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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Main Authors: Krajišnik Danina, Milić Jela, Savić Snežana
Format: Article
Language:srp
Published: Pharmaceutical Association of Serbia, Belgrade, Serbia 2019-01-01
Series:Arhiv za farmaciju
Subjects:
Online Access:https://scindeks-clanci.ceon.rs/data/pdf/0004-1963/2019/0004-19631903176K.pdf
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spelling 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
collection DOAJ
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
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AT milicjela challengesofinvitrocharacterizationofnonbiologicalcomplexdrugsexampleofparenteralpreparationswithliposomaldrugcarriers
AT savicsnezana challengesofinvitrocharacterizationofnonbiologicalcomplexdrugsexampleofparenteralpreparationswithliposomaldrugcarriers
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