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  - JOUR
AU  - Cvijić, Sandra
AU  - Parojčić, Jelena
AU  - Ibrić, Svetlana
AU  - Đurić, Zorica
PY  - 2011
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1540
AB  - The aim of this study was to develop a drug-specific absorption model for gliclazide (GLK) using mechanistic gastrointestinal simulation technology (GIST) implemented in GastroPlus(TM) software package. A range of experimentally determined, in silico predicted or literature data were used as input parameters. Experimentally determined pH-solubility profile was used for all simulations. The human jejunum effective permeability (P (eff)) value was estimated on the basis of in vitro measured Caco-2 permeability (literature data). The required PK inputs were taken from the literature. The results of the simulations were compared with actual clinical data and revealed that the GIST-model gave accurate prediction of gliclazide oral absorption. The generated absorption model provided the target in vivo dissolution profile for in vitro-in vivo correlation and identification of biorelevant dissolution specification for GLK immediate-release (IR) tablets. A set of virtual in vitro data was used for correlation purposes. The obtained results suggest that dissolution specification of more than 85% GLK dissolved in 60 min may be considered as "biorelevant" dissolution acceptance criteria for GLK IR tablets.
PB  - Springer, New York
T2  - AAPS PharmSciTech
T1  - In Vitro-In Vivo Correlation for Gliclazide Immediate-Release Tablets Based on Mechanistic Absorption Simulation
VL  - 12
IS  - 1
SP  - 165
EP  - 171
DO  - 10.1208/s12249-010-9573-y
ER  - 

@article{
author = "Cvijić, Sandra and Parojčić, Jelena and Ibrić, Svetlana and Đurić, Zorica",
year = "2011",
abstract = "The aim of this study was to develop a drug-specific absorption model for gliclazide (GLK) using mechanistic gastrointestinal simulation technology (GIST) implemented in GastroPlus(TM) software package. A range of experimentally determined, in silico predicted or literature data were used as input parameters. Experimentally determined pH-solubility profile was used for all simulations. The human jejunum effective permeability (P (eff)) value was estimated on the basis of in vitro measured Caco-2 permeability (literature data). The required PK inputs were taken from the literature. The results of the simulations were compared with actual clinical data and revealed that the GIST-model gave accurate prediction of gliclazide oral absorption. The generated absorption model provided the target in vivo dissolution profile for in vitro-in vivo correlation and identification of biorelevant dissolution specification for GLK immediate-release (IR) tablets. A set of virtual in vitro data was used for correlation purposes. The obtained results suggest that dissolution specification of more than 85% GLK dissolved in 60 min may be considered as "biorelevant" dissolution acceptance criteria for GLK IR tablets.",
publisher = "Springer, New York",
journal = "AAPS PharmSciTech",
title = "In Vitro-In Vivo Correlation for Gliclazide Immediate-Release Tablets Based on Mechanistic Absorption Simulation",
volume = "12",
number = "1",
pages = "165-171",
doi = "10.1208/s12249-010-9573-y"
}

Cvijić, S., Parojčić, J., Ibrić, S.,& Đurić, Z.. (2011). In Vitro-In Vivo Correlation for Gliclazide Immediate-Release Tablets Based on Mechanistic Absorption Simulation. in AAPS PharmSciTech
Springer, New York., 12(1), 165-171.
https://doi.org/10.1208/s12249-010-9573-y

Cvijić S, Parojčić J, Ibrić S, Đurić Z. In Vitro-In Vivo Correlation for Gliclazide Immediate-Release Tablets Based on Mechanistic Absorption Simulation. in AAPS PharmSciTech. 2011;12(1):165-171.
doi:10.1208/s12249-010-9573-y .

Cvijić, Sandra, Parojčić, Jelena, Ibrić, Svetlana, Đurić, Zorica, "In Vitro-In Vivo Correlation for Gliclazide Immediate-Release Tablets Based on Mechanistic Absorption Simulation" in AAPS PharmSciTech, 12, no. 1 (2011):165-171,
https://doi.org/10.1208/s12249-010-9573-y . .

