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Special Issue "Emerging Trends and Translational Challenges in Drug and Vaccine Delivery"

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A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Drug Delivery and Controlled Release".

Deadline for manuscript submissions: 31 May 2023 | Viewed by 7111

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Special Issue Editors

Dr. Vibhuti Agrahari

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Guest Editor

Department of Pharmaceutical Sciences, University of Oklahoma Health Sciences Center, 1110 N. Stonewall Avenue, CPB 325, Oklahoma City, OK 73117, USA
Interests: biomaterials; biologics; long-term drug delivery; nanomedicine; hydrogels; ocular; inner ear
Special Issues, Collections and Topics in MDPI journals

Dr. Prashant Kumar

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Guest Editor

Vaccine Analytics and Formulation Center, Department of Pharmaceutical Chemistry, University of Kansas, Lawrence, KS 66047, USA
Interests: vaccine; human vaccines; vaccine development; formulation development; attenuated vaccine; viral vaccines; bacterial vaccines; subunit vaccines; pediatric vaccines; COVID vaccines; measles and rubella vaccines; rotavirus vaccine; HPV vaccine; Shigella vaccine; Salmonella vaccine; combination vaccines; polio vaccine; stability study; potency assay; analytical assays; preclinical study; immunogenicity study; biophysical characterization; adjuvants; scale-up; technology transfer
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Drug and vaccine delivery are continuously progressing, and the developments in the past several decades have been enormous. Novel therapeutic modalities leverage advancements in long-term effects, controlled release, cocktail therapies, combinatorial methods, self-administration, and improved patient adherence by rationally designing innovative approaches for drug and vaccine delivery. Given the emerging trends and challenges, the comprehensive preclinical assessment of drug and vaccine delivery systems includes mechanistic chemistry, physicochemical characterizations, pre-formulation investigations, molecular pharmacology, and biological and toxicological evaluations. A better understanding of in vivo behavior, as well as the in vitro–in vivo characterization cascade of safety and efficacy testing, is needed to accelerate the translational challenges in developing a drug product from the proof-of-concept stage to scale-up issues, reproducibility, manufacturing, and commercialization processes. This Special Issue aims to provide the readers with the recent advancements in drug and vaccine delivery and associated challenges from bench to clinic and reflects on the pharma-/biotech- industrial applications. Research and review manuscripts focused on this theme are welcomed.

Dr. Vibhuti Agrahari
Dr. Prashant Kumar
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 2600 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

biomaterials and polymer chemistry
novel drug delivery designs
sustained/controlled release
vaccine delivery systems
DNA and gene vaccine delivery
delivery of mRNA vaccines
biomedical applications
development of 3D/organoids models to study delivery system
in vivo imaging techniques for drug delivery system
application of microfluidics, QbD, and PAT approaches in manufacturing, as well as scale-up techniques

Published Papers (6 papers)

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Research

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Open AccessArticle

A Single Injection with Sustained-Release Microspheres and a Prime-Boost Injection of Bovine Serum Albumin Elicit the Same IgG Antibody Response in Mice

Renée S. van der Kooij

and

Wouter L. J. Hinrichs

Pharmaceutics 2023, 15(2), 676; https://doi.org/10.3390/pharmaceutics15020676 - 16 Feb 2023

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Abstract

Although vaccination is still considered to be the cornerstone of public health care, the increase in vaccination coverage has stagnated for many diseases. Most of these vaccines require two or three doses to be administered across several months or years. Single-injection vaccine formulations are an effective method to overcome the logistical barrier to immunization that is posed by these multiple-injection schedules. Here, we developed subcutaneously (s.c.) injectable microspheres with a sustained release of the model antigen bovine serum albumin (BSA). The microspheres were composed of blends of two novel biodegradable multi-block copolymers consisting of amorphous, hydrophilic poly(ε-caprolactone)-poly(ethylene glycol)-poly(ε-caprolactone) (PCL-PEG-PCL) blocks and semi-crystalline poly(dioxanone) (PDO) blocks of different block sizes. In vitro studies demonstrated that the release of BSA could be tailored over a period of approximately four to nine weeks by changing the blend ratio of both polymers. Moreover, it was found that BSA remained structurally intact during release. Microspheres exhibiting sustained release of BSA for six weeks were selected for the in vivo study in mice. The induced BSA-specific IgG antibody titers increased up to four weeks after administration and were of the same magnitude as found in mice that received a priming and a booster dose of BSA in phosphate-buffered saline (PBS). Determination of the BSA concentration in plasma showed that in vivo release probably took place up to at least four weeks, although plasma concentrations peaked already one week after administration. The sustained-release microspheres might be a viable alternative to the conventional prime-boost immunization schedule, but a clinically relevant antigen should be incorporated to assess the full potential of these microspheres in practice. Full article

