model substance behavior. The results obtained from predicting the physico-chemical properties and from experimental evaluation of the model substance intrinsic dissolution rate and telmisartan dissolution rate from tablets, indicate the importance of physico-chemical characterization of the active substance during the preformulation investigation for predicting the drug behaviour in the body (absorption, bioavailability, tissue penetration, elimination). ., Telmisartan deluje kao antagonista angiotenzinskog II tipa-1 (AT1) receptora i indikovan je u terapiji esencijalne hipertenzije. Da bi se razjasnile farmakokinetičke osobine, farmakološka aktivnost, kao i optimalni način primene ove lekovite supstance, potrebno je poznavanje njenih fizičko-hemijskih osobina. Određivanje fizičko-hemijskih parametara lekovite supstance na osnovu hemijske strukture pri različitim pH vrednostima koje su karakteristične za fiziološke uslove omogućava predviđanje njenog ponašanja u organizmu pre nego što se lekovita supstanca sintetiše. Određivanje fizičko-hemijskih parametara u toku preformulacionih ispitivanja značajno je za razvijanje bezbednog, efikasnog i stabilnog farmaceutskog oblika. U ovom radu je, na osnovu izračunatih pKa vrednosti, izvršeno predviđanje raspodele jonizovanih i nejonizivanog oblika lekovite supstance u pH gradijentu od 1 do 8 i izračunavanje fizičko-hemijskih parametara telmisartana kao što su lipofilnost (log P) i osnovna rastvorljivost (log S0). Na osnovu izračunatih fizičko-hemijskih parametara konstruisane su krive pH-zavisne rastvorljivosti i lipofilnosti ove lekovite supstance. Određivanjem osnovnih brzina rastvaranja i brzina rastvaranja telmisartana iz tableta ispitan je uticaj pH vrednosti primenjenog medijuma na ponašanje model supstance. Rezultati dobijeni predviđanjem fizičko-hemijskih osobina, kao i eksperimentalnim određivanjem osnovne brzine rastvaranja model supstance i brzine rastvaranja telmisartana iz tableta ukazuju na značaj fizičko-hemijske karakterizacije aktivne supstance tokom preformulacionih ispitivanja za predviđanje njenog ponašanja u organizmu (resorpcije, biološke raspoloživosti, penetracije u tkiva, eliminacije).",
publisher = "Savez farmaceutskih udruženja Srbije, Beograd",
journal = "Arhiv za farmaciju",
title = "In vitro/in silico investigation of the drug substance and telmisartan tablets, In vitro/in silico ispitivanje lekovite supstance i tableta telmisartana",
volume = "62",
number = "6",
pages = "548-561",
url = "https://hdl.handle.net/21.15107/rcub_farfar_1812"
}
Homšek, I., Cvetković, N., Marić, L., Spasić, A., Ivić, B.,& Erić, S.. (2012). In vitro/in silico investigation of the drug substance and telmisartan tablets. in Arhiv za farmaciju
Savez farmaceutskih udruženja Srbije, Beograd., 62(6), 548-561.
https://hdl.handle.net/21.15107/rcub_farfar_1812
Homšek I, Cvetković N, Marić L, Spasić A, Ivić B, Erić S. In vitro/in silico investigation of the drug substance and telmisartan tablets. in Arhiv za farmaciju. 2012;62(6):548-561.
https://hdl.handle.net/21.15107/rcub_farfar_1812 .
Homšek, Irena, Cvetković, Nebojša, Marić, Ljiljana, Spasić, Aleksandra, Ivić, Branka, Erić, Slavica, "In vitro/in silico investigation of the drug substance and telmisartan tablets" in Arhiv za farmaciju, 62, no. 6 (2012):548-561,
https://hdl.handle.net/21.15107/rcub_farfar_1812 .

