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Evolution of Alzheimer’s Disease Therapeutics: From Conventional Drugs to Medicinal Plants, Immunotherapy, Microbiotherapy and Nanotherapy
Alginate Hydrogel Beads with a Leakproof Gold Shell for Ultrasound-Triggered Release
Exploring the Potential of Gold Nanoparticles in Proton Therapy: Mechanisms, Advances, and Clinical Horizons

Journal Description

Pharmaceutics

Pharmaceutics is a peer-reviewed, open access journal on the science and technology of pharmaceutics and biopharmaceutics, and is published monthly online by MDPI. The Spanish Society of Pharmaceutics and Pharmaceutical Technology (SEFIG), Pharmaceutical Solid State Research Cluster (PSSRC), Academy of Pharmaceutical Sciences (APS) and Korean Society of Pharmaceutical Sciences and Technology (KSPST) are affiliated with Pharmaceutics and their members receive a discount on the article processing charges.

Open Access— free for readers, with article processing charges (APC) paid by authors or their institutions.
High Visibility: indexed within Scopus, SCIE (Web of Science), PubMed, PMC, Embase, CAPlus / SciFinder, and other databases.
Journal Rank: JCR - Q1 (Pharmacology and Pharmacy) / CiteScore - Q1 (Pharmaceutical Science)
Rapid Publication: manuscripts are peer-reviewed and a first decision is provided to authors approximately 15.5 days after submission; acceptance to publication is undertaken in 2.9 days (median values for papers published in this journal in the second half of 2024).
Recognition of Reviewers: reviewers who provide timely, thorough peer-review reports receive vouchers entitling them to a discount on the APC of their next publication in any MDPI journal, in appreciation of the work done.
Companion journals for Pharmaceutics include: Future Pharmacology, Journal of Pharmaceutical and BioTech Industry and Medicines.

Impact Factor: 4.9 (2023); 5-Year Impact Factor: 5.5 (2023)

Imprint Information Journal Flyer Open Access ISSN: 1999-4923

Latest Articles

3 pages, 697 KiB

Open AccessCorrection

Correction: van den Born-Bondt et al. Development of an Adaptable Qualification Test Set for Personnel Involved in Visual Inspection Procedures of Parenteral Drug Products Manufactured Under Good Manufacturing Practice Conditions in Hospital Pharmacy Compounding Facilities. Pharmaceutics 2025, 17, 74

by Tessa van den Born-Bondt, Harmen P. S. Huizinga, Koen R. Kappert, Hans H. Westra, Jacoba van Zanten, Herman J. Woerdenbag, Jacoba M. Maurer and Bahez Gareb

Pharmaceutics 2025, 17(5), 564; https://doi.org/10.3390/pharmaceutics17050564 (registering DOI) - 25 Apr 2025

In the original publication [...] Full article

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13 pages, 842 KiB

Open AccessArticle

Membrane-Mediated Action of Phosphodiesterase 5 Inhibitors

by Anna I. Malykhina, Svetlana S. Efimova and Olga S. Ostroumova

Pharmaceutics 2025, 17(5), 563; https://doi.org/10.3390/pharmaceutics17050563 - 24 Apr 2025

Background/Objectives: Phosphodiesterase 5 (PDE5) inhibitors, sildenafil, vardenafil, and tadalafil, activate the cyclic guanosine monophosphate pathway resulting in vascular smooth muscle relaxation. They have been tested for a broad variety of conditions from cancer to Alzheimer’s disease with a positive impact. The known [...] Read more.

Background/Objectives: Phosphodiesterase 5 (PDE5) inhibitors, sildenafil, vardenafil, and tadalafil, activate the cyclic guanosine monophosphate pathway resulting in vascular smooth muscle relaxation. They have been tested for a broad variety of conditions from cancer to Alzheimer’s disease with a positive impact. The known mechanism of action of these drugs could not explain such a plethora of effects. We studied the influence of PDE5 inhibitors on lipid bilayers as a possible application point of their action. Methods: To monitor the membrane changes induced by PDE5 inhibitors, the differential scanning microcalorimetry and the molecular dynamics simulation were used. Results: We found that sildenafil, vardenafil, and tadalafil change elastic properties of model membranes: PDE5 inhibitors disorder thin membranes and order thick membranes. Moreover, PDE inhibitors were able to induce lipid interdigitation. To address the biological aspect of the findings, we performed molecular dynamics on smooth muscle cell’s lipid raft treated with PDE5 inhibitors and revealed the increased density of the lipids. Furthermore, we showed that the lipid condensation in the PDE inhibitors presence increases nitric oxide permeability. Conclusions: The obtained results may be of biological relevance as lipid raft thickening might have an impact on membrane protein function. Moreover, improved nitric oxide flow through membrane may partially explain therapeutic action of these drugs. The presented results are useful for finding novel implications for PDE inhibitors. Full article

(This article belongs to the Special Issue Recent Advances in Inhibitors for Targeted Therapies)

23 pages, 4258 KiB

Open AccessArticle

Box-Behnken Design Assisted Optimization and Characterization of Chitosan Film for Simultaneous Topical Delivery of Ascorbic Acid and Metronidazole

by Bilawal Khan, Pakorn Kraisit, Supaporn Santhan and Namon Hirun

Pharmaceutics 2025, 17(5), 562; https://doi.org/10.3390/pharmaceutics17050562 (registering DOI) - 24 Apr 2025

Background/Objectives: The objective of this study was to develop chitosan films plasticized with glycerol for the topical delivery of ascorbic acid and metronidazole. Methods: The films were prepared using a casting technique in which an aqueous ascorbic acid solution served as the solvent, [...] Read more.

