TY  - JOUR
AU  - Beloica, Sofija
AU  - Cvijić, Sandra
AU  - Homšek, Irena
AU  - Bogataj, M.
AU  - Parojčić, Jelena
PY  - 2015
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2434
AB  - The integrated in vitro - in silico - in vivo approach has emerged into a biopharmaceutical toolkit that could accelerate drug development and improve drug product clinical performance in patients. In the present study, the influence of physiologically based media and dynamic dissolution testing on drug release from two metformin hydrochloride immediate release products with proven bioequivalence was tested. Metformin-specific physiologically based pharmacokinetic (PBPK) model was developed based on a range of literature or in silico predicted data using gastrointestinal simulation technology implemented in the Simcyp (R) software package. Various approaches were employed in order to estimate the human effective permeability which was used as input for metformin plasma profile simulation. Influence of the rate and extent of metformin dissolution on drug absorption was evaluated. Both convolution and deconvolution approaches were used in order to establish a correlation between the in vitro and in vivo data. The results obtained indicate that physiologically based dissolution media and glass bead dissolution device exhibit certain advantages over the compendial dissolution apparatus and simple buffers which tended to be over-discriminative. Gastrointestinal simulation technology implemented in the Simcyp (R) Simulator was successfully used in developing drug-specific PBPK model for metformin. Simulations indicate that in vitro dissolution kinetics has no significant effect on metformin absorption, if more than 65% of drug is released in 1 hour. Level A in vitro-in vivo correlation was obtained using both convolution and deconvolution approaches.
PB  - Govi-Verlag  Pharmazeutischer Verlag Gmbh, Eschborn
T2  - Pharmazie
T1  - An in vitro - in silico - in vivo approach in biopharmaceutical drug characterization: metformin hydrochloride IR tablets
VL  - 70
IS  - 7
SP  - 458
EP  - 465
DO  - 10.1691/ph.2015.4168
ER  - 

@article{
author = "Beloica, Sofija and Cvijić, Sandra and Homšek, Irena and Bogataj, M. and Parojčić, Jelena",
year = "2015",
abstract = "The integrated in vitro - in silico - in vivo approach has emerged into a biopharmaceutical toolkit that could accelerate drug development and improve drug product clinical performance in patients. In the present study, the influence of physiologically based media and dynamic dissolution testing on drug release from two metformin hydrochloride immediate release products with proven bioequivalence was tested. Metformin-specific physiologically based pharmacokinetic (PBPK) model was developed based on a range of literature or in silico predicted data using gastrointestinal simulation technology implemented in the Simcyp (R) software package. Various approaches were employed in order to estimate the human effective permeability which was used as input for metformin plasma profile simulation. Influence of the rate and extent of metformin dissolution on drug absorption was evaluated. Both convolution and deconvolution approaches were used in order to establish a correlation between the in vitro and in vivo data. The results obtained indicate that physiologically based dissolution media and glass bead dissolution device exhibit certain advantages over the compendial dissolution apparatus and simple buffers which tended to be over-discriminative. Gastrointestinal simulation technology implemented in the Simcyp (R) Simulator was successfully used in developing drug-specific PBPK model for metformin. Simulations indicate that in vitro dissolution kinetics has no significant effect on metformin absorption, if more than 65% of drug is released in 1 hour. Level A in vitro-in vivo correlation was obtained using both convolution and deconvolution approaches.",
publisher = "Govi-Verlag  Pharmazeutischer Verlag Gmbh, Eschborn",
journal = "Pharmazie",
title = "An in vitro - in silico - in vivo approach in biopharmaceutical drug characterization: metformin hydrochloride IR tablets",
volume = "70",
number = "7",
pages = "458-465",
doi = "10.1691/ph.2015.4168"
}

Beloica, S., Cvijić, S., Homšek, I., Bogataj, M.,& Parojčić, J.. (2015). An in vitro - in silico - in vivo approach in biopharmaceutical drug characterization: metformin hydrochloride IR tablets. in Pharmazie
Govi-Verlag  Pharmazeutischer Verlag Gmbh, Eschborn., 70(7), 458-465.
https://doi.org/10.1691/ph.2015.4168

Beloica S, Cvijić S, Homšek I, Bogataj M, Parojčić J. An in vitro - in silico - in vivo approach in biopharmaceutical drug characterization: metformin hydrochloride IR tablets. in Pharmazie. 2015;70(7):458-465.
doi:10.1691/ph.2015.4168 .

Beloica, Sofija, Cvijić, Sandra, Homšek, Irena, Bogataj, M., Parojčić, Jelena, "An in vitro - in silico - in vivo approach in biopharmaceutical drug characterization: metformin hydrochloride IR tablets" in Pharmazie, 70, no. 7 (2015):458-465,
https://doi.org/10.1691/ph.2015.4168 . .

TY  - CONF
AU  - Homšek, Irena
AU  - Dacević, M.
AU  - Erić, Slavica
PY  - 2013
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1889
PB  - Elsevier Science BV, Amsterdam
C3  - European Journal of Pharmaceutical Sciences
T1  - A contribution to biopharmaceutical characterization of drug substances: cefaclor case
VL  - 50
IS  - Supplement 1
SP  - E213
EP  - E213
DO  - 10.1016/j.ejps.2013.09.012
ER  - 

@conference{
author = "Homšek, Irena and Dacević, M. and Erić, Slavica",
year = "2013",
publisher = "Elsevier Science BV, Amsterdam",
journal = "European Journal of Pharmaceutical Sciences",
title = "A contribution to biopharmaceutical characterization of drug substances: cefaclor case",
volume = "50",
number = "Supplement 1",
pages = "E213-E213",
doi = "10.1016/j.ejps.2013.09.012"
}

Homšek, I., Dacević, M.,& Erić, S.. (2013). A contribution to biopharmaceutical characterization of drug substances: cefaclor case. in European Journal of Pharmaceutical Sciences
Elsevier Science BV, Amsterdam., 50(Supplement 1), E213-E213.
https://doi.org/10.1016/j.ejps.2013.09.012

Homšek I, Dacević M, Erić S. A contribution to biopharmaceutical characterization of drug substances: cefaclor case. in European Journal of Pharmaceutical Sciences. 2013;50(Supplement 1):E213-E213.
doi:10.1016/j.ejps.2013.09.012 .

Homšek, Irena, Dacević, M., Erić, Slavica, "A contribution to biopharmaceutical characterization of drug substances: cefaclor case" in European Journal of Pharmaceutical Sciences, 50, no. Supplement 1 (2013):E213-E213,
https://doi.org/10.1016/j.ejps.2013.09.012 . .

