Penetration and permeation of corticosteroids from pharmaceutical preparations for the skin application
Penetracija i permeacija kortikosteroida iz farmaceutskih preparata za primenu na kožu
Апстракт
As corticosteroids (CS) represent large and significant group of dermatological drugs with a number of indications, performing of in vitro and/or in vivo penetration/permeation studies is of a paramount importance in evaluation of new and generic drugs. Choice of an effective therapeutic dose with acceptable risc/benefit ratio as well as suitable regime of drug use or an adequate vehicle formulation are just some of numerous reasons for employing these studies. One of the current intentions is to improve and standardize in vitro studies with human stratum corneum (SC) or reconstructed human epiderm to reach the comparative level with in vivo evaluation of pharmacodynamic CS response (skin blanchin assay) as well as with tape stripping technique. Skin blanching assay is FDA accepted and approved method for evaluation of bioavailability and bioequivavelence of dermatological CS, with emphasized need for an additional standardization of studies using objective chromametric measurements. A...lso, actual research activities are directed to further optimization and validation of tape stripping method, as surogate test for studying the bioavailability and bioequivavelence of dermatological drugs and thus locally applied CS. The aim is creating of practical regulatory test, that is a challenge for the future.
Kako kortikosteroidi (KS) predstavljaju veliku i značajnu grupu dermatoloških lekova sa brojnim indikacijama za primenu, sprovođenje in vitro i/ili in vivo studija penetracije/permeacije od velikog je značaja u proceni novih i generičkih lekova. Izbor efikasne terapijske doze sa prihvatljivim odnosom rizik/korist, pogodnog režima primene leka ili najprihvatljivije formulacije nosača su neke od brojnih primena ovih studija. Intencija je da se in vitro studije sa humanim SC-om ili rekonstruisanim humanim epidermom unaprede i standardizuju tako da budu komparativne sa in vivo procenom farmakodinamskog efekta KS (studija izbeljivanja kože) i tehnikom "tape stripping-a". Studija izbeljivanja kože je od FDA prihvaćena i odobrena metoda za procenu bioraspoloživosti i bioekvivalentnosti KS za dermatološku primenu, uz naglašenu potrebu dodatne standardizacije studija u kojima se koriste objektivna hromametrijska merenja. Takođe, trenutno angažovanje istraživača usmereno je ka daljoj optimizacij...i i validaciji metode sa trakama (eng. tape stripping), kao "surogat" testu za ispitivanje bioraspoloživosti i biekvivalentnosti dermatoloških lekova, a time i lokalno primenjenih KS. Cilj je koncipiranje praktičnog regulatorno prihvaćenog testa, što je izazov za budućnost.
Кључне речи:
corticosteroid / penetration / permeation / in vitro / in vivo / human SC / reconstructed human epiderm / skin blanching assay / tape stripping method / kortikosteroid / penetracija / permeacija / in vitro / in vivo / humani SC / rekonstruisani humani epiderm / metoda izbeljivanja kože / metoda sa trakamaИзвор:
Arhiv za farmaciju, 2008, 58, 2-3, 153-171Издавач:
- Savez farmaceutskih udruženja Srbije, Beograd
Институција/група
PharmacyTY - JOUR AU - Savić, Snežana AU - Vuleta, Gordana PY - 2008 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1157 AB - As corticosteroids (CS) represent large and significant group of dermatological drugs with a number of indications, performing of in vitro and/or in vivo penetration/permeation studies is of a paramount importance in evaluation of new and generic drugs. Choice of an effective therapeutic dose with acceptable risc/benefit ratio as well as suitable regime of drug use or an adequate vehicle formulation are just some of numerous reasons for employing these studies. One of the current intentions is to improve and standardize in vitro studies with human stratum corneum (SC) or reconstructed human epiderm to reach the comparative level with in vivo evaluation of pharmacodynamic CS response (skin blanchin assay) as well as with tape stripping technique. Skin blanching assay is FDA accepted and approved method for evaluation of bioavailability and bioequivavelence of dermatological CS, with emphasized need for an additional standardization of studies using objective chromametric measurements. Also, actual research activities are directed to further optimization and validation of tape stripping method, as surogate test for studying the bioavailability and bioequivavelence of dermatological drugs and thus locally applied CS. The aim is creating of practical regulatory test, that is a challenge for the future. AB - Kako kortikosteroidi (KS) predstavljaju veliku i značajnu grupu dermatoloških lekova sa brojnim indikacijama za primenu, sprovođenje in vitro i/ili in vivo studija penetracije/permeacije od velikog je značaja u proceni novih i generičkih lekova. Izbor efikasne terapijske doze sa prihvatljivim odnosom rizik/korist, pogodnog režima primene leka ili najprihvatljivije formulacije