Application of Design of Experiments and Multilayer Perceptrons Neural Network in the Optimization of Diclofenac Sodium Extended Release Tablets with Carbopol (R) 71G

Ivić, Branka; Ibrić, Svetlana; Cvetković, Nebojša; Petrović, Aleksandra; Trajković, Svetlana; Đurić, Zorica

(Pharmaceutical Soc Japan, Tokyo, 2010)

TY  - JOUR
AU  - Ivić, Branka
AU  - Ibrić, Svetlana
AU  - Cvetković, Nebojša
AU  - Petrović, Aleksandra
AU  - Trajković, Svetlana
AU  - Đurić, Zorica
PY  - 2010
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1401
AB  - The purpose of the study was to screen the effects of formulation factors on the in vitro release profile of diclofenac sodium from matrix tablets using design of experiment (DOE). Formulations of diclofenac sodium tablets, with Carbopol (R) 71G as matrix substance, were optimized by artificial neural network. According to Central Composite Design, 10 formulations of diclofenac sodium matrix tablets were prepared. As network inputs, concentration of Carbopol (R) 71G and the Kollidon (R) K-25 were selected. In vitro dissolution time profiles at 5 different sampling times were chosen as responses. The independent variables and the release parameters were processed by multilayer perceptrons neural network (MLP). Results of drug release studies indicate that drug release rates vary between different formulations, with a range of 1 h to more than 8 h to complete dissolution. For two tested formulations there was no difference between experimental and MLP predicted in vitro profiles. The M LP model was optimized. The root mean square value for the trained network was 0.07%, which indicated that the optimal MLP model was reached. The optimal tablet formulation predicted by MLP was with 23% of Carbopol (R) 710 and 0.8% of Kollidon (R) K-25. Calculated difference factor (f(1) 7.37) and similarity factor (f(2) 70.79) indicate that there is no difference between predicted and experimentally observed drug release profiles for the optimal formulation. The satisfactory prediction of drug release for optimal formulation by the MLP in this study has shown the applicability of this optimization method in modeling extended release tablet formulation.
PB  - Pharmaceutical Soc Japan, Tokyo
T2  - Chemical & Pharmaceutical Bulletin
T1  - Application of Design of Experiments and Multilayer Perceptrons Neural Network in the Optimization of Diclofenac Sodium Extended Release Tablets with Carbopol (R) 71G
VL  - 58
IS  - 7
SP  - 947
EP  - 949
DO  - 10.1248/cpb.58.947
UR  - https://hdl.handle.net/21.15107/rcub_farfar_1401
ER  - 
@article{
author = "Ivić, Branka and Ibrić, Svetlana and Cvetković, Nebojša and Petrović, Aleksandra and Trajković, Svetlana and Đurić, Zorica",
year = "2010",
abstract = "The purpose of the study was to screen the effects of formulation factors on the in vitro release profile of diclofenac sodium from matrix tablets using design of experiment (DOE). Formulations of diclofenac sodium tablets, with Carbopol (R) 71G as matrix substance, were optimized by artificial neural network. According to Central Composite Design, 10 formulations of diclofenac sodium matrix tablets were prepared. As network inputs, concentration of Carbopol (R) 71G and the Kollidon (R) K-25 were selected. In vitro dissolution time profiles at 5 different sampling times were chosen as responses. The independent variables and the release parameters were processed by multilayer perceptrons neural network (MLP). Results of drug release studies indicate that drug release rates vary between different formulations, with a range of 1 h to more than 8 h to complete dissolution. For two tested formulations there was no difference between experimental and MLP predicted in vitro profiles. The M LP model was optimized. The root mean square value for the trained network was 0.07%, which indicated that the optimal MLP model was reached. The optimal tablet formulation predicted by MLP was with 23% of Carbopol (R) 710 and 0.8% of Kollidon (R) K-25. Calculated difference factor (f(1) 7.37) and similarity factor (f(2) 70.79) indicate that there is no difference between predicted and experimentally observed drug release profiles for the optimal formulation. The satisfactory prediction of drug release for optimal formulation by the MLP in this study has shown the applicability of this optimization method in modeling extended release tablet formulation.",
publisher = "Pharmaceutical Soc Japan, Tokyo",
journal = "Chemical & Pharmaceutical Bulletin",
title = "Application of Design of Experiments and Multilayer Perceptrons Neural Network in the Optimization of Diclofenac Sodium Extended Release Tablets with Carbopol (R) 71G",
volume = "58",
number = "7",
pages = "947-949",
doi = "10.1248/cpb.58.947",
url = "https://hdl.handle.net/21.15107/rcub_farfar_1401"
}
Ivić, B., Ibrić, S., Cvetković, N., Petrović, A., Trajković, S.,& Đurić, Z.. (2010). Application of Design of Experiments and Multilayer Perceptrons Neural Network in the Optimization of Diclofenac Sodium Extended Release Tablets with Carbopol (R) 71G. in Chemical & Pharmaceutical Bulletin
Pharmaceutical Soc Japan, Tokyo., 58(7), 947-949.
https://doi.org/10.1248/cpb.58.947
https://hdl.handle.net/21.15107/rcub_farfar_1401
Ivić B, Ibrić S, Cvetković N, Petrović A, Trajković S, Đurić Z. Application of Design of Experiments and Multilayer Perceptrons Neural Network in the Optimization of Diclofenac Sodium Extended Release Tablets with Carbopol (R) 71G. in Chemical & Pharmaceutical Bulletin. 2010;58(7):947-949.
doi:10.1248/cpb.58.947
https://hdl.handle.net/21.15107/rcub_farfar_1401 .
Ivić, Branka, Ibrić, Svetlana, Cvetković, Nebojša, Petrović, Aleksandra, Trajković, Svetlana, Đurić, Zorica, "Application of Design of Experiments and Multilayer Perceptrons Neural Network in the Optimization of Diclofenac Sodium Extended Release Tablets with Carbopol (R) 71G" in Chemical & Pharmaceutical Bulletin, 58, no. 7 (2010):947-949,
https://doi.org/10.1248/cpb.58.947 .,
https://hdl.handle.net/21.15107/rcub_farfar_1401 .
13
11
14

