TY  - JOUR
AU  - Jončić-Savić, Katarina
AU  - Pešić, Jelena
AU  - Rajić, Mirjana
AU  - Lukić, Milica
AU  - Jakšić, Ivana
AU  - Milić, Jela
AU  - Vuleta, Gordana
AU  - Savić, Snežana
PY  - 2010
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1443
AB  - In recent years there has been a growing interest for the development and characterization of vehicles for active pharmaceutical ingredients (API) for semisolid dosage forms. Considering that research efforts applied on the new APIs are time consuming and costly, one of the approaches for advancement of therapies of skin and mucous tissue diseases or therapies for muscle and joint pain is focused on the modification of the existing formulations and development and characterization of new vehicles for APIs. The aim of this study was to evaluate the effect of variation of different factors of formulation such as type and concentration of gelling agents, concentration of isopropyl alcohol (IPA) as a solvent and as a penetration enhancer, physicochemical properties of the active substance (ketoprofen) obtained from different manufacturers, on properties and stability of hydrophilic gel with 2.5% m/m ketoprofen. Characterization of prepared samples was done through physicochemical, biopharmaceutical investigation and stability testing. Results obtained suggest satisfactory physicochemical stability of investigated samples as well as the formulation factors which have the most effect on physicochemical properties of ketoprofen gel product: the type of gelling agent followed by the concentration of the gelling agent, while the IPA concentration has the least effect (in the investigated range). Comparison of release profiles of the investigated formulations of carbomer gels did not show significant effect of the varied factors (concentration of the gelling agent and IPA) on ketoprofen release.
AB  - Poslednjih godina se sve više pažnje posvećuje razvoju i karakterizaciji podloga kao nosača lekovitih supstanci (aktivni farmaceutski sastojak, eng. API) u farmaceutskim oblicima polučvrste konzistencije za primenu na koži ili sluzokoži. S obzirom da ispitivanja novih lekovitih supstanci zahtevaju velika ulaganja i dugo traju, jedan od pristupa unapređenja terapije bolesti kože, sluzokože ili bolova u mišićima i zglobovima, usmeren je ka modifikaciji postojećih podloga i razvoju i karakterizaciji novih nosača lekovitih supstanci. Cilj rada je bio da se ispita uticaj variranja različitih faktora formulacije kao što su tip i koncentracija sredstva za geliranje, koncentracija izopropil alkohola (IPA) kao rastvarača i 'pojačivača'/inhensera penetracije, fizičkohemijske karakteristike uzoraka aktivne supstance (ketoprofen), nabavljenih od različitih proizvođača, na osobine i stabilnost hidrofilnog gela sa 2,5% (m/m) ketoprofena. Karakterizacija pripremljenih uzoraka ketoprofen gela sprovedena je kroz fizičkohemijska i biofarmaceutska ispitivanja i ispitivanje stabilnosti. Dobijeni rezultati ukazuju na zadovoljavajuću stabilnost ispitivanih uzoraka, kao i na to da faktori formulacije koji ispoljavaju najveći uticaj na fizičkohemijske karakteristike preparata ketoprofen gela jesu: tip upotrebljenog gelirajućeg sredstva, zatim koncentracija korišćenog sredstva za geliranje, a najmanji uticaj ima koncentracija IPA (u ispitivanom opsegu). Poređenjem profila oslobađanja lekovite supstance iz ispitivanih formulacija karbomernih gelova, nije zapažen značajan uticaj variranih faktora (koncentracije gelirajućeg sredstva i IPA) na oslobađanje ketoprofena.
PB  - Savez farmaceutskih udruženja Srbije, Beograd
T2  - Arhiv za farmaciju
T1  - The influence of different formulation factors on physicochemical and biopharmaceutical characteristics of ketoprofen 2,5% gel
T1  - Uticaj faktora formulacije na fizičkohemijske i biofarmaceutske karakteristike ketoprofen 2,5% gela
VL  - 60
IS  - 6
SP  - 1237
EP  - 1255
UR  - https://hdl.handle.net/21.15107/rcub_farfar_1443
ER  - 

