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Pharmaceutics
Special Issues
Methods and Delivery Systems for Improving Drug Bioavailability
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Methods and Delivery Systems for Improving Drug Bioavailability

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Biopharmaceutics".

Deadline for manuscript submissions: closed (31 August 2023) | Viewed by 1376

Special Issue Editors

Dr. Mireia Mallandrich Miret

E-Mail Website
Guest Editor
Department of Pharmacy, Pharmaceutical Technology and Physical Chemistry, Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain
Interests: nanocarriers; topical drug delivery systems; dermal absorption; skin models; in vitro studies; nanomedicine; transdermal delivery; transmucosal delivery; cronocosmetic; skin biodistribution
Special Issues, Collections and Topics in MDPI journals
Dr. David Limón

E-Mail Website
Guest Editor
1. Institut de Nanociència i Nanotecnologia IN2UB, Universitat de Barcelona, 08028 Barcelona, Spain
2. Department of Pharmacology, Toxicology and Medicinal Chemistry, Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain
Interests: materials chemistry; bioconjugation; nanochemistry; nanostructured formulations; nanocarriers; dermal delivery; mucosal delivery; topical drug delivery; permeation studies; drug release studies

Special Issue Information

Dear Colleagues,

The efficacy of drugs is often limited by their physicochemical properties such as very low or very high water solubility, leading to low absorption and thus low ability to reach systemic circulation. As well, their efficacy might be limited by their pharmacokinetic profile, encountering problems for reaching their therapeutic target at sufficient concentration and time.

To counteract these limitations, several strategies have been developed, including novel formulation systems based on micro- or nanostructured materials, which aim to increase drug stability and absorption, and can provide a controlled drug release, modifying the biopharmaceutical and pharmacokinetic profile. Formulations can be designed for oral delivery or for other routes of administration such as topical application (including transdermal, buccal, and sublingual mucosae), which avoid the first pass metabolism, and therefore increase drug bioavailability. As well, mechanically assisted techniques, such as microneedles, permit creating microchannels through the skin, through which the drug can permeate at a higher speed and to a higher extent. Finally, other mechanically assisted techniques such as ultrasound-stimulated microbubbles (cavitation) can help disrupt tissues such as the blood-brain barrier to permit the permeation of drugs to the Central Nervous System.

This special issue will cover topics including the design, development and characterization of new formulation systems, including nanostructured and microstructured materials, for oral or other routes of administration, mechanically-assisted techniques, or biopharmaceutic and pharmacokinetic studies, to show the progress achieved in improving the bioavailability of drugs.

This special issue is open for original research and review articles. We look forward to receiving your contributions.

Dr. Mireia Mallandrich
Dr. David Limón
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceutics is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • drug delivery systems
  • bioavailability
  • formulation
  • nanomaterials
  • hydrogels
  • nanoparticles
  • microspheres
  • microparticles
  • in vitro testing
  • in vivo testing
  • biopharmaceutical studies
  • pharmacokinetic studies

Published Papers (1 paper)

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Research

22 pages, 5229 KiB  
Article
Predictive Potential of Cmax Bioequivalence in Pilot Bioavailability/Bioequivalence Studies, through the Alternative ƒ2 Similarity Factor Method
by Sara Carolina Henriques, Paulo Paixão, Luis Almeida and Nuno Elvas Silva
Pharmaceutics 2023, 15(10), 2498; https://doi.org/10.3390/pharmaceutics15102498 - 20 Oct 2023
Viewed by 982
Abstract
Pilot bioavailability/bioequivalence (BA/BE) studies are downsized trials that can be conducted prior to the definitive pivotal trial. In these trials, 12 to 18 subjects are usually enrolled, although, in principle, a sample size is not formally calculated. In a previous work, authors recommended [...] Read more.
Pilot bioavailability/bioequivalence (BA/BE) studies are downsized trials that can be conducted prior to the definitive pivotal trial. In these trials, 12 to 18 subjects are usually enrolled, although, in principle, a sample size is not formally calculated. In a previous work, authors recommended the use of an alternative approach to the average bioequivalence methodology to evaluate pilot studies’ data, using the geometric mean (Gmean) ƒ2 factor with a cut off of 35, which has shown to be an appropriate method to assess the potential bioequivalence for the maximum observed concentration (Cmax) metric under the assumptions of a true Test-to-Reference Geometric Mean Ratio (GMR) of 100% and an inter-occasion variability (IOV) in the range of 10% to 45%. In this work, the authors evaluated the proposed ƒ2 factor in comparison with the standard average bioequivalence in more extreme scenarios, using a true GMR of 90% or 111% for truly bioequivalent formulations, and 80% or 125% for truly bioinequivalent formulations, in order to better derive conclusions on the potential of this analysis method. Several scenarios of pilot BA/BE crossover studies were simulated through population pharmacokinetic modelling, accounting for different IOV levels. A redefined decision tree is proposed, suggesting a fixed sample size of 20 subjects for pilot studies in the case of intra-subject coefficient of variation (ISCV%) > 20% or unknown variability, and suggesting the assessment of study results through the average bioequivalence analysis, and additionally through Gmean ƒ2 factor method in the case of the 90% confidence interval (CI) for GMR is outside the regulatory acceptance bioequivalence interval of [80.00–125.00]%. Using this alternative approach, the certainty levels to proceed with pivotal studies, depending on Gmean ƒ2 values and variability scenarios tested (20–60% IOV), were assessed, which is expected to be helpful in terms of the decision to proceed with pivotal bioequivalence studies. Full article
(This article belongs to the Special Issue Methods and Delivery Systems for Improving Drug Bioavailability)
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