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  - Cvijić, Sandra
AU  - Parojčić, Jelena
AU  - Malenović, Anđelija
AU  - Đurić, Zorica
AU  - Maksimović, Milica
PY  - 2010
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1395
AB  - Knowledge of druglike properties, such as dissociation constants (pK(a)), is of great importance in drug development and analysis. However, poor aqueous Solubility often Causes serious limitations ill accurate determination of a drug's pK(a). In this Study, the apparent dissociation constant (pK(a)') of the poorly soluble drug, glimepiride, has been determined by application of the spectrophotometric and Solubility methods. Compared to the literature reported glimepiride pK(a)' values of 4.99 +/- 0.50 and 6.2 +/- 0.1, the values obtained in the present study were 8.07 +/- 0.02 and 7.26 +/- 0.01 determined by the spectrophotometric and Solubility method, respectively. In addition, the advantages of these two methods in pK(a)' determination of glimepiride are discussed.
PB  - Amer Chemical Soc, Washington
T2  - Journal of Chemical and Engineering Data
T1  - A Contribution to the Glimepiride Dissociation Constant Determination
VL  - 55
IS  - 3
SP  - 1368
EP  - 1371
DO  - 10.1021/je900546z
ER  - 

@article{
author = "Cvijić, Sandra and Parojčić, Jelena and Malenović, Anđelija and Đurić, Zorica and Maksimović, Milica",
year = "2010",
abstract = "Knowledge of druglike properties, such as dissociation constants (pK(a)), is of great importance in drug development and analysis. However, poor aqueous Solubility often Causes serious limitations ill accurate determination of a drug's pK(a). In this Study, the apparent dissociation constant (pK(a)') of the poorly soluble drug, glimepiride, has been determined by application of the spectrophotometric and Solubility methods. Compared to the literature reported glimepiride pK(a)' values of 4.99 +/- 0.50 and 6.2 +/- 0.1, the values obtained in the present study were 8.07 +/- 0.02 and 7.26 +/- 0.01 determined by the spectrophotometric and Solubility method, respectively. In addition, the advantages of these two methods in pK(a)' determination of glimepiride are discussed.",
publisher = "Amer Chemical Soc, Washington",
journal = "Journal of Chemical and Engineering Data",
title = "A Contribution to the Glimepiride Dissociation Constant Determination",
volume = "55",
number = "3",
pages = "1368-1371",
doi = "10.1021/je900546z"
}

Cvijić, S., Parojčić, J., Malenović, A., Đurić, Z.,& Maksimović, M.. (2010). A Contribution to the Glimepiride Dissociation Constant Determination. in Journal of Chemical and Engineering Data
Amer Chemical Soc, Washington., 55(3), 1368-1371.
https://doi.org/10.1021/je900546z

Cvijić S, Parojčić J, Malenović A, Đurić Z, Maksimović M. A Contribution to the Glimepiride Dissociation Constant Determination. in Journal of Chemical and Engineering Data. 2010;55(3):1368-1371.
doi:10.1021/je900546z .

Cvijić, Sandra, Parojčić, Jelena, Malenović, Anđelija, Đurić, Zorica, Maksimović, Milica, "A Contribution to the Glimepiride Dissociation Constant Determination" in Journal of Chemical and Engineering Data, 55, no. 3 (2010):1368-1371,
https://doi.org/10.1021/je900546z . .

TY  - JOUR
AU  - Petrović, Jelena
AU  - Ibrić, Svetlana
AU  - Betz, Gabriele
AU  - Parojčić, Jelena
AU  - Đurić, Zorica
PY  - 2009
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1263
AB  - The main objective of this study was to demonstrate the possible use of dynamic neural networks to model diclofenac sodium release from polyethylene oxide hydrophilic matrix tablets. High and low molecular weight polymers in the range of 0.9-5 x 10(6) have been used as matrix forming materials and 12 different formulations were prepared for each polymer. Matrix tablets were made by direct compression method. Fractions of polymer and compression force have been selected as most influential factors on diclofenac sodium release profile. In vitro dissolution profile has been treated as time series using dynamic neural networks. Dynamic networks are expected to be advantageous in the modeling of drug release. Networks of different topologies have been constructed in order to obtain precise prediction of release profiles for test formulations. Short-term and long-term memory structures have been included in the design of network making it possible to treat dissolution profiles as time series. The ability of network to model drug release has been assessed by the determination of correlation between predicted and experimentally obtained data. Calculated difference (f(1)) and similarity (f(2)) factors indicate that dynamic networks are capable of accurate predictions. Dynamic neural networks were compared to most frequently used static network, multi-layered perceptron, and superiority of dynamic networks has been demonstrated. The study also demonstrated differences between the used polyethylene oxide polymers in respect to drug release and suggests explanations for the obtained results.
PB  - Elsevier Science BV, Amsterdam
T2  - European Journal of Pharmaceutical Sciences
T1  - Application of dynamic neural networks in the modeling of drug release from polyethylene oxide matrix tablets
VL  - 38
IS  - 2
SP  - 172
EP  - 180
DO  - 10.1016/j.ejps.2009.07.007
ER  - 

