TY  - JOUR
AU  - Drakul, Dragana
AU  - Matić, Predrag
AU  - Drobac, Milica
AU  - Kostić, Nađa
AU  - Vemić, Ana
AU  - Vasiljević, Dragana
AU  - Malenović, Anđelija
PY  - 2014
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2291
AB  - Vascular stents are general medical devices of class III or IIb, which are placed along the walls of the constricted coronary and peripheral blood vessels thus keeping them viable. According to the mechanism of expansion, stents may be balloon-expandable or self-expanding. Depending on the geometry they can be classified into: coil stents, open-cell modular stents and multi-cell closed cell stents. The most important characteristic of vascular stents is their flexibility, but a number of additional requirements must also be met: high radial strength, low elastic deformation, small diameter, the possibility of monitoring through the bloodstream, minimum subsequent shortening, minimum elastic longitudinal deformation, and the optimal retention at target site. Materials for production of stents must be biologically inert, visible by radiological techniques, biocompatible, corrosion-resistant and resistant to stress due to blood flow. The most significant adverse event after stent implantation is the occurrence of restenosis, which is most efficiently overcome by the application of drug releasing stents. These stents are composed of three parts: stent platform, drug carrier and a drug that inhibits neointimal hyperplasia - paclitaxel and limuses (sirolimus, everolimus, zotarolimus, tacrolimus, pimecrolimus, etc.). In recent years, stents with surfaces coated with substances that accelerate endothelialisation and thus reduce thrombosis have been developed. The latest approach is represented by a stent with the lumen coated with CD34 antibody, and the outer side coated with sirolimus. By using these devices a double effect is achieved: acceleration of endothelialisation and inhibition of neointimal hyperplasia.
AB  - Vaskularni stentovi su opšta medicinska sredstva klase III ili IIb, koja se postavljaju uz zidove koronarnih i perifernih krvnih sudova kada postoji suženje i na taj način ih održavaju prohodnim. Prema mehanizmu ekspanzije, stentovi mogu biti balon-ekspandirajući ili samoekspandirajući, a u zavisnosti od geometrijskog oblika dele se na: stentove u obliku spirale, modularne stentove sa otvorenim ćelijama i multićelijske stentove sa zatvorenim ćelijama. Najznačajnija karakteristika vaskularnih stentova je fleksibilnost, ali moraju da ispunjavaju i čitav niz dodatnih zahteva, kao što su: velika radijalna snaga, nizak stepen elastične deformacije, mali prečnik, mogućnost praćenja kroz krvotok, minimalno naknadno skraćivanje, minimalna elastična longitudinalna deformacija i optimalno zadržavanje na ciljnom mestu. Materijali za proizvodnju stentova moraju biti biološki inertni, vidljivi radiološkim tehnikama, biokompatibilni, otporni na koroziju i otporni na stres zbog protoka krvi. Najznačajniji neželjeni događaj nakon ugradnje stentova je pojava restenoze, koja se najefikasnije prevazilazi primenom stentova koji oslobađaju lek. Ovi stentovi se sastoje iz tri dela: platforme stenta, nosača leka i leka koji inhibira neointimalnu hiperplaziju, paklitaksel i limusi (sirolimus, everolimus, zotarolimus, takrolimus, pimekrolimus i dr). Poslednjih godina razvijeni su i stentovi kod kojih se površine oblažu supstancama koje ubrzavaju endotelizaciju i tako smanjuju trombozu. Najnoviji pristup predstavlja stent kod koga se lumen stenta oblaže CD34 antitelom, a spoljašnja strana sirolimusom. Primenom ovih stentova postiže se dvostruki efekat: ubrzavanje endotelizacije i inhibicija neointimalne hiperplazije.
PB  - Savez farmaceutskih udruženja Srbije, Beograd
T2  - Arhiv za farmaciju
T1  - Vascular stents: The most important types and characteristics
T1  - Vaskularni stentovi - najznačajnije vrste i osobine
VL  - 64
IS  - 5
SP  - 421
EP  - 437
DO  - 10.5937/arhfarm1405421D
ER  - 

