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Izazovi in vitro karakterizacije nebioloških kompleksnih lekova - primer parenteralnih preparata sa liposomskim nosačima lekovitih supstanci

Challenges of in vitro characterization of non-biological complex drugs - example of parenteral preparations with liposomal drug carriers

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2019
Izazovi_in_vitro_pub_2019.pdf (589.6Kb)
Authors
Krajišnik, Danina
Milić, Jela
Savić, Snežana
Article (Published version)
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Abstract
Parenteralnim putem se primenjuju različiti tipovi farmaceutskih preparata čiji sastav može biti jednostavan (vodeni rastvori) i manje ili više kompleksan (emulzije, suspenzije, liposomi kao nosači lekovitih supstanci, čestični sistemi, čvrsti implanti/implantati). Napredak u bio- i nanotehnologiji omogućio je razvoj nove klase kompleksnih lekova, bioloških i tzv. nebioloških kompleksnih lekova (i njihovih „similara”- sličnih lekova), čiji dalji razvoj se očekuje u bliskoj budućnosti, a koji se, u velikom broju slučajeva, primenjuju parenteralnim putem. Parenteralni preparati koji u svom sastavu sadrže lekovite supstance koje su inkapsulirane u nosače tipa liposoma predstavljaju nebiološke kompleksne lekove koji su do sada najduže u upotrebi i čije su osobine i definisana svojstva kvaliteta najviše ispitivana. U radu je dat pregled obaveznih i dodatnih (specifičnih) in vitro ispitivanja liposomskih nosača lekovitih supstanci za primen...u parenteralnim putem. Činjenica da postupci izvođenja ovih ispitivanja u osnovi nisu propisani u relevantnim farmakopejama (Ph. Eur., USP i JP) i da se mogu značajno razlikovati između laboratorija, doprinosi velikoj varijabilnosti dobijenih rezultata i ograničenjima u njihovom međusobnom poređenju. Regulatorna tela EMA i FDA učestvovala su u pripremi određenih dokumenata i razvoju odgovarajućih standarda i smernica u pogledu ispitivanja kvaliteta farmaceutskih oblika sa liposomskim nosačima lekovitih supstanci za parenteralnu primenu.

A greater variety of pharmaceutical preparations can be administered by the parenteral route, the composition of which can be simple (aqueous solutions) and more or less complex (emulsions, suspensions, liposomes as carriers of active pharmaceutical ingredients, particle systems, solid implants/implants). In addition, advances in bio- and nano- technology have enabled the development of new classes of complex drugs, so-called non-biological complex drugs (and their similars) whose further development is expected in the near future, and which are in many cases applied by parenteral route. Parenteral preparations containing active substances encapsulated in the liposome-type carriers represent a class of non-biological complex drugs which have the longest use so far and whose properties and defined quality characteristics are being most examined. In this paper, an overview of mandatory and additional (specific) in vitro tests for parenteral liposomal drug ...carriers is presented. The fact that standard testing procedures are often not available in relevant pharmacopoeias (Ph. Eur., USP and JP), so that they can vary significantly between laboratories, contributes to the great variability of the results obtained and constraints in their mutual comparison. EMA and FDA, as regulatory agencies, have also participated in the preparation of certain documents and development of appropriate standards and guidelines for quality control of liposomal drug carriers for parenteral application.

Keywords:
parenteralni preparati / nebiološki kompleksni lekovi / liposomi / in vitro karakterizacija / parenteral preparations / non-biological complex drugs / liposomes / in vitro characterization
Source:
Arhiv za farmaciju, 2019, 69, 3, 176-198
Publisher:
  • Beograd : Savez farmaceutskih udruženja Srbije
Funding / projects:
  • Development of micro- and nanosystems as carriers for drugs with anti-inflammatory effect and methods for their characterization (RS-34031)
  • Oxide-based environmentally-friendly porous materials for genotoxic substances removal (RS-172018)