@article{
author = "Jončić-Savić, Katarina and Pešić, Jelena and Rajić, Mirjana and Lukić, Milica and Jakšić, Ivana and Milić, Jela and Vuleta, Gordana and Savić, Snežana",
year = "2010",
abstract = "In recent years there has been a growing interest for the development and characterization of vehicles for active pharmaceutical ingredients (API) for semisolid dosage forms. Considering that research efforts applied on the new APIs are time consuming and costly, one of the approaches for advancement of therapies of skin and mucous tissue diseases or therapies for muscle and joint pain is focused on the modification of the existing formulations and development and characterization of new vehicles for APIs. The aim of this study was to evaluate the effect of variation of different factors of formulation such as type and concentration of gelling agents, concentration of isopropyl alcohol (IPA) as a solvent and as a penetration enhancer, physicochemical properties of the active substance (ketoprofen) obtained from different manufacturers, on properties and stability of hydrophilic gel with 2.5% m/m ketoprofen. Characterization of prepared samples was done through physicochemical, biopharmaceutical investigation and stability testing. Results obtained suggest satisfactory physicochemical stability of investigated samples as well as the formulation factors which have the most effect on physicochemical properties of ketoprofen gel product: the type of gelling agent followed by the concentration of the gelling agent, while the IPA concentration has the least effect (in the investigated range). Comparison of release profiles of the investigated formulations of carbomer gels did not show significant effect of the varied factors (concentration of the gelling agent and IPA) on ketoprofen release., Poslednjih godina se sve više pažnje posvećuje razvoju i karakterizaciji podloga kao nosača lekovitih supstanci (aktivni farmaceutski sastojak, eng. API) u farmaceutskim oblicima polučvrste konzistencije za primenu na koži ili sluzokoži. S obzirom da ispitivanja novih lekovitih supstanci zahtevaju velika ulaganja i dugo traju, jedan od pristupa unapređenja terapije bolesti kože, sluzokože ili bolova u mišićima i zglobovima, usmeren je ka modifikaciji postojećih podloga i razvoju i karakterizaciji novih nosača lekovitih supstanci. Cilj rada je bio da se ispita uticaj variranja različitih faktora formulacije kao što su tip i koncentracija sredstva za geliranje, koncentracija izopropil alkohola (IPA) kao rastvarača i 'pojačivača'/inhensera penetracije, fizičkohemijske karakteristike uzoraka aktivne supstance (ketoprofen), nabavljenih od različitih proizvođača, na osobine i stabilnost hidrofilnog gela sa 2,5% (m/m) ketoprofena. Karakterizacija pripremljenih uzoraka ketoprofen gela sprovedena je kroz fizičkohemijska i biofarmaceutska ispitivanja i ispitivanje stabilnosti. Dobijeni rezultati ukazuju na zadovoljavajuću stabilnost ispitivanih uzoraka, kao i na to da faktori formulacije koji ispoljavaju najveći uticaj na fizičkohemijske karakteristike preparata ketoprofen gela jesu: tip upotrebljenog gelirajućeg sredstva, zatim koncentracija korišćenog sredstva za geliranje, a najmanji uticaj ima koncentracija IPA (u ispitivanom opsegu). Poređenjem profila oslobađanja lekovite supstance iz ispitivanih formulacija karbomernih gelova, nije zapažen značajan uticaj variranih faktora (koncentracije gelirajućeg sredstva i IPA) na oslobađanje ketoprofena.",
publisher = "Savez farmaceutskih udruženja Srbije, Beograd",
journal = "Arhiv za farmaciju",
title = "The influence of different formulation factors on physicochemical and biopharmaceutical characteristics of ketoprofen 2,5% gel, Uticaj faktora formulacije na fizičkohemijske i biofarmaceutske karakteristike ketoprofen 2,5% gela",
volume = "60",
number = "6",
pages = "1237-1255",
url = "https://hdl.handle.net/21.15107/rcub_farfar_1443"
}

Jončić-Savić, K., Pešić, J., Rajić, M., Lukić, M., Jakšić, I., Milić, J., Vuleta, G.,& Savić, S.. (2010). The influence of different formulation factors on physicochemical and biopharmaceutical characteristics of ketoprofen 2,5% gel. in Arhiv za farmaciju
Savez farmaceutskih udruženja Srbije, Beograd., 60(6), 1237-1255.
https://hdl.handle.net/21.15107/rcub_farfar_1443

Jončić-Savić K, Pešić J, Rajić M, Lukić M, Jakšić I, Milić J, Vuleta G, Savić S. The influence of different formulation factors on physicochemical and biopharmaceutical characteristics of ketoprofen 2,5% gel. in Arhiv za farmaciju. 2010;60(6):1237-1255.
https://hdl.handle.net/21.15107/rcub_farfar_1443 .

Jončić-Savić, Katarina, Pešić, Jelena, Rajić, Mirjana, Lukić, Milica, Jakšić, Ivana, Milić, Jela, Vuleta, Gordana, Savić, Snežana, "The influence of different formulation factors on physicochemical and biopharmaceutical characteristics of ketoprofen 2,5% gel" in Arhiv za farmaciju, 60, no. 6 (2010):1237-1255,
https://hdl.handle.net/21.15107/rcub_farfar_1443 .