@article{
author = "Drakul, Dragana and Matić, Predrag and Drobac, Milica and Kostić, Nađa and Vemić, Ana and Vasiljević, Dragana and Malenović, Anđelija",
year = "2014",
abstract = "Vascular stents are general medical devices of class III or IIb, which are placed along the walls of the constricted coronary and peripheral blood vessels thus keeping them viable. According to the mechanism of expansion, stents may be balloon-expandable or self-expanding. Depending on the geometry they can be classified into: coil stents, open-cell modular stents and multi-cell closed cell stents. The most important characteristic of vascular stents is their flexibility, but a number of additional requirements must also be met: high radial strength, low elastic deformation, small diameter, the possibility of monitoring through the bloodstream, minimum subsequent shortening, minimum elastic longitudinal deformation, and the optimal retention at target site. Materials for production of stents must be biologically inert, visible by radiological techniques, biocompatible, corrosion-resistant and resistant to stress due to blood flow. The most significant adverse event after stent implantation is the occurrence of restenosis, which is most efficiently overcome by the application of drug releasing stents. These stents are composed of three parts: stent platform, drug carrier and a drug that inhibits neointimal hyperplasia - paclitaxel and limuses (sirolimus, everolimus, zotarolimus, tacrolimus, pimecrolimus, etc.). In recent years, stents with surfaces coated with substances that accelerate endothelialisation and thus reduce thrombosis have been developed. The latest approach is represented by a stent with the lumen coated with CD34 antibody, and the outer side coated with sirolimus. By using these devices a double effect is achieved: acceleration of endothelialisation and inhibition of neointimal hyperplasia., Vaskularni stentovi su opšta medicinska sredstva klase III ili IIb, koja se postavljaju uz zidove koronarnih i perifernih krvnih sudova kada postoji suženje i na taj način ih održavaju prohodnim. Prema mehanizmu ekspanzije, stentovi mogu biti balon-ekspandirajući ili samoekspandirajući, a u zavisnosti od geometrijskog oblika dele se na: stentove u obliku spirale, modularne stentove sa otvorenim ćelijama i multićelijske stentove sa zatvorenim ćelijama. Najznačajnija karakteristika vaskularnih stentova je fleksibilnost, ali moraju da ispunjavaju i čitav niz dodatnih zahteva, kao što su: velika radijalna snaga, nizak stepen elastične deformacije, mali prečnik, mogućnost praćenja kroz krvotok, minimalno naknadno skraćivanje, minimalna elastična longitudinalna deformacija i optimalno zadržavanje na ciljnom mestu. Materijali za proizvodnju stentova moraju biti biološki inertni, vidljivi radiološkim tehnikama, biokompatibilni, otporni na koroziju i otporni na stres zbog protoka krvi. Najznačajniji neželjeni događaj nakon ugradnje stentova je pojava restenoze, koja se najefikasnije prevazilazi primenom stentova koji oslobađaju lek. Ovi stentovi se sastoje iz tri dela: platforme stenta, nosača leka i leka koji inhibira neointimalnu hiperplaziju, paklitaksel i limusi (sirolimus, everolimus, zotarolimus, takrolimus, pimekrolimus i dr). Poslednjih godina razvijeni su i stentovi kod kojih se površine oblažu supstancama koje ubrzavaju endotelizaciju i tako smanjuju trombozu. Najnoviji pristup predstavlja stent kod koga se lumen stenta oblaže CD34 antitelom, a spoljašnja strana sirolimusom. Primenom ovih stentova postiže se dvostruki efekat: ubrzavanje endotelizacije i inhibicija neointimalne hiperplazije.",
publisher = "Savez farmaceutskih udruženja Srbije, Beograd",
journal = "Arhiv za farmaciju",
title = "Vascular stents: The most important types and characteristics, Vaskularni stentovi - najznačajnije vrste i osobine",
volume = "64",
number = "5",
pages = "421-437",
doi = "10.5937/arhfarm1405421D"
}

Drakul, D., Matić, P., Drobac, M., Kostić, N., Vemić, A., Vasiljević, D.,& Malenović, A.. (2014). Vascular stents: The most important types and characteristics. in Arhiv za farmaciju
Savez farmaceutskih udruženja Srbije, Beograd., 64(5), 421-437.
https://doi.org/10.5937/arhfarm1405421D

Drakul D, Matić P, Drobac M, Kostić N, Vemić A, Vasiljević D, Malenović A. Vascular stents: The most important types and characteristics. in Arhiv za farmaciju. 2014;64(5):421-437.
doi:10.5937/arhfarm1405421D .

Drakul, Dragana, Matić, Predrag, Drobac, Milica, Kostić, Nađa, Vemić, Ana, Vasiljević, Dragana, Malenović, Anđelija, "Vascular stents: The most important types and characteristics" in Arhiv za farmaciju, 64, no. 5 (2014):421-437,
https://doi.org/10.5937/arhfarm1405421D . .

