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Pharmaceutics
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Probiotics in Pharmaceutics: Exploring the Therapeutic Potential and Formulation Strategies
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Probiotics in Pharmaceutics: Exploring the Therapeutic Potential and Formulation Strategies

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

Deadline for manuscript submissions: 18 December 2026 | Viewed by 3902

Special Issue Editors

Prof. Dr. Karen Angeliki Krogfelt

E-Mail Website
Guest Editor
Department of Science and Environment, PandemiXcenter, Roskilde University, Roskilde, Denmark
Interests: gut health; microbiome; probiotics; clincal trials; Infectious diseases; diagnostics
Special Issues, Collections and Topics in MDPI journals
Prof. Dr. Luís Cláudio Nascimento da Silva

E-Mail Website
Guest Editor
Bioscience Applied to Health Graduate Program, CEUMA University, São Luis, Brazil
Interests: antimicrobial agents; antivirulence agents; immunomodulators; polymers; lectins; polysaccharides; infection models; wound healing; action mechanisms
Special Issues, Collections and Topics in MDPI journals
Dr. Andrea De Souza Monteiro

E-Mail Website
Guest Editor
Laboratório de Microbiologia Aplicada, Universidade CEUMA, São Luis 65075-120, Brazil
Interests: infectious diseases; diagnostics; probiotics; formulation; drug delivery
Dr. Adrielle Zagmignan

E-Mail Website
Guest Editor
Laboratório de Patogenicidade Microbiana, Universidade CEUMA, São Luis 65075-120, Brazil
Interests: probiotics; formulation; drug delivery; functional foods; immunomodulation

Special Issue Information

Dear Colleagues,

The impact of probiotics on human and animal health extends far beyond their well-established role in modulating the gut microbiome. Their therapeutic potential extends to the management of various diseases, such as neurodegenerative disorders, cancer, cardiovascular diseases, and inflammatory conditions. Moreover, probiotics offer a promising approach to combat multidrug-resistant pathogens and support the balance of the gut microbiota. The development of stable probiotic formulations is crucial to overcome the challenges of maintaining the viability of these live organisms during manufacturing, storage, and administration. Oral formulations are predominant due to their convenience, low infection risk, cost-effectiveness, and patient compliance. However, alternative routes of administration, including nasal, transdermal, vaginal, and rectal, are also being explored to optimize therapeutic efficacy.

Advances in nanotechnology have led to the use of micro- and nano-encapsulation techniques to improve the stability and targeted delivery of probiotics. Nanomaterials offer advantages such as biocompatibility, controlled drug release, and enhanced stability of bacterial cells, making them ideal candidates for probiotic encapsulation.

The classification of probiotics has evolved from nutritional to therapeutic and pharmaceutical, reflecting their transition from health supplements to potential drug candidates. This Special Issue aims to explore the cutting-edge advancements in probiotic research and development, with a particular emphasis on formulation strategies, delivery systems, and therapeutic applications.

We invite contributions that address the following key areas:

  • Probiotic Strain Selection and Characterization: The identification and characterization of novel probiotic strains with specific therapeutic properties.
  • Formulation and Delivery Systems: The development of innovative formulation strategies, including encapsulation techniques, to enhance probiotic stability, viability, and targeted delivery.
  • Preclinical and Clinical Studies: The evaluation of the efficacy and safety of probiotic formulations in various disease models and human clinical trials.
  • Mechanisms of Action: The elucidation of the underlying molecular mechanisms by which probiotics exert their therapeutic effects, including immunomodulation, anti-inflammatory, and antimicrobial activities.
  • Probiotics as Drug Delivery Systems: The utilization of probiotics as carriers for the delivery of therapeutic agents to specific target sites.
  • Regulatory Considerations: The regulatory challenges and opportunities associated with the development and commercialization of probiotic-based therapies.

Prof. Dr. Karen Angeliki Krogfelt
Prof. Dr. Luís Cláudio Nascimento da Silva
Dr. Andrea De Souza Monteiro
Dr. Adrielle Zagmignan
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 250 words) can be sent to the Editorial Office for assessment.