Application of Mixture Experimental Design in the Formulation and Optimization of Matrix Tablets Containing Carbomer and Hydroxypropylmethylcellulose

Petrović, Aleksandra; Cvetković, Nebojša; Ibrić, Svetlana; Trajković, Svetlana; Đurić, Zorica; Popadić, Dragica; Popović, Radmila

(Pharmaceutical Soc Korea, Seoul, 2009)

TY  - JOUR
AU  - Petrović, Aleksandra
AU  - Cvetković, Nebojša
AU  - Ibrić, Svetlana
AU  - Trajković, Svetlana
AU  - Đurić, Zorica
AU  - Popadić, Dragica
AU  - Popović, Radmila
PY  - 2009
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1191
AB  - Using mixture experimental design, the effect of carbomer (Carbopole (R) 971P NF) and hydroxypropylmethylcellulose (Methocel (R) K100M or Methocel (R) K4M) combination on the release profile and on the mechanism of drug liberation from matrix tablet was investigated. The numerical optimization procedure was also applied to establish and obtain formulation with desired drug release. The amount of TP released, release rate and mechanism varied with carbomer ratio in total matrix and HPMC viscosity. Increasing carbomer fractions led to a decrease in drug release. Anomalous diffusion was found in all matrices containing carbomer, while Case - II transport was predominant for tablet based on HPMC only. The predicted and obtained profiles for optimized formulations showed similarity. Those results indicate that Simplex Lattice Mixture experimental design and numerical optimization procedure can be applied during development to obtain sustained release matrix formulation with desired release profile.
PB  - Pharmaceutical Soc Korea, Seoul
T2  - Archives of Pharmacal Research
T1  - Application of Mixture Experimental Design in the Formulation and Optimization of Matrix Tablets Containing Carbomer and Hydroxypropylmethylcellulose
VL  - 32
IS  - 12
SP  - 1767
EP  - 1774
DO  - 10.1007/s12272-009-2215-9
ER  - 
@article{
author = "Petrović, Aleksandra and Cvetković, Nebojša and Ibrić, Svetlana and Trajković, Svetlana and Đurić, Zorica and Popadić, Dragica and Popović, Radmila",
year = "2009",
abstract = "Using mixture experimental design, the effect of carbomer (Carbopole (R) 971P NF) and hydroxypropylmethylcellulose (Methocel (R) K100M or Methocel (R) K4M) combination on the release profile and on the mechanism of drug liberation from matrix tablet was investigated. The numerical optimization procedure was also applied to establish and obtain formulation with desired drug release. The amount of TP released, release rate and mechanism varied with carbomer ratio in total matrix and HPMC viscosity. Increasing carbomer fractions led to a decrease in drug release. Anomalous diffusion was found in all matrices containing carbomer, while Case - II transport was predominant for tablet based on HPMC only. The predicted and obtained profiles for optimized formulations showed similarity. Those results indicate that Simplex Lattice Mixture experimental design and numerical optimization procedure can be applied during development to obtain sustained release matrix formulation with desired release profile.",
publisher = "Pharmaceutical Soc Korea, Seoul",
journal = "Archives of Pharmacal Research",
title = "Application of Mixture Experimental Design in the Formulation and Optimization of Matrix Tablets Containing Carbomer and Hydroxypropylmethylcellulose",
volume = "32",
number = "12",
pages = "1767-1774",
doi = "10.1007/s12272-009-2215-9"
}
Petrović, A., Cvetković, N., Ibrić, S., Trajković, S., Đurić, Z., Popadić, D.,& Popović, R.. (2009). Application of Mixture Experimental Design in the Formulation and Optimization of Matrix Tablets Containing Carbomer and Hydroxypropylmethylcellulose. in Archives of Pharmacal Research
Pharmaceutical Soc Korea, Seoul., 32(12), 1767-1774.
https://doi.org/10.1007/s12272-009-2215-9
Petrović A, Cvetković N, Ibrić S, Trajković S, Đurić Z, Popadić D, Popović R. Application of Mixture Experimental Design in the Formulation and Optimization of Matrix Tablets Containing Carbomer and Hydroxypropylmethylcellulose. in Archives of Pharmacal Research. 2009;32(12):1767-1774.
doi:10.1007/s12272-009-2215-9 .
Petrović, Aleksandra, Cvetković, Nebojša, Ibrić, Svetlana, Trajković, Svetlana, Đurić, Zorica, Popadić, Dragica, Popović, Radmila, "Application of Mixture Experimental Design in the Formulation and Optimization of Matrix Tablets Containing Carbomer and Hydroxypropylmethylcellulose" in Archives of Pharmacal Research, 32, no. 12 (2009):1767-1774,
https://doi.org/10.1007/s12272-009-2215-9 . .
10
12
17

