Non-invasive Delivery of Biologics: Formulation Strategies and Regulatory Aspects

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Physical Pharmacy and Formulation".

Deadline for manuscript submissions: closed (31 May 2022) | Viewed by 3961

Special Issue Editors

Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, H-6720 Szeged, Hungary
Interests: quality by design-based formulation strategies; regulatory science; patient centeredness in dosage form design; alternative administration routes; nose-to-brain delivery
Special Issues, Collections and Topics in MDPI journals
Institute of Pharmaceutical Technology and Regulatory Affairs, Faculty of Pharmacy, University of Szeged, Eötvös utca 6, H-6720 Szeged, Hungary
Interests: novel drug delivery systems; nanomedicines; biologics delivery; oral delivery; intranasal delivery; regulatory affairs; quality by design

Special Issue Information

Daer colleague,

Over the past two decades, biologics, ranging from small peptides to monoclonal antibodies, have revolutionized the treatment of difficult-to-treat diseases, notably cancer, metabolic disorders and systemic autoimmune diseases. Aiming to enhance patients’ adherence to the treatment and minimize the complications of the parenteral route, the non-invasive delivery of biologics is highly desired. This issue focuses on recently developed formulation strategies and novel delivery systems to advance the non-invasive administration of biological drugs, in addition to discussing regulatory aspects and future perspectives of biologics development.

Prof. Dr. Ildikó Csóka
Guest Editor
Dr. Ruba Ismail
Co-Guest Editor

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Keywords

  • biologics
  • peptides
  • proteins
  • monoclonal antibodies
  • vaccines
  • biologics formulation
  • non-invasive delivery
  • nanomedicine
  • novel drug delivery systems
  • regulatory affairs

Published Papers (1 paper)

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Research

14 pages, 1696 KiB  
Article
Nanostructured Lipid Carriers (NLCs) for Oral Peptide Drug Delivery: About the Impact of Surface Decoration
by Iram Shahzadi, Andrea Fürst, Patrick Knoll and Andreas Bernkop-Schnürch
Pharmaceutics 2021, 13(8), 1312; https://doi.org/10.3390/pharmaceutics13081312 - 22 Aug 2021
Cited by 17 | Viewed by 3160
Abstract
This study was aimed to evaluate the impact of surfactants used for nanostructured lipid carriers (NLCs) to provide enzymatic protection for incorporated peptides. Insulin as a model peptide was ion paired with sodium dodecyl sulfate to improve its lipophilicity. Three NLC formulations containing [...] Read more.
This study was aimed to evaluate the impact of surfactants used for nanostructured lipid carriers (NLCs) to provide enzymatic protection for incorporated peptides. Insulin as a model peptide was ion paired with sodium dodecyl sulfate to improve its lipophilicity. Three NLC formulations containing polyethylene glycol ester (PEG-ester), polyethylene glycol ether (PEG-ether), and polyglycerol ester (PG-ester) surfactants were prepared by solvent diffusion method. NLCs were characterized regarding particle size, polydispersity index, and zeta potential. Biocompatibility of NLCs was assessed on Caco-2 cells via resazurin assay. In vitro lipolysis study was performed using a standard lipid digestion method. Proteolytic studies were performed in simulated gastric fluid containing pepsin and simulated intestinal fluid containing pancreatin. Lipophilicity of insulin in terms of log Poctanol/water was improved from −1.8 to 2.1. NLCs were in the size range of 64–217 nm with a polydispersity index of 0.2–0.5 and exhibited a negative surface charge. PG-ester NLCs were non-cytotoxic up to a concentration of 0.5%, PEG-ester NLCs up to a concentration of 0.25% and PEG-ether NLC up to a concentration of 0.125% (w/v). The lipolysis study showed the release of >90%, 70%, and 10% of free fatty acids from PEG-ester, PG-ester, and PEG-ether NLCs, respectively. Proteolysis results revealed the highest protective effect of PEG-ether NLCs followed by PG-ester and PEG-ester NLCs for incorporated insulin complex. Findings suggest that NLCs bearing substructures less susceptible to degrading enzymes on their surface can provide higher protection for incorporated peptides toward gastrointestinal proteases. Full article
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