TY  - JOUR
AU  - Perović, Ivana
AU  - Malenović, Anđelija
AU  - Vemić, Ana
AU  - Kostić, Nađa
AU  - Ivanović, Darko
PY  - 2014
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2242
AB  - In this paper the experimental conditions for optimal reversed-phase liquid chromatographic (RP-HPLC) determination of sulfamethoxazole, trimethoprim and preservatives, as well as degradation products of sulfamethoxazole and trimethoprim in syrup were defined. The determination of active compounds and preservatives was carried out on Zorbax Eclipse XDB-C18, 150 mm × 4.6 mm, 5 μm particle size column, mobile phase flow rate was 1.5 mL min-1, and detection at 235 nm for the active compounds and 254 nm for preservatives. Mobile phase A consisted of 150 mL of acetonitrile, 850 mL of water and 1 mL of triethanolamine (pH 5.90 adjusted with diluted acetic acid), while mobile phase B was acetonitrile. The mobile phase ratio was defined by the gradient program. For the determination of degradation products Zorbax Eclipse Plus C18, 100 mm x 4.6 mm, 3.5 μm particle size column was used, the mobile phase flow rate was 0.5 mL min-1 and detection at 210 nm for 3,4,5-trimethoxybenzoic acid and 254 nm for sulfanilic acid and sulfanilamide. Mobile phase A was 50 mM potassium dihydrogenphosphate (pH 5.60 adjusted with a 0.5 mol L-1 potassium hydroxide), while mobile phase B was acetonitrile. The mobile phase ratio was defined by the gradient program. Through the validation of the developed methods their efficiency and reliability is confirmed and consequently the adequacy for the routine control.
AB  - U ovom radu prikazano je definisanje eksperimentalnih uslova i optimizacija metoda reverzno-fazne tečne hromatografije (RP-HPLC) za određivanje sulfametoksazola, trimetoprima i konzervanasa, odnosno degradacionih proizvoda sulfametoksazola i trimetoprima u sirupu. Određivanje sadržaja aktivnih komponenti i konzervanasa vršeno je na koloni Zorbax Eclipse XDB-C18, 150 mm × 4,6 mm, 5 μm veličine čestica, protok mobilne faze bio je 1,5 mL min-1, dok je detekcija vršena na 235 nm za aktivne komponente i 254 nm za konzervanse. Mobilna faza A sastojala se od smeše 150 mL acetonitrila, 850 mL vode i 1 mL trietanolamina (pH 5,9 podešen razblaženom sirćetnom kiselinom), a kao mobilna faza B korišćen je acetonitril. Odnos mobilnih faza tokom analize definisan je programom gradijenta. Određivanje sadržaja degradacionih proizvoda vršeno je na koloni Zorbax Eclipse Plus-C18, 100 mm × 4,6 mm, 3,5 μm veličine čestica, uz protok mobilne faze od 0,5 mL min-1 i detekciju na 210 nm za 3,4,5-trimetoksibenzojevu kiselinu i 254 nm za sulfanilnu kiselinu i sulfanilamid. Mobilna faza A bila je 50 mM kalijum-dihidrogenfosfat (pH 5,60 podešen sa 0,5 mol L-1 kalijum-hidroksidom), a mobilna faza B bio je acetonitril. Odnos mobilnih faza tokom analize definisan je programom gradijenta. Validacijom postavljenih metoda potvrđeno je da su efikasne i pouzdane, i kao takve pogodne za rutinsku kontrolu.
PB  - Savez farmaceutskih udruženja Srbije, Beograd
T2  - Arhiv za farmaciju
T1  - Development of chromatographic methods for analysis of sulfamethoxazole, trimethoprim, their degradation products and preservatives in syrup
T1  - Razvoj hromatografskih metoda za analizu sulfametoksazola, trimetoprima, njihovih degradacionih proizvoda i konzervanasa u sirupu
VL  - 64
IS  - 2
SP  - 112
EP  - 127
DO  - 10.5937/arhfarm1402112P
ER  - 

@article{
author = "Perović, Ivana and Malenović, Anđelija and Vemić, Ana and Kostić, Nađa and Ivanović, Darko",
year = "2014",
abstract = "In this paper the experimental conditions for optimal reversed-phase liquid chromatographic (RP-HPLC) determination of sulfamethoxazole, trimethoprim and preservatives, as well as degradation products of sulfamethoxazole and trimethoprim in syrup were defined. The determination of active compounds and preservatives was carried out on Zorbax Eclipse XDB-C18, 150 mm × 4.6 mm, 5 μm particle size column, mobile phase flow rate was 1.5 mL min-1, and detection at 235 nm for the active compounds and 254 nm for preservatives. Mobile phase A consisted of 150 mL of acetonitrile, 850 mL of water and 1 mL of triethanolamine (pH 5.90 adjusted with diluted acetic acid), while mobile phase B was acetonitrile. The mobile phase ratio was defined by the gradient program. For the determination of degradation products Zorbax Eclipse Plus C18, 100 mm x 4.6 mm, 3.5 μm particle size column was used, the mobile phase flow rate was 0.5 mL min-1 and detection at 210 nm for 3,4,5-trimethoxybenzoic acid and 254 nm for sulfanilic acid and sulfanilamide. Mobile phase A was 50 mM potassium dihydrogenphosphate (pH 5.60 adjusted with a 0.5 mol L-1 potassium hydroxide), while mobile phase B was acetonitrile. The mobile phase ratio was defined by the gradient program. Through the validation of the developed methods their efficiency and reliability is confirmed and consequently the adequacy for the routine control., U ovom radu prikazano je definisanje eksperimentalnih uslova i optimizacija metoda reverzno-fazne tečne hromatografije (RP-HPLC) za određivanje sulfametoksazola, trimetoprima i konzervanasa, odnosno degradacionih proizvoda sulfametoksazola i trimetoprima u sirupu. Određivanje sadržaja aktivnih komponenti i konzervanasa vršeno je na koloni Zorbax Eclipse XDB-C18, 150 mm × 4,6 mm, 5 μm veličine čestica, protok mobilne faze bio je 1,5 mL min-1, dok je detekcija vršena na 235 nm za aktivne komponente i 254 nm za konzervanse. Mobilna faza A sastojala se od smeše 150 mL acetonitrila, 850 mL vode i 1 mL trietanolamina (pH 5,9 podešen razblaženom sirćetnom kiselinom), a kao mobilna faza B korišćen je acetonitril. Odnos mobilnih faza tokom analize definisan je programom gradijenta. Određivanje sadržaja degradacionih proizvoda vršeno je na koloni Zorbax Eclipse Plus-C18, 100 mm × 4,6 mm, 3,5 μm veličine čestica, uz protok mobilne faze od 0,5 mL min-1 i detekciju na 210 nm za 3,4,5-trimetoksibenzojevu kiselinu i 254 nm za sulfanilnu kiselinu i sulfanilamid. Mobilna faza A bila je 50 mM kalijum-dihidrogenfosfat (pH 5,60 podešen sa 0,5 mol L-1 kalijum-hidroksidom), a mobilna faza B bio je acetonitril. Odnos mobilnih faza tokom analize definisan je programom gradijenta. Validacijom postavljenih metoda potvrđeno je da su efikasne i pouzdane, i kao takve pogodne za rutinsku kontrolu.",
publisher = "Savez farmaceutskih udruženja Srbije, Beograd",
journal = "Arhiv za farmaciju",
title = "Development of chromatographic methods for analysis of sulfamethoxazole, trimethoprim, their degradation products and preservatives in syrup, Razvoj hromatografskih metoda za analizu sulfametoksazola, trimetoprima, njihovih degradacionih proizvoda i konzervanasa u sirupu",
volume = "64",
number = "2",
pages = "112-127",
doi = "10.5937/arhfarm1402112P"
}

