TY  - JOUR
AU  - Korčok, Davor J.
AU  - Tršić-Milanović, Nada
AU  - Ilić, Marija
AU  - Mitić, Bogdan
AU  - Đorđević, Brižita
AU  - Ivanović, Nevena
PY  - 2021
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3820
AB  - In recent decades, probiotic products have been increasingly used to prevent certain gastrointestinal and urogenital disorders, to improve the general condition of the body and as a supplement to pharmacological therapy. They are most often registered as dietary supplements, and less often as drugs in the form of capsules, powders, and solutions. Optimization of technological processes of production and packaging of these products aims to maintain probiotic characteristics while adhering to all criteria during production that ensure quality, bioavailability and optimal therapeutic effects. In this paper, the importance of choosing primary and secondary packaging materials was explored with the aim of preserving the viability of probiotic cells in capsules for two years, i.e. during the shelf life. By comparing the applications of polyvinyl chloride (PVC) and PVC/polyvinylidene chloride/polyethylene blister foils, better protection of probiotic cells was observed by applying the multilayer foil. In addition, in this research, further improvements of probiotic cell protection were achieved by applying a secondary packing-flow pack bag with inert gas for storing multilayered blisters.
AB  - Probiotski proizvodi se poslednjih decenija sve više koriste za prevenciju određenih gastrointestinalnih i urogenitalnih poremećaja, za poboljšanje opšteg stanja organi-zma i kao dopuna farmakološke terapije. Najčešće su registrovani kao dijetetski suple-menti, a ređe kao lekovi u obliku kapsula, praškova i rastvora. Optimizacija tehnoloških procesa proizvodnje i pakovanje ovih proizvoda ima za cilj održavanje probiotskih karakteristika  uz istovremeno pridržavanje svih kriterijuma u toku proizvodnje koji osiguravaju kvalitet, biološku raspoloživost i optimalno terapijsko dejstvo U ovom radu razmatran je značaj izbora primarnog i sekundarnog materijala za pakovanje sa ciljem očuvanja vijabilnost probiotskih ćelija u kapsulama tokom dve godine tj. tokom roka upotrebe. Poređenjem primene PVC (polivinil hlorid) i PVC/poliviniliden  hlorid/poli-etilen (PVC/PVdC/PE) blister folija uočena je bolja zaštita probotskih ćelija od kiseonika i vlage primenom višeslojene folije. Dodatne efekte zaštite probiotskih ćelija u ovom radu potvrdjene su primenom dodatne zaštite blistera upotrebom sekundarnog pakovanja (engl. flow pack) kesice sa inertni gasom.
PB  - Association of the Chemical Engineers of Serbia
T2  - Hemijska industrija
T1  - Improving the viability and stability of a probiotic product with Saccharomyces boulardii DBVPG
T1  - Unapređenje vijabilnosti i stabilnosti probiotskog proizvoda sa Saccharomyces boulardii DBVPG
VL  - 75
IS  - 1
SP  - 25
EP  - 30
DO  - 10.2298/HEMIND201211008K
ER  - 

@article{
author = "Korčok, Davor J. and Tršić-Milanović, Nada and Ilić, Marija and Mitić, Bogdan and Đorđević, Brižita and Ivanović, Nevena",
year = "2021",
abstract = "In recent decades, probiotic products have been increasingly used to prevent certain gastrointestinal and urogenital disorders, to improve the general condition of the body and as a supplement to pharmacological therapy. They are most often registered as dietary supplements, and less often as drugs in the form of capsules, powders, and solutions. Optimization of technological processes of production and packaging of these products aims to maintain probiotic characteristics while adhering to all criteria during production that ensure quality, bioavailability and optimal therapeutic effects. In this paper, the importance of choosing primary and secondary packaging materials was explored with the aim of preserving the viability of probiotic cells in capsules for two years, i.e. during the shelf life. By comparing the applications of polyvinyl chloride (PVC) and PVC/polyvinylidene chloride/polyethylene blister foils, better protection of probiotic cells was observed by applying the multilayer foil. In addition, in this research, further improvements of probiotic cell protection were achieved by applying a secondary packing-flow pack bag with inert gas for storing multilayered blisters., Probiotski proizvodi se poslednjih decenija sve više koriste za prevenciju određenih gastrointestinalnih i urogenitalnih poremećaja, za poboljšanje opšteg stanja organi-zma i kao dopuna farmakološke terapije. Najčešće su registrovani kao dijetetski suple-menti, a ređe kao lekovi u obliku kapsula, praškova i rastvora. Optimizacija tehnoloških procesa proizvodnje i pakovanje ovih proizvoda ima za cilj održavanje probiotskih karakteristika  uz istovremeno pridržavanje svih kriterijuma u toku proizvodnje koji osiguravaju kvalitet, biološku raspoloživost i optimalno terapijsko dejstvo U ovom radu razmatran je značaj izbora primarnog i sekundarnog materijala za pakovanje sa ciljem očuvanja vijabilnost probiotskih ćelija u kapsulama tokom dve godine tj. tokom roka upotrebe. Poređenjem primene PVC (polivinil hlorid) i PVC/poliviniliden  hlorid/poli-etilen (PVC/PVdC/PE) blister folija uočena je bolja zaštita probotskih ćelija od kiseonika i vlage primenom višeslojene folije. Dodatne efekte zaštite probiotskih ćelija u ovom radu potvrdjene su primenom dodatne zaštite blistera upotrebom sekundarnog pakovanja (engl. flow pack) kesice sa inertni gasom.",
publisher = "Association of the Chemical Engineers of Serbia",
journal = "Hemijska industrija",
title = "Improving the viability and stability of a probiotic product with Saccharomyces boulardii DBVPG, Unapređenje vijabilnosti i stabilnosti probiotskog proizvoda sa Saccharomyces boulardii DBVPG",
volume = "75",
number = "1",
pages = "25-30",
doi = "10.2298/HEMIND201211008K"
}