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

  • probiotics
  • formulation
  • drug delivery
  • therapeutic potential
  • microbiome modulation
  • nutraceuticals
  • immunomodulation
  • clinical trials
  • regulatory affairs

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Published Papers (4 papers)

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Research

18 pages, 3058 KB  
Article
Anti-Inflammatory Properties of Curcumin as Add-On Therapy in Patients with MS—Prospective, Comparative, Randomized, Pilot Study
by Anna Kukushkina, Vladimir Rogovskii, Olga Zhilenkova, Timur Sadekov, Mikhail Melnikov and Alexey Boyko
Pharmaceutics 2026, 18(5), 519; https://doi.org/10.3390/pharmaceutics18050519 (registering DOI) - 24 Apr 2026
Viewed by 369
Abstract
Background: Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system and is the leading cause of neurological disability. Currently, the main strategy for MS therapy is the use of disease-modifying therapies (DMTs). If low-efficacy DMTs are ineffective, patients [...] Read more.
Background: Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system and is the leading cause of neurological disability. Currently, the main strategy for MS therapy is the use of disease-modifying therapies (DMTs). If low-efficacy DMTs are ineffective, patients are transferred to high-efficacy DMTs, which possess more severe side effects associated with immunosuppression. Therefore, the search for new add-on therapies for MS that can enhance the effect of low-efficacy DMTs is relevant. Curcumin, being a natural polyphenol, has immunoregulatory properties and a favorable safety profile. In addition, micellar forms of curcumin can increase its bioavailability. We studied the effect of micellar curcumin on clinical and laboratory parameters in patients with MS receiving low-efficacy DMTs (IFN-β). Methods: Sixty patients with MS and a suboptimal response to IFN-β were randomized (1:1) into two groups: the IFN-CUR group, which received add-on therapy with micellar curcumin (containing curcumin and Tween 80 as a solubilizer) for 6 months, and a control group (IFN group), which received IFN-β alone. The 6-month treatment period was followed by a subsequent 6-month follow-up off curcumin treatment (DMTs only). Results: The proportion of patients without relapses in the curcumin add-on group increased significantly after 6 months (from 57% to 90%, p = 0.007), and the risk of exacerbation was significantly lower compared to the control group (HR = 0.2; p = 0.03). The treatment was associated with EDSS score stabilization, a positive effect on depression (p = 0.05), and a reduction in plasma IFN-γ levels (p = 0.02). A decreasing trend in MRI lesion activity and reductions in specific microbiota-related markers, including the Eggerthella lenta-associated marker (i16a), were also observed. In ex vivo cultures, curcumin significantly inhibited IL-6 production in macrophages derived from patients with multiple sclerosis (MS) and healthy donors. Conclusions: Add-on therapy with micellar curcumin may enhance the efficacy of IFN-β, improving clinical outcomes and modulating inflammatory and microbial parameters in MS patients with a suboptimal response to IFN-β treatment. Full article
(This article belongs to the Special Issue Probiotics in Pharmaceutics: Exploring the Therapeutic Potential and Formulation Strategies)
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26 pages, 3289 KB  
Article
Extracellular Vesicles from Probiotic and Beneficial Escherichia coli Strains Exert Multifaceted Protective Effects Against Rotavirus Infection in Intestinal Epithelial Cells
by Cecilia Cordero, Aitor Caballero-Román, Sergio Martínez-Ruiz, Yenifer Olivo-Martínez, Laura Baldoma and Josefa Badia
Pharmaceutics 2026, 18(1), 120; https://doi.org/10.3390/pharmaceutics18010120 - 18 Jan 2026
Viewed by 674
Abstract
Background/Objectives: Rotavirus remains a major cause of severe acute gastroenteritis in infants worldwide. The suboptimal efficacy of current vaccines underscores the need for alternative microbiome-based interventions, including postbiotics. Extracellular vesicles (EVs) from probiotic and commensal E. coli strains have been shown to mitigate [...] Read more.