Perović, I., Malenović, A., Vemić, A., Kostić, N.,& Ivanović, D.. (2014). Development of chromatographic methods for analysis of sulfamethoxazole, trimethoprim, their degradation products and preservatives in syrup. in Arhiv za farmaciju
Savez farmaceutskih udruženja Srbije, Beograd., 64(2), 112-127.
https://doi.org/10.5937/arhfarm1402112P

Perović I, Malenović A, Vemić A, Kostić N, Ivanović D. Development of chromatographic methods for analysis of sulfamethoxazole, trimethoprim, their degradation products and preservatives in syrup. in Arhiv za farmaciju. 2014;64(2):112-127.
doi:10.5937/arhfarm1402112P .

Perović, Ivana, Malenović, Anđelija, Vemić, Ana, Kostić, Nađa, Ivanović, Darko, "Development of chromatographic methods for analysis of sulfamethoxazole, trimethoprim, their degradation products and preservatives in syrup" in Arhiv za farmaciju, 64, no. 2 (2014):112-127,
https://doi.org/10.5937/arhfarm1402112P . .

TY  - JOUR
AU  - Drobac, Milica
AU  - Jeremić, Veljko
AU  - Kostić, Nađa
AU  - Vemić, Ana
AU  - Vasiljević, Dragana
AU  - Malenović, Anđelija
PY  - 2013
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2046
AB  - Overall, the medical devices used in the treatment of wounds could be divided into traditional dressings, modern dressings (with advanced features), skin replacement products and wound healing devices. This paper provides an overview of traditional dressings, their most important characteristics and their common usage. Traditional dressings include cotton wool, gauzes, bandages and wound dressing pads. According to the Regulation on the classification of general medical devices, given traditional dressings are classified into Class I, if used as a mechanical barrier, for compression or for absorption of the fluid from the wound (e.g. cotton wool, gauzes, compresses, bandages and the like), or into Class IIa, if they possess specific characteristics to support the wound healing and have properties that regulate humidity, temperature, levels of oxygen and other gases, pH value, and the wound microenvironment (e.g. paraffin impregnated gauze). The advantages of the traditional dressings reflect in their ability to stop the bleeding, to stabilize the wound and in their low price. The disadvantages are that they usually adhere to the wound, do not maintain the moisture and need an often change.
AB  - Sveobuhvatna podela medicinskih sredstava koja se koriste za obradu rana je na konvencionalna sredstva, savremena sredstva (sa unapređenim karakteristikama), sredstva koja predstavljaju zamenu za kožu i sredstva za zaceljivanje kože. U ovom radu dat je pregled konvencionalnih medicinskih sredstava koja se koriste za obradu rana, njihove najznačajnije osobine i uobičajena upotreba. Konvencionalna medicinska sredstva koja se koriste za obradu rana su vate, gaze, zavoji i sredstva za prekrivanje rane. Prema Pravilniku o klasifikaciji opštih medicinskih sredstava, navedena konvencionalna medicinska sredstva se svrstavaju u Klasu I, ako se upotrebljavaju kao mehanička prepreka, za kompresiju ili upijanje tečnosti iz rana (npr. vate, gaze, komprese, zavoji i sl.), ili u Klasu IIa, kada imaju specifične karakteristike da potpomažu proces isceljivanja rana i imaju svojstva da regulišu vlagu, temperaturu, nivo kiseonika i drugih gasova, pH vrednost, odnosno mikrookolinu rane (npr. parafinske (vazelinske) gaze). Prednosti primene konvencionalnih medicinskih sredstava za obradu rana su: zaustavljanje krvarenja, stabilizacija rane, kao i niska cena. Nedostaci su što se obično lepe za ranu, ne održavaju odgovarajuću vlažnost rane i što moraju često da se menjaju.
PB  - Savez farmaceutskih udruženja Srbije, Beograd
T2  - Arhiv za farmaciju
T1  - Konvencionalna medicinska sredstva za obradu rana - osobine i upotreba
T1  - Traditional medical devices in wound treatment -
characteristics and usage
VL  - 63
IS  - 6
SP  - 513
EP  - 527
UR  - https://hdl.handle.net/21.15107/rcub_farfar_2046
ER  - 

