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Drug Delivery of Natural Active Principles: Focus on Topical and Oral Applications, 2nd Edition

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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: closed (30 April 2025) | Viewed by 14821

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Dr. Marta Miola

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Department of Applied Science and Technology, Politecnico di Torino, Turin, Italy
Interests: bioactive glasses/glass-ceramics; antibacterial materials; composites; magnetic materials; inorganic nanoparticles
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Dr. Marta Gallo

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DISAT Department, Politecnico di Torino, corso Duca degli Abruzzi 29, 10129 Torino, Italy
Interests: silica particles; polymer; oxide-based and hybrid systems
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Special Issue Information

Dear Colleagues,

Natural active principles still attract interest regarding their therapeutic purposes due to their lack of side effects, which makes them particularly appealing for the treatment of chronic diseases (e.g., hypertension and atherosclerosis).

However, strategies for optimising the delivery of natural compounds and enhancing their efficacy are still needed. Natural compounds, in fact, are often affected by low bioavailability, low stability or fast degradation.

Different strategies can be proposed, encompassing, for example, nano- or micro-carriers, polymer-based, lipid-based or oxide-based particles or hybrid systems, and specific formulations.

The present Special Issue aims to collect original research articles, review papers, or reviews regarding systems and approaches to delivering natural compounds, protecting them or enhancing their properties, with particular attention to oral and topical delivery.

Authors are encouraged to share their research on both the synthesis of new systems and their characterization. Works including in vitro and in vivo tests are welcome.

Potential topics concern, but are not limited to, the following:

Role of organic/inorganic carriers in natural active principle delivery;
Natural active principles to treat skin diseases (e.g., infection, cancer and psoriasis);
Delivery systems to improve natural active principles’ bioavailability and pharmacokinetics.

Dr. Marta Miola
Dr. Marta Gallo
Guest Editors

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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.

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Keywords

natural compounds
topical drug delivery
oral drug delivery
micro- and nano-particles
polymer-, lipid-, oxide-based and hybrid systems
synthesis and characterization
in vitro, in vivo tests

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Related Special Issue

Drug Delivery of Natural Active Principles: Focus on Topical and Oral Applications in Pharmaceutics (10 articles)

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Research

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15 pages, 1993 KiB

Open AccessArticle

Nanostructured Lipoxin A4: Understanding Its Biological Behavior and Impact on Alzheimer’s Disease (Proof of Concept)

by Natália Cristina Gomes-da-Silva, Isabelle Xavier-de-Britto, Marilia Amável Gomes Soares, Natalia Mayumi Andrade Yoshihara, Derya Ilem Özdemir, Eduardo Ricci-Junior, Pierre Basílio Almeida Fechine, Luciana Magalhães Rebelo Alencar, Maria das Graças Muller de Oliveira Henriques, Thereza Christina Barja-Fidalgo, Cristian Follmer and Ralph Santos-Oliveira

Pharmaceutics 2025, 17(5), 649; https://doi.org/10.3390/pharmaceutics17050649 - 15 May 2025

Viewed by 618

Abstract

Background/Objectives: Lipoxins, particularly Lipoxin A4 (LXA4), are endogenous lipid mediators with potent anti-inflammatory and pro-resolving properties, making them promising candidates for the treatment of inflammatory and neurodegenerative disorders. However, their therapeutic application is limited by poor stability and bioavailability. This study aimed to develop and characterize nanomicelles encapsulating LXA4 (nano-lipoxin A4) to improve its pharmacological efficacy against Alzheimer’s disease (AD), a neurodegenerative condition marked by chronic inflammation and beta-amyloid (Aβ) accumulation. Methods: Nano-lipoxin A4 was synthesized using Pluronic F-127 as a carrier and characterized in terms of morphology, physicochemical stability, and in vitro activity against Aβ fibrils. Dissociation of Aβ fibrils was assessed via Thioflavin-T fluorescence assays and transmission electron microscopy. In vivo biodistribution and pharmacokinetic profiles were evaluated using technetium-99m-labeled nano-lipoxin A4 in rodent models. Hepatic biochemical parameters were also measured to assess potential systemic effects. Results: In vitro studies demonstrated that nano-lipoxin A4 effectively dissociated Aβ fibrils at concentrations of 50 nM and 112 nM. Electron microscopy confirmed the disruption of fibrillar structures. In vivo imaging revealed predominant accumulation in the liver and spleen, consistent with reticuloendothelial system uptake. Pharmacokinetic analysis showed a prolonged half-life (63.95 h) and low clearance rate (0.001509 L/h), indicating sustained systemic presence. Biochemical assays revealed elevated liver enzyme levels, suggestive of increased hepatic metabolism or potential hepatotoxicity. Conclusions: Nano-lipoxin A4 exhibits significant therapeutic potential for Alzheimer’s disease through effective modulation of Aβ pathology and favorable pharmacokinetic characteristics. However, the elevation in liver enzymes necessitates further investigation into systemic safety to support clinical translation. Full article