Development of a drug release methodology for carbamazepine CR tablets based on bioequivalence evaluation

Homšek, Irena; Parojčić, Jelena; Mitić, M.; Simić, Slobodanka; Cvetković, Nebojša; Đurić, Zorica

(Editions Sante, Paris, 2008)

TY  - JOUR
AU  - Homšek, Irena
AU  - Parojčić, Jelena
AU  - Mitić, M.
AU  - Simić, Slobodanka
AU  - Cvetković, Nebojša
AU  - Đurić, Zorica
PY  - 2008
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1083
AB  - The aim of this study was to investigate the influence of experimental conditions on carbamazepine (CBZ) release from the two controlled-release (CR) tablet formulations with proven bioequivalence and to propose the universal release method which would be biorelevant, In vitro data were obtained in various release media using the USP apparatus II in order to assess their influence on CBZ release from CR tablets. An empirical correlation between in vivo plasma concentration data expressed as a fraction drug absorbed and the cumulative amount of in vitro release was established. The most complete release and highest level A correlation was observed by using the half change method (HCM) compared to other release methodologies tested. The results obtained indicate that the release test developed offers a promising in vitro tool for predicting the in vivo performance of CBZ CR tablets, ensuring batch to batch bioequivalence and verification of certain postapproval changes without the need for additional in vivo studies.
PB  - Editions Sante, Paris
T2  - Journal of Drug Delivery Science and Technology
T1  - Development of a drug release methodology for carbamazepine CR tablets based on bioequivalence evaluation
VL  - 18
IS  - 2
SP  - 139
EP  - 144
DO  - 10.1016/S1773-2247(08)50022-0
ER  - 
@article{
author = "Homšek, Irena and Parojčić, Jelena and Mitić, M. and Simić, Slobodanka and Cvetković, Nebojša and Đurić, Zorica",
year = "2008",
abstract = "The aim of this study was to investigate the influence of experimental conditions on carbamazepine (CBZ) release from the two controlled-release (CR) tablet formulations with proven bioequivalence and to propose the universal release method which would be biorelevant, In vitro data were obtained in various release media using the USP apparatus II in order to assess their influence on CBZ release from CR tablets. An empirical correlation between in vivo plasma concentration data expressed as a fraction drug absorbed and the cumulative amount of in vitro release was established. The most complete release and highest level A correlation was observed by using the half change method (HCM) compared to other release methodologies tested. The results obtained indicate that the release test developed offers a promising in vitro tool for predicting the in vivo performance of CBZ CR tablets, ensuring batch to batch bioequivalence and verification of certain postapproval changes without the need for additional in vivo studies.",
publisher = "Editions Sante, Paris",
journal = "Journal of Drug Delivery Science and Technology",
title = "Development of a drug release methodology for carbamazepine CR tablets based on bioequivalence evaluation",
volume = "18",
number = "2",
pages = "139-144",
doi = "10.1016/S1773-2247(08)50022-0"
}
Homšek, I., Parojčić, J., Mitić, M., Simić, S., Cvetković, N.,& Đurić, Z.. (2008). Development of a drug release methodology for carbamazepine CR tablets based on bioequivalence evaluation. in Journal of Drug Delivery Science and Technology
Editions Sante, Paris., 18(2), 139-144.
https://doi.org/10.1016/S1773-2247(08)50022-0
Homšek I, Parojčić J, Mitić M, Simić S, Cvetković N, Đurić Z. Development of a drug release methodology for carbamazepine CR tablets based on bioequivalence evaluation. in Journal of Drug Delivery Science and Technology. 2008;18(2):139-144.
doi:10.1016/S1773-2247(08)50022-0 .
Homšek, Irena, Parojčić, Jelena, Mitić, M., Simić, Slobodanka, Cvetković, Nebojša, Đurić, Zorica, "Development of a drug release methodology for carbamazepine CR tablets based on bioequivalence evaluation" in Journal of Drug Delivery Science and Technology, 18, no. 2 (2008):139-144,
https://doi.org/10.1016/S1773-2247(08)50022-0 . .
1
2
2