@article{
author = "Drobac, Milica and Jeremić, Veljko and Kostić, Nađa and Vemić, Ana and Vasiljević, Dragana and Malenović, Anđelija",
year = "2013",
abstract = "Overall, the medical devices used in the treatment of wounds could be divided into traditional dressings, modern dressings (with advanced features), skin replacement products and wound healing devices. This paper provides an overview of traditional dressings, their most important characteristics and their common usage. Traditional dressings include cotton wool, gauzes, bandages and wound dressing pads. According to the Regulation on the classification of general medical devices, given traditional dressings are classified into Class I, if used as a mechanical barrier, for compression or for absorption of the fluid from the wound (e.g. cotton wool, gauzes, compresses, bandages and the like), or into Class IIa, if they possess specific characteristics to support the wound healing and have properties that regulate humidity, temperature, levels of oxygen and other gases, pH value, and the wound microenvironment (e.g. paraffin impregnated gauze). The advantages of the traditional dressings reflect in their ability to stop the bleeding, to stabilize the wound and in their low price. The disadvantages are that they usually adhere to the wound, do not maintain the moisture and need an often change., Sveobuhvatna podela medicinskih sredstava koja se koriste za obradu rana je na konvencionalna sredstva, savremena sredstva (sa unapređenim karakteristikama), sredstva koja predstavljaju zamenu za kožu i sredstva za zaceljivanje kože. U ovom radu dat je pregled konvencionalnih medicinskih sredstava koja se koriste za obradu rana, njihove najznačajnije osobine i uobičajena upotreba. Konvencionalna medicinska sredstva koja se koriste za obradu rana su vate, gaze, zavoji i sredstva za prekrivanje rane. Prema Pravilniku o klasifikaciji opštih medicinskih sredstava, navedena konvencionalna medicinska sredstva se svrstavaju u Klasu I, ako se upotrebljavaju kao mehanička prepreka, za kompresiju ili upijanje tečnosti iz rana (npr. vate, gaze, komprese, zavoji i sl.), ili u Klasu IIa, kada imaju specifične karakteristike da potpomažu proces isceljivanja rana i imaju svojstva da regulišu vlagu, temperaturu, nivo kiseonika i drugih gasova, pH vrednost, odnosno mikrookolinu rane (npr. parafinske (vazelinske) gaze). Prednosti primene konvencionalnih medicinskih sredstava za obradu rana su: zaustavljanje krvarenja, stabilizacija rane, kao i niska cena. Nedostaci su što se obično lepe za ranu, ne održavaju odgovarajuću vlažnost rane i što moraju često da se menjaju.",
publisher = "Savez farmaceutskih udruženja Srbije, Beograd",
journal = "Arhiv za farmaciju",
title = "Konvencionalna medicinska sredstva za obradu rana - osobine i upotreba, Traditional medical devices in wound treatment -
characteristics and usage",
volume = "63",
number = "6",
pages = "513-527",
url = "https://hdl.handle.net/21.15107/rcub_farfar_2046"
}

Drobac, M., Jeremić, V., Kostić, N., Vemić, A., Vasiljević, D.,& Malenović, A.. (2013). Konvencionalna medicinska sredstva za obradu rana - osobine i upotreba. in Arhiv za farmaciju
Savez farmaceutskih udruženja Srbije, Beograd., 63(6), 513-527.
https://hdl.handle.net/21.15107/rcub_farfar_2046

Drobac M, Jeremić V, Kostić N, Vemić A, Vasiljević D, Malenović A. Konvencionalna medicinska sredstva za obradu rana - osobine i upotreba. in Arhiv za farmaciju. 2013;63(6):513-527.
https://hdl.handle.net/21.15107/rcub_farfar_2046 .

Drobac, Milica, Jeremić, Veljko, Kostić, Nađa, Vemić, Ana, Vasiljević, Dragana, Malenović, Anđelija, "Konvencionalna medicinska sredstva za obradu rana - osobine i upotreba" in Arhiv za farmaciju, 63, no. 6 (2013):513-527,
https://hdl.handle.net/21.15107/rcub_farfar_2046 .