Background/Objectives: The objective of this study was to develop chitosan films plasticized with glycerol for the topical delivery of ascorbic acid and metronidazole. Methods: The films were prepared using a casting technique in which an aqueous ascorbic acid solution served as the solvent, eliminating the need for additional mineral or organic acids. The influence of compositions on film characteristics—specifically mechanical properties and surface pH—was examined, and an optimized formulation was identified using a Box-Behnken design-response surface methodology. Relevant characterization techniques and in vitro evaluations were conducted to assess the properties and performance of the optimized film formulation. Results: Results showed that both glycerol and ascorbic acid contributed to the plasticization of the films. Fourier-transform infrared spectroscopic analysis of the optimized film revealed the formation of chitosan ascorbate and interactions between chitosan and glycerol. In addition, the thermogram and powder X-ray diffractogram demonstrated alterations in the thermal behavior and crystallinity of the embedded bioactive compounds. The developed film possessed the preferred swelling capacity. Moreover, in vitro release studies revealed a co-release pattern, delivering both bioactive compounds simultaneously. Conclusions: These findings suggest that the prepared chitosan-based film could serve as a promising platform for topical delivery. Full article

(This article belongs to the Special Issue Carbohydrate-Based Carriers for Drug Delivery, 2nd Edition)

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24 pages, 3847 KiB

Open AccessArticle

Silver Nanoparticles with Mebeverine in IBS Treatment: DFT Analysis, Spasmolytic, and Anti-Inflammatory Effects

by Mihaela Stoyanova, Miglena Milusheva, Vera Gledacheva, Mina Todorova, Nikoleta Kircheva, Silvia Angelova, Iliyana Stefanova, Mina Pencheva, Bela Vasileva, Kamelia Hristova-Panusheva, Natalia Krasteva, George Miloshev, Yulian Tumbarski, Milena Georgieva and Stoyanka Nikolova

Pharmaceutics 2025, 17(5), 561; https://doi.org/10.3390/pharmaceutics17050561 - 24 Apr 2025

Background/Objectives: Mebeverine hydrochloride (MBH) is an antispasmodic agent used to regulate bowel movements and relax intestinal smooth muscle, but its application is limited by specific side effects; therefore, this study investigates the effects of previously synthesized MBH-loaded silver nanoparticles (AgNPs) on smooth [...] Read more.

Background/Objectives: Mebeverine hydrochloride (MBH) is an antispasmodic agent used to regulate bowel movements and relax intestinal smooth muscle, but its application is limited by specific side effects; therefore, this study investigates the effects of previously synthesized MBH-loaded silver nanoparticles (AgNPs) on smooth muscle contractile activity and their anti-inflammatory potential as an alternative delivery system. Methods: The interactions of AgNPs with cholinergic inhibitors, selective antagonists, Ca²⁺ blockers, and key neurotransmitters were analyzed. In vitro, albumin denaturation suppression and ex vivo assays evaluated the anti-inflammatory effects of AgNPs-MBH, validated using a DFT in silico approach. To comprehensively assess the systemic impact and IBS treatment potential of AgNPs-MBH, we also examined in vitro their antimicrobial activity and hepatic cell responses, as the liver is a key organ in evaluating the overall safety and efficacy of nanoparticles. Additionally, the drug-release capabilities of Ag NPs were established. Results: Our findings indicate that AgNPs with MBH do not affect blocked cholinergic receptors, but their effects are more pronounced and distinct in amplitude and character than MBH. MBH-loaded AgNPs showed a lower anti-inflammatory effect than MBH but were still better than diclofenac. They also affected hepatic cell morphology and proliferation, suggesting potential for enhanced therapeutic efficacy. Drug-loaded AgNPs are considered not bactericidal. Conclusions: Based on our results, drug-loaded AgNPs might be a promising medication delivery system for MBH and a useful treatment option for IBS. Future in vivo and preclinical experiments will contribute to the establishment of drug-loaded AgNPs in IBS treatment. Full article

(This article belongs to the Special Issue Engineering and Characterisation of Novel Nanomedicine Formulations, 2nd Edition)

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11 pages, 9036 KiB

Open AccessArticle

Physiologically Based Pharmacokinetic Modeling of Biologic Case Studies in Monkeys and Humans Reveals the Necessity of an Additional Clearance Term

by Felix Stader, Pradeep Sharma, Weize Huang, Mary P. Choules, Marie-Emilie Willemin, Xinwen Zhang, Estelle Yau, Abdallah Derbalah, Adriana Zyla, Cong Liu and Armin Sepp

Pharmaceutics 2025, 17(5), 560; https://doi.org/10.3390/pharmaceutics17050560 - 24 Apr 2025

Background/Objectives: Physiologically based pharmacokinetic (PBPK) modeling is an important tool in biologic drug development. However, a standardized modeling strategy is currently missing. A cross-industry collaboration developed PBPK models for seven case studies, including monoclonal antibodies, antibody–drug conjugates, and bispecific T-cell engagers, to [...] Read more.

Background/Objectives: Physiologically based pharmacokinetic (PBPK) modeling is an important tool in biologic drug development. However, a standardized modeling strategy is currently missing. A cross-industry collaboration developed PBPK models for seven case studies, including monoclonal antibodies, antibody–drug conjugates, and bispecific T-cell engagers, to identify key parameters and establish a workflow to simulate biologic drugs in monkeys and in humans. Methods: PBPK models were developed in the monkey with limited data, including the molecular weight, the binding affinity to FcRn, and the additional systemic clearance of IgG, which is 20% of the total clearance. The binding affinity was only available for human FcRn and corrected for the known species-dependent differences in IgG binding. The strategy of monkey simulations was evaluated with an additional 14 studies published in the literature. Three different scenarios were simulated in humans afterwards: without, with allometrically scaled, and with optimized additional systemic clearance. Results: The plasma peak concentration and the area under the curve were predicted within 50% of the observed data for all studied case examples in the monkey, which demonstrates that sparse input parameters are sufficient for successful predictions in the monkey. Simulations in humans demonstrated the need for additional systemic clearance, because drug exposure was highly overpredicted without an additional systemic clearance term. Allometric scaling improved the predictions, but optimization led to the best fit, which is currently a limitation in the translation from animals to humans. Conclusions: This work highlights the importance of understanding the general mechanisms of drug uptake in different tissue types and cells in both target-dependent and -independent processes. Full article

(This article belongs to the Special Issue Advancing Biologic Drug Development Through Physiologically Based Pharmacokinetic Modelling and Simulations)

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24 pages, 1250 KiB

Open AccessReview

Breaking the Resistance: Photodynamic Therapy in Cancer Stem Cell-Driven Tumorigenesis

by Sheeja S. Rajan, J. P. Jose Merlin and Heidi Abrahamse

Pharmaceutics 2025, 17(5), 559; https://doi.org/10.3390/pharmaceutics17050559 - 24 Apr 2025

Cancer stem cells (CSCs) are essential for the growth of malignancies because they encourage resistance to cancer therapy and make metastasis and relapse easier. To effectively tackle the obstacles presented by CSCs, novel therapeutic approaches are required. Photodynamic therapy (PDT) is a promising [...] Read more.