Biopharmaceutical characterization of carbamazepine immediate release tablets - In vitro-in vivo comparison

Homšek, Irena; Parojčić, Jelena; Cvetković, Nebojša; Popadić, Dragica; Đurić, Zorica

(ECV-Editio Cantor Verlag Medizin Naturwissenschaften, Aulendorf, 2007)

TY  - JOUR
AU  - Homšek, Irena
AU  - Parojčić, Jelena
AU  - Cvetković, Nebojša
AU  - Popadić, Dragica
AU  - Đurić, Zorica
PY  - 2007
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/938
AB  - A growing concern for the biopharmaceutical characterization of pharmaceutical products increased the interest in the evaluation and identification of physicochemical properties of drugs and dosage forms that govern its biological performance. In vitro and in vivo characteristics of two carbamazepine (CAS 298-46-4) immediate release tablets were investigated and compared in order to establish level A in vitro-in vivo correlation. An in vivo study was conducted as a controlled, two-way, complete cross-over, single dose, pharmacokinetic trial in 18 subjects. The in vitro study was performed using various dissolution media in order to evaluate their potential influence on drug release and distinguish the set of experimental conditions relevant to the in vivo behavior of the investigated drug products. Beside significant differences among in vitro release profiles, the in vivo data indicated bioequivalence of the two formulations. Although a high level of correlation between in vivo and in vitro data was observed in some media, there was no single in vitro-in vivo correlation model applicable products. The obtained results add to the existing debate on the rationale for the use of surfactants in drug release media and their in vivo relevance, emphasizing the importance of in vitro dissolution testing in addition to in vivo bioequivalence testing.
PB  - ECV-Editio Cantor Verlag Medizin Naturwissenschaften, Aulendorf
T2  - Arzneimittelforschung - Drug Research
T1  - Biopharmaceutical characterization of carbamazepine immediate release tablets - In vitro-in vivo comparison
VL  - 57
IS  - 8
SP  - 511
EP  - 516
DO  - 10.1055/s-0031-1296640
UR  - https://hdl.handle.net/21.15107/rcub_farfar_938
ER  - 
@article{
author = "Homšek, Irena and Parojčić, Jelena and Cvetković, Nebojša and Popadić, Dragica and Đurić, Zorica",
year = "2007",
abstract = "A growing concern for the biopharmaceutical characterization of pharmaceutical products increased the interest in the evaluation and identification of physicochemical properties of drugs and dosage forms that govern its biological performance. In vitro and in vivo characteristics of two carbamazepine (CAS 298-46-4) immediate release tablets were investigated and compared in order to establish level A in vitro-in vivo correlation. An in vivo study was conducted as a controlled, two-way, complete cross-over, single dose, pharmacokinetic trial in 18 subjects. The in vitro study was performed using various dissolution media in order to evaluate their potential influence on drug release and distinguish the set of experimental conditions relevant to the in vivo behavior of the investigated drug products. Beside significant differences among in vitro release profiles, the in vivo data indicated bioequivalence of the two formulations. Although a high level of correlation between in vivo and in vitro data was observed in some media, there was no single in vitro-in vivo correlation model applicable products. The obtained results add to the existing debate on the rationale for the use of surfactants in drug release media and their in vivo relevance, emphasizing the importance of in vitro dissolution testing in addition to in vivo bioequivalence testing.",
publisher = "ECV-Editio Cantor Verlag Medizin Naturwissenschaften, Aulendorf",
journal = "Arzneimittelforschung - Drug Research",
title = "Biopharmaceutical characterization of carbamazepine immediate release tablets - In vitro-in vivo comparison",
volume = "57",
number = "8",
pages = "511-516",
doi = "10.1055/s-0031-1296640",
url = "https://hdl.handle.net/21.15107/rcub_farfar_938"
}
Homšek, I., Parojčić, J., Cvetković, N., Popadić, D.,& Đurić, Z.. (2007). Biopharmaceutical characterization of carbamazepine immediate release tablets - In vitro-in vivo comparison. in Arzneimittelforschung - Drug Research
ECV-Editio Cantor Verlag Medizin Naturwissenschaften, Aulendorf., 57(8), 511-516.
https://doi.org/10.1055/s-0031-1296640
https://hdl.handle.net/21.15107/rcub_farfar_938
Homšek I, Parojčić J, Cvetković N, Popadić D, Đurić Z. Biopharmaceutical characterization of carbamazepine immediate release tablets - In vitro-in vivo comparison. in Arzneimittelforschung - Drug Research. 2007;57(8):511-516.
doi:10.1055/s-0031-1296640
https://hdl.handle.net/21.15107/rcub_farfar_938 .
Homšek, Irena, Parojčić, Jelena, Cvetković, Nebojša, Popadić, Dragica, Đurić, Zorica, "Biopharmaceutical characterization of carbamazepine immediate release tablets - In vitro-in vivo comparison" in Arzneimittelforschung - Drug Research, 57, no. 8 (2007):511-516,
https://doi.org/10.1055/s-0031-1296640 .,
https://hdl.handle.net/21.15107/rcub_farfar_938 .
1
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The influence of different factors on diclofenac sodium release from extended release matrices