TY  - JOUR
AU  - Jančić-Stojanović, Biljana
AU  - Vemić, Ana
AU  - Rakić, Tijana
AU  - Kostić, Nađa M.
AU  - Malenović, Anđelija
PY  - 2012
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1766
AB  - Modern trends in drug quality control are moving toward incorporating quality into the method during its development. That course is in accordance with Quality by Design (QbD) concept defined by ICH Q 8 (R2) guideline. This implies that the method development begins by defining the method goals and collecting the relevant data, i.e., analyzing the properties of a given active pharmaceutical ingredient and evaluating the optimal experimental conditions. It is followed by a risk assessment defined by systematic robustness testing with the application of experimental design, while the final confirmation of the method reliability is done through the complete validation tests. In this paper, development of Karl Fischer titration for water determination in active pharmaceutical substance clindamycin phosphate is presented. Karl Fischer titration (KFT) is a widely used method in the pharmaceutical industry for determination of water content. For the analyzed substance, the European Pharmacopoeia suggests a relatively large amount of samples for the determination of water, so the objective of this study is to confirm the applicability of the developed method for the determination of water in small amount of samples applying QbD approach. According to QbD rules, detail development of coulometric Karl Fischer titration for water determination in clindamycin phosphate was done. For robustness testing, fractional factorial design 24-1 was successful applied and confirmed that the method was robust. Robustness was evaluated using statistical and graphical methods. Also, design space was defined so the region in which factors could be changed without significant changes in water content was defined. At the end, other validation parameters were determined and it was proven that the analytical test system was capable of providing useful and valid analytical data.
AB  - Savremeni zahtevi u industriji, posebno farmaceutskoj, postavljeni su na konceptu ugrađivanja kvaliteta u metodu tokom njenog razvoja (eng. Quality by Design - QbD koncept). Ovo podrazumeva da razvoj metode započinje definisanjem cilja metode i prikupljanjem odgovarajućih podataka, nastavlja se procenom rizika, a konačna potvrda pouzdanosti metode dobija se njenom validacijom. Ovakav pristup uspešno je primenjen na metodi Karl Fišer-ove titracije za određivanje sadržaja vode u klindamicin-fosfatu. Dobijeni rezultati su u skladu sa postavljenim QbD konceptom i predstavljaju značajan napredak u primeni metode titracije po Karl Fišer-u u farmaceutskoj industriji.
PB  - Savez hemijskih inženjera, Beograd
T2  - Hemijska industrija
T1  - Development of Karl Fischer titration method using Duality by Design concept
T1  - Razvoj metode titracije po Karl Fišeru primenom tzv. Quality by Design koncepta
VL  - 66
IS  - 5
SP  - 659
EP  - 665
DO  - 10.2298/HEMIND120120030J
ER  - 

@article{
author = "Jančić-Stojanović, Biljana and Vemić, Ana and Rakić, Tijana and Kostić, Nađa M. and Malenović, Anđelija",
year = "2012",
abstract = "Modern trends in drug quality control are moving toward incorporating quality into the method during its development. That course is in accordance with Quality by Design (QbD) concept defined by ICH Q 8 (R2) guideline. This implies that the method development begins by defining the method goals and collecting the relevant data, i.e., analyzing the properties of a given active pharmaceutical ingredient and evaluating the optimal experimental conditions. It is followed by a risk assessment defined by systematic robustness testing with the application of experimental design, while the final confirmation of the method reliability is done through the complete validation tests. In this paper, development of Karl Fischer titration for water determination in active pharmaceutical substance clindamycin phosphate is presented. Karl Fischer titration (KFT) is a widely used method in the pharmaceutical industry for determination of water content. For the analyzed substance, the European Pharmacopoeia suggests a relatively large amount of samples for the determination of water, so the objective of this study is to confirm the applicability of the developed method for the determination of water in small amount of samples applying QbD approach. According to QbD rules, detail development of coulometric Karl Fischer titration for water determination in clindamycin phosphate was done. For robustness testing, fractional factorial design 24-1 was successful applied and confirmed that the method was robust. Robustness was evaluated using statistical and graphical methods. Also, design space was defined so the region in which factors could be changed without significant changes in water content was defined. At the end, other validation parameters were determined and it was proven that the analytical test system was capable of providing useful and valid analytical data., Savremeni zahtevi u industriji, posebno farmaceutskoj, postavljeni su na konceptu ugrađivanja kvaliteta u metodu tokom njenog razvoja (eng. Quality by Design - QbD koncept). Ovo podrazumeva da razvoj metode započinje definisanjem cilja metode i prikupljanjem odgovarajućih podataka, nastavlja se procenom rizika, a konačna potvrda pouzdanosti metode dobija se njenom validacijom. Ovakav pristup uspešno je primenjen na metodi Karl Fišer-ove titracije za određivanje sadržaja vode u klindamicin-fosfatu. Dobijeni rezultati su u skladu sa postavljenim QbD konceptom i predstavljaju značajan napredak u primeni metode titracije po Karl Fišer-u u farmaceutskoj industriji.",
publisher = "Savez hemijskih inženjera, Beograd",
journal = "Hemijska industrija",
title = "Development of Karl Fischer titration method using Duality by Design concept, Razvoj metode titracije po Karl Fišeru primenom tzv. Quality by Design koncepta",
volume = "66",
number = "5",
pages = "659-665",
doi = "10.2298/HEMIND120120030J"
}