@article{
author = "Petrović, Jelena and Ibrić, Svetlana and Betz, Gabriele and Parojčić, Jelena and Đurić, Zorica",
year = "2009",
abstract = "The main objective of this study was to demonstrate the possible use of dynamic neural networks to model diclofenac sodium release from polyethylene oxide hydrophilic matrix tablets. High and low molecular weight polymers in the range of 0.9-5 x 10(6) have been used as matrix forming materials and 12 different formulations were prepared for each polymer. Matrix tablets were made by direct compression method. Fractions of polymer and compression force have been selected as most influential factors on diclofenac sodium release profile. In vitro dissolution profile has been treated as time series using dynamic neural networks. Dynamic networks are expected to be advantageous in the modeling of drug release. Networks of different topologies have been constructed in order to obtain precise prediction of release profiles for test formulations. Short-term and long-term memory structures have been included in the design of network making it possible to treat dissolution profiles as time series. The ability of network to model drug release has been assessed by the determination of correlation between predicted and experimentally obtained data. Calculated difference (f(1)) and similarity (f(2)) factors indicate that dynamic networks are capable of accurate predictions. Dynamic neural networks were compared to most frequently used static network, multi-layered perceptron, and superiority of dynamic networks has been demonstrated. The study also demonstrated differences between the used polyethylene oxide polymers in respect to drug release and suggests explanations for the obtained results.",
publisher = "Elsevier Science BV, Amsterdam",
journal = "European Journal of Pharmaceutical Sciences",
title = "Application of dynamic neural networks in the modeling of drug release from polyethylene oxide matrix tablets",
volume = "38",
number = "2",
pages = "172-180",
doi = "10.1016/j.ejps.2009.07.007"
}

Petrović, J., Ibrić, S., Betz, G., Parojčić, J.,& Đurić, Z.. (2009). Application of dynamic neural networks in the modeling of drug release from polyethylene oxide matrix tablets. in European Journal of Pharmaceutical Sciences
Elsevier Science BV, Amsterdam., 38(2), 172-180.
https://doi.org/10.1016/j.ejps.2009.07.007

Petrović J, Ibrić S, Betz G, Parojčić J, Đurić Z. Application of dynamic neural networks in the modeling of drug release from polyethylene oxide matrix tablets. in European Journal of Pharmaceutical Sciences. 2009;38(2):172-180.
doi:10.1016/j.ejps.2009.07.007 .

Petrović, Jelena, Ibrić, Svetlana, Betz, Gabriele, Parojčić, Jelena, Đurić, Zorica, "Application of dynamic neural networks in the modeling of drug release from polyethylene oxide matrix tablets" in European Journal of Pharmaceutical Sciences, 38, no. 2 (2009):172-180,
https://doi.org/10.1016/j.ejps.2009.07.007 . .