(This article belongs to the Special Issue Drug Delivery of Natural Active Principles: Focus on Topical and Oral Applications, 2nd Edition)

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18 pages, 14056 KiB

Open AccessArticle

Collagen–Chitosan Composites Enhanced with Hydroxytyrosol for Prospective Wound Healing Uses

by Miguel P. Batista, Margarida Pimenta, Naiara Fernández, Ana Rita C. Duarte, Maria do Rosário Bronze, Joana Marto and Frédéric Bustos Gaspar

Pharmaceutics 2025, 17(5), 618; https://doi.org/10.3390/pharmaceutics17050618 - 6 May 2025

Viewed by 2651

Abstract

Background/Objectives: Recent studies highlight the excellent wound-healing properties of collagen and chitosan materials. Combining these polymers with a bioactive compound could enhance their effectiveness as next-generation wound dressings. Hydroxytyrosol (HT), an antioxidant derived from olive oil, may aid wound healing due to its anti-inflammatory, antimicrobial, and angiogenesis-stimulating properties, making it a beneficial addition to collagen–chitosan dressings. It could be a beneficial addition to collagen–chitosan dressings, thus improving their therapeutic effects. This study screens the potential of collagen–chitosan composites with HT for wound-healing applications and assesses the influence of the compound’s incorporation on the materials’ properties. Methods: The material production involved incorporating chitosan and HT into a marine collagen extract. The resulting collagen–chitosan–HT material was obtained through freeze-drying. Prototype dressing characterization included morphology by scanning electron microscopy, solid and hydrated state by textural and rheological studies, and in vitro HT release studies. The materials’ cytocompatibility screening was assessed using a mouse fibroblast cell line, and the antibacterial activity was evaluated against microorganisms commonly implicated in wound infections. Results: Burst strength, viscosity, frequency sweep test, tackiness, and adhesion results indicate that chitosan contributes to the material’s mechanical robustness by maintaining a high viscosity and preserving the material’s gel structure. The in vitro release studies suggest an HT-controlled release profile with a maximum release (70%) achieved after 10 h. Biological experiments confirmed the materials’ cytocompatibility with skin cells and very promising antibacterial efficacy against Staphylococcus aureus and Pseudomonas aeruginosa. Conclusions: In conclusion, HT was successfully incorporated into a collagen–chitosan matrix, enhancing the therapeutic prospect of the resultant material. The collagen–chitosan–HT composite presents a promising potential as an advanced wound-healing material. Full article

(This article belongs to the Special Issue Drug Delivery of Natural Active Principles: Focus on Topical and Oral Applications, 2nd Edition)

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22 pages, 12952 KiB

Open AccessArticle

Ionotropic Gelation and Chemical Crosslinking as Tools to Obtain Gellan Gum-Based Beads with Mesalazine

by Piotr Gadziński, Agnieszka Skotnicka, Natalia Lisiak, Ewa Totoń, Błażej Rubiś, Ewa Florek, Dariusz T. Mlynarczyk, Mirosław Szybowicz, Ewelina Nowak and Tomasz Osmałek

Pharmaceutics 2025, 17(5), 569; https://doi.org/10.3390/pharmaceutics17050569 - 25 Apr 2025

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Abstract

Introduction: Many orally administered drugs are either unstable in the acidic environment of the stomach or cause moderate to severe side effects in the upper gastrointestinal tract (GIT). These limitations can reduce therapeutic efficacy, discourage patient compliance, worsen the disease, and even contribute to the risk of cancer development. To overcome these issues, drug release often needs to be modified and targeted to the distal parts of the GIT. This is typically achieved through the use of pH-sensitive polymer coatings or incorporation into polymeric delivery systems. With this in mind, the aim of this project was to design, develop, and characterize gellan gum-based beads for colon-specific prolonged release of mesalazine, with potential application in the chemoprevention and treatment of bowel diseases. Materials and Methods: The dehydrated capsules were characterized using Raman spectroscopy and scanning electron microscopy. The crosslinked gellan gum was additionally evaluated for cytotoxicity. Key parameters such as pH-dependent swelling behavior, drug content, encapsulation efficiency, and drug release in simulated gastrointestinal fluids were also assessed. Furthermore, the behavior of the capsules in the gastrointestinal tract was studied in a rat model to evaluate their in vivo performance. Results: Significant differences in drug release profiles were observed between formulations crosslinked solely with calcium ions and those additionally crosslinked with glutaraldehyde (GA). The incorporation of GA effectively prolonged the release of mesalazine. These findings were further supported by in vivo studies conducted on Wistar rats, where the GA-crosslinked formulation demonstrated a markedly extended release compared to the formulation prepared using only ionotropic gelation. Conclusions: The combination of ionotropic gelation and glutaraldehyde crosslinking in gellan gum-based beads appears to be a promising strategy for achieving colon-specific prolonged release of mesalazine, facilitating targeted delivery to the distal regions of the gastrointestinal tract. Full article

