TY  - JOUR
AU  - Turković, Erna
AU  - Vasiljević, Ivana
AU  - Drašković, Milica
AU  - Parojčić, Jelena
PY  - 2022
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/4336
AB  - Orodispersible films (ODFs) have recently emerged as innovative dosage form which provides distinct advantages in the patient centric pharmaceutical drug product design due to inherent dosing flexibility and improved patient acceptability. Although their potential advantages in pharmacotherapy are well recognized, there is still a lot of research work to be done in order to explore and understand complex relationships among different formulation factors, film mechanical properties, and their bioperformance. Lack of standardized characterization methods and relevant specifications pose additional limitation for their wider application. In the present study, in-depth review of the available body of data published on ODF development and characterization was performed. In total, 112 papers published between November 2008 and April 2022 were taken into consideration for dataset building. Data collected have been critically evaluated and compiled into the representative dataset formed around three domains, namely: (A) Manufacturing method and composition; (B) ODF characteristics; and (C) ODF sensory attributes. Based on the investigated dataset, an attempt was made to identify the acceptable range of Critical Quality Attributes (CQA) values and propose ODF specific Quality Targeted Product Profile (QTPP) as a foundation which should guide and facilitate pharmaceutical development.
PB  - Elsevier B.V.
T2  - Journal of Drug Delivery Science and Technology
T1  - Orodispersible films — Pharmaceutical development for improved performance: A review
VL  - 75
DO  - 10.1016/j.jddst.2022.103708
ER  - 

@article{
author = "Turković, Erna and Vasiljević, Ivana and Drašković, Milica and Parojčić, Jelena",
year = "2022",
abstract = "Orodispersible films (ODFs) have recently emerged as innovative dosage form which provides distinct advantages in the patient centric pharmaceutical drug product design due to inherent dosing flexibility and improved patient acceptability. Although their potential advantages in pharmacotherapy are well recognized, there is still a lot of research work to be done in order to explore and understand complex relationships among different formulation factors, film mechanical properties, and their bioperformance. Lack of standardized characterization methods and relevant specifications pose additional limitation for their wider application. In the present study, in-depth review of the available body of data published on ODF development and characterization was performed. In total, 112 papers published between November 2008 and April 2022 were taken into consideration for dataset building. Data collected have been critically evaluated and compiled into the representative dataset formed around three domains, namely: (A) Manufacturing method and composition; (B) ODF characteristics; and (C) ODF sensory attributes. Based on the investigated dataset, an attempt was made to identify the acceptable range of Critical Quality Attributes (CQA) values and propose ODF specific Quality Targeted Product Profile (QTPP) as a foundation which should guide and facilitate pharmaceutical development.",
publisher = "Elsevier B.V.",
journal = "Journal of Drug Delivery Science and Technology",
title = "Orodispersible films — Pharmaceutical development for improved performance: A review",
volume = "75",
doi = "10.1016/j.jddst.2022.103708"
}

Turković, E., Vasiljević, I., Drašković, M.,& Parojčić, J.. (2022). Orodispersible films — Pharmaceutical development for improved performance: A review. in Journal of Drug Delivery Science and Technology
Elsevier B.V.., 75.
https://doi.org/10.1016/j.jddst.2022.103708

Turković E, Vasiljević I, Drašković M, Parojčić J. Orodispersible films — Pharmaceutical development for improved performance: A review. in Journal of Drug Delivery Science and Technology. 2022;75.
doi:10.1016/j.jddst.2022.103708 .

Turković, Erna, Vasiljević, Ivana, Drašković, Milica, Parojčić, Jelena, "Orodispersible films — Pharmaceutical development for improved performance: A review" in Journal of Drug Delivery Science and Technology, 75 (2022),
https://doi.org/10.1016/j.jddst.2022.103708 . .

TY  - JOUR
AU  - Turković, Erna
AU  - Vasiljević, Ivana
AU  - Drašković, Milica
AU  - Obradović, Nataša
AU  - Vasiljević, Dragana
AU  - Parojčić, Jelena
PY  - 2021
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3819
AB  - Inkjet printing is novel approach in drug manufacturing that enables dispensing precisevolumes of ink onto substrates. Optimal substrate properties including suitable mechanical charac-teristic are recognized as crucial to achieve desired dosage form performance upon administration.Identification of relevant quality attributes and their quantification is subject of intensive scientificresearch. The aim of this work was to explore applicability of different materials as printing substratesand explore contribution of the investigated substrate properties to its printability. Substrates werecharacterized with regards to uniformity, porosity, disintegration time, mechanical properties anddrug dissolution. Experimentally obtained values were mathematically transformed and the obtainedresults were presented as relevant radar charts. It was shown that structurally different substratesmay be employed for orodispersible films inkjet printing.  Main disadvantage of single-polymerfilms was low drug load, and their printability was dependent on film flexibility and mechanicalstrength. Structured orodispersible film templates exhibited favorable mechanical properties anddrug load capacity.  Wafer edible sheets were characterized with high mechanical resistance andbrittleness which somewhat diminished printability, but did not hinder high drug load. Obtainedresults provide insight into application of different materials as printing substrates and contribute tounderstanding of substrate properties which can affect printability.
PB  - MDPI
T2  - Pharmaceutics
T1  - An investigation into mechanical properties and printability of potential substrates for inkjet printing of orodispersible films
VL  - 13
IS  - 4
DO  - 10.3390/pharmaceutics13040468
ER  - 