TY  - JOUR
AU  - Petrović, Jelena
AU  - Jocković, Jelena
AU  - Ibrić, Svetlana
AU  - Đurić, Zorica
PY  - 2009
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1193
AB  - Objectives The main objective of this study was to develop a mathematical model for the characterization of diclofenac sodium diffusion from polyethylene oxide (PEO) matrices. A model was developed on the basis of the diffusion theory accounting for the characteristics of the polymer: swelling with subsequent dissolution in water. The concentration-dependent diffusion of drug and water was taken into account. Experimental data were analysed using a computer software program as an aid for solving partial differential equations. Methods Six formulations of matrix tablets with different drug-excipient ratios were prepared using low-molecular-weight PEO as a matrix-forming material. For obtaining drug release data, dissolution studies were performed and water uptake by pure PEO matrices was studied as well. Key findings A good agreement of the developed model with experimental results was demonstrated. Some anomalies in drug diffusion were observed and their origin was questioned. Changes in the parameters characterizing the process of diffusion are attributed to glassy-rubbery polymer transitions. Additional interpretation of this phenomenon on the basis of percolation theory is also provided. Conclusions The obtained model has the ability to predict the required characteristics of matrices for desired drug release. The composition of batches with undesirable release properties can be predetermined and avoided in manufacturing.
PB  - Wiley-Blackwell Publishing, Inc, Malden
T2  - Journal of Pharmacy and Pharmacology
T1  - Modelling of diclofenac sodium diffusion from swellable and water-soluble polyethylene oxide matrices
VL  - 61
IS  - 11
SP  - 1449
EP  - 1456
DO  - 10.1211/jpp/61.11.0003
ER  - 

@article{
author = "Petrović, Jelena and Jocković, Jelena and Ibrić, Svetlana and Đurić, Zorica",
year = "2009",
abstract = "Objectives The main objective of this study was to develop a mathematical model for the characterization of diclofenac sodium diffusion from polyethylene oxide (PEO) matrices. A model was developed on the basis of the diffusion theory accounting for the characteristics of the polymer: swelling with subsequent dissolution in water. The concentration-dependent diffusion of drug and water was taken into account. Experimental data were analysed using a computer software program as an aid for solving partial differential equations. Methods Six formulations of matrix tablets with different drug-excipient ratios were prepared using low-molecular-weight PEO as a matrix-forming material. For obtaining drug release data, dissolution studies were performed and water uptake by pure PEO matrices was studied as well. Key findings A good agreement of the developed model with experimental results was demonstrated. Some anomalies in drug diffusion were observed and their origin was questioned. Changes in the parameters characterizing the process of diffusion are attributed to glassy-rubbery polymer transitions. Additional interpretation of this phenomenon on the basis of percolation theory is also provided. Conclusions The obtained model has the ability to predict the required characteristics of matrices for desired drug release. The composition of batches with undesirable release properties can be predetermined and avoided in manufacturing.",
publisher = "Wiley-Blackwell Publishing, Inc, Malden",
journal = "Journal of Pharmacy and Pharmacology",
title = "Modelling of diclofenac sodium diffusion from swellable and water-soluble polyethylene oxide matrices",
volume = "61",
number = "11",
pages = "1449-1456",
doi = "10.1211/jpp/61.11.0003"
}

Petrović, J., Jocković, J., Ibrić, S.,& Đurić, Z.. (2009). Modelling of diclofenac sodium diffusion from swellable and water-soluble polyethylene oxide matrices. in Journal of Pharmacy and Pharmacology
Wiley-Blackwell Publishing, Inc, Malden., 61(11), 1449-1456.
https://doi.org/10.1211/jpp/61.11.0003

Petrović J, Jocković J, Ibrić S, Đurić Z. Modelling of diclofenac sodium diffusion from swellable and water-soluble polyethylene oxide matrices. in Journal of Pharmacy and Pharmacology. 2009;61(11):1449-1456.
doi:10.1211/jpp/61.11.0003 .

Petrović, Jelena, Jocković, Jelena, Ibrić, Svetlana, Đurić, Zorica, "Modelling of diclofenac sodium diffusion from swellable and water-soluble polyethylene oxide matrices" in Journal of Pharmacy and Pharmacology, 61, no. 11 (2009):1449-1456,
https://doi.org/10.1211/jpp/61.11.0003 . .