(This article belongs to the Special Issue Drug Delivery of Natural Active Principles: Focus on Topical and Oral Applications, 2nd Edition)

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29 pages, 22746 KiB

Open AccessArticle

Polyphenols from Bacopa procumbens Nanostructured with Gold Nanoparticles Stimulate Hair Growth Through Apoptosis Modulation in C57BL/6 Mice

by Salvador Pérez-Mora, Juan Ocampo-López, María del Consuelo Gómez-García, Sandra Viridiana Salgado-Hernández, Yazmin Montserrat Flores-Martinez and David Guillermo Pérez-Ishiwara

Pharmaceutics 2025, 17(2), 222; https://doi.org/10.3390/pharmaceutics17020222 - 9 Feb 2025

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Abstract

Background/Objectives: Alopecia is a hair disorder with a significant impact on quality of life, and its incidence has been increasing in recent years. Current therapeutic options are limited and may cause adverse side effects, highlighting the need to develop safer and more effective formulations. Therefore, the objective of this study was to evaluate the effect of a formulation based on the bioactive fraction of Bacopa procumbens (BFNB), conjugated with gold nanoparticles, on hair growth through the modulation of apoptosis in C57BL/6 mice. Methods: The potential biological activities of the secondary metabolites of B. procumbens present in BFNB were analyzed in silico. In vivo experiments evaluated the expression of pro-apoptotic markers p53, caspase 3-p11, caspase 9-p10, and Bax, as well as anti-apoptotic marker Bcl-2, through Western blotting. Immunohistochemistry further assessed the expression and localization of some of these markers. Additionally, molecular docking and interactomic analyses were performed, complemented by functional enrichment, to explore molecular pathways modulated by the evaluated proteins. Results: In silico analyses suggested that BFNB metabolites are involved in the modulation of hair growth, hair fragility, and apoptosis. This finding was supported by in vivo experiments in mice, where BFNB significantly decreased the expression of p53, caspase 3-p11, caspase 9-p10, and Bax while increasing Bcl-2 levels. Immunohistochemistry showcased a reduction in pro-apoptotic markers in dermal and follicular bulb cells. Furthermore, molecular docking studies identified BFNB metabolites as potential direct modulators of these key proteins, strengthening evidence of their role in apoptotic regulation. The interactomic analysis highlighted 50 proteins associated with apoptosis, and functional enrichment underscored key processes such as p53 signaling, regulation of the apoptosome, and mitochondrial membrane involvement in the intrinsic apoptosis mechanism, among other pathways. Conclusions: This study demonstrates that BFNB effectively modulates apoptosis through key molecular mechanisms, highlighting its potential as an innovative therapy for promoting hair growth. Full article

(This article belongs to the Special Issue Drug Delivery of Natural Active Principles: Focus on Topical and Oral Applications, 2nd Edition)

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14 pages, 3619 KiB

Open AccessEditor’s ChoiceArticle

Bioadhesive Chitosan Films Loading Curcumin for Safe and Effective Skin Cancer Topical Treatment

by Seila Tolentino, Mylene M. Monteiro, Felipe Saldanha-Araújo, Marcilio Cunha-Filho, Tais Gratieri, Eliete N. Silva Guerra and Guilherme M. Gelfuso

Pharmaceutics 2025, 17(1), 18; https://doi.org/10.3390/pharmaceutics17010018 - 26 Dec 2024