TY  - JOUR
AU  - Jakšić, Ivana
AU  - Lukić, Milica
AU  - Rajić, Mirjana
AU  - Jončić-Savić, Katarina
AU  - Radulović, Vesna
AU  - Milić, Jela
AU  - Savić, Snežana
PY  - 2010
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1428
AB  - A growing interest in natural surfactants characterized as skin- and environmentfriendly has been observed recently, especially in a group of alkyl polyglucoside (APG) emulsifiers, comprised of natural-origin sugar units and fatty alcohol. The aim of this study was to evaluate the potential of a natural mixed emulsifier (cetostearyl glukozide&cetostearyl alcohol) as an excipiens for stabilisation of emulsion vehicles for model NSAID drugs. Formulations were kept as simple as possible, in order to assess their use in compounding practice or as so-called ready-to-use vehicles. Taking into consideration poor solubility of many, particularly new drug entities, the addition of isopropyl alcohol as a co-solvent and potential penetration enhancer was varied. Characterization of both active and placebo samples (prior to drug incorporation), was organized in three phases that included physicochemical investigation, preliminary NSAID bioavailability screening and safety profile assessment. Results obtained suggest satisfactory physicochemical stability of investigated simple vehicles based on natural mixed emulsifier, fallowed by an exceptional safety profile. Additionally, emulsion vehicles demonstrated an ability to sustain alcohol phase (10% m/m). It can be concluded that these vehicles present promising tools in preparation of various galenic dermatological preparations.
AB  - Poslednjih godina raste interesovanje za grupu prirodnih emulgatora okarakterisanih kao 'prijatelji kože i životne sredine', pri čemu se posebno izdvojila grupa alkil poliglukozidnih (APG) emulgatora, koji se dobijaju iz šećernih jedinica prirodnog porekla i masnog alkohola. Cilj ove studije bio je da se ispita potencijal prirodnog mešanog emulgatora (cetostearil glukozid i cetostearil alkohol) kao ekscipijensa za stabilizaciju emulzionih nosača za model lekovite supstance iz grupe NSAIL. Izabrane su formulacije kremovanosača jednostavnog sastava, kako bi se ujedno procenila mogućnost primene APG emulgatora da stabilizuju jednostavne tzv. 'ready-to-use' podloge namenjene izradi magistralnih dermatoloških lekova. Imajući u vidu slabu rastvorljivost mnogih, a naročito novosintetisanih lekovitih supstanci, variran je dodatak izopropil alkohola u sastavu podloge, koji bi imao ulogu korastvarača i potencijalnog ubrzivača penetracije. Karakterizacija pripremljenih uzoraka kremova (sa i bez dodatka model NSAILnesteroidnih antiinflamatornih lekova) sprovedena je u tri faze, kojima su obuhvaćena fizičkohemijska i biofarmaceutska ispitivanja i procena bezbednosnog profila model podloga sa APG emulgatorom. Uporedna ispitivanja sprovedena su u odnosu na referentnu, farmakopejsku podlogu (Nejonski hidrofilni krem, DAB 2006). Dobijeni rezultati ukazali su na zadovoljavajuće fizičkohemijske i biofarmaceutske karakteristike ispitanih podloga sa prirodnim mešanim emulgatorom APG tipa, koje su imale povoljan bezbednosni profil. Dodatak izopropil alkohola (10% (m/m)) nije se odrazio na stabilnost i bezbednost primene podloga sa APG emulgatorom. U zavisnosti od inkorporirane lekovite supstance iz grupe NSAIL u ispitivane podloge, uočen je različit uticaj na biofarmaceutska svojstva izrađenih uzoraka kremova.
PB  - Savez farmaceutskih udruženja Srbije, Beograd
T2  - Arhiv za farmaciju
T1  - Phisicochemical characterization and safety evaluation of model vehicles based on alkyl polyglucoside emulsifier for the incorporation of NSAID
T1  - Fizičkohemijska karakterizacija i procena bezbednosti model podloga sa alkil poliglukozidnim emulgatorom za NSAIL
VL  - 60
IS  - 1
SP  - 26
EP  - 47
UR  - https://hdl.handle.net/21.15107/rcub_farfar_1428
ER  - 