TY  - JOUR
AU  - Kolasinac, Nemanja
AU  - Kachrimanis, Kyriakos
AU  - Đuriš, Jelena
AU  - Homšek, Irena
AU  - Grujić, Branka
AU  - Ibrić, Svetlana
PY  - 2013
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1989
AB  - Solid dispersion systems have been widely used to enhance dissolution rate and oral bioavailability of poorly water-soluble drugs. However, the formulation process development and scale-up present a number of difficulties which has greatly limited their commercial applications. In this study, solid dispersions (SDs) of desloratadine (DSL) with povidone (PVP) and crospovidone (cPVP) were prepared by spray coating technique. The process involved the spray application of 96% ethanol solution of DSL and PVP/cPVP, and subsequent deposition of the coprecipitates onto microcrystalline cellulose pellets during drying by air flow in a mini spray coater. The results from the present study demonstrated that the spray coating process is efficient in preparing SDs with enhanced drug dissolution rate and it is highly efficient in organic solvent removal. Both PVP and cPVP greatly improved drug dissolution rate by SDs, with PVP showing better solubilization capability. Very fast drug dissolution rate is achieved from SDs containing PVP regardless of differences in K grade. SD with smaller particles of cPVP have higher drug dissolution rate in comparison to the cPVP with larger particles. Results from physical state characterization indicate that DSL in SDs exist in the amorphous (high free-energy) state which is probably stabilized by PVP/cPVP. After 6-month accelerated stability study, DSL remains amorphous, while PVP and cPVP act as anti-plasticizing agents, offering efficient steric hindrance for nucleation and crystal growth.
PB  - Taylor & Francis Ltd, Abingdon
T2  - Drug Development and Industrial Pharmacy
T1  - Spray coating as a powerful technique in preparation of solid dispersions with enhanced desloratadine dissolution rate
VL  - 39
IS  - 7
SP  - 1020
EP  - 1027
DO  - 10.3109/03639045.2012.694890
ER  - 

@article{
author = "Kolasinac, Nemanja and Kachrimanis, Kyriakos and Đuriš, Jelena and Homšek, Irena and Grujić, Branka and Ibrić, Svetlana",
year = "2013",
abstract = "Solid dispersion systems have been widely used to enhance dissolution rate and oral bioavailability of poorly water-soluble drugs. However, the formulation process development and scale-up present a number of difficulties which has greatly limited their commercial applications. In this study, solid dispersions (SDs) of desloratadine (DSL) with povidone (PVP) and crospovidone (cPVP) were prepared by spray coating technique. The process involved the spray application of 96% ethanol solution of DSL and PVP/cPVP, and subsequent deposition of the coprecipitates onto microcrystalline cellulose pellets during drying by air flow in a mini spray coater. The results from the present study demonstrated that the spray coating process is efficient in preparing SDs with enhanced drug dissolution rate and it is highly efficient in organic solvent removal. Both PVP and cPVP greatly improved drug dissolution rate by SDs, with PVP showing better solubilization capability. Very fast drug dissolution rate is achieved from SDs containing PVP regardless of differences in K grade. SD with smaller particles of cPVP have higher drug dissolution rate in comparison to the cPVP with larger particles. Results from physical state characterization indicate that DSL in SDs exist in the amorphous (high free-energy) state which is probably stabilized by PVP/cPVP. After 6-month accelerated stability study, DSL remains amorphous, while PVP and cPVP act as anti-plasticizing agents, offering efficient steric hindrance for nucleation and crystal growth.",
publisher = "Taylor & Francis Ltd, Abingdon",
journal = "Drug Development and Industrial Pharmacy",
title = "Spray coating as a powerful technique in preparation of solid dispersions with enhanced desloratadine dissolution rate",
volume = "39",
number = "7",
pages = "1020-1027",
doi = "10.3109/03639045.2012.694890"
}

Kolasinac, N., Kachrimanis, K., Đuriš, J., Homšek, I., Grujić, B.,& Ibrić, S.. (2013). Spray coating as a powerful technique in preparation of solid dispersions with enhanced desloratadine dissolution rate. in Drug Development and Industrial Pharmacy
Taylor & Francis Ltd, Abingdon., 39(7), 1020-1027.
https://doi.org/10.3109/03639045.2012.694890

Kolasinac N, Kachrimanis K, Đuriš J, Homšek I, Grujić B, Ibrić S. Spray coating as a powerful technique in preparation of solid dispersions with enhanced desloratadine dissolution rate. in Drug Development and Industrial Pharmacy. 2013;39(7):1020-1027.
doi:10.3109/03639045.2012.694890 .

Kolasinac, Nemanja, Kachrimanis, Kyriakos, Đuriš, Jelena, Homšek, Irena, Grujić, Branka, Ibrić, Svetlana, "Spray coating as a powerful technique in preparation of solid dispersions with enhanced desloratadine dissolution rate" in Drug Development and Industrial Pharmacy, 39, no. 7 (2013):1020-1027,
https://doi.org/10.3109/03639045.2012.694890 . .

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 .

TY  - JOUR
AU  - Kocić, Ivana
AU  - Homšek, Irena
AU  - Dacević, Mirjana
AU  - Cvijić, Sandra
AU  - Parojčić, Jelena
AU  - Vučićević, Katarina
AU  - Prostran, Milica
AU  - Miljković, Branislava
PY  - 2012
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1704
AB  - The aim of this case study was to develop a drug-specific absorption model for levothyroxine (LT4) using mechanistic gastrointestinal simulation technology (GIST) implemented in the GastroPlus (TM) software package. The required input parameters were determined experimentally, in silico predicted and/or taken from the literature. The simulated plasma profile was similar and in a good agreement with the data observed in the in vivo bioequivalence study, indicating that the GIST model gave an accurate prediction of LT4 oral absorption. Additionally, plasma concentrationtime profiles were simulated based on a set of experimental and virtual in vitro dissolution data in order to estimate the influence of different in vitro drug dissolution kinetics on the simulated plasma profiles and to identify biorelevant dissolution specification for LT4 immediate-release (IR) tablets. A set of experimental and virtual in vitro data was also used for correlation purposes. In vitroin vivo correlation model based on the convolution approach was applied in order to assess the relationship between the in vitro and in vivo data. The obtained results suggest that dissolution specification of more than 85% LT4 dissolved in 60 min might be considered as biorelevant dissolution specification criteria for LT4 IR tablets. Copyright
PB  - Wiley-Blackwell, Malden
T2  - Biopharmaceutics & Drug Disposition
T1  - A case study on the in silico absorption simulations of levothyroxine sodium immediate-release tablets
VL  - 33
IS  - 3
SP  - 146
EP  - 159
DO  - 10.1002/bdd.1780
ER  - 

@article{
author = "Kocić, Ivana and Homšek, Irena and Dacević, Mirjana and Cvijić, Sandra and Parojčić, Jelena and Vučićević, Katarina and Prostran, Milica and Miljković, Branislava",
year = "2012",
abstract = "The aim of this case study was to develop a drug-specific absorption model for levothyroxine (LT4) using mechanistic gastrointestinal simulation technology (GIST) implemented in the GastroPlus (TM) software package. The required input parameters were determined experimentally, in silico predicted and/or taken from the literature. The simulated plasma profile was similar and in a good agreement with the data observed in the in vivo bioequivalence study, indicating that the GIST model gave an accurate prediction of LT4 oral absorption. Additionally, plasma concentrationtime profiles were simulated based on a set of experimental and virtual in vitro dissolution data in order to estimate the influence of different in vitro drug dissolution kinetics on the simulated plasma profiles and to identify biorelevant dissolution specification for LT4 immediate-release (IR) tablets. A set of experimental and virtual in vitro data was also used for correlation purposes. In vitroin vivo correlation model based on the convolution approach was applied in order to assess the relationship between the in vitro and in vivo data. The obtained results suggest that dissolution specification of more than 85% LT4 dissolved in 60 min might be considered as biorelevant dissolution specification criteria for LT4 IR tablets. Copyright",
publisher = "Wiley-Blackwell, Malden",
journal = "Biopharmaceutics & Drug Disposition",
title = "A case study on the in silico absorption simulations of levothyroxine sodium immediate-release tablets",
volume = "33",
number = "3",
pages = "146-159",
doi = "10.1002/bdd.1780"
}