Korčok, D. J., Tršić-Milanović, N., Ilić, M., Mitić, B., Đorđević, B.,& Ivanović, N.. (2021). Improving the viability and stability of a probiotic product with Saccharomyces boulardii DBVPG. in Hemijska industrija
Association of the Chemical Engineers of Serbia., 75(1), 25-30.
https://doi.org/10.2298/HEMIND201211008K

Korčok DJ, Tršić-Milanović N, Ilić M, Mitić B, Đorđević B, Ivanović N. Improving the viability and stability of a probiotic product with Saccharomyces boulardii DBVPG. in Hemijska industrija. 2021;75(1):25-30.
doi:10.2298/HEMIND201211008K .

Korčok, Davor J., Tršić-Milanović, Nada, Ilić, Marija, Mitić, Bogdan, Đorđević, Brižita, Ivanović, Nevena, "Improving the viability and stability of a probiotic product with Saccharomyces boulardii DBVPG" in Hemijska industrija, 75, no. 1 (2021):25-30,
https://doi.org/10.2298/HEMIND201211008K . .

TY  - JOUR
AU  - Ilić, Marija
AU  - Kovacević, Ivan
AU  - Parojčić, Jelena
PY  - 2015
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2316
AB  - With the increased reliance on in vitro dissolution testing as an indicator of in vivo drug behavior and the trend towards the in silico modeling of dosage form performance, the need for bioperformance dissolution methodology development has been enhanced. Determination of the in vivo drug delivery profile is essential for the bioperformance dissolution test development and in vitro/in vivo correlation modeling, as well as the understanding of absorption mechanisms. The aim of this study was to compare different methods in terms of their usefulness and applicability in deciphering in vivo delivery of nifedipine administered in modified release dosage forms. A detailed survey of publications on nifedipine pharmacokinetics was done and used to identify the magnitude of food effect. In vitro dissolution testing was performed under various experimental conditions. Obtained results indicate the potential for using the developed in silico model coupled with discriminative in vitro dissolution data for identification of the in vivo drug product behavior.
PB  - Hrvatsko Farmaceutsko Drustov (HFD)-Croation Pharmaceutical Soc, Zagreb
T2  - Acta Pharmaceutica
T1  - Deciphering nifedipine in vivo delivery from modified release dosage forms: Identification of food effect
VL  - 65
IS  - 4
SP  - 427
EP  - 441
DO  - 10.1515/acph-2015-0039
ER  - 

@article{
author = "Ilić, Marija and Kovacević, Ivan and Parojčić, Jelena",
year = "2015",
abstract = "With the increased reliance on in vitro dissolution testing as an indicator of in vivo drug behavior and the trend towards the in silico modeling of dosage form performance, the need for bioperformance dissolution methodology development has been enhanced. Determination of the in vivo drug delivery profile is essential for the bioperformance dissolution test development and in vitro/in vivo correlation modeling, as well as the understanding of absorption mechanisms. The aim of this study was to compare different methods in terms of their usefulness and applicability in deciphering in vivo delivery of nifedipine administered in modified release dosage forms. A detailed survey of publications on nifedipine pharmacokinetics was done and used to identify the magnitude of food effect. In vitro dissolution testing was performed under various experimental conditions. Obtained results indicate the potential for using the developed in silico model coupled with discriminative in vitro dissolution data for identification of the in vivo drug product behavior.",
publisher = "Hrvatsko Farmaceutsko Drustov (HFD)-Croation Pharmaceutical Soc, Zagreb",
journal = "Acta Pharmaceutica",
title = "Deciphering nifedipine in vivo delivery from modified release dosage forms: Identification of food effect",
volume = "65",
number = "4",
pages = "427-441",
doi = "10.1515/acph-2015-0039"
}