TY  - JOUR
AU  - Petrović, Jelena
AU  - Ibrić, Svetlana
AU  - Jocković, Jelena
AU  - Parojčić, Jelena
AU  - Đurić, Zorica
PY  - 2009
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1175
AB  - The purpose of this study was to implement the concepts of percolation theory in the characterization of drug release from hydrophilic matrix tablets. Percolation theory is a powerful statistical tool that enables mathematical insight into geometrically complex and disordered systems. Matrix tablets are effective substrate for the implementation of percolation theory because of their inherent disordered structure. The objective was to predict percolation thresholds of polyethylene oxide and polyacrylic polymers in diclofenac sodium hydrophilic matrices. Matrix tablets were prepared using polyethylene oxide or polyacrylic acid as matrix forming materials and diclofenac sodium was used as a model drug substance. Ten formulations with different drug/excipient ratios were prepared using the direct compression method. Dissolution studies were performed using the paddle apparatus method. For estimating percolation threshold the change of the kinetic parameters in aspect to the volumetric-fraction of excipient plus initial porosity of the tablets was studied. Observed critical points with sudden changes lit behavior of kinetic Parameters can be attributed to the percolation thresholds. Percolation threshold is found to be 60.22% v/v polyethylene oxide + initial porosity and 39.94% v/v polyacrylic acid + initial porosity. The results obtained demonstrate that percolation theory call be used to design and develop matrix tablet formulations. Determination of percolation threshold is a useful tool for preparing robust formulations.
PB  - Editions Sante, Paris
T2  - Journal of Drug Delivery Science and Technology
T1  - Determination of the percolation thresholds for polyethylene oxide and polyacrylic acid matrix tablets
VL  - 19
IS  - 5
SP  - 359
EP  - 364
DO  - 10.1016/S1773-2247(09)50074-3
ER  - 

@article{
author = "Petrović, Jelena and Ibrić, Svetlana and Jocković, Jelena and Parojčić, Jelena and Đurić, Zorica",
year = "2009",
abstract = "The purpose of this study was to implement the concepts of percolation theory in the characterization of drug release from hydrophilic matrix tablets. Percolation theory is a powerful statistical tool that enables mathematical insight into geometrically complex and disordered systems. Matrix tablets are effective substrate for the implementation of percolation theory because of their inherent disordered structure. The objective was to predict percolation thresholds of polyethylene oxide and polyacrylic polymers in diclofenac sodium hydrophilic matrices. Matrix tablets were prepared using polyethylene oxide or polyacrylic acid as matrix forming materials and diclofenac sodium was used as a model drug substance. Ten formulations with different drug/excipient ratios were prepared using the direct compression method. Dissolution studies were performed using the paddle apparatus method. For estimating percolation threshold the change of the kinetic parameters in aspect to the volumetric-fraction of excipient plus initial porosity of the tablets was studied. Observed critical points with sudden changes lit behavior of kinetic Parameters can be attributed to the percolation thresholds. Percolation threshold is found to be 60.22% v/v polyethylene oxide + initial porosity and 39.94% v/v polyacrylic acid + initial porosity. The results obtained demonstrate that percolation theory call be used to design and develop matrix tablet formulations. Determination of percolation threshold is a useful tool for preparing robust formulations.",
publisher = "Editions Sante, Paris",
journal = "Journal of Drug Delivery Science and Technology",
title = "Determination of the percolation thresholds for polyethylene oxide and polyacrylic acid matrix tablets",
volume = "19",
number = "5",
pages = "359-364",
doi = "10.1016/S1773-2247(09)50074-3"
}

Petrović, J., Ibrić, S., Jocković, J., Parojčić, J.,& Đurić, Z.. (2009). Determination of the percolation thresholds for polyethylene oxide and polyacrylic acid matrix tablets. in Journal of Drug Delivery Science and Technology
Editions Sante, Paris., 19(5), 359-364.
https://doi.org/10.1016/S1773-2247(09)50074-3

Petrović J, Ibrić S, Jocković J, Parojčić J, Đurić Z. Determination of the percolation thresholds for polyethylene oxide and polyacrylic acid matrix tablets. in Journal of Drug Delivery Science and Technology. 2009;19(5):359-364.
doi:10.1016/S1773-2247(09)50074-3 .

Petrović, Jelena, Ibrić, Svetlana, Jocković, Jelena, Parojčić, Jelena, Đurić, Zorica, "Determination of the percolation thresholds for polyethylene oxide and polyacrylic acid matrix tablets" in Journal of Drug Delivery Science and Technology, 19, no. 5 (2009):359-364,
https://doi.org/10.1016/S1773-2247(09)50074-3 . .