Kocić, I., Homšek, I., Dacević, M., Cvijić, S., Parojčić, J., Vučićević, K., Prostran, M.,& Miljković, B.. (2012). A case study on the in silico absorption simulations of levothyroxine sodium immediate-release tablets. in Biopharmaceutics & Drug Disposition
Wiley-Blackwell, Malden., 33(3), 146-159.
https://doi.org/10.1002/bdd.1780

Kocić I, Homšek I, Dacević M, Cvijić S, Parojčić J, Vučićević K, Prostran M, Miljković B. A case study on the in silico absorption simulations of levothyroxine sodium immediate-release tablets. in Biopharmaceutics & Drug Disposition. 2012;33(3):146-159.
doi:10.1002/bdd.1780 .

Kocić, Ivana, Homšek, Irena, Dacević, Mirjana, Cvijić, Sandra, Parojčić, Jelena, Vučićević, Katarina, Prostran, Milica, Miljković, Branislava, "A case study on the in silico absorption simulations of levothyroxine sodium immediate-release tablets" in Biopharmaceutics & Drug Disposition, 33, no. 3 (2012):146-159,
https://doi.org/10.1002/bdd.1780 . .

TY  - JOUR
AU  - Kolasinac, Nemanja
AU  - Kachrimanis, Kyriakos
AU  - Homšek, Irena
AU  - Grujić, Branka
AU  - Đurić, Zorica
AU  - Ibrić, Svetlana
PY  - 2012
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1640
AB  - The present study investigates the possibility of using poloxamers as solubility and dissolution rate enhancing agents of the poorly water soluble drug substance desloratadine that can be used for the preparation of immediate release tablet formulation. Two commercially available poloxamer grades (poloxamer P 188 and poloxamer P 407) were selected, and solid dispersions (SDs) containing different weight ratio of poloxamers and desloratadine were prepared by a low temperature melting method. All SDs were subjected to basic physicochemical characterization by thermal and vibrational spectroscopy methods in order to evaluate the efficiency of poloxamers as solubility enhancers. Immediate release tablets were prepared by direct compression of powdered solid dispersions according to a General Factorial Design, in order to evaluate the statistical significance of two formulation (X-1 - type of poloxamer in SD and X-2 - poloxamer ratio in SD) and one process variable (X-3 - compression force) on the drug dissolution rate. It was found that desloratadine in SDs existed in the amorphous state, and that can be largely responsible for the enhanced intrinsic solubility, which was more pronounced in SDs containing poloxamer 188. Statistical analysis of the factorial design revealed that both investigated formulation variables exert a significant effect on the drug dissolution rate. Increased poloxamer ratio in SDs resulted in increased drug dissolution rate, with poloxamer 188 contributing to a faster dissolution rate than poloxamer 407, in accordance with the results of intrinsic dissolution tests. Moreover, there is a significant interaction between poloxamer ratio in SD and compression force. Higher poloxamer ratio in SDs and higher compression force results in a significant decrease of the drug dissolution rate, which can be attributed to the lower porosity of the tablets and more pronounced bonding between poloxamer particles.
PB  - Elsevier Science BV, Amsterdam
T2  - International Journal of Pharmaceutics
T1  - Solubility enhancement of desloratadine by solid dispersion in poloxamers
VL  - 436
IS  - 1-2
SP  - 161
EP  - 170
DO  - 10.1016/j.ijpharm.2012.06.060
ER  - 

@article{
author = "Kolasinac, Nemanja and Kachrimanis, Kyriakos and Homšek, Irena and Grujić, Branka and Đurić, Zorica and Ibrić, Svetlana",
year = "2012",
abstract = "The present study investigates the possibility of using poloxamers as solubility and dissolution rate enhancing agents of the poorly water soluble drug substance desloratadine that can be used for the preparation of immediate release tablet formulation. Two commercially available poloxamer grades (poloxamer P 188 and poloxamer P 407) were selected, and solid dispersions (SDs) containing different weight ratio of poloxamers and desloratadine were prepared by a low temperature melting method. All SDs were subjected to basic physicochemical characterization by thermal and vibrational spectroscopy methods in order to evaluate the efficiency of poloxamers as solubility enhancers. Immediate release tablets were prepared by direct compression of powdered solid dispersions according to a General Factorial Design, in order to evaluate the statistical significance of two formulation (X-1 - type of poloxamer in SD and X-2 - poloxamer ratio in SD) and one process variable (X-3 - compression force) on the drug dissolution rate. It was found that desloratadine in SDs existed in the amorphous state, and that can be largely responsible for the enhanced intrinsic solubility, which was more pronounced in SDs containing poloxamer 188. Statistical analysis of the factorial design revealed that both investigated formulation variables exert a significant effect on the drug dissolution rate. Increased poloxamer ratio in SDs resulted in increased drug dissolution rate, with poloxamer 188 contributing to a faster dissolution rate than poloxamer 407, in accordance with the results of intrinsic dissolution tests. Moreover, there is a significant interaction between poloxamer ratio in SD and compression force. Higher poloxamer ratio in SDs and higher compression force results in a significant decrease of the drug dissolution rate, which can be attributed to the lower porosity of the tablets and more pronounced bonding between poloxamer particles.",
publisher = "Elsevier Science BV, Amsterdam",
journal = "International Journal of Pharmaceutics",
title = "Solubility enhancement of desloratadine by solid dispersion in poloxamers",
volume = "436",
number = "1-2",
pages = "161-170",
doi = "10.1016/j.ijpharm.2012.06.060"
}

Kolasinac, N., Kachrimanis, K., Homšek, I., Grujić, B., Đurić, Z.,& Ibrić, S.. (2012). Solubility enhancement of desloratadine by solid dispersion in poloxamers. in International Journal of Pharmaceutics
Elsevier Science BV, Amsterdam., 436(1-2), 161-170.
https://doi.org/10.1016/j.ijpharm.2012.06.060

Kolasinac N, Kachrimanis K, Homšek I, Grujić B, Đurić Z, Ibrić S. Solubility enhancement of desloratadine by solid dispersion in poloxamers. in International Journal of Pharmaceutics. 2012;436(1-2):161-170.
doi:10.1016/j.ijpharm.2012.06.060 .

Kolasinac, Nemanja, Kachrimanis, Kyriakos, Homšek, Irena, Grujić, Branka, Đurić, Zorica, Ibrić, Svetlana, "Solubility enhancement of desloratadine by solid dispersion in poloxamers" in International Journal of Pharmaceutics, 436, no. 1-2 (2012):161-170,
https://doi.org/10.1016/j.ijpharm.2012.06.060 . .