Cancer stem cells (CSCs) are essential for the growth of malignancies because they encourage resistance to cancer therapy and make metastasis and relapse easier. To effectively tackle the obstacles presented by CSCs, novel therapeutic approaches are required. Photodynamic therapy (PDT) is a promising treatment option for cancer cells, which uses light-sensitive medications that are activated by light wavelengths. This review investigates the use of PDT to overcome malignancies driven by CSCs that have innate resistance mechanisms. PDT works by causing tumor cells to accumulate photosensitizers (PSs) selectively. The reactive oxygen species (ROS), which kill cells, are released by these PSs when they are stimulated by light. According to recent developments in PDT, its efficacy may go beyond traditional tumor cells, providing a viable remedy for the resistance shown by CSCs. Researchers want to improve the targeted elimination and selective targeting of CSCs by combining PDT with new PSs and customized delivery systems. Studies emphasize how PDT affects CSCs as well as bulk tumor cells. According to studies, PDT not only limits CSC growth but also modifies their microenvironment, which lowers the possibility of recovery. Additionally, studies are being conducted on the utilization of PDT and immunotherapeutic techniques to improve treatment efficacy and overcome inherent resistance of CSCs. In conclusion, PDT is a viable strategy for treating carcinogenesis driven by CSCs. By applying the most recent advancements in PDT technologies and recognizing how it interacts with CSCs, this treatment has the potential to surpass traditional resistance mechanisms and improve the future of cancer patients. Clinical and preclinical studies highlight that combining PDT with CSC-targeted approaches has the potential to overcome current therapy limitations. Future efforts should focus on clinical validation, optimizing light delivery and PS use, and developing effective combination strategies to target CSCs. Full article

(This article belongs to the Special Issue Innovative Applications of Nanotechnology and Photothermal Therapy in Cancer Treatment and Drug Delivery)

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28 pages, 626 KiB

Open AccessReview

Metformin-Based Combination Approaches for Triple-Negative Breast Cancer

by Zaid Sirhan, Aya Abu Nada, Nadeen Anabtawi, Anita Thyagarajan and Ravi P. Sahu

Pharmaceutics 2025, 17(5), 558; https://doi.org/10.3390/pharmaceutics17050558 - 24 Apr 2025

Numerous anti-diabetic medications, including metformin, have been explored for their anticancer effects because of the substantial correlation between diabetes and cancer incidence. Metformin has recently gained interest for its anticancer effects against malignancies such as breast cancer, one of the leading causes of [...] Read more.

Numerous anti-diabetic medications, including metformin, have been explored for their anticancer effects because of the substantial correlation between diabetes and cancer incidence. Metformin has recently gained interest for its anticancer effects against malignancies such as breast cancer, one of the leading causes of death among women worldwide. The cancer-related characteristics of cell proliferation, invasion, migration, and apoptosis are all targeted by metformin. Among breast cancer patients, triple-negative breast cancer (TNBC) is linked to an increased risk of early recurrence and metastases and has poor prognosis. In addition, TNBC has fewer treatment options compared to other breast cancer subtypes because it lacks hormone receptors and human epidermal growth factor receptor 2 (HER2), and it often develops resistance to available treatment options. The current review highlights the recent updates on the mechanistic insights and the efficacy of metformin and metformin-based approaches for the treatment of TNBC. We logically discuss the experimental evidence from the in vitro and in vivo studies exploring metformin’s effects on metabolic pathways, and then its combination with other therapeutic agents, targeting cell signaling pathways, and approaches to enhance metformin’s effects. We also present clinical studies that underscore the beneficial outcomes of metformin or its combination with other agents in TNBC patients. Full article

(This article belongs to the Special Issue Combination Therapy Approaches for Cancer Treatment)

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22 pages, 10571 KiB

Open AccessArticle

The Molecular Chaperone TCP1 Affects Carcinogenicity and Is a Potential Therapeutic Target for Acute Myeloid Leukemia

by Yong Wu, Guihui Tu, Yuxia Yuan, Jingwen Liu, Qingna Jiang, Yang Liu, Qiurong Wu, Lixian Wu and Yuanzhong Chen

Pharmaceutics 2025, 17(5), 557; https://doi.org/10.3390/pharmaceutics17050557 - 24 Apr 2025

Background/Objectives: Acute myeloid leukemia (AML) is an aggressive malignancy marked by high relapse rates and molecular heterogeneity, necessitating the identification of novel therapeutic targets. T-complex protein 1 (TCP1), a chaperonin implicated in protein folding, remains underexplored in AML pathogenesis. This study investigates the [...] Read more.

Background/Objectives: Acute myeloid leukemia (AML) is an aggressive malignancy marked by high relapse rates and molecular heterogeneity, necessitating the identification of novel therapeutic targets. T-complex protein 1 (TCP1), a chaperonin implicated in protein folding, remains underexplored in AML pathogenesis. This study investigates the functional role of TCP1 in AML progression and evaluates its therapeutic potential. Methods: Using successive generations of xenografted tumor models, we systematically assessed the correlation between TCP1 expression and AML tumorigenicity. Functional consequences of TCP1 silence were evaluated through in vitro proliferation assays and in vivo tumor growth monitoring. Two distinct inhibitory strategies were employed: miR-340-5p-mediated transcriptional silencing and FTY720-induced disruption of TCP1 chaperone activity. Mechanistic insights were derived from ubiquitin–proteasome pathway analysis, cell cycle profiling, and apoptosis assays. Results: High TCP1 expression correlated strongly with enhanced AML tumorigenicity. Knockdown of TCP1 significantly inhibited AML cell growth and induced degradation of AML1-ETO and PLK1 proteins through the ubiquitin–proteasome pathway. miR-340-5p effectively silenced TCP1 expression, exhibiting an inverse correlation with TCP1 levels. FTY720 disrupted TCP1′s chaperone function, leading to cell cycle arrest, apoptosis, and reduced xenograft tumor growth in murine models. Conclusion: Our findings establish TCP1 as a promising therapeutic target for AML. Both miR-340-5p and FTY720 demonstrate potent anti-leukemic effects by suppressing TCP1 activity, highlighting their potential as novel strategies to inhibit AML proliferation and improve therapeutic outcomes. Full article