Ilić, M., Kovacević, I.,& Parojčić, J.. (2015). Deciphering nifedipine in vivo delivery from modified release dosage forms: Identification of food effect. in Acta Pharmaceutica
Hrvatsko Farmaceutsko Drustov (HFD)-Croation Pharmaceutical Soc, Zagreb., 65(4), 427-441.
https://doi.org/10.1515/acph-2015-0039

Ilić M, Kovacević I, Parojčić J. Deciphering nifedipine in vivo delivery from modified release dosage forms: Identification of food effect. in Acta Pharmaceutica. 2015;65(4):427-441.
doi:10.1515/acph-2015-0039 .

Ilić, Marija, Kovacević, Ivan, Parojčić, Jelena, "Deciphering nifedipine in vivo delivery from modified release dosage forms: Identification of food effect" in Acta Pharmaceutica, 65, no. 4 (2015):427-441,
https://doi.org/10.1515/acph-2015-0039 . .

TY  - JOUR
AU  - Ilić, Marija
AU  - Đuriš, Jelena
AU  - Kovacević, Ivan
AU  - Ibrić, Svetlana
AU  - Parojčić, Jelena
PY  - 2014
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2076
AB  - In vitro - in vivo correlations (IVIVC) are generally accepted as a valuable tool in modified release formulation development aimed at (i) quantifying the in vivo drug delivery profile and formulation related effects on absorption; (ii) establishing clinically relevant dissolution specifications and (iii) supporting the biowaiver claims. The aim of the present study was to develop relevant IVIVC models based on mechanistic gastrointestinal simulation (GIS) and artificial neural network (ANN) analysis and to evaluate their applicability and usefulness in biopharmaceutical drug characterisation. Nifedipine osmotic release tablets were selected as model drug product on the basis of their robustness, dissolution limited drug absorption and the availability of relevant literature data. Although the osmotic release tablets have been designed to be robust against the influence of physiological conditions in the gastrointestinal tract, notable differences in nifedipine dissolution kinetics were observed depending on the in vitro experimental conditions employed. The results obtained indicate that both GIS and ANN model developed were sensitive to input kinetics represented by the in vitro profiles obtained under various experimental conditions. Different in silico approaches may be successfully employed in the in vitro - in silico - in vivo model development. However, the results obtained may differ and relevant outcomes are sensitive to the methodology employed.
PB  - Elsevier Science BV, Amsterdam
T2  - European Journal of Pharmaceutical Sciences
T1  - In vitro - in silico - in vivo drug absorption model development based on mechanistic gastrointestinal simulation and artificial neural networks: Nifedipine osmotic release tablets case study
VL  - 62
SP  - 212
EP  - 218
DO  - 10.1016/j.ejps.2014.05.030
ER  - 

@article{
author = "Ilić, Marija and Đuriš, Jelena and Kovacević, Ivan and Ibrić, Svetlana and Parojčić, Jelena",
year = "2014",
abstract = "In vitro - in vivo correlations (IVIVC) are generally accepted as a valuable tool in modified release formulation development aimed at (i) quantifying the in vivo drug delivery profile and formulation related effects on absorption; (ii) establishing clinically relevant dissolution specifications and (iii) supporting the biowaiver claims. The aim of the present study was to develop relevant IVIVC models based on mechanistic gastrointestinal simulation (GIS) and artificial neural network (ANN) analysis and to evaluate their applicability and usefulness in biopharmaceutical drug characterisation. Nifedipine osmotic release tablets were selected as model drug product on the basis of their robustness, dissolution limited drug absorption and the availability of relevant literature data. Although the osmotic release tablets have been designed to be robust against the influence of physiological conditions in the gastrointestinal tract, notable differences in nifedipine dissolution kinetics were observed depending on the in vitro experimental conditions employed. The results obtained indicate that both GIS and ANN model developed were sensitive to input kinetics represented by the in vitro profiles obtained under various experimental conditions. Different in silico approaches may be successfully employed in the in vitro - in silico - in vivo model development. However, the results obtained may differ and relevant outcomes are sensitive to the methodology employed.",
publisher = "Elsevier Science BV, Amsterdam",
journal = "European Journal of Pharmaceutical Sciences",
title = "In vitro - in silico - in vivo drug absorption model development based on mechanistic gastrointestinal simulation and artificial neural networks: Nifedipine osmotic release tablets case study",
volume = "62",
pages = "212-218",
doi = "10.1016/j.ejps.2014.05.030"
}