TY  - JOUR
AU  - Homšek, Irena
AU  - Popadić, Dragica
AU  - Simić, Slobodanka
AU  - Ristić, Slavica M.
AU  - Vučićević, Katarina
AU  - Miljković, Branislava
PY  - 2011
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1613
AB  - Controlled-release (CR) pharmaceutical formulations offer several advantages over the conventional, immediate release dosage forms of the same drug, including reduced dosing frequency, decreased incidence and/or intensity of adverse effects, greater selectivity of pharmacological activity, reduced drug plasma fluctuation, and better compliance. After a drug product has been registered, and is already on market, minor changes in formulation might be needed. At the same time, the product has to remain effective and safe for patients that could be confirmed via plasma drug concentrations and pharmacokinetic characteristics. It is challenging to predict human absorption and pharmacokinetic characteristics of a drug based on the in vitro dissolution test and the animal pharmacokinetic data. Therefore, the objective of this study was to establish correlation of the pharmacokinetic parameters of carbamazepine (CBZ) CR tablet formulation between the rabbit and the human model, and to establish in vitro in vivo correlation (IVIVC) based on the predicted fractions of absorbed CBZ. Although differences in mean plasma concentration profiles were notified, the data concerning the predicted fraction of drug absorbed were almost superimposable. Accordingly, it can be concluded that rabbits may be representative as an in vivo model for predicting the pharmacokinetics of the CR formulation of CBZ in humans.
AB  - Farmaceutske formulacije sa kontrolisanim oslobađanjem imaju nekoliko prednosti u odnosu na konvencionalne dozirane oblike sa trenutnim oslobađanjem iste lekovite supstance. To se pre svega ogleda u redukovanoj učestalosti doziranja, smanjenoj pojavi i/ili intenzitetu neželjenih efekata, većoj farmakološkoj selektivnosti, redukovanoj fluktuaciji lekovite supstance u plazmi i boljoj podnošljivosti. Kada se posle završene registracije preparat nađe na tržištu, može se javiti potreba za manjim izmenama u formulaciji. U isto vreme on treba da ostane efikasan i bezbedan za pacijente, što može biti potvrđeno na osnovu koncentracije lekovite supstance u plazmi i farmakokinetičkih podataka. Poseban izazov predstavlja predviđanje resorpcije i farmakokinetičkih osobina lekovite supstance kod ljudi na osnovu određivanja in vitro brzine rastvaranja i farmakokinetičkih podataka dobijenih ispitivanjem na životinjskom modelu. Zbog toga je cilj ovog ispitivanja bio da se uspostavi korelacija farmakokinetičkih parametara između modela kunića i humanog modela za formulacije tableta sa kontrolisanim oslobađanjem karbamazepina (KBZ) kao i in vitro in vivo korelacija zasnovana na predviđenoj frakciji resorbovanog leka. I pored uočenih razlika u srednjim profilima plazma koncentracija, rezultati koji se odnose na predviđenu frakciju resorbovane lekovite supstance bili su gotovo identični. Na osnovu toga se može zaključiti da se kunić može koristiti kao reprezentativan in vivo model za predviđanje farmakokinetičkih karakteristika formulacije sa kontrolisanim oslobađanjem KBZ kod ljudi.
PB  - Univerzitet u Beogradu - Fakultet veterinarske medicine, Beograd
T2  - Veterinarski glasnik
T1  - Predicting absorption and pharmacokinetic profile of carbamazepine from controlled-release tablet formulation in humans using rabbit model
T1  - Predviđanje resorpcije i farmakokinetičkog profila karbamazepina iz tableta sa kontrolisanim oslobađanjem kod ljudi korišćenjem modela kunića
VL  - 65
IS  - 1-2
SP  - 71
EP  - 81
DO  - 10.2298/VETGL1102071H
ER  - 

@article{
author = "Homšek, Irena and Popadić, Dragica and Simić, Slobodanka and Ristić, Slavica M. and Vučićević, Katarina and Miljković, Branislava",
year = "2011",
abstract = "Controlled-release (CR) pharmaceutical formulations offer several advantages over the conventional, immediate release dosage forms of the same drug, including reduced dosing frequency, decreased incidence and/or intensity of adverse effects, greater selectivity of pharmacological activity, reduced drug plasma fluctuation, and better compliance. After a drug product has been registered, and is already on market, minor changes in formulation might be needed. At the same time, the product has to remain effective and safe for patients that could be confirmed via plasma drug concentrations and pharmacokinetic characteristics. It is challenging to predict human absorption and pharmacokinetic characteristics of a drug based on the in vitro dissolution test and the animal pharmacokinetic data. Therefore, the objective of this study was to establish correlation of the pharmacokinetic parameters of carbamazepine (CBZ) CR tablet formulation between the rabbit and the human model, and to establish in vitro in vivo correlation (IVIVC) based on the predicted fractions of absorbed CBZ. Although differences in mean plasma concentration profiles were notified, the data concerning the predicted fraction of drug absorbed were almost superimposable. Accordingly, it can be concluded that rabbits may be representative as an in vivo model for predicting the pharmacokinetics of the CR formulation of CBZ in humans., Farmaceutske formulacije sa kontrolisanim oslobađanjem imaju nekoliko prednosti u odnosu na konvencionalne dozirane oblike sa trenutnim oslobađanjem iste lekovite supstance. To se pre svega ogleda u redukovanoj učestalosti doziranja, smanjenoj pojavi i/ili intenzitetu neželjenih efekata, većoj farmakološkoj selektivnosti, redukovanoj fluktuaciji lekovite supstance u plazmi i boljoj podnošljivosti. Kada se posle završene registracije preparat nađe na tržištu, može se javiti potreba za manjim izmenama u formulaciji. U isto vreme on treba da ostane efikasan i bezbedan za pacijente, što može biti potvrđeno na osnovu koncentracije lekovite supstance u plazmi i farmakokinetičkih podataka. Poseban izazov predstavlja predviđanje resorpcije i farmakokinetičkih osobina lekovite supstance kod ljudi na osnovu određivanja in vitro brzine rastvaranja i farmakokinetičkih podataka dobijenih ispitivanjem na životinjskom modelu. Zbog toga je cilj ovog ispitivanja bio da se uspostavi korelacija farmakokinetičkih parametara između modela kunića i humanog modela za formulacije tableta sa kontrolisanim oslobađanjem karbamazepina (KBZ) kao i in vitro in vivo korelacija zasnovana na predviđenoj frakciji resorbovanog leka. I pored uočenih razlika u srednjim profilima plazma koncentracija, rezultati koji se odnose na predviđenu frakciju resorbovane lekovite supstance bili su gotovo identični. Na osnovu toga se može zaključiti da se kunić može koristiti kao reprezentativan in vivo model za predviđanje farmakokinetičkih karakteristika formulacije sa kontrolisanim oslobađanjem KBZ kod ljudi.",
publisher = "Univerzitet u Beogradu - Fakultet veterinarske medicine, Beograd",
journal = "Veterinarski glasnik",
title = "Predicting absorption and pharmacokinetic profile of carbamazepine from controlled-release tablet formulation in humans using rabbit model, Predviđanje resorpcije i farmakokinetičkog profila karbamazepina iz tableta sa kontrolisanim oslobađanjem kod ljudi korišćenjem modela kunića",
volume = "65",
number = "1-2",
pages = "71-81",
doi = "10.2298/VETGL1102071H"
}

Homšek, I., Popadić, D., Simić, S., Ristić, S. M., Vučićević, K.,& Miljković, B.. (2011). Predicting absorption and pharmacokinetic profile of carbamazepine from controlled-release tablet formulation in humans using rabbit model. in Veterinarski glasnik
Univerzitet u Beogradu - Fakultet veterinarske medicine, Beograd., 65(1-2), 71-81.
https://doi.org/10.2298/VETGL1102071H

Homšek I, Popadić D, Simić S, Ristić SM, Vučićević K, Miljković B. Predicting absorption and pharmacokinetic profile of carbamazepine from controlled-release tablet formulation in humans using rabbit model. in Veterinarski glasnik. 2011;65(1-2):71-81.
doi:10.2298/VETGL1102071H .