@article{
author = "Turković, Erna and Vasiljević, Ivana and Drašković, Milica and Obradović, Nataša and Vasiljević, Dragana and Parojčić, Jelena",
year = "2021",
abstract = "Inkjet printing is novel approach in drug manufacturing that enables dispensing precisevolumes of ink onto substrates. Optimal substrate properties including suitable mechanical charac-teristic are recognized as crucial to achieve desired dosage form performance upon administration.Identification of relevant quality attributes and their quantification is subject of intensive scientificresearch. The aim of this work was to explore applicability of different materials as printing substratesand explore contribution of the investigated substrate properties to its printability. Substrates werecharacterized with regards to uniformity, porosity, disintegration time, mechanical properties anddrug dissolution. Experimentally obtained values were mathematically transformed and the obtainedresults were presented as relevant radar charts. It was shown that structurally different substratesmay be employed for orodispersible films inkjet printing.  Main disadvantage of single-polymerfilms was low drug load, and their printability was dependent on film flexibility and mechanicalstrength. Structured orodispersible film templates exhibited favorable mechanical properties anddrug load capacity.  Wafer edible sheets were characterized with high mechanical resistance andbrittleness which somewhat diminished printability, but did not hinder high drug load. Obtainedresults provide insight into application of different materials as printing substrates and contribute tounderstanding of substrate properties which can affect printability.",
publisher = "MDPI",
journal = "Pharmaceutics",
title = "An investigation into mechanical properties and printability of potential substrates for inkjet printing of orodispersible films",
volume = "13",
number = "4",
doi = "10.3390/pharmaceutics13040468"
}

Turković, E., Vasiljević, I., Drašković, M., Obradović, N., Vasiljević, D.,& Parojčić, J.. (2021). An investigation into mechanical properties and printability of potential substrates for inkjet printing of orodispersible films. in Pharmaceutics
MDPI., 13(4).
https://doi.org/10.3390/pharmaceutics13040468

Turković E, Vasiljević I, Drašković M, Obradović N, Vasiljević D, Parojčić J. An investigation into mechanical properties and printability of potential substrates for inkjet printing of orodispersible films. in Pharmaceutics. 2021;13(4).
doi:10.3390/pharmaceutics13040468 .

Turković, Erna, Vasiljević, Ivana, Drašković, Milica, Obradović, Nataša, Vasiljević, Dragana, Parojčić, Jelena, "An investigation into mechanical properties and printability of potential substrates for inkjet printing of orodispersible films" in Pharmaceutics, 13, no. 4 (2021),
https://doi.org/10.3390/pharmaceutics13040468 . .