Background/Objectives: Rotavirus remains a major cause of severe acute gastroenteritis in infants worldwide. The suboptimal efficacy of current vaccines underscores the need for alternative microbiome-based interventions, including postbiotics. Extracellular vesicles (EVs) from probiotic and commensal E. coli strains have been shown to mitigate diarrhea and enhance immune responses in a suckling-rat model of rotavirus infection. Here, we investigate the regulatory mechanisms activated by EVs in rotavirus-infected enterocytes. Methods: Polarized Caco-2 monolayers were used as a model of mature enterocytes. Cells were pre-incubated with EVs from the probiotic E. coli Nissle 1917 (EcN) or the commensal EcoR12 strain before rotavirus infection. Intracellular Ca2+ concentration, ROS levels, and the expression of immune- and barrier-related genes and proteins were assessed at multiple time points post-infection. Results: EVs from both strains exerted broad protective effects against rotavirus-induced cellular dysregulation, with several responses being strain-specific. EVs interfered with viral replication by counteracting host cellular processes essential for rotavirus propagation. Specifically, EV treatment significantly reduced rotavirus-induced intracellular Ca2+ mobilization, ROS production, and COX-2 expression. In addition, both EV types reduced virus-induced mucin secretion and preserved tight junction organization, thereby limiting viral access to basolateral coreceptors. Additionally, EVs enhanced innate antiviral defenses via distinct, strain-dependent pathways: EcN EVs amplified IL-8-mediated responses, whereas EcoR12 EVs preserved the expression of interferon-related signaling genes. Conclusions: EVs from EcN and EcoR12 act through multiple complementary mechanisms to restrict rotavirus replication, spread, and immune evasion. These findings support their potential as effective postbiotic candidates for preventing or treating rotavirus infection. Full article
(This article belongs to the Special Issue Probiotics in Pharmaceutics: Exploring the Therapeutic Potential and Formulation Strategies)
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26 pages, 1934 KB  
Article
Probiotic Potential and Genome-Based Characterization of Lactiplantibacillus plantarum M2, a Promising Isolate Obtained from Spontaneous Fermentation of Humiria balsamifera Pulp
by Carlos Drielson da Silva Pereira, Roberval Nascimento Moraes Neto, Carlos Eduardo Morais de Sousa, Enio Ciro Dantas de Farias Rocha, Diogo Zeque Bastos, Suana Millen Bruzaca Mota, Romulo Maia Ferreira, Adrielle Zagminan and Luís Cláudio Nascimento da Silva
Pharmaceutics 2025, 17(12), 1557; https://doi.org/10.3390/pharmaceutics17121557 - 3 Dec 2025
Viewed by 765
Abstract
Background/Objectives: The growing demand for functional foods and alternative therapeutic strategies has intensified the search for novel probiotic strains from underexplored ecosystems. This study aimed to isolate and phenotypically characterize lactic acid bacteria (LAB) from spontaneously fermented fruits found in the Legal Amazon [...] Read more.
Background/Objectives: The growing demand for functional foods and alternative therapeutic strategies has intensified the search for novel probiotic strains from underexplored ecosystems. This study aimed to isolate and phenotypically characterize lactic acid bacteria (LAB) from spontaneously fermented fruits found in the Legal Amazon (Ananas comosus, Humiria balsamifera, Manilkara zapota, and Platonia insignis) and to perform genome-based analysis of the most promising isolate to evaluate its probiotic potential. Methods: The isolates were identified by MALDI-TOF-MS and screened for tolerance to low pH, bile salts, lysozyme, growth at 39 °C, and antimicrobial activity against five enteric pathogens. The most promising isolate was evaluated by coaggregation and biofilm assays, in silico proteome and CAZyme analysis, bacteriocin cluster mining, and in vivo efficacy testing using Tenebrio molitor larvae. Results: Three isolates from H. balsamifera were identified as Lactiplantibacillus