(This article belongs to the Section Drug Targeting and Design)

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30 pages, 8835 KiB

Open AccessArticle

Colistin-Conjugated Selenium Nanoparticles: A Dual-Action Strategy Against Drug-Resistant Infections and Cancer

by Mais E. Ahmed, Kholoud K. Alzahrani, Nedal M. Fahmy, Hayfa Habes Almutairi, Zainab H. Almansour and Mir Waqas Alam

Pharmaceutics 2025, 17(5), 556; https://doi.org/10.3390/pharmaceutics17050556 - 24 Apr 2025

Background/Objective: Antimicrobial resistance (AMR) and therapy-resistant cancer cells represent major clinical challenges, necessitating the development of novel therapeutic strategies. This study explores the use of selenium nanoparticles (SeNPs) and colistin-conjugated selenium nanoparticles (Col-SeNPs) as a dual-function nanotherapeutic against multidrug-resistant Pseudomonas aeruginosa, [...] Read more.

Background/Objective: Antimicrobial resistance (AMR) and therapy-resistant cancer cells represent major clinical challenges, necessitating the development of novel therapeutic strategies. This study explores the use of selenium nanoparticles (SeNPs) and colistin-conjugated selenium nanoparticles (Col-SeNPs) as a dual-function nanotherapeutic against multidrug-resistant Pseudomonas aeruginosa, antifungal-drug-resistant Candida spp., and human breast carcinoma (MCF-7) cells. Methods: SeNPs were synthesized and characterized using UV-Vis spectroscopy, atomic force microscopy (AFM), energy-dispersive X-ray spectroscopy (EDX), X-ray diffraction (XRD), field emission scanning electron microscopy (FESEM), transmission electron microscopy (TEM), and Fourier-transform infrared spectroscopy (FTIR), confirming their nanoscale morphology, purity, and stability. Results: The antimicrobial activity of SeNPs and Col-SeNPs was assessed based on the minimum inhibitory concentration (MIC) and bacterial viability assays. Col-SeNPs exhibited enhanced antibacterial effects against P. aeruginosa, along with significant downregulation of the mexY efflux pump gene, which is associated with colistin resistance. Additionally, Col-SeNPs demonstrated superior antifungal activity against Candida albicans, C. glabrata, and C. krusei compared to SeNPs alone. The anticancer potential of Col-SeNPs was evaluated in MCF-7 cells using the MTT assay, revealing dose-dependent cytotoxicity through apoptosis and oxidative stress pathways. Although MCF-7 is not inherently drug-resistant, this model was used to explore the potential of Col-SeNPs in overcoming resistance mechanisms commonly encountered in cancer therapy. Conclusions: these findings support the promise of Col-SeNPs as a novel approach for addressing both antimicrobial resistance and cancer treatment challenges. Further in vivo studies, including pharmacokinetics and combination therapies, are warranted to advance clinical translation. Full article

(This article belongs to the Section Nanomedicine and Nanotechnology)

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25 pages, 2761 KiB

Open AccessReview

Transforming Pharmacogenomics and CRISPR Gene Editing with the Power of Artificial Intelligence for Precision Medicine

by Amit Kumar Srivastav, Manoj Kumar Mishra, James W. Lillard, Jr. and Rajesh Singh

Pharmaceutics 2025, 17(5), 555; https://doi.org/10.3390/pharmaceutics17050555 - 24 Apr 2025

Background: Advancements in pharmacogenomics, artificial intelligence (AI), and CRISPR gene-editing technology are revolutionizing precision medicine by enabling highly individualized therapeutic strategies. Artificial intelligence-driven computational techniques improve biomarker discovery and drug optimization while pharmacogenomics helps to identify genetic polymorphisms affecting medicine metabolism, efficacy, [...] Read more.

Background: Advancements in pharmacogenomics, artificial intelligence (AI), and CRISPR gene-editing technology are revolutionizing precision medicine by enabling highly individualized therapeutic strategies. Artificial intelligence-driven computational techniques improve biomarker discovery and drug optimization while pharmacogenomics helps to identify genetic polymorphisms affecting medicine metabolism, efficacy, and toxicity. Genetically editing based on CRISPR presents a precise method for changing gene expression and repairing damaging mutations. This review explores the convergence of these three fields to enhance improved precision medicine. Method: A methodical study of the current literature was performed on the effects of pharmacogenomics on drug response variability, artificial intelligence, and CRISPR in predictive modeling and gene-editing applications. Results: Driven by artificial intelligence, pharmacogenomics allows clinicians to classify patients and select the appropriate medications depending on their DNA profiles. This reduces the side effect risk and increases the therapeutic efficacy. Precision genetic modifications made feasible by CRISPR technology improve therapy outcomes in oncology, metabolic illnesses, neurological diseases, and other fields. The integration of artificial intelligence streamlines genome-editing applications, lowers off-target effects, and increases CRISPR specificity. Notwithstanding these advances, issues including computational biases, moral dilemmas, and legal constraints still arise. Conclusions: The synergy of artificial intelligence, pharmacogenomics, and CRISPR alters precision medicine by letting customized therapeutic interventions. Clinically translating, however, hinges on resolving data privacy concerns, assuring equitable access, and strengthening legal systems. Future research should focus on refining CRISPR gene-editing technologies, enhancing AI-driven pharmacogenomics, and developing moral guidelines for applying these tools in individualized medicine going forward. Full article

(This article belongs to the Section Gene and Cell Therapy)

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32 pages, 16024 KiB

Open AccessArticle

Modulating NPC1L1 to Potentiate PARP Inhibitor-Induced Ferroptosis and Immune Response in Triple-Negative Breast Cancer

by Ge Li, Yuxia Yuan, Xinhua Wu and Lixian Wu

Pharmaceutics 2025, 17(5), 554; https://doi.org/10.3390/pharmaceutics17050554 - 24 Apr 2025

Background/Objectives: Poly (ADP-ribose) polymerase (PARP) inhibitors have shown significant efficacy in treating BRCA-mutated cancers; however, a significant proportion of patients fail to respond. Emerging evidence highlights the role of PARP in lipid metabolism, suggest-ing its modulation as a novel strategy to regulate tumor [...] Read more.