TY  - THES
AU  - Drašković, Milica
PY  - 2020
UR  - http://eteze.bg.ac.rs/application/showtheses?thesesId=7514
UR  - https://fedorabg.bg.ac.rs/fedora/get/o:22400/bdef:Content/download
UR  - http://vbs.rs/scripts/cobiss?command=DISPLAY&base=70036&RID=16614665
UR  - http://nardus.mpn.gov.rs/handle/123456789/17331
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3707
AB  - Oralno-disperzibilne tablete (ODT) i oralno-disperzibilni filmovi (ODF) predstavljajukompleksne formulacije koje su namenjene primeni u ustima, gde se u kontaktu sa salivom,gotovo trenutno raspadaju. Pored zahteva za brzo raspadanje, potrebno je da pokazuju iprihvatljivu mehaničku otpornosti kako bi se obezbedila adekvatna manipulacija tokomproizvodnje i primene leka. Cilj istraživanja je bilo ispitivanje i mehanističko objašnjenjeuticaja različitih faktora formulacije i procesnih parametara na raspadljivost i mehaničkekarakteristike, koji su prepoznati kao kritični atributi kvaliteta ODT/ODF.Dinamička analiza kompakcije i teorija perkolacije primenjene su sa ciljem procenefunkcionalnosti novih, direktno kompresibilnih, koprocesovanih ekscipijenasa dizajniranihposebno za razvoj formulacije ODT. Test na istezanje i oscilatorna reološka merenjasprovedena su u svrhu sveobuhvatne analize uticaja različitih ekscipijenasa (hidrofilnipolimeri, superdezintegratori) i variranja udela plastifikatora na mehanička svojstva ODF,pripremljenih metodom izlivanja. Direktno oblaganje čestica sprovedeno je sa ciljemmaskiranja neprijatnog ukusa ispitivanih lekovitih supstanci, nakon čega je sprovedena in vivoi in vitro procena efikasnosti primenjenog pristupa. Fiziološki zasnovano farmakokinetičkomodelovanje primenjeno je sa ciljem simuliranja in vivo ponašanja ispitivanih preparata iprocene obima apsorpcije lekovite supstance iz odabranih ODT/ODF primenom nedavnorazvijenog prostornog modela apsorpcije i tranzita kroz usnu duplju (OCCATTM).Rezultati sveobuhvatne farmaceutsko-tehnološke karakterizacije i dinamičke analizekompakcije ispitivanih korpocesovanih ekscipijenasa ukazali su na kompleksne odnoseizmeđu osnovnih karakteristika materijala i njihove funkcionalnosti. Uprkos činjenici da sebrzo raspadanje najčešće dovodi u vezu sa lošijom mehaničkom otpornošću tableta, bilo jemoguće formulisati ODT sa visokim udelom lekovitih supstanci (37-67% kofeina, odnosno18-49% ibuprofena) bez narušavanja kritičnih karakteristika kvaliteta (vreme raspadanja < 3mi; zatezna čvrstina > 1 MPa). U slučaju ODF, ispitivani hidrofilni polimeri su obezbediliinkorporiranje 20-25% kofeina, odnosno ibuprofena uz održavanje brzog raspadanja iodgovarajućih mehaničkih svojstava. In vivo i in vitro procenom efikasnosti maskiranja ukusapotvrđena je uspešnost direktnog oblaganja čestica kao metode za maskiranje neprijatnogukusa lekovitih supstanci. Visok stepen korelacije između in vivo i in vitro podataka ukazujeda se modifikovani test dispergovanja lekovitih supstanci u maloj zapremini medijuma možekoristiti kao zamena za in vivo ispitivanja efikasnosti maskiranja ukusa. In silico rezultatisimulacije apsorpcije kofeina, odnosno ibuprofena iz pripremljenih oralno-disperzibilnihfarmaceutskih oblika ukazuju da se nakon primene ispitivanih formulacija može očekivatizanemarljiv obim intraoralne apsorpcije i biološka raspoloživost slična onoj koja se postiženakon primene konvencionalnih peroralnih farmaceutskih oblika sa trenutnim oslobađanjem.
AB  - Novel solid dosage forms, orodispersible tablets (ODTs) and orodispersible films (ODFs), aredeveloped as complex formulations providing fast dosage form disintegration in oral cavitycoupled with adequate mechanical resistance to withstand manipulation during manufactureand drug administration. The aim of the study was to investigate and mechanistically explainthe influence of different formulation factors and process parameters on dosage formdisintegration and mechanical properties identified as ODT/ODF critical quality attributes(CQAs).Dynamic compaction analysis and percolation theory were employed in order to explorematerial properties of novel, directly compressible coprocessed excipients designedspecifically for ODT formulation. Tensile tests and oscillatory rheology were employed forcomprehensive evaluation of various excipients selection, including film-forming polymers,superdisintegrants and plasticizer load on mechanical properties of ODFs prepared by solventcasting method. Direct drug coating was applied with the aim to mask unpleasant taste of theinvestigated active substances, accompanied with the in vivo and in vitro evaluation of tastemasking effectiveness. Physiologically based pharmacokinetic modeling has been performedwith the aim to simulate in vivo dosage form performance and predict drug absorption fromthe investigated ODT/ODF using recently developed Oral Cavity Compartmental Absorption& Transit (OCCATTM) model.Comprehensive pharmaceutical-technological evaluation and dynamic compaction analysis ofthe investigated coprocessed excipients revealed complex relation between fundamentalmaterial characteristics and their functionality. Despite the fact that fast disintegration is,generally, associated with poor mechanical resistance of the solid dosage form, it was possibleto obtain ODTs with high drug load (37-67% in the case of caffeine, and 18-49% in the caseof ibuprofen) without compromising the targeted CQAs (i.e. the obtained disintegration timewas less than 3 min, and tensile strength higher than 1 MPa). In the case of ODFs, theinvestigated film-forming agents have provided incorporation of 20-25% of caffeine, oribuprofen load while maintaining fast disintegration and suitable mechanical properties. Invivo and in vitro evaluation of drug taste masking effectiveness indicate usefulness of directdrug coating. Strong correlation between in vivo and in vitro data implicate that small-volumedissolution method may be used as a surrogate for human panel taste-masking assessment, inthe case of physical taste-masking approach application. Outcomes of physiologically basedpharmacokinetic modeling indicate that intraoral drug absorption from the investigatedODF/ODT would be negligible and that administration of orodispersible drug dosage formswould provide similar bioavailability as conventional immediate release dosage forms.
PB  - Универзитет у Београду, Фармацеутски факултет
T2  - Универзитет у Београду
T1  - Formulacija i karakterizacija oralno-disperzibilnih farmaceutskih oblika sa visokim udelom lekovitih supstanci: doprinos mehanističkom razumevanju sistema
UR  - https://hdl.handle.net/21.15107/rcub_nardus_17331
ER  - 