Viewed by 1287

Abstract

Background/Objectives: This study aimed to evaluate the safety and efficacy of chitosan-based bioadhesive films for facilitating the topical delivery of curcumin in skin cancer treatment, addressing the pharmacokinetic limitations associated with oral administration. Methods: The films, which incorporated curcumin, were formulated using varying proportions of chitosan, polyvinyl alcohol, Poloxamer^® 407, and propylene glycol. These films were assessed for stability, drug release, in vitro skin permeation, cell viability (with and without radiotherapy), and skin irritation. Results: The films demonstrated physical stability and preserved curcumin content at room temperature for 90 days. Drug release was effectively controlled during the first 8 h, with release rates ranging from 51.6 ± 4.8% to 65.6 ± 13.0%. The films also enhanced drug penetration into the skin compared to a curcumin solution used as a control (stratum corneum: 1.3 ± 0.1 to 1.9 ± 0.8 µg/cm²; deeper skin layers: 1.7 ± 0.1 to 2.7 ± 0.2 µg/cm²). A cytotoxicity test on metastatic melanoma cells showed that curcumin at topical doses exerted activity similar to that delivered via the skin. Furthermore, curcumin alone was more effective in inhibiting tumor cells than radiotherapy alone (p < 0.01), with no additional benefit observed when curcumin was combined with radiotherapy. Finally, irritation tests confirmed that the films were safe for topical application. Conclusion: The developed chitosan-based bioadhesive films represent a promising alternative for the topical treatment of skin tumors using curcumin. Full article

(This article belongs to the Special Issue Drug Delivery of Natural Active Principles: Focus on Topical and Oral Applications, 2nd Edition)

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10 pages, 1763 KiB

Open AccessEditor’s ChoiceArticle

The Distinctive Role of Gluconic Acid in Retarding Percutaneous Drug Permeation: Formulation of Lidocaine-Loaded Chitosan Nanoparticles

by Amnon C. Sintov

Pharmaceutics 2024, 16(6), 831; https://doi.org/10.3390/pharmaceutics16060831 - 19 Jun 2024

Viewed by 1284

Abstract

The objective of the present investigation was to evidence the skin retardation phenomenon of lidocaine by gluconic acid as an inactive ingredient involved in citrate-crosslinking chitosan nanoparticles. Lidocaine hydrochloride was loaded in nanoparticles based on chitosan, fabricated by using a water-in-oil microemulsion as a template and citric acid as an ionic cross-linker. Gluconic acid (pentahydroxy hexanoic acid) was added during the fabrication and compared with caproic acid, a non-hydroxy hexanoic acid. The chitosan nanoparticulate systems were characterized for mean particle size, particle size distribution, and zeta potential. The pentahydroxy hexanoic acid decreased the zeta potential to a significantly lower value than those obtained from both plain citrate and citrate–hexanoic acid formulations. The relatively lower value implies that gluconate ions are partly attached to the nanoparticle’s surface and mask its positively charged groups. It was also noted that the in vitro percutaneous permeation flux of lidocaine significantly decreased when gluconate-containing chitosan nanoparticles were applied, i.e., 6.1 ± 1.5 μg‧cm⁻²‧h⁻¹ without gluconic acid to 3.4 ± 2.3 μg‧cm⁻²‧h⁻¹ with gluconic acid. According to this result, it is suggested that gluconate ions played a role in retarding drug permeation through the skin, probably by calcium chelation in the stratum granulosum, which in turn stimulated lamellar body secretion, lipid synthesis, and intracellular release of Ca²⁺ from the endoplasmic reticulum. Full article

(This article belongs to the Special Issue Drug Delivery of Natural Active Principles: Focus on Topical and Oral Applications, 2nd Edition)

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8 pages, 666 KiB

Open AccessCommunication

Mesoporous Silica as an Alternative Vehicle to Overcome Solubility Limitations

by Tim Becker, Jan Heitkötter, Anna K. Krome, Andrea Schiefer, Kenneth Pfarr, Alexandra Ehrens, Miriam Grosse, Birthe Sandargo, Ingo Stammberger, Marc Stadler, Marc P. Hübner, Stefan Kehraus, Achim Hoerauf and Karl G. Wagner

Pharmaceutics 2024, 16(3), 386; https://doi.org/10.3390/pharmaceutics16030386 - 12 Mar 2024

Cited by 1 | Viewed by 2488

Abstract

Toxicological studies are a part of the drug development process and the preclinical stages, for which suitable vehicles ensuring easy and safe administration are crucial. However, poor aqueous solubility of drugs complicates vehicle screening for oral administration since non-aqueous solvents are often not tolerable. In the case of the anti-infective corallopyronin A, currently undergoing preclinical investigation for filarial nematode and bacterial infections, commonly used vehicles such as polyethylene glycol 200, aqueous solutions combined with cosolvents or solubilizers, or aqueous suspension have failed due to insufficient tolerability, solubility, or the generation of a non-homogeneous suspension. To this end, the aim of the study was to establish an alternative approach which offers suitable tolerability, dissolution, and ease of handling. Thus, a corallopyronin A-mesoporous silica formulation was successfully processed and tested in a seven-day toxicology study focused on Beagle dogs, including a toxicokinetic investigation on day one. Sufficient tolerability was confirmed by the vehicle control group. The vehicle enabled high-dose levels resulting in a low-, middle-, and high-dose of 150, 450, and 750 mg/kg. Overall, it was possible to achieve high plasma concentrations and exposures, leading to a valuable outcome of the toxicology study and establishing mesoporous silica as a valuable contender for challenging drug candidates. Full article

