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  1. Article ; Online: Optimizing the Filtration of Liposomes Using Sterilizing-Grade Filters.

    Zourna, Kalliopi / Iwaniec, Aude / Turner, Stephen / Jackson, Nigel B / Welsh, John H

    PDA journal of pharmaceutical science and technology

    2020  Volume 75, Issue 2, Page(s) 128–140

    Abstract: Liposomes are increasingly being investigated and implemented as injectable drug delivery systems. The preferred method for sterilizing injectable drug formulations using liposomes is to use filtration. However, because of the size of liposomes and their ...

    Abstract Liposomes are increasingly being investigated and implemented as injectable drug delivery systems. The preferred method for sterilizing injectable drug formulations using liposomes is to use filtration. However, because of the size of liposomes and their physicochemical properties, this can be challenging with sterilizing-grade filters rated at 0.2 µm. Filter validation studies with injectable liposomes have shown a higher likelihood of premature filter blockage and bacterial penetration compared to other parenteral drug types. Consequently, a greater understanding of the sterilizing filtration of liposomes is required so that appropriate decisions are made concerning the selection and validation of sterilizing-grade filters for these applications. In this work, Lipoid S100 liposomes were produced using a microfluidization technique without any encapsulated drug (empty) to investigate their filtration through a polyethersulfone filter. In order to improve the sterilizing-grade filtration of liposomes, optimization of both the filtration process and the formulation characteristics is important. To show this, the effect of the different filtration conditions/parameters (prefiltration, serial filtration, differential pressure, inlet pressure) and liposome characteristics such as size and size distribution on filtration were examined. For example, by decreasing the size of the liposome from 179.0 to 127.3 nm, the volumetric throughput (L/m
    MeSH term(s) Bacteria ; Filtration ; Liposomes ; Sterilization
    Chemical Substances Liposomes
    Language English
    Publishing date 2020-09-30
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1205009-x
    ISSN 1948-2124 ; 0277-3406 ; 1076-397X ; 0279-7976 ; 1079-7440
    ISSN (online) 1948-2124
    ISSN 0277-3406 ; 1076-397X ; 0279-7976 ; 1079-7440
    DOI 10.5731/pdajpst.2020.011866
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Liposome Sterile Filtration Characterization via X-ray Computed Tomography and Confocal Microscopy.

    Johnson, Thomas F / Jones, Kyle / Iacoviello, Francesco / Turner, Stephen / Jackson, Nigel B / Zourna, Kalliopi / Welsh, John H / Shearing, Paul R / Hoare, Mike / Bracewell, Daniel G

    Membranes

    2021  Volume 11, Issue 11

    Abstract: Two high resolution, 3D imaging techniques were applied to visualize and characterize sterilizing grade dual-layer filtration of liposomes, enabling membrane structure to be related with function and performance. Two polyethersulfone membranes with ... ...

    Abstract Two high resolution, 3D imaging techniques were applied to visualize and characterize sterilizing grade dual-layer filtration of liposomes, enabling membrane structure to be related with function and performance. Two polyethersulfone membranes with nominal retention ratings of 650 nm and 200 nm were used to filter liposomes of an average diameter of 143 nm and a polydispersity index of 0.1. Operating conditions including differential pressure were evaluated. X-ray computed tomography at a pixel size of 63 nm was capable of resolving the internal geometry of each membrane. The respective asymmetry and symmetry of the upstream and downstream membranes could be measured, with pore network modeling used to identify pore sizes as a function of distance through the imaged volume. Reconstructed 3D digital datasets were the basis of tortuous flow simulation through each porous structure. Confocal microscopy visualized liposome retention within each membrane using fluorescent dyes, with bacterial challenges also performed. It was found that increasing pressure drop from 0.07 MPa to 0.21 MPa resulted in differing fluorescent retention profiles in the upstream membrane. These results highlighted the capability for complementary imaging approaches to deepen understanding of liposome sterilizing grade filtration.
    Language English
    Publishing date 2021-11-22
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2614641-1
    ISSN 2077-0375
    ISSN 2077-0375
    DOI 10.3390/membranes11110905
    Database MEDical Literature Analysis and Retrieval System OnLINE

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