DOI: 10.5937/arhfarm1903176K

ISSN: 0004-1963

Scopus: 2-s2.0-85080921516
[ Google Scholar ]
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/3490
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - JOUR
AU  - Krajišnik, Danina
AU  - Milić, Jela
AU  - Savić, Snežana
PY  - 2019
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3490
AB  - Parenteralnim  putem  se  primenjuju  različiti  tipovi  farmaceutskih  preparata  čiji  sastav može  biti  jednostavan  (vodeni  rastvori)  i  manje  ili  više  kompleksan  (emulzije,  suspenzije, liposomi kao nosači lekovitih supstanci, čestični sistemi, čvrsti implanti/implantati). Napredak u bio-  i  nanotehnologiji  omogućio  je  razvoj  nove  klase  kompleksnih  lekova,  bioloških  i  tzv. nebioloških  kompleksnih  lekova  (i  njihovih  „similara”-  sličnih lekova),  čiji  dalji  razvoj  se očekuje u bliskoj budućnosti, a  koji se, u velikom broju slučajeva, primenjuju parenteralnim putem.  Parenteralni preparati koji u svom sastavu sadrže lekovite supstance koje su inkapsulirane u nosače tipa liposoma predstavljaju nebiološke kompleksne lekove koji su do sada najduže u upotrebi i čije su osobine i definisana svojstva kvaliteta najviše ispitivana. U radu je dat pregled obaveznih  i  dodatnih  (specifičnih) in  vitro  ispitivanja  liposomskih  nosača  lekovitih supstanci za primenu parenteralnim putem. Činjenica da postupci izvođenja ovih ispitivanja u  osnovi  nisu  propisani  u  relevantnim  farmakopejama  (Ph.  Eur., USP  i  JP)  i  da  se  mogu značajno razlikovati između laboratorija, doprinosi velikoj varijabilnosti dobijenih rezultata i ograničenjima u njihovom međusobnom poređenju. Regulatorna tela EMA i FDA učestvovala su u pripremi određenih dokumenata i razvoju odgovarajućih standarda i smernica u pogledu ispitivanja  kvaliteta  farmaceutskih  oblika  sa  liposomskim  nosačima  lekovitih  supstanci  za parenteralnu primenu.
AB  - A greater variety of pharmaceutical preparations can be administered by the parenteral route, the composition of which can be simple (aqueous solutions) and more or less complex (emulsions,  suspensions,  liposomes  as  carriers  of  active  pharmaceutical  ingredients,  particle systems,  solid  implants/implants).  In  addition,  advances  in  bio-  and  nano-  technology  have enabled the development of new classes of complex drugs, so-called non-biological complex drugs (and their similars) whose further development is expected in the near future, and which are in many cases applied by parenteral route.  Parenteral preparations containing active substances encapsulated in the liposome-type carriers represent a class of non-biological complex drugs which have the longest use so far and whose properties and defined quality characteristics are being most examined. In this paper, an overview  of  mandatory  and  additional  (specific) in  vitro  tests  for  parenteral  liposomal  drug carriers is presented. The fact that standard testing procedures are often not available in relevant pharmacopoeias  (Ph.  Eur.,  USP  and  JP),  so  that  they  can  vary  significantly  between laboratories, contributes to the great variability of the results obtained and constraints in their mutual  comparison.  EMA  and  FDA,  as  regulatory  agencies,  have  also  participated  in  the preparation of certain documents and development of appropriate standards and guidelines for quality control of liposomal drug carriers for parenteral application.
PB  - Beograd : Savez farmaceutskih udruženja Srbije
T2  - Arhiv za farmaciju
T1  - Izazovi in vitro karakterizacije nebioloških kompleksnih lekova - primer parenteralnih preparata sa liposomskim nosačima lekovitih supstanci
T1  - Challenges of in vitro characterization of non-biological complex drugs - example of parenteral preparations with liposomal drug carriers
VL  - 69
IS  - 3
SP  - 176
EP  - 198
DO  - 10.5937/arhfarm1903176K
ER  - 
@article{
author = "Krajišnik, Danina and Milić, Jela and Savić, Snežana",
year = "2019",