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  - Tubić-Grozdanis, Marija
AU  - Langguth, Peter
PY  - 2009
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1239
AB  - The Biopharmaceutics Classification System (BCS) is based on the mechanistic assumptions that the rate and extent of oral drug absorption are governed by drug solubility, intestinal permeability, and dissolution rate from the dosage form administered. One of the goals of BCS is to identify classes of drugs for which bioequivalence may be established based solely on the in vitro dissolution data, i.e., which would be eligible for biowaiver. On the basis of BCS, currently, the biowaiver concept is adopted and recommended for immediate release of drug products containing highly soluble and highly permeable compounds (BCS class 1 drugs). Dissolution testing properties are proposed to be more stringent: very rapid dissolution is demanded when generic drug application is submitted with the exemption of in vivo bioequivalence study. In the present paper, Gastrointestinal Simulation Technology has been applied in order to evaluate the potential for different in vitro drug dissolution kinetics to influence dosage forms in vivo behavior and the relevance of "very rapid dissolution" criteria to be met (i.e., more than 85% of dose dissolved in 15 min).
PB  - Springer, New York
T2  - AAPS Journal
T1  - An Investigation into the Importance of "Very Rapid Dissolution" Criteria for Drug Bioequivalence Demonstration using Gastrointestinal Simulation Technology
VL  - 11
IS  - 2
SP  - 381
EP  - 384
DO  - 10.1208/s12248-009-9114-3
ER  - 

@article{
author = "Kovacević, Ivan and Parojčić, Jelena and Tubić-Grozdanis, Marija and Langguth, Peter",
year = "2009",
abstract = "The Biopharmaceutics Classification System (BCS) is based on the mechanistic assumptions that the rate and extent of oral drug absorption are governed by drug solubility, intestinal permeability, and dissolution rate from the dosage form administered. One of the goals of BCS is to identify classes of drugs for which bioequivalence may be established based solely on the in vitro dissolution data, i.e., which would be eligible for biowaiver. On the basis of BCS, currently, the biowaiver concept is adopted and recommended for immediate release of drug products containing highly soluble and highly permeable compounds (BCS class 1 drugs). Dissolution testing properties are proposed to be more stringent: very rapid dissolution is demanded when generic drug application is submitted with the exemption of in vivo bioequivalence study. In the present paper, Gastrointestinal Simulation Technology has been applied in order to evaluate the potential for different in vitro drug dissolution kinetics to influence dosage forms in vivo behavior and the relevance of "very rapid dissolution" criteria to be met (i.e., more than 85% of dose dissolved in 15 min).",
publisher = "Springer, New York",
journal = "AAPS Journal",
title = "An Investigation into the Importance of "Very Rapid Dissolution" Criteria for Drug Bioequivalence Demonstration using Gastrointestinal Simulation Technology",
volume = "11",
number = "2",
pages = "381-384",
doi = "10.1208/s12248-009-9114-3"
}

Kovacević, I., Parojčić, J., Tubić-Grozdanis, M.,& Langguth, P.. (2009). An Investigation into the Importance of "Very Rapid Dissolution" Criteria for Drug Bioequivalence Demonstration using Gastrointestinal Simulation Technology. in AAPS Journal
Springer, New York., 11(2), 381-384.
https://doi.org/10.1208/s12248-009-9114-3

Kovacević I, Parojčić J, Tubić-Grozdanis M, Langguth P. An Investigation into the Importance of "Very Rapid Dissolution" Criteria for Drug Bioequivalence Demonstration using Gastrointestinal Simulation Technology. in AAPS Journal. 2009;11(2):381-384.
doi:10.1208/s12248-009-9114-3 .

Kovacević, Ivan, Parojčić, Jelena, Tubić-Grozdanis, Marija, Langguth, Peter, "An Investigation into the Importance of "Very Rapid Dissolution" Criteria for Drug Bioequivalence Demonstration using Gastrointestinal Simulation Technology" in AAPS Journal, 11, no. 2 (2009):381-384,
https://doi.org/10.1208/s12248-009-9114-3 . .