Ivić, Branka; Cvetković, Nebojša; Ibrić, Svetlana; Petrović, Aleksandra; Trajković, Svetlana; Đurić, Zorica

(Savez farmaceutskih udruženja Srbije, Beograd, 2006)

TY  - CONF
AU  - Ivić, Branka
AU  - Cvetković, Nebojša
AU  - Ibrić, Svetlana
AU  - Petrović, Aleksandra
AU  - Trajković, Svetlana
AU  - Đurić, Zorica
PY  - 2006
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/796
PB  - Savez farmaceutskih udruženja Srbije, Beograd
C3  - Arhiv za farmaciju
T1  - The influence of different factors on diclofenac sodium release from extended release matrices
T1  - Uticaj različitih faktora na oslobađanje diklofenak natrijuma iz matriks tableta sa produženim oslobađanjem
VL  - 56
IS  - 4
SP  - 474
EP  - 475
UR  - https://hdl.handle.net/21.15107/rcub_farfar_796
ER  - 
@conference{
author = "Ivić, Branka and Cvetković, Nebojša and Ibrić, Svetlana and Petrović, Aleksandra and Trajković, Svetlana and Đurić, Zorica",
year = "2006",
publisher = "Savez farmaceutskih udruženja Srbije, Beograd",
journal = "Arhiv za farmaciju",
title = "The influence of different factors on diclofenac sodium release from extended release matrices, Uticaj različitih faktora na oslobađanje diklofenak natrijuma iz matriks tableta sa produženim oslobađanjem",
volume = "56",
number = "4",
pages = "474-475",
url = "https://hdl.handle.net/21.15107/rcub_farfar_796"
}
Ivić, B., Cvetković, N., Ibrić, S., Petrović, A., Trajković, S.,& Đurić, Z.. (2006). The influence of different factors on diclofenac sodium release from extended release matrices. in Arhiv za farmaciju
Savez farmaceutskih udruženja Srbije, Beograd., 56(4), 474-475.
https://hdl.handle.net/21.15107/rcub_farfar_796
Ivić B, Cvetković N, Ibrić S, Petrović A, Trajković S, Đurić Z. The influence of different factors on diclofenac sodium release from extended release matrices. in Arhiv za farmaciju. 2006;56(4):474-475.
https://hdl.handle.net/21.15107/rcub_farfar_796 .
Ivić, Branka, Cvetković, Nebojša, Ibrić, Svetlana, Petrović, Aleksandra, Trajković, Svetlana, Đurić, Zorica, "The influence of different factors on diclofenac sodium release from extended release matrices" in Arhiv za farmaciju, 56, no. 4 (2006):474-475,
https://hdl.handle.net/21.15107/rcub_farfar_796 .

