Evidence map›Paper›PMID 34371762›Full record

ArticlePharmaceutics2021

An Updated Risk Assessment as Part of the QbD-Based Liposome Design and Development.

Zsófia Németh, Edina Pallagi, Dorina Gabriella Dobó, Gábor Kozma, Zoltán Kónya, Ildikó Csóka

Abstract read
In one paragraph

Article in Pharmaceutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed.

  1. Quality by Design-Guided Development ofMolecules (Basel, Switzerland) · 2026
    Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Improved Activity of Herbal Medicines through Nanotechnology.Nanomaterials (Basel, Switzerland) · 2022
    Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Zsófia NémethFaculty of Pharmacy, Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, 6. Eötvös u, H-6720 Szeged, Hungary.ORCID 0000-0003-3953-9831
Edina PallagiFaculty of Pharmacy, Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, 6. Eötvös u, H-6720 Szeged, Hungary.
Dorina Gabriella DobóFaculty of Pharmacy, Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, 6. Eötvös u, H-6720 Szeged, Hungary.
Gábor KozmaDepartment of Applied and Environmental Chemistry, Faculty of Science and Informatics, Institute of Chemistry, University of Szeged, 1, Rerrich Béla tér, H-6720 Szeged, Hungary.ORCID 0000-0003-2033-0720
Zoltán KónyaDepartment of Applied and Environmental Chemistry, Faculty of Science and Informatics, Institute of Chemistry, University of Szeged, 1, Rerrich Béla tér, H-6720 Szeged, Hungary.ORCID 0000-0002-9406-8596
Ildikó CsókaFaculty of Pharmacy, Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, 6. Eötvös u, H-6720 Szeged, Hungary.ORCID 0000-0003-0807-2781

Funding

Emberi Eroforrások Minisztériuma EFOP 3.6.3-VEKOP-16-2017-00009Emberi Eroforrások Minisztériuma Grant TKP-2020Nemzeti Kutatási Fejlesztési és Innovációs Hivatal GINOP-2.3.2-15-2016-00060Szegedi Tudományegyetem 5367
6 · The paper itself

Abstract

Liposomal formulation development is a challenging process. Certain factors have a critical influence on the characteristics of the liposomes, and even the relevant properties can vary based on the predefined interests of the research. In this paper, a Quality by Design-guided and Risk Assessment (RA)-based study was performed to determine the Critical Material Attributes and the Critical Process Parameters of an "intermediate" active pharmaceutical ingredient-free liposome formulation prepared via the thin-film hydration method, collect the Critical Quality Attributes of the future carrier system and show the process of narrowing a general initial RA for a specific case. The theoretical liposome design was proved through experimental models. The investigated critical factors covered the working temperature, the ratio between the wall-forming agents (phosphatidylcholine and cholesterol), the PEGylated phospholipid content (DPPE-PEG

Indexed as

critical factorsinitial risk assessment“intermediate” liposome formulationliposome characterisationQuality by Designthin-film hydration methodupdated risk assessment

Identifiers

PMID34371762
PMCPMC8309007

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.