TY  - JOUR
AU  - Grbić, Sandra
AU  - Parojčić, Jelena
AU  - Đurić, Zorica
AU  - Ibrić, Svetlana
PY  - 2009
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1286
AB  - Aim: The equilibrium-based mathematical model was used to describe the pH-surfactant-mediated solubilization of weakly acidic electrolyte, nimesulide, in buffer solutions. This model assumed that the total drug solubility could be expressed as a sum of the solubilities of four different species: unionized and ionized form in solution and their corresponding micellar forms. Sucrose-laurate, new synthetic surfactant, and polysorbate 80 were investigated for their benefits in the testing of poorly soluble acidic model drug. Method: Two sets of solubility data, determined at pH values 4.5 and 9.0 in media containing different surfactant concentrations, were used to calculate solubilization slopes and corresponding micellar equilibrium constants for the unionized (K(n)) and ionized (K(i)) drug. These values were used to estimate drug solubilization in media considered to represent physiologically relevant conditions. Results: Predicted solubility values were in good agreement with the experimental data, suggesting that the impact of pH and surfactant on nimesulide solubility could be well characterized by the equilibrium model described in this article. Conclusions: Obtained results indicated that the extent of solubilization was significantly dependent on the surfactant used.
PB  - Taylor & Francis Inc, Philadelphia
T2  - Drug Development and Industrial Pharmacy
T1  - Mathematical modeling of pH-surfactant-mediated solubilization of nimesulide
VL  - 35
IS  - 7
SP  - 852
EP  - 856
DO  - 10.1080/03639040802680230
ER  - 

@article{
author = "Grbić, Sandra and Parojčić, Jelena and Đurić, Zorica and Ibrić, Svetlana",
year = "2009",
abstract = "Aim: The equilibrium-based mathematical model was used to describe the pH-surfactant-mediated solubilization of weakly acidic electrolyte, nimesulide, in buffer solutions. This model assumed that the total drug solubility could be expressed as a sum of the solubilities of four different species: unionized and ionized form in solution and their corresponding micellar forms. Sucrose-laurate, new synthetic surfactant, and polysorbate 80 were investigated for their benefits in the testing of poorly soluble acidic model drug. Method: Two sets of solubility data, determined at pH values 4.5 and 9.0 in media containing different surfactant concentrations, were used to calculate solubilization slopes and corresponding micellar equilibrium constants for the unionized (K(n)) and ionized (K(i)) drug. These values were used to estimate drug solubilization in media considered to represent physiologically relevant conditions. Results: Predicted solubility values were in good agreement with the experimental data, suggesting that the impact of pH and surfactant on nimesulide solubility could be well characterized by the equilibrium model described in this article. Conclusions: Obtained results indicated that the extent of solubilization was significantly dependent on the surfactant used.",
publisher = "Taylor & Francis Inc, Philadelphia",
journal = "Drug Development and Industrial Pharmacy",
title = "Mathematical modeling of pH-surfactant-mediated solubilization of nimesulide",
volume = "35",
number = "7",
pages = "852-856",
doi = "10.1080/03639040802680230"
}

Grbić, S., Parojčić, J., Đurić, Z.,& Ibrić, S.. (2009). Mathematical modeling of pH-surfactant-mediated solubilization of nimesulide. in Drug Development and Industrial Pharmacy
Taylor & Francis Inc, Philadelphia., 35(7), 852-856.
https://doi.org/10.1080/03639040802680230

Grbić S, Parojčić J, Đurić Z, Ibrić S. Mathematical modeling of pH-surfactant-mediated solubilization of nimesulide. in Drug Development and Industrial Pharmacy. 2009;35(7):852-856.
doi:10.1080/03639040802680230 .

Grbić, Sandra, Parojčić, Jelena, Đurić, Zorica, Ibrić, Svetlana, "Mathematical modeling of pH-surfactant-mediated solubilization of nimesulide" in Drug Development and Industrial Pharmacy, 35, no. 7 (2009):852-856,
https://doi.org/10.1080/03639040802680230 . .