(This article belongs to the Special Issue Drug Delivery of Natural Active Principles: Focus on Topical and Oral Applications, 2nd Edition)

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18 pages, 3684 KiB

Open AccessArticle

Preparation of trans-Crocetin with High Solubility, Stability, and Oral Bioavailability by Incorporation into Three Types of Cyclodextrins

by Nan Liu, Jie Xiao, Ling-He Zang, Peng Quan and Dong-Chun Liu

Pharmaceutics 2023, 15(12), 2790; https://doi.org/10.3390/pharmaceutics15122790 - 16 Dec 2023

Cited by 3 | Viewed by 2336

Abstract

Crocetin (CRT), an active compound isolated from saffron, exhibits several pharmacological activities, including anti-tumor and immune-regulatory activities, and is effective against myocardial ischemia and coronary heart disease; however, its low stability and solubility limit its clinical application. Therefore, we investigated CRT inclusion complexes (ICs) with three cyclodextrins—α-CD, HP-β-CD, and γ-CD—suitable for oral administration prepared using an ultrasonic method. Fourier transform infrared spectroscopy and powder X-ray diffraction indicated that the crystalline state of CRT in ICs disappeared, and intermolecular interactions were observed between CRT and CDs. ¹H nuclear magnetic resonance and phase solubility studies confirmed CRT encapsulation in the CD cavity and the formation of ICs. In addition, we observed the morphology of ICs using scanning electron microscopy. All ICs showed a high drug encapsulation efficiency (approximately 90%) with 6500–10,000 times better solubilities than those of the pure drug. CRT showed rapid dissolution, whereas pure CRT was water-insoluble. The formation of ICs significantly improved the storage stability of CRT under heat, light, and moisture conditions. Further, the peak time of CRT in rats significantly decreased, and the relative bioavailability increased by approximately 3–4 times. In addition, the oral bioavailability of CRT IC was evaluated. Notably, the absorption rate and degree of the drug in rats were improved. This study illustrated the potential applications of CRT/CD ICs in the food, healthcare, and pharmaceutical industries, owing to their favorable dissolution, solubility, stability, and oral bioavailability. Full article

(This article belongs to the Special Issue Drug Delivery of Natural Active Principles: Focus on Topical and Oral Applications, 2nd Edition)

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Review

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23 pages, 1742 KiB

Open AccessReview

Terpenes and Essential Oils in Pharmaceutics: Applications as Therapeutic Agents and Penetration Enhancers with Advanced Delivery Systems for Improved Stability and Bioavailability

by Greta Kaspute, Tatjana Ivaskiene, Arunas Ramanavicius, Simonas Ramanavicius and Urte Prentice

Pharmaceutics 2025, 17(6), 793; https://doi.org/10.3390/pharmaceutics17060793 - 18 Jun 2025

Cited by 1 | Viewed by 741

Abstract

This review examines the pharmaceutical applications of essential oils (EOs) and terpenes, highlighting their dual role as therapeutic agents and natural penetration enhancers. These volatile, hydrophobic compounds have well-documented antimicrobial, antioxidant, and anti-inflammatory properties. However, their clinical potential is limited by poor water solubility, high volatility, and sensitivity to environmental factors, including light, heat, and oxygen. To address these challenges, various advanced delivery systems have been developed to enhance stability, bioavailability, and controlled release. These systems not only protect chemical integrity but also exploit these compounds’ abilities to interact with lipid membranes, facilitating the transport of active compounds across biological barriers. Additionally, their inherent antimicrobial properties can contribute to the overall stability of formulations. The review critically examines the incorporation of terpenes and major essential oil (EO) components, such as limonene, linalool, eugenol, α-pinene, and menthol, into delivery systems, assessing their performance in enhancing drug permeability and targeting specific tissues. Current challenges and future directions in terpenes and EO-based delivery strategies are discussed, highlighting their promising role in developing multifunctional and efficient pharmaceutical formulations. Full article

(This article belongs to the Special Issue Drug Delivery of Natural Active Principles: Focus on Topical and Oral Applications, 2nd Edition)

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