Evaluation of drug release from matrix tablets containing carbomer and HPMC using experimental design

Petrović, Aleksandra; Cvetković, Nebojša; Ibrić, Svetlana; Trajković, Svetlana; Popadić, Dragica; Đurić, Zorica

(Savez farmaceutskih udruženja Srbije, Beograd, 2006)

TY  - CONF
AU  - Petrović, Aleksandra
AU  - Cvetković, Nebojša
AU  - Ibrić, Svetlana
AU  - Trajković, Svetlana
AU  - Popadić, Dragica
AU  - Đurić, Zorica
PY  - 2006
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/788
PB  - Savez farmaceutskih udruženja Srbije, Beograd
C3  - Arhiv za farmaciju
T1  - Evaluation of drug release from matrix tablets containing carbomer and HPMC using experimental design
T1  - Ispitivanje oslobađanja leka iz matriks tableta na bazi karbomer-a i HPMC-a primenom eksperimentalnog dizajna
VL  - 56
IS  - 4
SP  - 460
EP  - 461
UR  - https://hdl.handle.net/21.15107/rcub_farfar_788
ER  - 
@conference{
author = "Petrović, Aleksandra and Cvetković, Nebojša and Ibrić, Svetlana and Trajković, Svetlana and Popadić, Dragica and Đurić, Zorica",
year = "2006",
publisher = "Savez farmaceutskih udruženja Srbije, Beograd",
journal = "Arhiv za farmaciju",
title = "Evaluation of drug release from matrix tablets containing carbomer and HPMC using experimental design, Ispitivanje oslobađanja leka iz matriks tableta na bazi karbomer-a i HPMC-a primenom eksperimentalnog dizajna",
volume = "56",
number = "4",
pages = "460-461",
url = "https://hdl.handle.net/21.15107/rcub_farfar_788"
}
Petrović, A., Cvetković, N., Ibrić, S., Trajković, S., Popadić, D.,& Đurić, Z.. (2006). Evaluation of drug release from matrix tablets containing carbomer and HPMC using experimental design. in Arhiv za farmaciju
Savez farmaceutskih udruženja Srbije, Beograd., 56(4), 460-461.
https://hdl.handle.net/21.15107/rcub_farfar_788
Petrović A, Cvetković N, Ibrić S, Trajković S, Popadić D, Đurić Z. Evaluation of drug release from matrix tablets containing carbomer and HPMC using experimental design. in Arhiv za farmaciju. 2006;56(4):460-461.
https://hdl.handle.net/21.15107/rcub_farfar_788 .
Petrović, Aleksandra, Cvetković, Nebojša, Ibrić, Svetlana, Trajković, Svetlana, Popadić, Dragica, Đurić, Zorica, "Evaluation of drug release from matrix tablets containing carbomer and HPMC using experimental design" in Arhiv za farmaciju, 56, no. 4 (2006):460-461,
https://hdl.handle.net/21.15107/rcub_farfar_788 .

Influence of surfactant concentration on carbamazepine release from tablets and in vitro: In vivo correlation

Homšek, Irena; Parojčić, Jelena; Cvetković, Nebojša; Mitić, M.; Đurić, Zorica

(Savez farmaceutskih udruženja Srbije, Beograd, 2006)