Homšek, Irena, Popadić, Dragica, Simić, Slobodanka, Ristić, Slavica M., Vučićević, Katarina, Miljković, Branislava, "Predicting absorption and pharmacokinetic profile of carbamazepine from controlled-release tablet formulation in humans using rabbit model" in Veterinarski glasnik, 65, no. 1-2 (2011):71-81,
https://doi.org/10.2298/VETGL1102071H . .

TY  - CONF
AU  - Kocić, Ivana
AU  - Homšek, Irena
AU  - Dacević, M.
AU  - Grbić, S.
AU  - Parojčić, Jelena
AU  - Miljković, Branislava
PY  - 2011
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1461
PB  - Elsevier Science BV, Amsterdam
C3  - European Journal of Pharmaceutical Sciences
T1  - Application of gastrointestinal simulation for development of in vitro-in vivo correlation for levothyroxine sodium immediate-release tablets
VL  - 44
IS  - Supplement 1
SP  - 112
EP  - 113
DO  - 10.1016/j.ejps.2011.08.002
UR  - https://hdl.handle.net/21.15107/rcub_farfar_1461
ER  - 

@conference{
author = "Kocić, Ivana and Homšek, Irena and Dacević, M. and Grbić, S. and Parojčić, Jelena and Miljković, Branislava",
year = "2011",
publisher = "Elsevier Science BV, Amsterdam",
journal = "European Journal of Pharmaceutical Sciences",
title = "Application of gastrointestinal simulation for development of in vitro-in vivo correlation for levothyroxine sodium immediate-release tablets",
volume = "44",
number = "Supplement 1",
pages = "112-113",
doi = "10.1016/j.ejps.2011.08.002",
url = "https://hdl.handle.net/21.15107/rcub_farfar_1461"
}

Kocić, I., Homšek, I., Dacević, M., Grbić, S., Parojčić, J.,& Miljković, B.. (2011). Application of gastrointestinal simulation for development of in vitro-in vivo correlation for levothyroxine sodium immediate-release tablets. in European Journal of Pharmaceutical Sciences
Elsevier Science BV, Amsterdam., 44(Supplement 1), 112-113.
https://doi.org/10.1016/j.ejps.2011.08.002
https://hdl.handle.net/21.15107/rcub_farfar_1461

Kocić I, Homšek I, Dacević M, Grbić S, Parojčić J, Miljković B. Application of gastrointestinal simulation for development of in vitro-in vivo correlation for levothyroxine sodium immediate-release tablets. in European Journal of Pharmaceutical Sciences. 2011;44(Supplement 1):112-113.
doi:10.1016/j.ejps.2011.08.002
https://hdl.handle.net/21.15107/rcub_farfar_1461 .

Kocić, Ivana, Homšek, Irena, Dacević, M., Grbić, S., Parojčić, Jelena, Miljković, Branislava, "Application of gastrointestinal simulation for development of in vitro-in vivo correlation for levothyroxine sodium immediate-release tablets" in European Journal of Pharmaceutical Sciences, 44, no. Supplement 1 (2011):112-113,
https://doi.org/10.1016/j.ejps.2011.08.002 .,
https://hdl.handle.net/21.15107/rcub_farfar_1461 .

TY  - JOUR
AU  - Kocić, Ivana
AU  - Homšek, Irena
AU  - Dacević, Mirjana
AU  - Parojčić, Jelena
AU  - Miljković, Branislava
PY  - 2011
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1476
AB  - The aim of this study was to investigate the influence of experimental conditions on levothyroxine sodium release from two immediate-release tablet formulations which narrowly passed the standard requirements for bioequivalence studies. The in vivo study was conducted as randomised, single-dose, two-way cross-over pharmacokinetic study in 24 healthy subjects. The in vitro study was performed using various dissolution media, and obtained dissolution profiles were compared using the similarity factor value. Drug solubility in different media was also determined. The in vivo results showed narrowly passing bioequivalence. Considering that levothyroxine sodium is classified as Class III drug according to the Biopharmaceutics Classification System, drug bioavailability will be less sensitive to the variation in its dissolution characteristics and it can be assumed that the differences observed in vitro in some of investigated media probably do not have significant influence on the absorption process, as long as rapid and complete dissolution exists. The study results indicate that the current regulatory criteria for the value of similarity factor in comparative dissolution testing, as well as request for very rapid dissolution (more than 85% of drug dissolved in 15 min), are very restricted for immediate-release dosage forms containing highly soluble drug substance and need further investigation. The obtained results also add to the existing debate on the appropriateness of the current bioequivalence standards for levothyroxine sodium products.
PB  - Springer, New York
T2  - AAPS PharmSciTech
T1  - An Investigation into the Influence of Experimental Conditions on In Vitro Drug Release from Immediate-Release Tablets of Levothyroxine Sodium and Its Relation to Oral Bioavailability
VL  - 12
IS  - 3
SP  - 938
EP  - 948
DO  - 10.1208/s12249-011-9660-8
ER  - 

@article{
author = "Kocić, Ivana and Homšek, Irena and Dacević, Mirjana and Parojčić, Jelena and Miljković, Branislava",
year = "2011",
abstract = "The aim of this study was to investigate the influence of experimental conditions on levothyroxine sodium release from two immediate-release tablet formulations which narrowly passed the standard requirements for bioequivalence studies. The in vivo study was conducted as randomised, single-dose, two-way cross-over pharmacokinetic study in 24 healthy subjects. The in vitro study was performed using various dissolution media, and obtained dissolution profiles were compared using the similarity factor value. Drug solubility in different media was also determined. The in vivo results showed narrowly passing bioequivalence. Considering that levothyroxine sodium is classified as Class III drug according to the Biopharmaceutics Classification System, drug bioavailability will be less sensitive to the variation in its dissolution characteristics and it can be assumed that the differences observed in vitro in some of investigated media probably do not have significant influence on the absorption process, as long as rapid and complete dissolution exists. The study results indicate that the current regulatory criteria for the value of similarity factor in comparative dissolution testing, as well as request for very rapid dissolution (more than 85% of drug dissolved in 15 min), are very restricted for immediate-release dosage forms containing highly soluble drug substance and need further investigation. The obtained results also add to the existing debate on the appropriateness of the current bioequivalence standards for levothyroxine sodium products.",
publisher = "Springer, New York",
journal = "AAPS PharmSciTech",
title = "An Investigation into the Influence of Experimental Conditions on In Vitro Drug Release from Immediate-Release Tablets of Levothyroxine Sodium and Its Relation to Oral Bioavailability",
volume = "12",
number = "3",
pages = "938-948",
doi = "10.1208/s12249-011-9660-8"
}

