Challenges of in vitro characterization of nonbiological complex drugs: Example of parenteral preparations with liposomal drug carriers
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/impl...
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Pharmaceutical Association of Serbia, Belgrade, Serbia
2019-01-01
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doaj-023a8332b58f45f6aafcd4a042e5668b2021-03-22T20:07:18ZsrpPharmaceutical Association of Serbia, Belgrade, SerbiaArhiv za farmaciju0004-19632217-87672019-01-0169317619810.5937/arhfarm1903176K0004-19631903176KChallenges of in vitro characterization of nonbiological complex drugs: Example of parenteral preparations with liposomal drug carriersKrajišnik Danina0https://orcid.org/0000-0002-5525-0109Milić Jela1Savić Snežana2https://orcid.org/0000-0002-6236-9730Univerzitet u Beogradu, Farmaceutski fakultet, Katedra za farmaceutsku tehnologiju i kozmetologiju, Beograd, SerbiaUniverzitet u Beogradu, Farmaceutski fakultet, Katedra za farmaceutsku tehnologiju i kozmetologiju, Beograd, SerbiaUniverzitet u Beogradu, Farmaceutski fakultet, Katedra za farmaceutsku tehnologiju i kozmetologiju, Beograd, SerbiaA 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 bioand nanotechnology 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.https://scindeks-clanci.ceon.rs/data/pdf/0004-1963/2019/0004-19631903176K.pdfparenteral preparations, non-biological complex drugs, liposomesin vitro characterization |
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language |
srp |
format |
Article |
sources |
DOAJ |
author |
Krajišnik Danina Milić Jela Savić Snežana |
spellingShingle |
Krajišnik Danina Milić Jela Savić Snežana Challenges of in vitro characterization of nonbiological complex drugs: Example of parenteral preparations with liposomal drug carriers Arhiv za farmaciju parenteral preparations, non-biological complex drugs, liposomes in vitro characterization |
author_facet |
Krajišnik Danina Milić Jela Savić Snežana |
author_sort |
Krajišnik Danina |
title |
Challenges of in vitro characterization of nonbiological complex drugs: Example of parenteral preparations with liposomal drug carriers |
title_short |
Challenges of in vitro characterization of nonbiological complex drugs: Example of parenteral preparations with liposomal drug carriers |
title_full |
Challenges of in vitro characterization of nonbiological complex drugs: Example of parenteral preparations with liposomal drug carriers |
title_fullStr |
Challenges of in vitro characterization of nonbiological complex drugs: Example of parenteral preparations with liposomal drug carriers |
title_full_unstemmed |
Challenges of in vitro characterization of nonbiological complex drugs: Example of parenteral preparations with liposomal drug carriers |
title_sort |
challenges of in vitro characterization of nonbiological complex drugs: example of parenteral preparations with liposomal drug carriers |
publisher |
Pharmaceutical Association of Serbia, Belgrade, Serbia |
series |
Arhiv za farmaciju |
issn |
0004-1963 2217-8767 |
publishDate |
2019-01-01 |
description |
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 bioand nanotechnology 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. |
topic |
parenteral preparations, non-biological complex drugs, liposomes in vitro characterization |
url |
https://scindeks-clanci.ceon.rs/data/pdf/0004-1963/2019/0004-19631903176K.pdf |
work_keys_str_mv |
AT krajisnikdanina challengesofinvitrocharacterizationofnonbiologicalcomplexdrugsexampleofparenteralpreparationswithliposomaldrugcarriers AT milicjela challengesofinvitrocharacterizationofnonbiologicalcomplexdrugsexampleofparenteralpreparationswithliposomaldrugcarriers AT savicsnezana challengesofinvitrocharacterizationofnonbiologicalcomplexdrugsexampleofparenteralpreparationswithliposomaldrugcarriers |
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1724207081209200640 |