(This article belongs to the Special Issue Emerging Trends and Translational Challenges in Drug and Vaccine Delivery)

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Open AccessArticle

Deferasirox Nanosuspension Loaded Dissolving Microneedles for Intradermal Delivery

Hafsa Shahid Faizi

Lalitkumar K. Vora

Muhammad Iqbal Nasiri

Raghu Raj Singh Thakur

Muhammad Usman Minhas

and

Ryan F. Donnelly

Pharmaceutics 2022, 14(12), 2817; https://doi.org/10.3390/pharmaceutics14122817 - 15 Dec 2022

Cited by 1 | Viewed by 1190

Abstract

Microneedles are minimally invasive systems that can deliver drugs intradermally without pain and bleeding and can advantageously replace the hypodermal needles and oral routes of delivery. Deferasirox (DFS) is an iron chelator employed in several ailments where iron overload plays an important role in disease manifestation. In this study, DFS was formulated into a nanosuspension (NSs) through wet media milling employing PVA as a stabilizer and successfully loaded in polymeric dissolving microneedles (DMNs). The release studies for DFS-NS clearly showed a threefold increased dissolution rate compared to pure DFS. The mechanical characterization of DFS-NS-DMNs revealed that the system was sufficiently strong for efficacious skin penetration. Optical coherence tomography images confirmed an insertion of up to 378 µm into full-thickness porcine skin layers. The skin deposition studies showed 60% drug deposition from NS-DMN, which was much higher than from the DFS-NS transdermal patch (DFS-NS-TP) (without needles) or pure DFS-DMNs. Moreover, DFS-NS without DMNs did not deposit well inside the skin, indicating that DMNs played an important role in effectively delivering drugs inside the skin. Therefore, it is evident from the findings that loading DFS-NS into novel DMN devices can effectively deliver DFS transdermally. Full article

(This article belongs to the Special Issue Emerging Trends and Translational Challenges in Drug and Vaccine Delivery)

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Open AccessArticle

Formulated Phospholipids as Non-Canonical TLR4 Agonists

and

Pharmaceutics 2022, 14(12), 2557; https://doi.org/10.3390/pharmaceutics14122557 - 22 Nov 2022

Viewed by 939

Abstract

Immunogenic agents known as adjuvants play a critical role in many vaccine formulations. Adjuvants often signal through Toll-like receptor (TLR) pathways, including formulations in licensed vaccines that target TLR4. While TLR4 is predominantly known for responding to lipopolysaccharide (LPS), a component of Gram-negative bacterial membranes, it has been shown to be a receptor for a number of molecular structures, including phospholipids. Therefore, phospholipid-based pharmaceutical formulations might have off-target effects by signaling through TLR4, confounding interpretation of pharmaceutical bioactivity. In this study we examined the individual components of a clinical stage oil-in-water vaccine adjuvant emulsion (referred to as a stable emulsion or SE) and their ability to signal through murine and human TLR4s. We found that the phospholipid 1,2-dimyristoyl-sn-glycero-3-phosphocholine (DMPC) activated TLR4 and elicited many of the same immune phenotypes as canonical TLR4 agonists. This pathway was dependent on the saturation, size, and headgroup of the phospholipid. Interestingly, DMPC effects on human cells were evident but overall appeared less impactful than emulsion oil composition. Considering the prevalence of DMPC and other phospholipids used across the pharmaceutical space, these findings may contextualize off-target innate immune responses that could impact preclinical and clinical development. Full article

(This article belongs to the Special Issue Emerging Trends and Translational Challenges in Drug and Vaccine Delivery)

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Open AccessArticle

Amphotericin B- and Levofloxacin-Loaded Chitosan Films for Potential Use in Antimicrobial Wound Dressings: Analytical Method Development and Its Application