Ilić, M., Đuriš, J., Kovacević, I., Ibrić, S.,& Parojčić, J.. (2014). In vitro - in silico - in vivo drug absorption model development based on mechanistic gastrointestinal simulation and artificial neural networks: Nifedipine osmotic release tablets case study. in European Journal of Pharmaceutical Sciences
Elsevier Science BV, Amsterdam., 62, 212-218.
https://doi.org/10.1016/j.ejps.2014.05.030

Ilić M, Đuriš J, Kovacević I, Ibrić S, Parojčić J. In vitro - in silico - in vivo drug absorption model development based on mechanistic gastrointestinal simulation and artificial neural networks: Nifedipine osmotic release tablets case study. in European Journal of Pharmaceutical Sciences. 2014;62:212-218.
doi:10.1016/j.ejps.2014.05.030 .

Ilić, Marija, Đuriš, Jelena, Kovacević, Ivan, Ibrić, Svetlana, Parojčić, Jelena, "In vitro - in silico - in vivo drug absorption model development based on mechanistic gastrointestinal simulation and artificial neural networks: Nifedipine osmotic release tablets case study" in European Journal of Pharmaceutical Sciences, 62 (2014):212-218,
https://doi.org/10.1016/j.ejps.2014.05.030 . .

TY  - JOUR
AU  - Rakić-Ignjatović, Anita
AU  - Miljković, Branislava
AU  - Ilić, Marija
AU  - Pokrajac, Milena
AU  - Prostran, Milica
PY  - 2010
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1448
AB  - In recent years there has been a significant paradigm shift in pre-clinical drug metabolism studies. Most importantly, this has included a reduced reliance on animal models and increased use of human tissues (i.e. human liver microsomes and other subcellular fractions, primary culture of human hepatocytes, recombinant human enzymes/transgenic cell lines). During the pre-clinical phase of drug development such studies assess the metabolic stability, reaction phenotyping (elucidation of specific enzyme(s) involved in phase I and II metabolism), metabolic fingerprinting (identification and structural determination of the metabolic end products) and drug interaction issues pertaining to enzyme inhibition and induction. Such studies are now increasingly being used for qualitative and quantitative prediction of drug biotransformation in humans and in the identification of likely determinants of metabolism following drug administration to humans, including possible drug interactions. Results from a multitude of such experiments help in identifying/optimizing a lead compound and rejecting compounds that are likely to be problematic with regards to causing toxicity or adverse drug-drug interactions. Therefore, well designed in vitro methodologies are vital to reducing the number of human trials during the late stages of drug development.
AB  - Upotreba eksperimentalnih životinja i in vitro modela životinjskog porekla u pretkliničkim studijama metabolizma lekova je u velikoj meri potisnuta in vitro eksperimentalnim modelima poreklom od humanih tkiva. Danas se najviše koriste komercijalno dostupni preparati ljudske jetre, kao što su rekombinantni enzimi/transgenske ćelijske linije, subcelularne frakcije (mikrozomi, citozol i S9 frakcija) i primarni hepatociti. Primenom ovih modela u toku pretkliničke faze razvoja novog leka ispituje se stepen metaboličke transformacije leka, vrši se fenotipizacija metaboličkih reakcija (identifikacija specifičnog/ih enzima uključenih u I i II fazu metabolizma leka), određivanje metaboličkog profila (metabolic fingerprinting - identifikacija i određivanje strukture krajnjih produkata metabolizma leka) i razmatra se potencijal za stupanje u interakcije sa drugim lekovima, sa aspekta inhibicije i indukcije metaboličkih enzima. Primena in vitro - in vivo korelacije uz dobro razumevanje farmakokinetičkih principa omogućava predviđanje metabolizma i interakcija lekova in vivo na osnovu dobijenih in vitro podataka. Rezultati brojnih in vitro eksperimenata imaju značajnu ulogu u identifikaciji/optimizaciji vodećeg kandidata za novi lek. Dobro dizajnirane in vitro studije omogućavaju smanjenje broja kliničkih ispitivanja kod ljudi, koja se sprovode u kasnijim fazama razvoja leka.
PB  - Savez farmaceutskih udruženja Srbije, Beograd
T2  - Arhiv za farmaciju
T1  - Role of metabolism in drug development: In vitro studies
T1  - Značaj izučavanja metabolizma u razvoju novih lekova - in vitro pristup
VL  - 60
IS  - 4
SP  - 353
EP  - 372
UR  - https://hdl.handle.net/21.15107/rcub_farfar_1448
ER  - 