@phdthesis{
author = "Drašković, Milica",
year = "2020",
abstract = "Oralno-disperzibilne tablete (ODT) i oralno-disperzibilni filmovi (ODF) predstavljajukompleksne formulacije koje su namenjene primeni u ustima, gde se u kontaktu sa salivom,gotovo trenutno raspadaju. Pored zahteva za brzo raspadanje, potrebno je da pokazuju iprihvatljivu mehaničku otpornosti kako bi se obezbedila adekvatna manipulacija tokomproizvodnje i primene leka. Cilj istraživanja je bilo ispitivanje i mehanističko objašnjenjeuticaja različitih faktora formulacije i procesnih parametara na raspadljivost i mehaničkekarakteristike, koji su prepoznati kao kritični atributi kvaliteta ODT/ODF.Dinamička analiza kompakcije i teorija perkolacije primenjene su sa ciljem procenefunkcionalnosti novih, direktno kompresibilnih, koprocesovanih ekscipijenasa dizajniranihposebno za razvoj formulacije ODT. Test na istezanje i oscilatorna reološka merenjasprovedena su u svrhu sveobuhvatne analize uticaja različitih ekscipijenasa (hidrofilnipolimeri, superdezintegratori) i variranja udela plastifikatora na mehanička svojstva ODF,pripremljenih metodom izlivanja. Direktno oblaganje čestica sprovedeno je sa ciljemmaskiranja neprijatnog ukusa ispitivanih lekovitih supstanci, nakon čega je sprovedena in vivoi in vitro procena efikasnosti primenjenog pristupa. Fiziološki zasnovano farmakokinetičkomodelovanje primenjeno je sa ciljem simuliranja in vivo ponašanja ispitivanih preparata iprocene obima apsorpcije lekovite supstance iz odabranih ODT/ODF primenom nedavnorazvijenog prostornog modela apsorpcije i tranzita kroz usnu duplju (OCCATTM).Rezultati sveobuhvatne farmaceutsko-tehnološke karakterizacije i dinamičke analizekompakcije ispitivanih korpocesovanih ekscipijenasa ukazali su na kompleksne odnoseizmeđu osnovnih karakteristika materijala i njihove funkcionalnosti. Uprkos činjenici da sebrzo raspadanje najčešće dovodi u vezu sa lošijom mehaničkom otpornošću tableta, bilo jemoguće formulisati ODT sa visokim udelom lekovitih supstanci (37-67% kofeina, odnosno18-49% ibuprofena) bez narušavanja kritičnih karakteristika kvaliteta (vreme raspadanja < 3mi; zatezna čvrstina > 1 MPa). U slučaju ODF, ispitivani hidrofilni polimeri su obezbediliinkorporiranje 20-25% kofeina, odnosno ibuprofena uz održavanje brzog raspadanja iodgovarajućih mehaničkih svojstava. In vivo i in vitro procenom efikasnosti maskiranja ukusapotvrđena je uspešnost direktnog oblaganja čestica kao metode za maskiranje neprijatnogukusa lekovitih supstanci. Visok stepen korelacije između in vivo i in vitro podataka ukazujeda se modifikovani test dispergovanja lekovitih supstanci u maloj zapremini medijuma možekoristiti kao zamena za in vivo ispitivanja efikasnosti maskiranja ukusa. In silico rezultatisimulacije apsorpcije kofeina, odnosno ibuprofena iz pripremljenih oralno-disperzibilnihfarmaceutskih oblika ukazuju da se nakon primene ispitivanih formulacija može očekivatizanemarljiv obim intraoralne apsorpcije i biološka raspoloživost slična onoj koja se postiženakon primene konvencionalnih peroralnih farmaceutskih oblika sa trenutnim oslobađanjem., Novel solid dosage forms, orodispersible tablets (ODTs) and orodispersible films (ODFs), aredeveloped as complex formulations providing fast dosage form disintegration in oral cavitycoupled with adequate mechanical resistance to withstand manipulation during manufactureand drug administration. The aim of the study was to investigate and mechanistically explainthe influence of different formulation factors and process parameters on dosage formdisintegration and mechanical properties identified as ODT/ODF critical quality attributes(CQAs).Dynamic compaction analysis and percolation theory were employed in order to explorematerial properties of novel, directly compressible coprocessed excipients designedspecifically for ODT formulation. Tensile tests and oscillatory rheology were employed forcomprehensive evaluation of various excipients selection, including film-forming polymers,superdisintegrants and plasticizer load on mechanical properties of ODFs prepared by solventcasting method. Direct drug coating was applied with the aim to mask unpleasant taste of theinvestigated active substances, accompanied with the in vivo and in vitro evaluation of tastemasking effectiveness. Physiologically based pharmacokinetic modeling has been performedwith the aim to simulate in vivo dosage form performance and predict drug absorption fromthe investigated ODT/ODF using recently developed Oral Cavity Compartmental Absorption& Transit (OCCATTM) model.Comprehensive pharmaceutical-technological evaluation and dynamic compaction analysis ofthe investigated coprocessed excipients revealed complex relation between fundamentalmaterial characteristics and their functionality. Despite the fact that fast disintegration is,generally, associated with poor mechanical resistance of the solid dosage form, it was possibleto obtain ODTs with high drug load (37-67% in the case of caffeine, and 18-49% in the caseof ibuprofen) without compromising the targeted CQAs (i.e. the obtained disintegration timewas less than 3 min, and tensile strength higher than 1 MPa). In the case of ODFs, theinvestigated film-forming agents have provided incorporation of 20-25% of caffeine, oribuprofen load while maintaining fast disintegration and suitable mechanical properties. Invivo and in vitro evaluation of drug taste masking effectiveness indicate usefulness of directdrug coating. Strong correlation between in vivo and in vitro data implicate that small-volumedissolution method may be used as a surrogate for human panel taste-masking assessment, inthe case of physical taste-masking approach application. Outcomes of physiologically basedpharmacokinetic modeling indicate that intraoral drug absorption from the investigatedODF/ODT would be negligible and that administration of orodispersible drug dosage formswould provide similar bioavailability as conventional immediate release dosage forms.",
publisher = "Универзитет у Београду, Фармацеутски факултет",
journal = "Универзитет у Београду",
title = "Formulacija i karakterizacija oralno-disperzibilnih farmaceutskih oblika sa visokim udelom lekovitih supstanci: doprinos mehanističkom razumevanju sistema",
url = "https://hdl.handle.net/21.15107/rcub_nardus_17331"
}

Drašković, M.. (2020). Formulacija i karakterizacija oralno-disperzibilnih farmaceutskih oblika sa visokim udelom lekovitih supstanci: doprinos mehanističkom razumevanju sistema. in Универзитет у Београду
Универзитет у Београду, Фармацеутски факултет..
https://hdl.handle.net/21.15107/rcub_nardus_17331

Drašković M. Formulacija i karakterizacija oralno-disperzibilnih farmaceutskih oblika sa visokim udelom lekovitih supstanci: doprinos mehanističkom razumevanju sistema. in Универзитет у Београду. 2020;.
https://hdl.handle.net/21.15107/rcub_nardus_17331 .

Drašković, Milica, "Formulacija i karakterizacija oralno-disperzibilnih farmaceutskih oblika sa visokim udelom lekovitih supstanci: doprinos mehanističkom razumevanju sistema" in Универзитет у Београду (2020),
https://hdl.handle.net/21.15107/rcub_nardus_17331 .