Background/Objectives: Poly (ADP-ribose) polymerase (PARP) inhibitors have shown significant efficacy in treating BRCA-mutated cancers; however, a significant proportion of patients fail to respond. Emerging evidence highlights the role of PARP in lipid metabolism, suggest-ing its modulation as a novel strategy to regulate tumor progression. Methods: In this study, lipidomics and transcriptomics analyses were conducted to elucidate the mechanisms underlying PARP inhibitor-induced ferroptosis and immune modulation in triple-negative breast cancer (TNBC). Results: We demonstrated that the PARP inhibitor Niraparib significantly reprograms lipid metabolism in TNBC cells, marked by elevated phosphatidylethanolamine (PE) and cholesterol ester (ChE) levels. This metabolic shift was mechanistically linked to upregulation of the cholesterol transporter NPC1L1 via the PARP1-RELA-NPC1L1 signaling axis, which subsequently activated the AKT pathway. Combinatorial treatment with Niraparib and either Ezetimibe (an NPC1L1 inhibitor) or AZD5363 (an AKT inhibitor) synergistically enhanced TNBC cell death by promoting ferroptosis through glutathione depletion and lipid peroxidation. Furthermore, NPC1L1 inhibition amplified PARP inhibitor-induced immune responses, increasing CD8⁺ T cell infiltration and cytotoxicity in tumors. Conclusions: In conclusion, our findings establish NPC1L1 as a critical mediator of PARP inhibitor efficacy and propose dual targeting of lipid metabolism, providing a new therapeutic approach for the combination treatment of TNBC. Full article

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16 pages, 15162 KiB

Open AccessArticle

Facial Skin Density Enhancement Using Hyaluronic Acid—Based Bioactive Hydrogel: Cannula-Assisted Delivery and Ultrasound Evaluation in a Retrospective Controlled Study

by Lidia Majewska, Karolina Dorosz and Jacek Kijowski

Pharmaceutics 2025, 17(5), 553; https://doi.org/10.3390/pharmaceutics17050553 - 24 Apr 2025

Background: Hyaluronic acid (HA) – based bioactive hydrogels have emerged as multifunctional platforms for skin bioregeneration. While traditional mesotherapy using multicomponent substances has been widely practiced for improving skin quality, the time-consuming nature of this approach has led to exploration of alternative [...] Read more.

Background: Hyaluronic acid (HA) – based bioactive hydrogels have emerged as multifunctional platforms for skin bioregeneration. While traditional mesotherapy using multicomponent substances has been widely practiced for improving skin quality, the time-consuming nature of this approach has led to exploration of alternative delivery methods. Aims: This study evaluated the clinical effectiveness of an HA bioactive hydrogel-based bioregeneration system (containing non-stabilized hyaluronic acid and 14 bioactive ingredients) administered via cannula and its impact on facial skin density as assessed by ultrasound imaging. Methods: We conducted a retrospective review of data from 20 female patients aged 30–42 years who received a single cannula-delivered injection of a bioactive hyaluronic acid hydrogel (TEOSYAL^® Redensity [I]) in the midface region. The formulation combines the structural benefits of hyaluronic acid with the biochemical stimulation provided by amino acids, antioxidants, minerals, and vitamins. Skin density was measured using high-frequency ultrasound at baseline, immediately post-procedure, and at 3–4 weeks follow-up. A control group of seven individuals received no treatment. Results: Ultrasound assessments revealed a statistically significant increase in skin density (92.7%, p < 0.001) within the treated area compared to no significant changes in the control group. This substantial improvement in dermal architecture demonstrates the efficacy of bioactive hydrogels in stimulating fibroblast function and extracellular matrix regeneration. Patient satisfaction was high, with 85% of patients reporting being satisfied or very satisfied. Side effects were minimal, with minor bruising (10%) and transient swelling (15%). Conclusions: Cannula-delivered bioactive hyaluronic acid hydrogel effectively enhances facial skin density with high patient satisfaction and minimal downtime, demonstrating the potential of advanced hydrogel formulations as multifunctional therapeutic platforms that extend beyond traditional applications into aesthetic and regenerative dermatology. Full article

(This article belongs to the Special Issue Bioactive Hydrogels as Multifunctional Dressing Materials)

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19 pages, 11219 KiB

Open AccessArticle

The Development of Al¹⁸F-NOTA-FAP-2286 as an FAP-Targeted PET Tracer and the Translational Application in the Diagnosis of Acquired Drug Resistance in Progressive Prostate Cancer

by Xia Du, Yu Zhang, Yao Jia and Bo Gao

Pharmaceutics 2025, 17(5), 552; https://doi.org/10.3390/pharmaceutics17050552 - 23 Apr 2025

Objectives: Tumor heterogeneity and acquired resistance to prostate-specific membrane antigen (PSMA) radioligand therapy (PRLT) pose significant challenges to PSMA PET-based diagnosis. This study aimed to develop an Al¹⁸F-labeled FAP-targeted tracer and explore the diagnostic value in acquired drug-resistant tumor models. [...] Read more.