@article{
author = "Jakšić, Ivana and Lukić, Milica and Rajić, Mirjana and Jončić-Savić, Katarina and Radulović, Vesna and Milić, Jela and Savić, Snežana",
year = "2010",
abstract = "A growing interest in natural surfactants characterized as skin- and environmentfriendly has been observed recently, especially in a group of alkyl polyglucoside (APG) emulsifiers, comprised of natural-origin sugar units and fatty alcohol. The aim of this study was to evaluate the potential of a natural mixed emulsifier (cetostearyl glukozide&cetostearyl alcohol) as an excipiens for stabilisation of emulsion vehicles for model NSAID drugs. Formulations were kept as simple as possible, in order to assess their use in compounding practice or as so-called ready-to-use vehicles. Taking into consideration poor solubility of many, particularly new drug entities, the addition of isopropyl alcohol as a co-solvent and potential penetration enhancer was varied. Characterization of both active and placebo samples (prior to drug incorporation), was organized in three phases that included physicochemical investigation, preliminary NSAID bioavailability screening and safety profile assessment. Results obtained suggest satisfactory physicochemical stability of investigated simple vehicles based on natural mixed emulsifier, fallowed by an exceptional safety profile. Additionally, emulsion vehicles demonstrated an ability to sustain alcohol phase (10% m/m). It can be concluded that these vehicles present promising tools in preparation of various galenic dermatological preparations., Poslednjih godina raste interesovanje za grupu prirodnih emulgatora okarakterisanih kao 'prijatelji kože i životne sredine', pri čemu se posebno izdvojila grupa alkil poliglukozidnih (APG) emulgatora, koji se dobijaju iz šećernih jedinica prirodnog porekla i masnog alkohola. Cilj ove studije bio je da se ispita potencijal prirodnog mešanog emulgatora (cetostearil glukozid i cetostearil alkohol) kao ekscipijensa za stabilizaciju emulzionih nosača za model lekovite supstance iz grupe NSAIL. Izabrane su formulacije kremovanosača jednostavnog sastava, kako bi se ujedno procenila mogućnost primene APG emulgatora da stabilizuju jednostavne tzv. 'ready-to-use' podloge namenjene izradi magistralnih dermatoloških lekova. Imajući u vidu slabu rastvorljivost mnogih, a naročito novosintetisanih lekovitih supstanci, variran je dodatak izopropil alkohola u sastavu podloge, koji bi imao ulogu korastvarača i potencijalnog ubrzivača penetracije. Karakterizacija pripremljenih uzoraka kremova (sa i bez dodatka model NSAILnesteroidnih antiinflamatornih lekova) sprovedena je u tri faze, kojima su obuhvaćena fizičkohemijska i biofarmaceutska ispitivanja i procena bezbednosnog profila model podloga sa APG emulgatorom. Uporedna ispitivanja sprovedena su u odnosu na referentnu, farmakopejsku podlogu (Nejonski hidrofilni krem, DAB 2006). Dobijeni rezultati ukazali su na zadovoljavajuće fizičkohemijske i biofarmaceutske karakteristike ispitanih podloga sa prirodnim mešanim emulgatorom APG tipa, koje su imale povoljan bezbednosni profil. Dodatak izopropil alkohola (10% (m/m)) nije se odrazio na stabilnost i bezbednost primene podloga sa APG emulgatorom. U zavisnosti od inkorporirane lekovite supstance iz grupe NSAIL u ispitivane podloge, uočen je različit uticaj na biofarmaceutska svojstva izrađenih uzoraka kremova.",
publisher = "Savez farmaceutskih udruženja Srbije, Beograd",
journal = "Arhiv za farmaciju",
title = "Phisicochemical characterization and safety evaluation of model vehicles based on alkyl polyglucoside emulsifier for the incorporation of NSAID, Fizičkohemijska karakterizacija i procena bezbednosti model podloga sa alkil poliglukozidnim emulgatorom za NSAIL",
volume = "60",
number = "1",
pages = "26-47",
url = "https://hdl.handle.net/21.15107/rcub_farfar_1428"
}

Jakšić, I., Lukić, M., Rajić, M., Jončić-Savić, K., Radulović, V., Milić, J.,& Savić, S.. (2010). Phisicochemical characterization and safety evaluation of model vehicles based on alkyl polyglucoside emulsifier for the incorporation of NSAID. in Arhiv za farmaciju
Savez farmaceutskih udruženja Srbije, Beograd., 60(1), 26-47.
https://hdl.handle.net/21.15107/rcub_farfar_1428

Jakšić I, Lukić M, Rajić M, Jončić-Savić K, Radulović V, Milić J, Savić S. Phisicochemical characterization and safety evaluation of model vehicles based on alkyl polyglucoside emulsifier for the incorporation of NSAID. in Arhiv za farmaciju. 2010;60(1):26-47.
https://hdl.handle.net/21.15107/rcub_farfar_1428 .

Jakšić, Ivana, Lukić, Milica, Rajić, Mirjana, Jončić-Savić, Katarina, Radulović, Vesna, Milić, Jela, Savić, Snežana, "Phisicochemical characterization and safety evaluation of model vehicles based on alkyl polyglucoside emulsifier for the incorporation of NSAID" in Arhiv za farmaciju, 60, no. 1 (2010):26-47,
https://hdl.handle.net/21.15107/rcub_farfar_1428 .