TY  - JOUR
AU  - Drašković, Milica
AU  - Cvijić, Sandra
AU  - Ibrić, Svetlana
AU  - Parojčić, Jelena
PY  - 2018
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3098
AB  - Orodispersible dosage forms are intended to be placed on tongue where, in contact with limited saliva volume, fast disintegration, followed by facilitated swallowing, occurred. Intraoral disintegration might be accompanied by drug release and dissolution in oral cavity. Dissolved drug could interact with receptors on taste buds causing taste sensation. The most important critical quality attributes of orodispersible dosage forms are acceptable mechanical resistance, fast disintegration and pleasant taste which have to be monitored and evaluated during formulation development and production. However, compendial methods for orodispersible dosage forms characterization are still lacking, while many authors attempt to develop different, more suitable approaches. The highest variability during determination of disintegration properties is observed. It can be concluded that for the proper disintegration assessment influence of tongue force have to be considered, especially in the case of different polymeric orodispersible films. For reliable development of in vivo study for evaluation of tastemasking efficacy, proper selection and training of panelists accompanied by bitterness threshold determination are of the utmost importance. In order to correlate in vitro and in vivo data, it is necessary to develop analytical method for evaluation of taste-masking efficacy that mimic, in great extent, physiological intraoral conditions.
AB  - Oralno-disperzibilni farmaceutski oblici lekova predstavljaju savremene farmaceutske oblike koji su namenjeni za primenu u usnoj duplji, gde se, u kontaktu sa salivom, gotovo trenutno raspadaju i, nakon toga, gutaju sa ciljem postizanja sistemskog terapijskog efekta. Intraoralno raspadanje preparata može biti praćeno oslobađanjem i rastvaranjem lekovite supstance, nakon čega dolazi do interakcije sa receptorima na kvržicama jezika i senzacije ukusa. Prihvatljiva mehanička otpornost, brza dezintegracija i prijatan ukus predstavljaju kritična svojstva kvaliteta oralno-disperzibilnih preparata, zbog čega je potrebno vršiti njihovu procenu prilikom razvoja formulacije i tokom proizvodnog procesa. Međutim, u literaturi se uočava nekonzistentnost u načinima sprovođenja pomenutih ispitivanja, zbog nedostatka standardizovanih farmakopejskih metoda. Najveća varijabilnost u postupcima karakterizacije uočena je pri ispitivanju raspadljivosti i proceni uspešnosti maskiranja ukusa. Na osnovu izloženog može se zaključiti da je za adekvatnu procenu raspadljivosti oralno-disperzibilnih preparata potrebno uzeti u obzir uticaj pritiska jezika, što je posebno evidentno u slučaju različitih polimernih filmova. Za pouzdanu in vivo studiju procene efikasnosti maskiranja ukusa lekovite supstance potrebno je izvršiti adekvatan odabir i obuku ispitanika, uz određivanje granice gorčine. Kako bi se rezultati in vivo studije doveli u vezu sa rezultatima in vitro metoda procene efikasnosti maskiranja ukusa, neophodno je uslove za sprovođenje analitičke metode približiti fiziološkim uslovima.
PB  - Savez farmaceutskih udruženja Srbije, Beograd
T2  - Arhiv za farmaciju
T1  - Characterization of orodispersible tablets and orodispersible films
T1  - Farmaceutsko-tehnološka karakterizacija oralno-disperzibilnih tableta i filmova
VL  - 68
IS  - 4
SP  - 839
EP  - 859
DO  - 10.5937/ArhFarm1804839D
ER  - 

@article{
author = "Drašković, Milica and Cvijić, Sandra and Ibrić, Svetlana and Parojčić, Jelena",
year = "2018",
abstract = "Orodispersible dosage forms are intended to be placed on tongue where, in contact with limited saliva volume, fast disintegration, followed by facilitated swallowing, occurred. Intraoral disintegration might be accompanied by drug release and dissolution in oral cavity. Dissolved drug could interact with receptors on taste buds causing taste sensation. The most important critical quality attributes of orodispersible dosage forms are acceptable mechanical resistance, fast disintegration and pleasant taste which have to be monitored and evaluated during formulation development and production. However, compendial methods for orodispersible dosage forms characterization are still lacking, while many authors attempt to develop different, more suitable approaches. The highest variability during determination of disintegration properties is observed. It can be concluded that for the proper disintegration assessment influence of tongue force have to be considered, especially in the case of different polymeric orodispersible films. For reliable development of in vivo study for evaluation of tastemasking efficacy, proper selection and training of panelists accompanied by bitterness threshold determination are of the utmost importance. In order to correlate in vitro and in vivo data, it is necessary to develop analytical method for evaluation of taste-masking efficacy that mimic, in great extent, physiological intraoral conditions., Oralno-disperzibilni farmaceutski oblici lekova predstavljaju savremene farmaceutske oblike koji su namenjeni za primenu u usnoj duplji, gde se, u kontaktu sa salivom, gotovo trenutno raspadaju i, nakon toga, gutaju sa ciljem postizanja sistemskog terapijskog efekta. Intraoralno raspadanje preparata može biti praćeno oslobađanjem i rastvaranjem lekovite supstance, nakon čega dolazi do interakcije sa receptorima na kvržicama jezika i senzacije ukusa. Prihvatljiva mehanička otpornost, brza dezintegracija i prijatan ukus predstavljaju kritična svojstva kvaliteta oralno-disperzibilnih preparata, zbog čega je potrebno vršiti njihovu procenu prilikom razvoja formulacije i tokom proizvodnog procesa. Međutim, u literaturi se uočava nekonzistentnost u načinima sprovođenja pomenutih ispitivanja, zbog nedostatka standardizovanih farmakopejskih metoda. Najveća varijabilnost u postupcima karakterizacije uočena je pri ispitivanju raspadljivosti i proceni uspešnosti maskiranja ukusa. Na osnovu izloženog može se zaključiti da je za adekvatnu procenu raspadljivosti oralno-disperzibilnih preparata potrebno uzeti u obzir uticaj pritiska jezika, što je posebno evidentno u slučaju različitih polimernih filmova. Za pouzdanu in vivo studiju procene efikasnosti maskiranja ukusa lekovite supstance potrebno je izvršiti adekvatan odabir i obuku ispitanika, uz određivanje granice gorčine. Kako bi se rezultati in vivo studije doveli u vezu sa rezultatima in vitro metoda procene efikasnosti maskiranja ukusa, neophodno je uslove za sprovođenje analitičke metode približiti fiziološkim uslovima.",
publisher = "Savez farmaceutskih udruženja Srbije, Beograd",
journal = "Arhiv za farmaciju",
title = "Characterization of orodispersible tablets and orodispersible films, Farmaceutsko-tehnološka karakterizacija oralno-disperzibilnih tableta i filmova",
volume = "68",
number = "4",
pages = "839-859",
doi = "10.5937/ArhFarm1804839D"
}

