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 .