Kocić, I., Homšek, I., Dacević, M., Parojčić, J.,& Miljković, B.. (2011). An Investigation into the Influence of Experimental Conditions on In Vitro Drug Release from Immediate-Release Tablets of Levothyroxine Sodium and Its Relation to Oral Bioavailability. in AAPS PharmSciTech
Springer, New York., 12(3), 938-948.
https://doi.org/10.1208/s12249-011-9660-8

Kocić I, Homšek I, Dacević M, Parojčić J, Miljković B. An Investigation into the Influence of Experimental Conditions on In Vitro Drug Release from Immediate-Release Tablets of Levothyroxine Sodium and Its Relation to Oral Bioavailability. in AAPS PharmSciTech. 2011;12(3):938-948.
doi:10.1208/s12249-011-9660-8 .

Kocić, Ivana, Homšek, Irena, Dacević, Mirjana, Parojčić, Jelena, Miljković, Branislava, "An Investigation into the Influence of Experimental Conditions on In Vitro Drug Release from Immediate-Release Tablets of Levothyroxine Sodium and Its Relation to Oral Bioavailability" in AAPS PharmSciTech, 12, no. 3 (2011):938-948,
https://doi.org/10.1208/s12249-011-9660-8 . .

TY  - JOUR
AU  - Homšek, Irena
AU  - Parojčić, Jelena
AU  - Dacević, Mirjana
AU  - Petrović, Ljiljana
AU  - Jovanović, Dušan
PY  - 2010
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1404
AB  - The Biopharmaceutics Classification System (BCS) represents the framework for predicting the intestinal drug absorption based on its solubility and intestinal permeability. Recent research has lead to the use of in vitro tests to waive additional in vivo bioequivalence studies for some pharmaceutical products (i.e. biowaiver). The current regulations permit waivers for BCS Class I (highly soluble/highly permeable) drug substances, which represent up to 25% of the drugs. Efforts in both the science and regulatory bodies are being made to extend biowaivers to certain Class II and III products, which would represent more than 50% of all drugs coming to the market. The aim of this study was to investigate the influence of experimental conditions on metformin hydrochloride (CAS 1115-70-4) release from two immediate-release tablet formulations with proven bioequivalence and justify the biowaiver request for dissolution profile similarity in three pH media. The results obtained indicate that differences in drug dissolution observed in vitro were not reflected in vivo. Such data support the existing idea that BCS Class III drugs are eligible biowaiver candidates, even if a very rapid dissolution criterion is not fulfilled.
PB  - ECV-Editio Cantor Verlag Medizin Naturwissenschaften, Aulendorf
T2  - Arzneimittelforschung - Drug Research
T1  - Justification of metformin hydrochloride biowaiver criteria based on bioequivalence study
VL  - 60
IS  - 9
SP  - 553
EP  - 559
DO  - 10.1055/s-0031-1296324
UR  - https://hdl.handle.net/21.15107/rcub_farfar_1404
ER  - 

@article{
author = "Homšek, Irena and Parojčić, Jelena and Dacević, Mirjana and Petrović, Ljiljana and Jovanović, Dušan",
year = "2010",
abstract = "The Biopharmaceutics Classification System (BCS) represents the framework for predicting the intestinal drug absorption based on its solubility and intestinal permeability. Recent research has lead to the use of in vitro tests to waive additional in vivo bioequivalence studies for some pharmaceutical products (i.e. biowaiver). The current regulations permit waivers for BCS Class I (highly soluble/highly permeable) drug substances, which represent up to 25% of the drugs. Efforts in both the science and regulatory bodies are being made to extend biowaivers to certain Class II and III products, which would represent more than 50% of all drugs coming to the market. The aim of this study was to investigate the influence of experimental conditions on metformin hydrochloride (CAS 1115-70-4) release from two immediate-release tablet formulations with proven bioequivalence and justify the biowaiver request for dissolution profile similarity in three pH media. The results obtained indicate that differences in drug dissolution observed in vitro were not reflected in vivo. Such data support the existing idea that BCS Class III drugs are eligible biowaiver candidates, even if a very rapid dissolution criterion is not fulfilled.",
publisher = "ECV-Editio Cantor Verlag Medizin Naturwissenschaften, Aulendorf",
journal = "Arzneimittelforschung - Drug Research",
title = "Justification of metformin hydrochloride biowaiver criteria based on bioequivalence study",
volume = "60",
number = "9",
pages = "553-559",
doi = "10.1055/s-0031-1296324",
url = "https://hdl.handle.net/21.15107/rcub_farfar_1404"
}

Homšek, I., Parojčić, J., Dacević, M., Petrović, L.,& Jovanović, D.. (2010). Justification of metformin hydrochloride biowaiver criteria based on bioequivalence study. in Arzneimittelforschung - Drug Research
ECV-Editio Cantor Verlag Medizin Naturwissenschaften, Aulendorf., 60(9), 553-559.
https://doi.org/10.1055/s-0031-1296324
https://hdl.handle.net/21.15107/rcub_farfar_1404

Homšek I, Parojčić J, Dacević M, Petrović L, Jovanović D. Justification of metformin hydrochloride biowaiver criteria based on bioequivalence study. in Arzneimittelforschung - Drug Research. 2010;60(9):553-559.
doi:10.1055/s-0031-1296324
https://hdl.handle.net/21.15107/rcub_farfar_1404 .

Homšek, Irena, Parojčić, Jelena, Dacević, Mirjana, Petrović, Ljiljana, Jovanović, Dušan, "Justification of metformin hydrochloride biowaiver criteria based on bioequivalence study" in Arzneimittelforschung - Drug Research, 60, no. 9 (2010):553-559,
https://doi.org/10.1055/s-0031-1296324 .,
https://hdl.handle.net/21.15107/rcub_farfar_1404 .