Jančić-Stojanović, B., Vemić, A., Rakić, T., Kostić, N. M.,& Malenović, A.. (2012). Development of Karl Fischer titration method using Duality by Design concept. in Hemijska industrija
Savez hemijskih inženjera, Beograd., 66(5), 659-665.
https://doi.org/10.2298/HEMIND120120030J

Jančić-Stojanović B, Vemić A, Rakić T, Kostić NM, Malenović A. Development of Karl Fischer titration method using Duality by Design concept. in Hemijska industrija. 2012;66(5):659-665.
doi:10.2298/HEMIND120120030J .

Jančić-Stojanović, Biljana, Vemić, Ana, Rakić, Tijana, Kostić, Nađa M., Malenović, Anđelija, "Development of Karl Fischer titration method using Duality by Design concept" in Hemijska industrija, 66, no. 5 (2012):659-665,
https://doi.org/10.2298/HEMIND120120030J . .

TY  - JOUR
AU  - Malenović, Anđelija
AU  - Kostić, Nađa
AU  - Vemić, Ana
AU  - Rakić, Tijana
AU  - Jančić-Stojanović, Biljana
PY  - 2012
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1793
AB  - In the current paper, multi-criteria decision making (MCDM) approach was applied to optimize micellar liquid chromatography (MLC) intended for the pharmaceutical analysis of atorvastatin and its impurities, trans-atorvastatin and desfluoro-atorvastatin. MLC is a reversedphase liquid chromatographic (RPLC) mode where the modification of mobile phase leads to the stationary phase modification. This results in the diverse interactions (hydrophobic, ionic and steric) significantly affecting retention and selectivity. For that reason double chained surfactant sodium dioctyl sulfosuccinate - AOT (Aerosol OT), with oxygen atoms in its tails, was used for the first time in such kind of separation. As the most efficient way to investigate a high number of factors, and simultaneously optimize defined antagonistic objectives (minimization of run time and maximization of atorvastatin and trans-atorvastatin resolution) MCDM approach was employed. Central composite design (CCD) with fractional factorial design, ± 0.5 star design and four replications in central point was used to define plan of experiments. Five responses selected during method development were optimized simultaneously using Derringer's desirability function. The predicted optimum was: 32 % acetonitrile, 2 % ethylene glycol, 66 % 6.4 mmol L-1 AOT in 20 mmol L-1 ammonium acetate, pH of the water phase 5.50 adjusted with acetic acid, flow rate 1.15 mL min-1 and column temperature of 10C.
AB  - U ovom radu, za optimizaciju metode micelarne tečne hromatografije (MLC) namenjene za farmaceutsku analizu atorvastatina i njegovih nečistoća, trans-atorvastatina i desfluoroatorvastatina primenjen je multikriterijumski pristup. MLC je oblik reverzno-fazne tečne hromatografije gde promene u mobilnoj fazi dovode i do modifikacije stacionarne faze. Ovo rezultuje različitim interakcijama (hidrofobnim, jonskim, sternim) sa značajnim uticajem na retenciju i selektivnost. Zbog toga je za separaciju odabran surfaktant koji sadrži dvostruki lanac i atom kiseonika, natrijum dioktil sulfosukcinat - AOT (Aerosol OT). Kao najefikasniji način za istraživanje velikog broja faktora i istovremenu optimizaciju suprotstavljenih ciljeva (minimizacija vremena trajanja razdvajanja i maksimizacija rezolucije između atorvastatina i trans-atorvastatina) primenjena je multikriterijumska optimizacija. Centralni kompozicioni dizajn (CCD) sa frakcionim faktorskim dizajnom, ± 0.5 zvezda dizajnom i četiri replikacije u centralnoj tački korišćen je za definisanje plana eksperimenta. Korišćenjem Derringer funkcije poželjnih odgovora, optimizirano je pet odgovora. Predviđeni optimalni uslovi bili su: 32 % acetonitrila, 2 % etilen-glikola, 66 % 6,4 mmol L-1 AOT u 20 mmol L-1 amonijum-acetatu, pH vodene faze 5,50 podešen sirćetnom kiselinom, protok 1,15 mL min-1 uz temperaturu kolone 10 C.
PB  - Savez farmaceutskih udruženja Srbije, Beograd
T2  - Arhiv za farmaciju
T1  - Multi-criteria decision making approach for the optimization of atorvastatin and its impurities separation by micellar liquid chromatography
T1  - Multikriterijumski pristup optimizaciji metode micelarne tečne hromatografije za analizu atorvastatina i njegovih nečistoća
VL  - 62
IS  - 3
SP  - 191
EP  - 207
UR  - https://hdl.handle.net/21.15107/rcub_farfar_1793
ER  - 