TY  - JOUR
AU  - Ivić, Branka
AU  - Ibrić, Svetlana
AU  - Betz, Gabriele
AU  - Đurić, Zorica
PY  - 2009
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1162
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 pellets compressed into multiple unit pellet system (MUPS) tablets using design of experiment (DOE). Extended release of diclofenac sodium was accomplished using Carbopol (R) 71G as matrix substance. According to Fractional Factorial Design FFD 2(3-1) four formulations of diclofenac sodium MUPS matrix tablets were prepared. The process of direct pelletization and subsequently compression of the pellets into tablets was applied in order to investigate a different approach in formulation of matrix systems and to achieve a better control of the process factors over the principal response - the release of the drug. The investigated factors were X-1-the percentage of polymer Carbopol (R) 71G, X-2-crushing strength of the tablet and X-3-different batches of the diclofenac sodium. In vitro dissolution time profiles at 6 different sampling times were chosen as responses. Results of drug release studies indicated that drug release rates vary between different formulations, with a range of 1 to 8 h to complete dissolution. The most important impact on the drug release hart factor X-1-the percentage of polymer Carbopol (R) 71G. The polymer percentage is suggested as release regulator for diclofenac sodium release from MUPS matrix tablets. All other investigated factors had no significant influence on the release profile of diclofenac sodium.
PB  - Pharmaceutical Soc Japan, Tokyo
T2  - Zdravstveno varstvo
T1  - Evaluation of Diclofenac Sodium Release from Matrix Pellets Compressed into MUPS Tablets
VL  - 129
IS  - 11
SP  - 1375
EP  - 1384
DO  - 10.1248/yakushi.129.1375
ER  - 

@article{
author = "Ivić, Branka and Ibrić, Svetlana and Betz, Gabriele and Đurić, Zorica",
year = "2009",
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 pellets compressed into multiple unit pellet system (MUPS) tablets using design of experiment (DOE). Extended release of diclofenac sodium was accomplished using Carbopol (R) 71G as matrix substance. According to Fractional Factorial Design FFD 2(3-1) four formulations of diclofenac sodium MUPS matrix tablets were prepared. The process of direct pelletization and subsequently compression of the pellets into tablets was applied in order to investigate a different approach in formulation of matrix systems and to achieve a better control of the process factors over the principal response - the release of the drug. The investigated factors were X-1-the percentage of polymer Carbopol (R) 71G, X-2-crushing strength of the tablet and X-3-different batches of the diclofenac sodium. In vitro dissolution time profiles at 6 different sampling times were chosen as responses. Results of drug release studies indicated that drug release rates vary between different formulations, with a range of 1 to 8 h to complete dissolution. The most important impact on the drug release hart factor X-1-the percentage of polymer Carbopol (R) 71G. The polymer percentage is suggested as release regulator for diclofenac sodium release from MUPS matrix tablets. All other investigated factors had no significant influence on the release profile of diclofenac sodium.",
publisher = "Pharmaceutical Soc Japan, Tokyo",
journal = "Zdravstveno varstvo",
title = "Evaluation of Diclofenac Sodium Release from Matrix Pellets Compressed into MUPS Tablets",
volume = "129",
number = "11",
pages = "1375-1384",
doi = "10.1248/yakushi.129.1375"
}

Ivić, B., Ibrić, S., Betz, G.,& Đurić, Z.. (2009). Evaluation of Diclofenac Sodium Release from Matrix Pellets Compressed into MUPS Tablets. in Zdravstveno varstvo
Pharmaceutical Soc Japan, Tokyo., 129(11), 1375-1384.
https://doi.org/10.1248/yakushi.129.1375

Ivić B, Ibrić S, Betz G, Đurić Z. Evaluation of Diclofenac Sodium Release from Matrix Pellets Compressed into MUPS Tablets. in Zdravstveno varstvo. 2009;129(11):1375-1384.
doi:10.1248/yakushi.129.1375 .

Ivić, Branka, Ibrić, Svetlana, Betz, Gabriele, Đurić, Zorica, "Evaluation of Diclofenac Sodium Release from Matrix Pellets Compressed into MUPS Tablets" in Zdravstveno varstvo, 129, no. 11 (2009):1375-1384,
https://doi.org/10.1248/yakushi.129.1375 . .