TY  - JOUR
AU  - Mašić, Ivana
AU  - Ilić, Marija
AU  - Petrović, Ljiljana
AU  - Trajković, Svetlana
AU  - Homšek, Irena
AU  - Parojčić, Jelena
AU  - Đurić, Zorica
PY  - 2009
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1316
AB  - With the introduction of Biopharmaceutics Classification System (BCS) and 'biowaiver' concept, there is an increased interest in the extension of biowaiver criteria to highly soluble/low permeable drugs (i.e. BCS class 3 drugs). In order to justify the exemption from in vivo studies, a discriminating in vitro dissolution method should be established. The aim of this study was to evaluate the effects of the type of apparatus, agitation intensity and pH value on metformin hydrochloride release from commercially available immediate release tablets. The tablets were also assayed for their disintegration time. The results obtained revealed that the drug release rate was considerably influenced by the agitation intensity. The fastest dissolution rates were observed in the basket apparatus while the slowest drug release from all the investigated products was obtained in the mini paddle apparatus. Significant differences were observed between the dissolution profiles of the investigated products nevertheless of the experimental conditions applied. The results obtained showed that there is a connection between tablet disintegration times and dissolution rates. The results obtained indicate that current similarity factor criteria might be too conservative, as well as the recommended request for very rapid dissolution in the biowaiver application for highly soluble drugs and merits further consideration.
AB  - Prihvatanje Biofarmaceutskog sistema klasifikacije (BSK) i 'biowaiver' koncepta od strane regulatornih agencija, doveo je do povećanog interesa za mogućnost njihove primene u slučaju visoko rastvorljivih/nisko permeabilnih lekova (koji pripadaju BSK grupi 3). Da bi se opravdao zahtev za izostavljanje in vivo ispitivanja, potrebno je razviti diskriminatoran metod za in vitro ispitivanje brzine rastvaranja. Cilj ovog rada bio je da se ispita uticaj vrste aparature, intenziteta mešanja i pH vrednosti medijuma na brzinu rastvaranja metformin-hidrohlorida iz tableta različitih proizvođača. Takođe je ispitana i raspadljivost tableta. Rezultati ispitivanja su pokazali da intenzitet mešanja u znatnoj meri utiče na brzinu rastvaranja metformin-hidrohlorida iz tableta. Najbrže rastvaranje postignuto je u aparaturi sa korpicom, pri 100 rpm, dok je rastvaranje metformin-hidrohlorida bilo najsporije u aparaturi tipa mini lopatice, pri 50 rpm. Uočene su značajne razlike između ispitivanih preparata bez obzira na primenjene eksperimentalne uslove. Rezultati ispitivanja brzine rastvaranja bili su u korelaciji sa raspadljivošću tableta. Dobijeni rezultati ukazuju da je postojeći kriterijum prihvatljivosti za vrednost faktora sličnosti pri uporednom ispitivanju brzine rastvaranja, kao i zahtev za 'veoma brzo rastvaranje' s ciljem izostavljanja in vivo ispitivanja u slučaju visoko rastvorljivih lekovitih supstanci veoma strog i zaslužuje da bude dodatno razmotren.
PB  - Savez farmaceutskih udruženja Srbije, Beograd
T2  - Arhiv za farmaciju
T1  - Comparative dissolution study of commercially available metformin hydrochloride immediate-release tablets
T1  - Uporedno ispitivanje brzine rastvaranja metformin-hidrohlorida iz tableta različitih proizvođača
VL  - 59
IS  - 4
SP  - 279
EP  - 293
UR  - https://hdl.handle.net/21.15107/rcub_farfar_1316
ER  - 

@article{
author = "Mašić, Ivana and Ilić, Marija and Petrović, Ljiljana and Trajković, Svetlana and Homšek, Irena and Parojčić, Jelena and Đurić, Zorica",
year = "2009",
abstract = "With the introduction of Biopharmaceutics Classification System (BCS) and 'biowaiver' concept, there is an increased interest in the extension of biowaiver criteria to highly soluble/low permeable drugs (i.e. BCS class 3 drugs). In order to justify the exemption from in vivo studies, a discriminating in vitro dissolution method should be established. The aim of this study was to evaluate the effects of the type of apparatus, agitation intensity and pH value on metformin hydrochloride release from commercially available immediate release tablets. The tablets were also assayed for their disintegration time. The results obtained revealed that the drug release rate was considerably influenced by the agitation intensity. The fastest dissolution rates were observed in the basket apparatus while the slowest drug release from all the investigated products was obtained in the mini paddle apparatus. Significant differences were observed between the dissolution profiles of the investigated products nevertheless of the experimental conditions applied. The results obtained showed that there is a connection between tablet disintegration times and dissolution rates. The results obtained indicate that current similarity factor criteria might be too conservative, as well as the recommended request for very rapid dissolution in the biowaiver application for highly soluble drugs and merits further consideration., Prihvatanje Biofarmaceutskog sistema klasifikacije (BSK) i 'biowaiver' koncepta od strane regulatornih agencija, doveo je do povećanog interesa za mogućnost njihove primene u slučaju visoko rastvorljivih/nisko permeabilnih lekova (koji pripadaju BSK grupi 3). Da bi se opravdao zahtev za izostavljanje in vivo ispitivanja, potrebno je razviti diskriminatoran metod za in vitro ispitivanje brzine rastvaranja. Cilj ovog rada bio je da se ispita uticaj vrste aparature, intenziteta mešanja i pH vrednosti medijuma na brzinu rastvaranja metformin-hidrohlorida iz tableta različitih proizvođača. Takođe je ispitana i raspadljivost tableta. Rezultati ispitivanja su pokazali da intenzitet mešanja u znatnoj meri utiče na brzinu rastvaranja metformin-hidrohlorida iz tableta. Najbrže rastvaranje postignuto je u aparaturi sa korpicom, pri 100 rpm, dok je rastvaranje metformin-hidrohlorida bilo najsporije u aparaturi tipa mini lopatice, pri 50 rpm. Uočene su značajne razlike između ispitivanih preparata bez obzira na primenjene eksperimentalne uslove. Rezultati ispitivanja brzine rastvaranja bili su u korelaciji sa raspadljivošću tableta. Dobijeni rezultati ukazuju da je postojeći kriterijum prihvatljivosti za vrednost faktora sličnosti pri uporednom ispitivanju brzine rastvaranja, kao i zahtev za 'veoma brzo rastvaranje' s ciljem izostavljanja in vivo ispitivanja u slučaju visoko rastvorljivih lekovitih supstanci veoma strog i zaslužuje da bude dodatno razmotren.",
publisher = "Savez farmaceutskih udruženja Srbije, Beograd",
journal = "Arhiv za farmaciju",
title = "Comparative dissolution study of commercially available metformin hydrochloride immediate-release tablets, Uporedno ispitivanje brzine rastvaranja metformin-hidrohlorida iz tableta različitih proizvođača",
volume = "59",
number = "4",
pages = "279-293",
url = "https://hdl.handle.net/21.15107/rcub_farfar_1316"
}

Mašić, I., Ilić, M., Petrović, L., Trajković, S., Homšek, I., Parojčić, J.,& Đurić, Z.. (2009). Comparative dissolution study of commercially available metformin hydrochloride immediate-release tablets. in Arhiv za farmaciju
Savez farmaceutskih udruženja Srbije, Beograd., 59(4), 279-293.
https://hdl.handle.net/21.15107/rcub_farfar_1316

Mašić I, Ilić M, Petrović L, Trajković S, Homšek I, Parojčić J, Đurić Z. Comparative dissolution study of commercially available metformin hydrochloride immediate-release tablets. in Arhiv za farmaciju. 2009;59(4):279-293.
https://hdl.handle.net/21.15107/rcub_farfar_1316 .

Mašić, Ivana, Ilić, Marija, Petrović, Ljiljana, Trajković, Svetlana, Homšek, Irena, Parojčić, Jelena, Đurić, Zorica, "Comparative dissolution study of commercially available metformin hydrochloride immediate-release tablets" in Arhiv za farmaciju, 59, no. 4 (2009):279-293,
https://hdl.handle.net/21.15107/rcub_farfar_1316 .