abstract = "Parenteralnim  putem  se  primenjuju  različiti  tipovi  farmaceutskih  preparata  čiji  sastav može  biti  jednostavan  (vodeni  rastvori)  i  manje  ili  više  kompleksan  (emulzije,  suspenzije, liposomi kao nosači lekovitih supstanci, čestični sistemi, čvrsti implanti/implantati). Napredak u bio-  i  nanotehnologiji  omogućio  je  razvoj  nove  klase  kompleksnih  lekova,  bioloških  i  tzv. nebioloških  kompleksnih  lekova  (i  njihovih  „similara”-  sličnih lekova),  čiji  dalji  razvoj  se očekuje u bliskoj budućnosti, a  koji se, u velikom broju slučajeva, primenjuju parenteralnim putem.  Parenteralni preparati koji u svom sastavu sadrže lekovite supstance koje su inkapsulirane u nosače tipa liposoma predstavljaju nebiološke kompleksne lekove koji su do sada najduže u upotrebi i čije su osobine i definisana svojstva kvaliteta najviše ispitivana. U radu je dat pregled obaveznih  i  dodatnih  (specifičnih) in  vitro  ispitivanja  liposomskih  nosača  lekovitih supstanci za primenu parenteralnim putem. Činjenica da postupci izvođenja ovih ispitivanja u  osnovi  nisu  propisani  u  relevantnim  farmakopejama  (Ph.  Eur., USP  i  JP)  i  da  se  mogu značajno razlikovati između laboratorija, doprinosi velikoj varijabilnosti dobijenih rezultata i ograničenjima u njihovom međusobnom poređenju. Regulatorna tela EMA i FDA učestvovala su u pripremi određenih dokumenata i razvoju odgovarajućih standarda i smernica u pogledu ispitivanja  kvaliteta  farmaceutskih  oblika  sa  liposomskim  nosačima  lekovitih  supstanci  za parenteralnu primenu., A greater variety of pharmaceutical preparations can be administered by the parenteral route, the composition of which can be simple (aqueous solutions) and more or less complex (emulsions,  suspensions,  liposomes  as  carriers  of  active  pharmaceutical  ingredients,  particle systems,  solid  implants/implants).  In  addition,  advances  in  bio-  and  nano-  technology  have enabled the development of new classes of complex drugs, so-called non-biological complex drugs (and their similars) whose further development is expected in the near future, and which are in many cases applied by parenteral route.  Parenteral preparations containing active substances encapsulated in the liposome-type carriers represent a class of non-biological complex drugs which have the longest use so far and whose properties and defined quality characteristics are being most examined. In this paper, an overview  of  mandatory  and  additional  (specific) in  vitro  tests  for  parenteral  liposomal  drug carriers is presented. The fact that standard testing procedures are often not available in relevant pharmacopoeias  (Ph.  Eur.,  USP  and  JP),  so  that  they  can  vary  significantly  between laboratories, contributes to the great variability of the results obtained and constraints in their mutual  comparison.  EMA  and  FDA,  as  regulatory  agencies,  have  also  participated  in  the preparation of certain documents and development of appropriate standards and guidelines for quality control of liposomal drug carriers for parenteral application.",
publisher = "Beograd : Savez farmaceutskih udruženja Srbije",
journal = "Arhiv za farmaciju",
title = "Izazovi in vitro karakterizacije nebioloških kompleksnih lekova - primer parenteralnih preparata sa liposomskim nosačima lekovitih supstanci, Challenges of in vitro characterization of non-biological complex drugs - example of parenteral preparations with liposomal drug carriers",
volume = "69",
number = "3",
pages = "176-198",
doi = "10.5937/arhfarm1903176K"
}
Krajišnik, D., Milić, J.,& Savić, S.. (2019). Izazovi in vitro karakterizacije nebioloških kompleksnih lekova - primer parenteralnih preparata sa liposomskim nosačima lekovitih supstanci. in Arhiv za farmaciju
Beograd : Savez farmaceutskih udruženja Srbije., 69(3), 176-198.
https://doi.org/10.5937/arhfarm1903176K
Krajišnik D, Milić J, Savić S. Izazovi in vitro karakterizacije nebioloških kompleksnih lekova - primer parenteralnih preparata sa liposomskim nosačima lekovitih supstanci. in Arhiv za farmaciju. 2019;69(3):176-198.
doi:10.5937/arhfarm1903176K .
Krajišnik, Danina, Milić, Jela, Savić, Snežana, "Izazovi in vitro karakterizacije nebioloških kompleksnih lekova - primer parenteralnih preparata sa liposomskim nosačima lekovitih supstanci" in Arhiv za farmaciju, 69, no. 3 (2019):176-198,
https://doi.org/10.5937/arhfarm1903176K . .

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