plantarum (M1, M2, M4) by MALDI-TOF-MS. These isolates exhibited high resilience to all tested physiological stressors. Antimicrobial activity was contact-dependent, with no inhibition by cell-free supernatants. M2 showed the strongest pathogen exclusion, moderate biofilm formation, and high coaggregation with S. enterica and E. faecalis. Genome analysis of M2 revealed a 3.40 Mb chromosome, absence of acquired resistance or virulence genes, two plantaricin gene clusters, and 93 CAZymes, including GT families linked to exopolysaccharides biosynthesis. SignalP predicted secretion signals in 10 CAZymes. M2 significantly improved larval survival against E. coli and S. enterica, especially under prophylactic treatment. Conclusions: L. plantarum M2 combines safety, stress tolerance, genomic features, and in vivo efficacy, positioning it as a promising probiotic candidate adapted to tropical niches. These findings highlight H. balsamifera as a reservoir of novel probiotic strains. Full article
(This article belongs to the Special Issue Probiotics in Pharmaceutics: Exploring the Therapeutic Potential and Formulation Strategies)
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33 pages, 2639 KB  
Article
Functional and Safety Profile of Limosilactobacillus vaginalis and Development of Oral Fast-Disintegrating Tablets for Gut Microbiota Modulation
by Barbara Giordani, Federica Monti, Elisa Corazza, Sofia Gasperini, Carola Parolin, Angela Abruzzo, Claudio Foschi, Antonella Marangoni, Monia Lenzi, Barbara Luppi and Beatrice Vitali
Pharmaceutics 2025, 17(8), 1011; https://doi.org/10.3390/pharmaceutics17081011 - 1 Aug 2025
Cited by 2 | Viewed by 1352
Abstract
Background/Objectives: Early gut colonization by bifidobacteria, occurring more favorably in vaginally born infants than in those delivered via C-section, is crucial for maintaining overall health. The study investigated the health-promoting properties of Limosilactobacillus vaginalis BC17 both as viable cells and as postbiotics [...] Read more.
Background/Objectives: Early gut colonization by bifidobacteria, occurring more favorably in vaginally born infants than in those delivered via C-section, is crucial for maintaining overall health. The study investigated the health-promoting properties of Limosilactobacillus vaginalis BC17 both as viable cells and as postbiotics (i.e., cell-free supernatant and heat-killed cells), with the purpose of developing oral formulations to support intestinal health. Methods: The safety, effects on the adhesion of bifidobacteria and enteropathogens to intestinal cells, and anti-inflammatory properties of L. vaginalis BC17 viable cells and postbiotics were evaluated. Fast-disintegrating tablets were formulated by freeze-drying cell-free supernatant in combination with heat-killed or viable cells alongside maltodextrins. Results: The formulations were shown to be non-genotoxic and compatible with intestinal cell lines (Caco-2 and HT-29). BC17 viable cells survived in co-culture with intestinal cells up to 48 h and exhibited moderate adhesion to the cell lines. Notably, both BC17 viable cells and postbiotics enhanced the adhesion of beneficial bifidobacteria to Caco-2 cells by up to 250%, while reducing enteropathogens adhesion by 40–70%. Moreover, they exerted significant anti-inflammatory effects, reducing nitric oxide production in macrophages by 40–50% and protecting intestinal cells from SDS-induced damage. The formulations allowed administration of at least 109 BC17 cells in infants and adults through easy and rapid dispersion in milk or water, or directly in the oral cavity without chewing, and preserved their functional properties for up to 3 months of storage. Conclusions: L. vaginalis BC17 viable cells and postbiotics, as well as fast-disintegrating tablets, showed promising functional and safety profiles. Although further in vivo validation is needed, this approach represents a compelling strategy for promoting gut health. Full article
(This article belongs to the Special Issue Probiotics in Pharmaceutics: Exploring the Therapeutic Potential and Formulation Strategies)
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