Drašković, M., Cvijić, S., Ibrić, S.,& Parojčić, J.. (2018). Characterization of orodispersible tablets and orodispersible films. in Arhiv za farmaciju
Savez farmaceutskih udruženja Srbije, Beograd., 68(4), 839-859.
https://doi.org/10.5937/ArhFarm1804839D

Drašković M, Cvijić S, Ibrić S, Parojčić J. Characterization of orodispersible tablets and orodispersible films. in Arhiv za farmaciju. 2018;68(4):839-859.
doi:10.5937/ArhFarm1804839D .

Drašković, Milica, Cvijić, Sandra, Ibrić, Svetlana, Parojčić, Jelena, "Characterization of orodispersible tablets and orodispersible films" in Arhiv za farmaciju, 68, no. 4 (2018):839-859,
https://doi.org/10.5937/ArhFarm1804839D . .

TY  - JOUR
AU  - Drašković, Milica
AU  - Đuriš, Jelena
AU  - Ibrić, Svetlana
AU  - Parojčić, Jelena
PY  - 2018
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3184
AB  - In the present work functional properties of new, co-processed excipients, Pharmaburst (R) 500, Parteck (R) ODT, Ludiflash (R) and Disintequikn (TM) ODT, intended for direct compression of orally disintegrating tablets (ODTs), were investigated based on dynamic compaction analysis and percolation theory. Tablet disintegration time and mechanical properties have been recognized as critical quality attributes (CQAs) which should be optimized through pharmaceutical development. According to the obtained results, in order to achieve adequate mechanical resistance, excipients exhibiting high compactibility and tabletability are required, while, on the contrary, high porosity excipients with higher extent of elastic deformations, average tabletability and compactibility are necessary to obtain fast tablet disintegration. The results obtained in this study indicate that the most important excipient properties affecting tablet CQAs are porosity, mechanism of consolidation, compactibility and tabletability. Pharmaburst (R) 500, excipient with the highest elastic recovery, the lowest relative density, average compactibility and tabletability, and remarkably high dilution capacity (69.6% w/w of caffeine or 49.1% w/w of ibuprofen) exhibited favourable performance for ODT direct compression. Dynamic compaction analysis and percolation theory proved to be useful tools which can contribute to identification of the most important excipient functional properties influencing critical quality attributes of the prepared ODTs.
PB  - Elsevier Science BV, Amsterdam
T2  - Powder Technology
T1  - Functionality and performance evaluation of directly compressible co-processed excipients based on dynamic compaction analysis and percolation theory
VL  - 326
SP  - 292
EP  - 301
DO  - 10.1016/j.powtec.2017.12.021
ER  - 

@article{
author = "Drašković, Milica and Đuriš, Jelena and Ibrić, Svetlana and Parojčić, Jelena",
year = "2018",
abstract = "In the present work functional properties of new, co-processed excipients, Pharmaburst (R) 500, Parteck (R) ODT, Ludiflash (R) and Disintequikn (TM) ODT, intended for direct compression of orally disintegrating tablets (ODTs), were investigated based on dynamic compaction analysis and percolation theory. Tablet disintegration time and mechanical properties have been recognized as critical quality attributes (CQAs) which should be optimized through pharmaceutical development. According to the obtained results, in order to achieve adequate mechanical resistance, excipients exhibiting high compactibility and tabletability are required, while, on the contrary, high porosity excipients with higher extent of elastic deformations, average tabletability and compactibility are necessary to obtain fast tablet disintegration. The results obtained in this study indicate that the most important excipient properties affecting tablet CQAs are porosity, mechanism of consolidation, compactibility and tabletability. Pharmaburst (R) 500, excipient with the highest elastic recovery, the lowest relative density, average compactibility and tabletability, and remarkably high dilution capacity (69.6% w/w of caffeine or 49.1% w/w of ibuprofen) exhibited favourable performance for ODT direct compression. Dynamic compaction analysis and percolation theory proved to be useful tools which can contribute to identification of the most important excipient functional properties influencing critical quality attributes of the prepared ODTs.",
publisher = "Elsevier Science BV, Amsterdam",
journal = "Powder Technology",
title = "Functionality and performance evaluation of directly compressible co-processed excipients based on dynamic compaction analysis and percolation theory",
volume = "326",
pages = "292-301",
doi = "10.1016/j.powtec.2017.12.021"
}

Drašković, M., Đuriš, J., Ibrić, S.,& Parojčić, J.. (2018). Functionality and performance evaluation of directly compressible co-processed excipients based on dynamic compaction analysis and percolation theory. in Powder Technology
Elsevier Science BV, Amsterdam., 326, 292-301.
https://doi.org/10.1016/j.powtec.2017.12.021

Drašković M, Đuriš J, Ibrić S, Parojčić J. Functionality and performance evaluation of directly compressible co-processed excipients based on dynamic compaction analysis and percolation theory. in Powder Technology. 2018;326:292-301.
doi:10.1016/j.powtec.2017.12.021 .