@article{
author = "Malenović, Anđelija and Kostić, Nađa and Vemić, Ana and Rakić, Tijana and Jančić-Stojanović, Biljana",
year = "2012",
abstract = "In the current paper, multi-criteria decision making (MCDM) approach was applied to optimize micellar liquid chromatography (MLC) intended for the pharmaceutical analysis of atorvastatin and its impurities, trans-atorvastatin and desfluoro-atorvastatin. MLC is a reversedphase liquid chromatographic (RPLC) mode where the modification of mobile phase leads to the stationary phase modification. This results in the diverse interactions (hydrophobic, ionic and steric) significantly affecting retention and selectivity. For that reason double chained surfactant sodium dioctyl sulfosuccinate - AOT (Aerosol OT), with oxygen atoms in its tails, was used for the first time in such kind of separation. As the most efficient way to investigate a high number of factors, and simultaneously optimize defined antagonistic objectives (minimization of run time and maximization of atorvastatin and trans-atorvastatin resolution) MCDM approach was employed. Central composite design (CCD) with fractional factorial design, ± 0.5 star design and four replications in central point was used to define plan of experiments. Five responses selected during method development were optimized simultaneously using Derringer's desirability function. The predicted optimum was: 32 % acetonitrile, 2 % ethylene glycol, 66 % 6.4 mmol L-1 AOT in 20 mmol L-1 ammonium acetate, pH of the water phase 5.50 adjusted with acetic acid, flow rate 1.15 mL min-1 and column temperature of 10C., U ovom radu, za optimizaciju metode micelarne tečne hromatografije (MLC) namenjene za farmaceutsku analizu atorvastatina i njegovih nečistoća, trans-atorvastatina i desfluoroatorvastatina primenjen je multikriterijumski pristup. MLC je oblik reverzno-fazne tečne hromatografije gde promene u mobilnoj fazi dovode i do modifikacije stacionarne faze. Ovo rezultuje različitim interakcijama (hidrofobnim, jonskim, sternim) sa značajnim uticajem na retenciju i selektivnost. Zbog toga je za separaciju odabran surfaktant koji sadrži dvostruki lanac i atom kiseonika, natrijum dioktil sulfosukcinat - AOT (Aerosol OT). Kao najefikasniji način za istraživanje velikog broja faktora i istovremenu optimizaciju suprotstavljenih ciljeva (minimizacija vremena trajanja razdvajanja i maksimizacija rezolucije između atorvastatina i trans-atorvastatina) primenjena je multikriterijumska optimizacija. Centralni kompozicioni dizajn (CCD) sa frakcionim faktorskim dizajnom, ± 0.5 zvezda dizajnom i četiri replikacije u centralnoj tački korišćen je za definisanje plana eksperimenta. Korišćenjem Derringer funkcije poželjnih odgovora, optimizirano je pet odgovora. Predviđeni optimalni uslovi bili su: 32 % acetonitrila, 2 % etilen-glikola, 66 % 6,4 mmol L-1 AOT u 20 mmol L-1 amonijum-acetatu, pH vodene faze 5,50 podešen sirćetnom kiselinom, protok 1,15 mL min-1 uz temperaturu kolone 10 C.",
publisher = "Savez farmaceutskih udruženja Srbije, Beograd",
journal = "Arhiv za farmaciju",
title = "Multi-criteria decision making approach for the optimization of atorvastatin and its impurities separation by micellar liquid chromatography, Multikriterijumski pristup optimizaciji metode micelarne tečne hromatografije za analizu atorvastatina i njegovih nečistoća",
volume = "62",
number = "3",
pages = "191-207",
url = "https://hdl.handle.net/21.15107/rcub_farfar_1793"
}

Malenović, A., Kostić, N., Vemić, A., Rakić, T.,& Jančić-Stojanović, B.. (2012). Multi-criteria decision making approach for the optimization of atorvastatin and its impurities separation by micellar liquid chromatography. in Arhiv za farmaciju
Savez farmaceutskih udruženja Srbije, Beograd., 62(3), 191-207.
https://hdl.handle.net/21.15107/rcub_farfar_1793

Malenović A, Kostić N, Vemić A, Rakić T, Jančić-Stojanović B. Multi-criteria decision making approach for the optimization of atorvastatin and its impurities separation by micellar liquid chromatography. in Arhiv za farmaciju. 2012;62(3):191-207.
https://hdl.handle.net/21.15107/rcub_farfar_1793 .

Malenović, Anđelija, Kostić, Nađa, Vemić, Ana, Rakić, Tijana, Jančić-Stojanović, Biljana, "Multi-criteria decision making approach for the optimization of atorvastatin and its impurities separation by micellar liquid chromatography" in Arhiv za farmaciju, 62, no. 3 (2012):191-207,
https://hdl.handle.net/21.15107/rcub_farfar_1793 .