TY  - CONF
AU  - Homšek, Irena
AU  - Parojčić, Jelena
AU  - Cvetković, Nebojša
AU  - Mitić, M.
AU  - Đurić, Zorica
PY  - 2006
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/774
PB  - Savez farmaceutskih udruženja Srbije, Beograd
C3  - Arhiv za farmaciju
T1  - Influence of surfactant concentration on carbamazepine release from tablets and in vitro: In vivo correlation
T1  - Uticaj tenzida u medijumu za rastvaranje na brzinu oslobađanja karbamazepina iz tableta i uspostavljanje in vitro - in vivo korelacije
VL  - 56
IS  - 4
SP  - 484
EP  - 485
UR  - https://hdl.handle.net/21.15107/rcub_farfar_774
ER  - 
@conference{
author = "Homšek, Irena and Parojčić, Jelena and Cvetković, Nebojša and Mitić, M. and Đurić, Zorica",
year = "2006",
publisher = "Savez farmaceutskih udruženja Srbije, Beograd",
journal = "Arhiv za farmaciju",
title = "Influence of surfactant concentration on carbamazepine release from tablets and in vitro: In vivo correlation, Uticaj tenzida u medijumu za rastvaranje na brzinu oslobađanja karbamazepina iz tableta i uspostavljanje in vitro - in vivo korelacije",
volume = "56",
number = "4",
pages = "484-485",
url = "https://hdl.handle.net/21.15107/rcub_farfar_774"
}
Homšek, I., Parojčić, J., Cvetković, N., Mitić, M.,& Đurić, Z.. (2006). Influence of surfactant concentration on carbamazepine release from tablets and in vitro: In vivo correlation. in Arhiv za farmaciju
Savez farmaceutskih udruženja Srbije, Beograd., 56(4), 484-485.
https://hdl.handle.net/21.15107/rcub_farfar_774
Homšek I, Parojčić J, Cvetković N, Mitić M, Đurić Z. Influence of surfactant concentration on carbamazepine release from tablets and in vitro: In vivo correlation. in Arhiv za farmaciju. 2006;56(4):484-485.
https://hdl.handle.net/21.15107/rcub_farfar_774 .
Homšek, Irena, Parojčić, Jelena, Cvetković, Nebojša, Mitić, M., Đurić, Zorica, "Influence of surfactant concentration on carbamazepine release from tablets and in vitro: In vivo correlation" in Arhiv za farmaciju, 56, no. 4 (2006):484-485,
https://hdl.handle.net/21.15107/rcub_farfar_774 .

Mixture design evaluation of drug release from matrix tablets containing carbomer and HPMC

Petrović, Aleksandra; Cvetković, Nebojša; Trajković, Svetlana; Ibrić, Svetlana; Popadić, Dragica; Đurić, Zorica

(Elsevier Science BV, Amsterdam, 2006)

TY  - CONF
AU  - Petrović, Aleksandra
AU  - Cvetković, Nebojša
AU  - Trajković, Svetlana
AU  - Ibrić, Svetlana
AU  - Popadić, Dragica
AU  - Đurić, Zorica
PY  - 2006
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/792
PB  - Elsevier Science BV, Amsterdam
C3  - Journal of Controlled Release
T1  - Mixture design evaluation of drug release from matrix tablets containing carbomer and HPMC
VL  - 116
IS  - 2
DO  - 10.1016/j.jconrel.2006.09.073
ER  - 
@conference{
author = "Petrović, Aleksandra and Cvetković, Nebojša and Trajković, Svetlana and Ibrić, Svetlana and Popadić, Dragica and Đurić, Zorica",
year = "2006",
publisher = "Elsevier Science BV, Amsterdam",
journal = "Journal of Controlled Release",
title = "Mixture design evaluation of drug release from matrix tablets containing carbomer and HPMC",
volume = "116",
number = "2",
doi = "10.1016/j.jconrel.2006.09.073"
}
Petrović, A., Cvetković, N., Trajković, S., Ibrić, S., Popadić, D.,& Đurić, Z.. (2006). Mixture design evaluation of drug release from matrix tablets containing carbomer and HPMC. in Journal of Controlled Release
Elsevier Science BV, Amsterdam., 116(2).
https://doi.org/10.1016/j.jconrel.2006.09.073
Petrović A, Cvetković N, Trajković S, Ibrić S, Popadić D, Đurić Z. Mixture design evaluation of drug release from matrix tablets containing carbomer and HPMC. in Journal of Controlled Release. 2006;116(2).
doi:10.1016/j.jconrel.2006.09.073 .
Petrović, Aleksandra, Cvetković, Nebojša, Trajković, Svetlana, Ibrić, Svetlana, Popadić, Dragica, Đurić, Zorica, "Mixture design evaluation of drug release from matrix tablets containing carbomer and HPMC" in Journal of Controlled Release, 116, no. 2 (2006),
https://doi.org/10.1016/j.jconrel.2006.09.073 . .
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