Drašković, Milica, Đuriš, Jelena, Ibrić, Svetlana, Parojčić, Jelena, "Functionality and performance evaluation of directly compressible co-processed excipients based on dynamic compaction analysis and percolation theory" in Powder Technology, 326 (2018):292-301,
https://doi.org/10.1016/j.powtec.2017.12.021 . .

TY  - JOUR
AU  - Drašković, Milica
AU  - Medarević, Đorđe
AU  - Aleksić, Ivana
AU  - Parojčić, Jelena
PY  - 2017
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3429
AB  - Context: Considering that bitter taste of drugs incorporated in orally disintegrating tablets (ODTs) can be the main reason for avoiding drug therapy, it is of the utmost importance to achieve successful taste-masking. The evaluation of taste-masking effectiveness is still a major challenge. Objective: The objective of this study was to mask bitter taste of the selected model drugs by drug particle coating with Eudragit (R) E PO, as well as to evaluate taste-masking effectiveness of prepared ODTs using compendial dissolution testing, dissolution in the small-volume shake-flask assembly and trained human taste panel. Materials and methods: Model drugs were coated in fluidized bed. Disintequik (TM) ODT was used as a novel co-processed excipient for ODT preparation. Selected formulations were investigated in vitro and in vivo using techniques for taste-masking assessment. Results and discussion: Significantly slower drug dissolution was observed from tablets with coated drug particles during the first 3 min of investigation. Results of in vivo taste-masking assessment demonstrated significant improvement in drug bitterness suppression in formulations with coated drug. Strong correlation between the results of drug dissolution in the small-volume shake-flask assembly and in vivo evaluation data was established (R >= 0.970). Conclusion: Drug particle coating with Eudragit (R) E PO can be a suitable approach for bitter taste-masking. Strong correlation between in vivo and in vitro results implicate that small-volume dissolution method may be used as surrogate for human panel taste-masking assessment, in the case of physical taste-masking approach application.
PB  - Taylor & Francis Ltd, Abingdon
T2  - Drug Development and Industrial Pharmacy
T1  - In vitro and in vivo investigation of taste-masking effectiveness of Eudragit E PO as drug particle coating agent in orally disintegrating tablets
VL  - 43
IS  - 5
SP  - 723
EP  - 731
DO  - 10.1080/03639045.2016.1220572
ER  - 

@article{
author = "Drašković, Milica and Medarević, Đorđe and Aleksić, Ivana and Parojčić, Jelena",
year = "2017",
abstract = "Context: Considering that bitter taste of drugs incorporated in orally disintegrating tablets (ODTs) can be the main reason for avoiding drug therapy, it is of the utmost importance to achieve successful taste-masking. The evaluation of taste-masking effectiveness is still a major challenge. Objective: The objective of this study was to mask bitter taste of the selected model drugs by drug particle coating with Eudragit (R) E PO, as well as to evaluate taste-masking effectiveness of prepared ODTs using compendial dissolution testing, dissolution in the small-volume shake-flask assembly and trained human taste panel. Materials and methods: Model drugs were coated in fluidized bed. Disintequik (TM) ODT was used as a novel co-processed excipient for ODT preparation. Selected formulations were investigated in vitro and in vivo using techniques for taste-masking assessment. Results and discussion: Significantly slower drug dissolution was observed from tablets with coated drug particles during the first 3 min of investigation. Results of in vivo taste-masking assessment demonstrated significant improvement in drug bitterness suppression in formulations with coated drug. Strong correlation between the results of drug dissolution in the small-volume shake-flask assembly and in vivo evaluation data was established (R >= 0.970). Conclusion: Drug particle coating with Eudragit (R) E PO can be a suitable approach for bitter taste-masking. Strong correlation between in vivo and in vitro results implicate that small-volume dissolution method may be used as surrogate for human panel taste-masking assessment, in the case of physical taste-masking approach application.",
publisher = "Taylor & Francis Ltd, Abingdon",
journal = "Drug Development and Industrial Pharmacy",
title = "In vitro and in vivo investigation of taste-masking effectiveness of Eudragit E PO as drug particle coating agent in orally disintegrating tablets",
volume = "43",
number = "5",
pages = "723-731",
doi = "10.1080/03639045.2016.1220572"
}

Drašković, M., Medarević, Đ., Aleksić, I.,& Parojčić, J.. (2017). In vitro and in vivo investigation of taste-masking effectiveness of Eudragit E PO as drug particle coating agent in orally disintegrating tablets. in Drug Development and Industrial Pharmacy
Taylor & Francis Ltd, Abingdon., 43(5), 723-731.
https://doi.org/10.1080/03639045.2016.1220572

Drašković M, Medarević Đ, Aleksić I, Parojčić J. In vitro and in vivo investigation of taste-masking effectiveness of Eudragit E PO as drug particle coating agent in orally disintegrating tablets. in Drug Development and Industrial Pharmacy. 2017;43(5):723-731.
doi:10.1080/03639045.2016.1220572 .