@article{
author = "Rakić-Ignjatović, Anita and Miljković, Branislava and Ilić, Marija and Pokrajac, Milena and Prostran, Milica",
year = "2010",
abstract = "In recent years there has been a significant paradigm shift in pre-clinical drug metabolism studies. Most importantly, this has included a reduced reliance on animal models and increased use of human tissues (i.e. human liver microsomes and other subcellular fractions, primary culture of human hepatocytes, recombinant human enzymes/transgenic cell lines). During the pre-clinical phase of drug development such studies assess the metabolic stability, reaction phenotyping (elucidation of specific enzyme(s) involved in phase I and II metabolism), metabolic fingerprinting (identification and structural determination of the metabolic end products) and drug interaction issues pertaining to enzyme inhibition and induction. Such studies are now increasingly being used for qualitative and quantitative prediction of drug biotransformation in humans and in the identification of likely determinants of metabolism following drug administration to humans, including possible drug interactions. Results from a multitude of such experiments help in identifying/optimizing a lead compound and rejecting compounds that are likely to be problematic with regards to causing toxicity or adverse drug-drug interactions. Therefore, well designed in vitro methodologies are vital to reducing the number of human trials during the late stages of drug development., Upotreba eksperimentalnih životinja i in vitro modela životinjskog porekla u pretkliničkim studijama metabolizma lekova je u velikoj meri potisnuta in vitro eksperimentalnim modelima poreklom od humanih tkiva. Danas se najviše koriste komercijalno dostupni preparati ljudske jetre, kao što su rekombinantni enzimi/transgenske ćelijske linije, subcelularne frakcije (mikrozomi, citozol i S9 frakcija) i primarni hepatociti. Primenom ovih modela u toku pretkliničke faze razvoja novog leka ispituje se stepen metaboličke transformacije leka, vrši se fenotipizacija metaboličkih reakcija (identifikacija specifičnog/ih enzima uključenih u I i II fazu metabolizma leka), određivanje metaboličkog profila (metabolic fingerprinting - identifikacija i određivanje strukture krajnjih produkata metabolizma leka) i razmatra se potencijal za stupanje u interakcije sa drugim lekovima, sa aspekta inhibicije i indukcije metaboličkih enzima. Primena in vitro - in vivo korelacije uz dobro razumevanje farmakokinetičkih principa omogućava predviđanje metabolizma i interakcija lekova in vivo na osnovu dobijenih in vitro podataka. Rezultati brojnih in vitro eksperimenata imaju značajnu ulogu u identifikaciji/optimizaciji vodećeg kandidata za novi lek. Dobro dizajnirane in vitro studije omogućavaju smanjenje broja kliničkih ispitivanja kod ljudi, koja se sprovode u kasnijim fazama razvoja leka.",
publisher = "Savez farmaceutskih udruženja Srbije, Beograd",
journal = "Arhiv za farmaciju",
title = "Role of metabolism in drug development: In vitro studies, Značaj izučavanja metabolizma u razvoju novih lekova - in vitro pristup",
volume = "60",
number = "4",
pages = "353-372",
url = "https://hdl.handle.net/21.15107/rcub_farfar_1448"
}

Rakić-Ignjatović, A., Miljković, B., Ilić, M., Pokrajac, M.,& Prostran, M.. (2010). Role of metabolism in drug development: In vitro studies. in Arhiv za farmaciju
Savez farmaceutskih udruženja Srbije, Beograd., 60(4), 353-372.
https://hdl.handle.net/21.15107/rcub_farfar_1448

Rakić-Ignjatović A, Miljković B, Ilić M, Pokrajac M, Prostran M. Role of metabolism in drug development: In vitro studies. in Arhiv za farmaciju. 2010;60(4):353-372.
https://hdl.handle.net/21.15107/rcub_farfar_1448 .

Rakić-Ignjatović, Anita, Miljković, Branislava, Ilić, Marija, Pokrajac, Milena, Prostran, Milica, "Role of metabolism in drug development: In vitro studies" in Arhiv za farmaciju, 60, no. 4 (2010):353-372,
https://hdl.handle.net/21.15107/rcub_farfar_1448 .

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 .