Objectives: Tumor heterogeneity and acquired resistance to prostate-specific membrane antigen (PSMA) radioligand therapy (PRLT) pose significant challenges to PSMA PET-based diagnosis. This study aimed to develop an Al¹⁸F-labeled FAP-targeted tracer and explore the diagnostic value in acquired drug-resistant tumor models. Methods: To identify potential targets for imaging drug-resistant prostate cancer, bioinformatic analysis was employed to correlate FAP expression levels with genes associated with tumor progression and radiotherapy resistance. Molecular docking technology simulations were utilized to screen FAP ligands for optimal binding affinity and target specificity. The most promising ligand, FAP-2286, was radiolabeled with ¹⁸F to develop a novel PET imaging agent, Al¹⁸F-NOTA-FAP-2286 PET. To evaluate the diagnostic potential of this agent, various tumor models were established. U87 cells were used to optimize the imaging protocol and assess targeting efficiency and 22RV-1-resistant cells co-xenografted with NIH-3T3 cells were used to model acquired drug-resistant prostate cancer. The diagnostic efficacy of Al¹⁸F-NOTA-FAP-2286 PET in this acquired drug-resistant model was assessed and validated through immunohistochemical staining of tumor tissue. Results: Bioinformatic analysis confirmed the association between FAP expression and key genes involved in radiotherapy resistance, such as HIF1α, BCL2, ATM, and EGFR. Molecular docking studies demonstrated the strong binding affinity of FAP-2286 to FAPα (−10 kcal/mol). Al¹⁸F-NOTA-FAP-2286 PET/CT imaging in U87 tumor-bearing mice revealed accurate targeting of high FAP-expressing xenografts. The imaging characteristics of Al¹⁸F-NOTA-FAP-2286 were comparable to ¹⁸F-FDG and ⁶⁸Ga-FAP-2286 but with a prolonged imaging window compared to ⁶⁸Ga-FAP-2286. In acquired drug-resistant prostate cancer xenograft nude mice, Al¹⁸F-NOTA-FAP-2286 could effectively detect tumor lesions, as confirmed by immunohistochemical analysis. Conclusions: Al¹⁸F-NOTA-FAP-2286, as a PSMA-independent imaging agent, holds promise as a valuable complementary molecular imaging tool for assessing acquired resistance to PRLT. Full article

(This article belongs to the Section Drug Targeting and Design)

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26 pages, 4052 KiB

Open AccessReview

Use of Computational Intelligence in Customizing Drug Release from 3D-Printed Products: A Comprehensive Review

by Fantahun Molla Kassa, Souha H. Youssef, Yunmei Song and Sanjay Garg

Pharmaceutics 2025, 17(5), 551; https://doi.org/10.3390/pharmaceutics17050551 - 23 Apr 2025

Computational intelligence (CI) mimics human intelligence by expanding the capabilities of machines in data analysis, pattern recognition, and making informed decisions. CI has shown promising contributions to advancements in drug discovery, formulation, and manufacturing. Its ability to analyze vast amounts of patient data [...] Read more.

Computational intelligence (CI) mimics human intelligence by expanding the capabilities of machines in data analysis, pattern recognition, and making informed decisions. CI has shown promising contributions to advancements in drug discovery, formulation, and manufacturing. Its ability to analyze vast amounts of patient data and optimize drug formulations by predicting pharmacokinetic and pharmacodynamic responses makes it a very useful platform for personalized medicine. The integration of CI with 3D printing further strengthens this potential, as 3D printing enables the fabrication of personalized medicines with precise doses, controlled-release profiles, and complex formulations. Furthermore, the automated and digital capabilities of 3D printing make it suitable for integration with CI. CI has proven useful in predicting material printability, optimizing drug release rates, designing complex structures, ensuring quality control, and improving manufacturing processes in 3D printing. In the context of customizing drug release from 3D-printed products, CI techniques have been applied to predict drug release from input variables and to design geometries that achieve the desired release profile. This review explores the role of CI in customizing drug release from 3D-printed formulations. It provides overview of limitations of 3D printing; how CI can overcome these challenges, and its potential in customizing drug release; a comparison of CI with other methods of optimization; and real-world examples of CI integration in 3D printing. Full article

(This article belongs to the Special Issue 3D Printing of Drug Delivery Systems)

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50 pages, 6313 KiB

Open AccessReview

A Review on the Stability Challenges of Advanced Biologic Therapeutics

by Sruthi Sarvepalli, Shashank Reddy Pasika, Vartika Verma, Anusha Thumma, Sandeep Bolla, Pavan Kumar Nukala, Arun Butreddy and Pradeep Kumar Bolla

Pharmaceutics 2025, 17(5), 550; https://doi.org/10.3390/pharmaceutics17050550 - 23 Apr 2025

Advanced biotherapeutic systems such as gene therapy, mRNA lipid nanoparticles, antibody–drug conjugates, fusion proteins, and cell therapy have proven to be promising platforms for delivering targeted biologic therapeutics. Preserving the intrinsic stability of these advanced therapeutics is essential to maintain their innate structure, [...] Read more.

Advanced biotherapeutic systems such as gene therapy, mRNA lipid nanoparticles, antibody–drug conjugates, fusion proteins, and cell therapy have proven to be promising platforms for delivering targeted biologic therapeutics. Preserving the intrinsic stability of these advanced therapeutics is essential to maintain their innate structure, functionality, and shelf life. Nevertheless, various challenges and obstacles arise during formulation development and throughout the storage period due to their complex nature and sensitivity to various stress factors. Key stability concerns include physical degradation and chemical instability due to various factors such as fluctuations in pH and temperature, which results in conformational and colloidal instabilities of the biologics, adversely affecting their quality and therapeutic efficacy. This review emphasizes key stability issues associated with these advanced biotherapeutic systems and approaches to identify and overcome them. In gene therapy, the brittleness of viral vectors and gene encapsulation limits their stability, requiring the use of stabilizers, excipients, and lyophilization. Keeping cells viable throughout the whole cell therapy process, from culture to final formulation, is still a major difficulty. In mRNA therapeutics, stabilization strategies such as the optimization of mRNA nucleotides and lipid compositions are used to address the instability of both the mRNA and lipid nanoparticles. Monoclonal antibodies are colloidally and conformationally unstable. Hence, buffers and stabilizers are useful to maintain stability. Although fusion proteins and monoclonal antibodies share structural similarities, they show a similar pattern of instability. Antibody–drug conjugates possess issues with conjugation and linker stability. This review outlines the stability issues associated with advanced biotherapeutics and provides insights into the approaches to address these challenges. Full article