Drašković, Milica, Medarević, Đorđe, Aleksić, Ivana, Parojčić, Jelena, "In vitro and in vivo investigation of taste-masking effectiveness of Eudragit E PO as drug particle coating agent in orally disintegrating tablets" in Drug Development and Industrial Pharmacy, 43, no. 5 (2017):723-731,
https://doi.org/10.1080/03639045.2016.1220572 . .

TY  - JOUR
AU  - Drašković, Milica
AU  - Medarević, Đorđe
AU  - Aleksić, Ivana
AU  - Parojčić, Jelena
PY  - 2017
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2910
AB  - Context: Considering that bitter taste of drugs incorporated in orally disintegrating tablets (ODTs) can be the main reason for avoiding drug therapy, it is of the utmost importance to achieve successful taste-masking. The evaluation of taste-masking effectiveness is still a major challenge. Objective: The objective of this study was to mask bitter taste of the selected model drugs by drug particle coating with Eudragit (R) E PO, as well as to evaluate taste-masking effectiveness of prepared ODTs using compendial dissolution testing, dissolution in the small-volume shake-flask assembly and trained human taste panel. Materials and methods: Model drugs were coated in fluidized bed. Disintequik (TM) ODT was used as a novel co-processed excipient for ODT preparation. Selected formulations were investigated in vitro and in vivo using techniques for taste-masking assessment. Results and discussion: Significantly slower drug dissolution was observed from tablets with coated drug particles during the first 3 min of investigation. Results of in vivo taste-masking assessment demonstrated significant improvement in drug bitterness suppression in formulations with coated drug. Strong correlation between the results of drug dissolution in the small-volume shake-flask assembly and in vivo evaluation data was established (R >= 0.970). Conclusion: Drug particle coating with Eudragit (R) E PO can be a suitable approach for bitter taste-masking. Strong correlation between in vivo and in vitro results implicate that small-volume dissolution method may be used as surrogate for human panel taste-masking assessment, in the case of physical taste-masking approach application.
PB  - Taylor & Francis Ltd, Abingdon
T2  - Drug Development and Industrial Pharmacy
T1  - In vitro and in vivo investigation of taste-masking effectiveness of Eudragit E PO as drug particle coating agent in orally disintegrating tablets
VL  - 43
IS  - 5
SP  - 723
EP  - 731
DO  - 10.1080/03639045.2016.1220572
ER  - 

@article{
author = "Drašković, Milica and Medarević, Đorđe and Aleksić, Ivana and Parojčić, Jelena",
year = "2017",
abstract = "Context: Considering that bitter taste of drugs incorporated in orally disintegrating tablets (ODTs) can be the main reason for avoiding drug therapy, it is of the utmost importance to achieve successful taste-masking. The evaluation of taste-masking effectiveness is still a major challenge. Objective: The objective of this study was to mask bitter taste of the selected model drugs by drug particle coating with Eudragit (R) E PO, as well as to evaluate taste-masking effectiveness of prepared ODTs using compendial dissolution testing, dissolution in the small-volume shake-flask assembly and trained human taste panel. Materials and methods: Model drugs were coated in fluidized bed. Disintequik (TM) ODT was used as a novel co-processed excipient for ODT preparation. Selected formulations were investigated in vitro and in vivo using techniques for taste-masking assessment. Results and discussion: Significantly slower drug dissolution was observed from tablets with coated drug particles during the first 3 min of investigation. Results of in vivo taste-masking assessment demonstrated significant improvement in drug bitterness suppression in formulations with coated drug. Strong correlation between the results of drug dissolution in the small-volume shake-flask assembly and in vivo evaluation data was established (R >= 0.970). Conclusion: Drug particle coating with Eudragit (R) E PO can be a suitable approach for bitter taste-masking. Strong correlation between in vivo and in vitro results implicate that small-volume dissolution method may be used as surrogate for human panel taste-masking assessment, in the case of physical taste-masking approach application.",
publisher = "Taylor & Francis Ltd, Abingdon",
journal = "Drug Development and Industrial Pharmacy",
title = "In vitro and in vivo investigation of taste-masking effectiveness of Eudragit E PO as drug particle coating agent in orally disintegrating tablets",
volume = "43",
number = "5",
pages = "723-731",
doi = "10.1080/03639045.2016.1220572"
}

Drašković, M., Medarević, Đ., Aleksić, I.,& Parojčić, J.. (2017). In vitro and in vivo investigation of taste-masking effectiveness of Eudragit E PO as drug particle coating agent in orally disintegrating tablets. in Drug Development and Industrial Pharmacy
Taylor & Francis Ltd, Abingdon., 43(5), 723-731.
https://doi.org/10.1080/03639045.2016.1220572

Drašković M, Medarević Đ, Aleksić I, Parojčić J. In vitro and in vivo investigation of taste-masking effectiveness of Eudragit E PO as drug particle coating agent in orally disintegrating tablets. in Drug Development and Industrial Pharmacy. 2017;43(5):723-731.
doi:10.1080/03639045.2016.1220572 .

Drašković, Milica, Medarević, Đorđe, Aleksić, Ivana, Parojčić, Jelena, "In vitro and in vivo investigation of taste-masking effectiveness of Eudragit E PO as drug particle coating agent in orally disintegrating tablets" in Drug Development and Industrial Pharmacy, 43, no. 5 (2017):723-731,
https://doi.org/10.1080/03639045.2016.1220572 . .