Ke Peng

Mingshan Li

Achmad Himawan

Juan Domínguez-Robles

and

Pharmaceutics 2022, 14(11), 2497; https://doi.org/10.3390/pharmaceutics14112497 - 17 Nov 2022

Cited by 1 | Viewed by 1222

Abstract

Levofloxacin (LVX) and amphotericin B (AMB) have been widely used to treat bacterial and fungal infections in the clinic. Herein, we report, for the first time, chitosan films loaded with AMB and LVX as wound dressings to combat antimicrobial infections. Additionally, we developed and validated a high-performance liquid chromatography (HPLC) method coupled with a UV detector to simultaneously quantify both AMB and LVX. The method is easy, precise, accurate and linear for both drugs at a concentration range of 0.7–5 µg/mL. The validated method was used to analyse the drug release, ex vivo deposition and permeation from the chitosan films. LVX was released completely from the chitosan film after a week, while approximately 60% of the AMB was released. Ex vivo deposition study revealed that, after 24-hour application, 20.96 ± 13.54 µg of LVX and approximately 0.35 ± 0.04 µg of AMB was deposited in porcine skin. Approximately 0.58 ± 0.16 µg of LVX permeated through the skin. AMB was undetectable in the receptor compartment due to its poor solubility and permeability. Furthermore, chitosan films loaded with AMB and LVX were found to be able to inhibit the growth of both Candida albicans and Staphylococcus aureus, indicating their potential for antimicrobial applications. Full article

(This article belongs to the Special Issue Emerging Trends and Translational Challenges in Drug and Vaccine Delivery)

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Review

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Open AccessReview

An Overview of the Stability and Delivery Challenges of Commercial Nucleic Acid Therapeutics

Rahul G. Ingle

and

Wei-Jie Fang

Pharmaceutics 2023, 15(4), 1158; https://doi.org/10.3390/pharmaceutics15041158 - 06 Apr 2023

Viewed by 958

Abstract

Nucleic acid (NA)-based biopharmaceuticals have emerged as promising therapeutic modalities. NA therapeutics are a diverse class of RNA and DNA and include antisense oligonucleotides, siRNA, miRNA, mRNA, small activating RNA, and gene therapies. Meanwhile, NA therapeutics have posed significant stability and delivery challenges and are expensive. This article discusses the challenges and opportunities for achieving stable formulations of NAs with novel drug delivery systems (DDSs). Here we review the current progress in the stability issues and the significance of novel DDSs associated with NA-based biopharmaceuticals, as well as mRNA vaccines. We also highlight the European Medicines Agency (EMA) and US Food and Drug Administration (FDA)-approved NA-based therapeutics with their formulation profiles. NA therapeutics could impact future markets if the remaining challenges and requirements are addressed. Regardless of the limited information available for NA therapeutics, reviewing and collating the relevant facts and figures generates a precious resource for formulation experts familiar with the NA therapeutics’ stability profile, their delivery challenges, and regulatory acceptance. Full article

(This article belongs to the Special Issue Emerging Trends and Translational Challenges in Drug and Vaccine Delivery)

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Open AccessReview

Novel Developments to Enable Treatment of CNS Diseases with Targeted Drug Delivery

Ramakrishna Venugopalan

and

Didier R. Lefebvre

Pharmaceutics 2023, 15(4), 1100; https://doi.org/10.3390/pharmaceutics15041100 - 29 Mar 2023

Viewed by 1144

Abstract

The blood-brain barrier (BBB) is a major hurdle for the development of systemically delivered drugs against diseases of the central nervous system (CNS). Because of this barrier there is still a huge unmet need for the treatment of these diseases, despite years of research efforts across the pharmaceutical industry. Novel therapeutic entities, such as gene therapy and degradomers, have become increasingly popular in recent years, but have not been the focus for CNS indications so far. To unfold their full potential for the treatment of CNS diseases, these therapeutic entities will most likely have to rely on innovative delivery technologies. Here we will describe and assess approaches, both invasive and non-invasive, that can enable, or at least increase, the probability of a successful drug development of such novel therapeutics for CNS indications. Full article

(This article belongs to the Special Issue Emerging Trends and Translational Challenges in Drug and Vaccine Delivery)

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