nosača su neke od brojnih primena ovih studija. Intencija je da se in vitro studije sa humanim SC-om ili rekonstruisanim humanim epidermom unaprede i standardizuju tako da budu komparativne sa in vivo procenom farmakodinamskog efekta KS (studija izbeljivanja kože) i tehnikom "tape stripping-a". Studija izbeljivanja kože je od FDA prihvaćena i odobrena metoda za procenu bioraspoloživosti i bioekvivalentnosti KS za dermatološku primenu, uz naglašenu potrebu dodatne standardizacije studija u kojima se koriste objektivna hromametrijska merenja. Takođe, trenutno angažovanje istraživača usmereno je ka daljoj optimizaciji i validaciji metode sa trakama (eng. tape stripping), kao "surogat" testu za ispitivanje bioraspoloživosti i biekvivalentnosti dermatoloških lekova, a time i lokalno primenjenih KS. Cilj je koncipiranje praktičnog regulatorno prihvaćenog testa, što je izazov za budućnost. PB - Savez farmaceutskih udruženja Srbije, Beograd T2 - Arhiv za farmaciju T1 - Penetration and permeation of corticosteroids from pharmaceutical preparations for the skin application T1 - Penetracija i permeacija kortikosteroida iz farmaceutskih preparata za primenu na kožu VL - 58 IS - 2-3 SP - 153 EP - 171 UR - https://hdl.handle.net/21.15107/rcub_farfar_1157 ER -
@article{ author = "Savić, Snežana and Vuleta, Gordana", year = "2008", abstract = "As corticosteroids (CS) represent large and significant group of dermatological drugs with a number of indications, performing of in vitro and/or in vivo penetration/permeation studies is of a paramount importance in evaluation of new and generic drugs. Choice of an effective therapeutic dose with acceptable risc/benefit ratio as well as suitable regime of drug use or an adequate vehicle formulation are just some of numerous reasons for employing these studies. One of the current intentions is to improve and standardize in vitro studies with human stratum corneum (SC) or reconstructed human epiderm to reach the comparative level with in vivo evaluation of pharmacodynamic CS response (skin blanchin assay) as well as with tape stripping technique. Skin blanching assay is FDA accepted and approved method for evaluation of bioavailability and bioequivavelence of dermatological CS, with emphasized need for an additional standardization of studies using objective chromametric measurements. Also, actual research activities are directed to further optimization and validation of tape stripping method, as surogate test for studying the bioavailability and bioequivavelence of dermatological drugs and thus locally applied CS. The aim is creating of practical regulatory test, that is a challenge for the future., Kako kortikosteroidi (KS) predstavljaju veliku i značajnu grupu dermatoloških lekova sa brojnim indikacijama za primenu, sprovođenje in vitro i/ili in vivo studija penetracije/permeacije od velikog je značaja u proceni novih i generičkih lekova. Izbor efikasne terapijske doze sa prihvatljivim odnosom rizik/korist, pogodnog režima primene leka ili najprihvatljivije formulacije nosača su neke od brojnih primena ovih studija. Intencija je da se in vitro studije sa humanim SC-om ili rekonstruisanim humanim epidermom unaprede i standardizuju tako da budu komparativne sa in vivo procenom farmakodinamskog efekta KS (studija izbeljivanja kože) i tehnikom "tape stripping-a". Studija izbeljivanja kože je od FDA prihvaćena i odobrena metoda za procenu bioraspoloživosti i bioekvivalentnosti KS za dermatološku primenu, uz naglašenu potrebu dodatne standardizacije studija u kojima se koriste objektivna hromametrijska merenja. Takođe, trenutno angažovanje istraživača usmereno je ka daljoj optimizaciji i validaciji metode sa trakama (eng. tape stripping), kao "surogat" testu za ispitivanje bioraspoloživosti i biekvivalentnosti dermatoloških lekova, a time i lokalno primenjenih KS. Cilj je koncipiranje praktičnog regulatorno prihvaćenog testa, što je izazov za budućnost.", publisher = "Savez farmaceutskih udruženja Srbije, Beograd", journal = "Arhiv za farmaciju", title = "Penetration and permeation of corticosteroids from pharmaceutical preparations for the skin application, Penetracija i permeacija kortikosteroida iz farmaceutskih preparata za primenu na kožu", volume = "58", number = "2-3", pages = "153-171", url = "https://hdl.handle.net/21.15107/rcub_farfar_1157" }
Savić, S.,& Vuleta, G.. (2008). Penetration and permeation of corticosteroids from pharmaceutical preparations for the skin application. in Arhiv za farmaciju Savez farmaceutskih udruženja Srbije, Beograd., 58(2-3), 153-171. https://hdl.handle.net/21.15107/rcub_farfar_1157
Savić S, Vuleta G. Penetration and permeation of corticosteroids from pharmaceutical preparations for the skin application. in Arhiv za farmaciju. 2008;58(2-3):153-171. https://hdl.handle.net/21.15107/rcub_farfar_1157 .
Savić, Snežana, Vuleta, Gordana, "Penetration and permeation of corticosteroids from pharmaceutical preparations for the skin application" in Arhiv za farmaciju, 58, no. 2-3 (2008):153-171, https://hdl.handle.net/21.15107/rcub_farfar_1157 .