Evidence map›Paper›PMID 32143286›Full record

ReviewNanomaterials (Basel, Switzerland)2020

Nanopharmaceutics: Part II-Production Scales and Clinically Compliant Production Methods.

Eliana B Souto, Gabriela F Silva, João Dias-Ferreira, Aleksandra Zielinska, Fátima Ventura, Alessandra Durazzo, Massimo Lucarini, Ettore Novellino, Antonello Santini

Abstract readReview
In one paragraph

Review in Nanomaterials (Basel, Switzerland), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
–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

31 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  13. The Honey BeeBiology · 2022
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  17. Hydroxyurea-loaded FeNaunyn-Schmiedeberg's archives of pharmacology · 2022
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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

9 authors.

Eliana B SoutoDepartment of Pharmaceutical Technology, Faculty of Pharmacy, University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal.
Gabriela F SilvaDepartment of Pharmaceutical Technology, Faculty of Pharmacy, University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal.
João Dias-FerreiraDepartment of Pharmaceutical Technology, Faculty of Pharmacy, University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal.
Aleksandra ZielinskaDepartment of Pharmaceutical Technology, Faculty of Pharmacy, University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal.ORCID 0000-0003-2603-1377
Fátima VenturaDepartment of Biochemistry and Human Biology, Faculty of Pharmacy of University of Lisbon, 1649-003 Lisbon, Portugal.
Alessandra DurazzoCREA-Research Centre for Food and Nutrition, Via Ardeatina 546, 00178 Rome, Italy.
Massimo LucariniCREA-Research Centre for Food and Nutrition, Via Ardeatina 546, 00178 Rome, Italy.
Ettore NovellinoDepartment of Pharmacy, University of Napoli Federico II, Via D. Montesano 49, 80131 Napoli, Italy.
Antonello SantiniDepartment of Pharmacy, University of Napoli Federico II, Via D. Montesano 49, 80131 Napoli, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Due the implementation of nanotechnologies in the pharmaceutical industry over the last few decades, new type of cutting-edge formulations-nanopharmaceutics-have been proposed. These comprise pharmaceutical products at the nanoscale, developed from different types of materials with the purpose to, e.g., overcome solubility problems of poorly water-soluble drugs, the pharmacokinetic and pharmacodynamic profiles of known drugs but also of new biomolecules, to modify the release profile of loaded compounds, or to decrease the risk of toxicity by providing site-specific delivery reducing the systemic distribution and thus adverse side effects. To succeed with the development of a nanopharmaceutical formulation, it is first necessary to analyze the type of drug which is to be encapsulated, select the type matrix to load it (e.g., polymers, lipids, polysaccharides, proteins, metals), followed by the production procedure. Together these elements have to be compatible with the administration route. To be launched onto the market, the selected production method has to be scaled-up, and quality assurance implemented for the product to reach clinical trials, during which in vivo performance is evaluated. Regulatory issues concerning nanopharmaceutics still require expertise for harmonizing legislation and a clear understanding of clinically compliant production methods. The first part of this study addressing "Nanopharmaceutics: Part I-Clinical trials legislation and Good Manufacturing Practices (GMP) of nanotherapeutics in the EU" has been published in Pharmaceutics. This second part complements the study with the discussion about the production scales and clinically compliant production methods of nanopharmaceutics.

Indexed as

clinical requirementslegislationlipid-basedmetal-basednanonutraceuticsnanopharmaceuticspolymer-based

Identifiers

PMID32143286
PMCPMC7153617

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.