(This article belongs to the Section Gene and Cell Therapy)

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26 pages, 13470 KiB

Open AccessArticle

Drug Combinations Targeting FAK and MEK Overcomes Tumor Heterogeneity in Glioblastoma

by Muhammad Furqan, Richard J. R. Elliott, Peter W. K. Nagle, John C. Dawson, Roza Masalmeh, Virginia Alvarez Garcia, Alison F. Munro, Camilla Drake, Gillian M. Morrison, Steven M. Pollard, Daniel Ebner, Valerie G. Brunton, Margaret C. Frame and Neil O. Carragher

Pharmaceutics 2025, 17(5), 549; https://doi.org/10.3390/pharmaceutics17050549 - 23 Apr 2025

Background/Objectives: Glioblastoma (GBM) is an aggressive brain tumor with limited treatment options and poor prognosis, largely owing to its heterogeneity and the involvement of multiple intracellular signaling pathways that contribute to drug resistance. While recent advancements in targeted drug combination therapies, such [...] Read more.

Background/Objectives: Glioblastoma (GBM) is an aggressive brain tumor with limited treatment options and poor prognosis, largely owing to its heterogeneity and the involvement of multiple intracellular signaling pathways that contribute to drug resistance. While recent advancements in targeted drug combination therapies, such as dabrafenib and trametinib, show promise for certain GBM subgroups, identifying effective drug combinations across the broader GBM population remains a challenge. Integrin-mediated signaling, particularly through Focal Adhesion Kinase (FAK), plays a pivotal role in GBM pathogenesis and invasion, making it a potential therapeutic target and component of future drug combination strategies. Methods: In this study, we utilized a chemogenomic screening approach to identify synergistic drug combinations that target FAK in glioblastoma. We initially employed a CRISPR-engineered GBM model to assess the effects of FAK depletion and subsequently discovered that combining FAK inhibitors such as VS4718 with MEK inhibitors, particularly trametinib, demonstrated synergistic effects. This potent combination was validated using various 2D and 3D assays, including cell viability/apoptosis assessment, synergistic analysis, cellular imaging, and target engagement assays. This combination also effectively inhibited spheroid growth and invasion across a diverse panel of patient-derived GBM stem cells. Molecular mechanisms underlying these effects include suppression of multiple kinase signaling pathways and enhanced apoptosis, elucidated using Reverse-Phase Protein Array (RPPA) profiling and Western blot validation. Result: In vivo, combination therapy significantly reduced the tumor volume in orthotopic transplantation models. Conclusions: These findings suggest that the combination of FAK and MEK inhibitors represents a promising therapeutic strategy to overcome the challenges of GBM treatment. Full article

(This article belongs to the Special Issue Combination Therapy Approaches for Cancer Treatment)

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14 pages, 1851 KiB

Open AccessArticle

The Natural Anthraquinone Parietin Inactivates Candida tropicalis Biofilm by Photodynamic Mechanisms

by Juliana Marioni, Bianca C. Romero, Ma. Laura Mugas, Florencia Martinez, Tomas I. Gómez, Jesús M. N. Morales, Brenda S. Konigheim, Claudio D. Borsarelli and Susana C. Nuñez-Montoya

Pharmaceutics 2025, 17(5), 548; https://doi.org/10.3390/pharmaceutics17050548 - 23 Apr 2025

Background/Objectives: Parietin (PTN), a blue-light absorbing pigment from Teloschistes spp. lichens, exhibit photosensitizing properties via Type I (superoxide anion, O₂^•−) and Type II (singlet oxygen, ¹O₂) mechanisms, inactivating bacteria in vitro after photoexcitation. We evaluate the [...] Read more.

Background/Objectives: Parietin (PTN), a blue-light absorbing pigment from Teloschistes spp. lichens, exhibit photosensitizing properties via Type I (superoxide anion, O₂^•−) and Type II (singlet oxygen, ¹O₂) mechanisms, inactivating bacteria in vitro after photoexcitation. We evaluate the in vitro antifungal activity of PTN against Candida tropicalis biofilms under actinic irradiation, its role in O₂^•− and ¹O₂ production, and the cellular stress response. Methods: Minimum inhibitory concentration (MIC) of PTN was determined in C. tropicalis NCPF 3111 under dark and actinic light conditions. Biofilm susceptibility was assessed at MIC/2, MIC, MICx2, MICx4, and MICx6 in the same conditions, and viability was measured by colony-forming units. Photodynamic mechanisms were examined using Tiron (O₂^•− scavenger) or sodium azide (¹O₂ quencher). O₂^•− production was measured by the nitro-blue tetrazolium (NBT) reduction and nitric oxide (NO) generation by Griess assay. Total antioxidant capacity was studied by FRAP (Ferrous Reduction Antioxidant Potency) assay and superoxide dismutase (SOD) activity by NBT assay. Results: Photoexcitation of PTN reduced C. tropicalis biofilm viability by four logs at MICx2. Sodium azide partially reversed the effect, whereas Tiron fully inhibited it, indicating the critical role of O₂^•−. PTN also increased O₂^•− and NO levels, enhancing SOD activity and FRAP. However, this antioxidant response was insufficient to prevent biofilm photoinactivation. Conclusions: Photoinactivation of C. tropicalis biofilms by PTN is primarily mediated by O₂^•−, with a minor contribution from ¹O₂ and an imbalance in NO levels. These findings suggest PTN is a promising photosensitizer for antifungal photodynamic therapy. Full article

(This article belongs to the Special Issue Natural Products in Photodynamic Therapy)

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18 pages, 267 KiB

Open AccessReview

Oral Lipid Nanoparticles for Improving the Efficiency of Drug Delivery Systems in Ulcerative Colitis: Recent Advances and Future Prospects

by Siyu Zhu, Zhenlin Yang, Yulong Liu, Lan Cheng, Dingpei Long and Fangyin Dai

Pharmaceutics 2025, 17(5), 547; https://doi.org/10.3390/pharmaceutics17050547 - 23 Apr 2025

Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by persistent, recurrent, and relapsing inflammation of the mucosal layer. Its pathogenesis is complex and not yet fully understood, with current treatments mainly focused on alleviating symptoms through pharmacological methods. Direct drug administration [...] Read more.

Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by persistent, recurrent, and relapsing inflammation of the mucosal layer. Its pathogenesis is complex and not yet fully understood, with current treatments mainly focused on alleviating symptoms through pharmacological methods. Direct drug administration for UC often leads to poor intestinal bioavailability, suboptimal targeting, and an increased risk of resistance. Therefore, there is an urgent need for effective drug delivery systems. Lipid nanoparticles (LNPs) are promising candidates for UC drug delivery due to their high biocompatibility, stability, and customizable properties. Oral administration, as a preferred treatment approach for UC, offers benefits such as convenience, cost-effectiveness, and better patient compliance. However, oral drug delivery systems must navigate the complex gastrointestinal tract to effectively target colonic lesions, posing significant challenges for LNP-based systems. Researchers are exploring ways to enhance oral delivery efficiency by adjusting LNP composition, surface functionalization, and coating. This article reviews recent advancements in oral LNP research aimed at improving drug delivery efficiency for UC treatment and discusses future prospects. Full article

(This article belongs to the Special Issue Advances in Oral Delivery of Lipid Nanoparticles for Treating Inflammatory Diseases)

17 pages, 5983 KiB

Open AccessArticle

Development of Herbal Mouthwash Powder Using a Self-Nanoemulsifying Drug Delivery System Containing Galangal Extract and Lemongrass Oil for Oral Candidiasis Treatment

by Premnapa Sisopa, Supaporn Lamlertthon, Ruchadaporn Kaomongkolgit, Pratthana Chomchalao and Waree Tiyaboonchai

Pharmaceutics 2025, 17(5), 546; https://doi.org/10.3390/pharmaceutics17050546 - 23 Apr 2025

Objective: This study aimed to develop and characterize the physicochemical properties of a self-emulsion drug delivery system (SNEDDS) incorporating galangal extract (GE) and lemongrass oil (LGO). Then, to develop mouthwash powders containing GE- and LGO-loaded SNEDDS (GL-mouthwash powder) as a promising alternative for [...] Read more.

Objective: This study aimed to develop and characterize the physicochemical properties of a self-emulsion drug delivery system (SNEDDS) incorporating galangal extract (GE) and lemongrass oil (LGO). Then, to develop mouthwash powders containing GE- and LGO-loaded SNEDDS (GL-mouthwash powder) as a promising alternative for preventing and treating denture stomatitis. Methods: The solubility of GE in various vehicles was determined. Subsequently, pseudo-ternary phase diagrams of the different ingredients, oil (LGO), surfactant (Tween^® 80), and co-surfactant (Propylene glycol) were selected to develop the SNEDDS. Then, SNEDDS containing GE and LGO (GL-SNEDDS) were prepared and characterized. The optimized liquid GL-SNEDDS was transformed into GL-mouthwash powder by absorbing onto mannitol and blending with a sweetener. Subsequently, various evaluations including drug recovery, moisture content, emulsification time, stability, anti-Candida activity, and in vitro cytotoxicity were performed. Results: The developed SNEDDS formulation improved GE and LGO solubility. The optimized GL-SNEDDS exhibited a small droplet size of 148.2 ± 2.1 nm with a polydispersity index of 0.11 ± 0.03 and a zeta potential of 2.14 ± 0.11 mV. In addition, the GL-mouthwash powder demonstrated a high drug recovery of >80% with a low moisture of <10% and exhibited greater physicochemical stability under accelerated conditions. The developed GL-mouthwash powder rapidly formed a stable nanoemulsion within 2 min after reconstitution. Interestingly, GL-mouthwash powder exhibited strong anti-Candida activity with no toxicity to human fibroblast cells, which demonstrated superior biocompatibility relative to existing commercial products. Conclusions: These findings suggest that GL-mouthwash powder has potential as an alternative prevention and treatment of oral Candida infection. Full article

(This article belongs to the Special Issue Development of New Nanotechnological Systems Loaded with Drugs for Infectious Disease Application)

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21 pages, 2272 KiB

Open AccessArticle

The Advancement of In Vitro Lipolysis: Two-Step Flow-Through Method for the Evaluation of Lipid-Based Drug Delivery Systems

by Katarina Rede, Mirjana Gašperlin, Marija Bogataj and Katarina Bolko Seljak

Pharmaceutics 2025, 17(5), 545; https://doi.org/10.3390/pharmaceutics17050545 - 23 Apr 2025

Objectives: A novel two-step flow-through in vitro lipolysis model was developed for the evaluation of drug release from a self-microemulsifying drug delivery system (SMEDDS). Methods: Firstly, the SMEDDS was dispersed in an acidic medium. Subsequently, the pH was increased, and a [...] Read more.

Objectives: A novel two-step flow-through in vitro lipolysis model was developed for the evaluation of drug release from a self-microemulsifying drug delivery system (SMEDDS). Methods: Firstly, the SMEDDS was dispersed in an acidic medium. Subsequently, the pH was increased, and a lipolytic reaction was immediately initiated, accompanied by medium flow onset. The latter enabled increase of the initial low pH of the medium, improving the physiological relevance of the method by simulating dosage form retainment in the stomach and transfer to the duodenum, which is very important for a weakly basic active pharmaceutical ingredient (API) incorporated in an SMEDDS. Results: Conversely to the traditional pH-stat in vitro lipolysis, the developed method is not established on titration, as the reaction vessel pH is regulated by a medium flow and buffer capacity. Individual parameters, such as pancreatin activity, buffer capacity, and medium shift, were researched using traditional pH-stat in vitro lipolysis prior to their implementation in the flow-through setup. Conclusions: The concentration of the solubilized model API, carvedilol, was increased as pancreatin activity decreased and as buffer capacity increased. The ratios between release profiles obtained under different conditions utilizing the pH-stat and novel two-step flow-through in vitro lipolysis were comparable; however, the differences were more pronounced in the flow-through method. Full article

(This article belongs to the Special Issue Advanced Materials Science and Technology in Drug Delivery)

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