TY  - JOUR
AU  - Kovacević, Ivan
AU  - Parojčić, Jelena
AU  - Homšek, Irena
AU  - Tubić-Grozdanis, Marija
AU  - Langguth, Peter
PY  - 2009
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1252
AB  - The aim of the present study was to use gastrointestinal simulation technology and in vitro-in vivo correlation (IVIVC) as tools to investigate a possible extension of biowaiver criteria to BCS class II drugs using carbamazepine (CBZ) as a candidate compound. Gastrointestinal simulation based on the advanced compartmental absorption and transit model implemented in GastroPlus was used. Actual in vitro and in vivo data generated in CBZ bioequivalence studies were used for correlation purposes. The simulated plasma profile, based on the CBZ physicochemical and pharmacokinetic properties, was almost identical with that observed in vivo. Parameter sensitivity analysis (PSA) indicated that the percent of drug absorbed is relatively insensitive to the variation of the input parameters. Additionally, plasma concentration-time profiles were simulated based on dissolution profiles observed under the different experimental conditions. Regardless of the differences observed in vitro, the predicted pharmacokinetic profiles were similar in the extent of drug exposure (AUC) while there were certain differences in parameters defining the drug absorption rate (C-max, t(max)). High level A IVIVC was established for the pooled data set (r = 0.9624), indicating that 1% SLS may be considered as the universal biorelevant dissolution medium for both the IR and CR CBZ tablets. The proposed methodology involving gastrointestinal simulation technology and IVIVC suggests that there is a rationale for considering CBZ biowaiver extension and introduction of the wider dissolution specifications for CBZ immediate release tablets.
PB  - Amer Chemical Soc, Washington
T2  - Molecular Pharmaceutics
T1  - Justification of Biowaiver for Carbamazepine, a Low Soluble High Permeable Compound, in Solid Dosage Forms Based on IVIVC and Gastrointestinal Simulation
VL  - 6
IS  - 1
SP  - 40
EP  - 47
DO  - 10.1021/mp800128y
ER  - 

@article{
author = "Kovacević, Ivan and Parojčić, Jelena and Homšek, Irena and Tubić-Grozdanis, Marija and Langguth, Peter",
year = "2009",
abstract = "The aim of the present study was to use gastrointestinal simulation technology and in vitro-in vivo correlation (IVIVC) as tools to investigate a possible extension of biowaiver criteria to BCS class II drugs using carbamazepine (CBZ) as a candidate compound. Gastrointestinal simulation based on the advanced compartmental absorption and transit model implemented in GastroPlus was used. Actual in vitro and in vivo data generated in CBZ bioequivalence studies were used for correlation purposes. The simulated plasma profile, based on the CBZ physicochemical and pharmacokinetic properties, was almost identical with that observed in vivo. Parameter sensitivity analysis (PSA) indicated that the percent of drug absorbed is relatively insensitive to the variation of the input parameters. Additionally, plasma concentration-time profiles were simulated based on dissolution profiles observed under the different experimental conditions. Regardless of the differences observed in vitro, the predicted pharmacokinetic profiles were similar in the extent of drug exposure (AUC) while there were certain differences in parameters defining the drug absorption rate (C-max, t(max)). High level A IVIVC was established for the pooled data set (r = 0.9624), indicating that 1% SLS may be considered as the universal biorelevant dissolution medium for both the IR and CR CBZ tablets. The proposed methodology involving gastrointestinal simulation technology and IVIVC suggests that there is a rationale for considering CBZ biowaiver extension and introduction of the wider dissolution specifications for CBZ immediate release tablets.",
publisher = "Amer Chemical Soc, Washington",
journal = "Molecular Pharmaceutics",
title = "Justification of Biowaiver for Carbamazepine, a Low Soluble High Permeable Compound, in Solid Dosage Forms Based on IVIVC and Gastrointestinal Simulation",
volume = "6",
number = "1",
pages = "40-47",
doi = "10.1021/mp800128y"
}

Kovacević, I., Parojčić, J., Homšek, I., Tubić-Grozdanis, M.,& Langguth, P.. (2009). Justification of Biowaiver for Carbamazepine, a Low Soluble High Permeable Compound, in Solid Dosage Forms Based on IVIVC and Gastrointestinal Simulation. in Molecular Pharmaceutics
Amer Chemical Soc, Washington., 6(1), 40-47.
https://doi.org/10.1021/mp800128y

Kovacević I, Parojčić J, Homšek I, Tubić-Grozdanis M, Langguth P. Justification of Biowaiver for Carbamazepine, a Low Soluble High Permeable Compound, in Solid Dosage Forms Based on IVIVC and Gastrointestinal Simulation. in Molecular Pharmaceutics. 2009;6(1):40-47.
doi:10.1021/mp800128y .

Kovacević, Ivan, Parojčić, Jelena, Homšek, Irena, Tubić-Grozdanis, Marija, Langguth, Peter, "Justification of Biowaiver for Carbamazepine, a Low Soluble High Permeable Compound, in Solid Dosage Forms Based on IVIVC and Gastrointestinal Simulation" in Molecular Pharmaceutics, 6, no. 1 (2009):40-47,
https://doi.org/10.1021/mp800128y . .

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 . .

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 .

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 .

TY  - CONF
AU  - Homšek, Irena
AU  - Parojčić, Jelena
AU  - Cvetković, N
AU  - Popadić, Dragica
AU  - Đurić, Zorica
PY  - 2005
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/583
PB  - Elsevier Science BV
C3  - European Journal of Pharmaceutical Sciences
T1  - Development of level a in vitro - in vivo correlation for carbamazepine immediate release tablets
VL  - 25
IS  - SUPPL. 1
SP  - 117
EP  - 119
DO  - 10.1016/j.ejps.2005.04.007
ER  - 

@conference{
author = "Homšek, Irena and Parojčić, Jelena and Cvetković, N and Popadić, Dragica and Đurić, Zorica",
year = "2005",
publisher = "Elsevier Science BV",
journal = "European Journal of Pharmaceutical Sciences",
title = "Development of level a in vitro - in vivo correlation for carbamazepine immediate release tablets",
volume = "25",
number = "SUPPL. 1",
pages = "117-119",
doi = "10.1016/j.ejps.2005.04.007"
}

Homšek, I., Parojčić, J., Cvetković, N., Popadić, D.,& Đurić, Z.. (2005). Development of level a in vitro - in vivo correlation for carbamazepine immediate release tablets. in European Journal of Pharmaceutical Sciences
Elsevier Science BV., 25(SUPPL. 1), 117-119.
https://doi.org/10.1016/j.ejps.2005.04.007

Homšek I, Parojčić J, Cvetković N, Popadić D, Đurić Z. Development of level a in vitro - in vivo correlation for carbamazepine immediate release tablets. in European Journal of Pharmaceutical Sciences. 2005;25(SUPPL. 1):117-119.
doi:10.1016/j.ejps.2005.04.007 .

Homšek, Irena, Parojčić, Jelena, Cvetković, N, Popadić, Dragica, Đurić, Zorica, "Development of level a in vitro - in vivo correlation for carbamazepine immediate release tablets" in European Journal of Pharmaceutical Sciences, 25, no. SUPPL. 1 (2005):117-119,
https://doi.org/10.1016/j.ejps.2005.04.007 . .