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Burst-Free Sustained Release of Proteins from Thermal Gelling Polymer Solutions
Topical Ocular Drug Delivery: The Impact of Permeation Enhancers
PROTAC Delivery Strategies for Overcoming Physicochemical Properties and Physiological Barriers in Targeted Protein Degradation

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 14.9 days after submission; acceptance to publication is undertaken in 3.3 days (median values for papers published in this journal in the first half of 2025).
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.
Journal Clusters-Pharmaceutical Science: Scientia Pharmaceutica, Pharmaceuticals, Pharmaceutics, Pharmacy, Future Pharmacology, Pharmacoepidemiology, Drugs and Drug Candidates and Journal of Pharmaceutical and BioTech Industry.

Impact Factor: 5.5 (2024); 5-Year Impact Factor: 5.8 (2024)

Imprint Information Journal Flyer Open Access ISSN: 1999-4923

Latest Articles

22 pages, 5759 KiB

Open AccessArticle

Poloxamer-Based Biomaterial as a Pharmaceutical Strategy to Improve the Ivermectin Performance

by Belén Alejandra Mezzano, Maria Soledad Bueno, Valeria Cintia Fuertes, Marcela Raquel Longhi and Claudia Garnero

Pharmaceutics 2025, 17(9), 1101; https://doi.org/10.3390/pharmaceutics17091101 (registering DOI) - 23 Aug 2025

Background: Poloxamers are promising biomaterials for drug delivery applications due to their ability to enhance biopharmaceutical properties. Methods: This study focused on designing solid dispersions of ivermectin using poloxamer 407 by the fusion method and evaluating how variables of synthesis affect the polymer’s [...] Read more.

Background: Poloxamers are promising biomaterials for drug delivery applications due to their ability to enhance biopharmaceutical properties. Methods: This study focused on designing solid dispersions of ivermectin using poloxamer 407 by the fusion method and evaluating how variables of synthesis affect the polymer’s behavior and the resulting biopharmaceutical properties of ivermectin. Poloxamer 407 was selected based on a solubility test of preformulation studies. Initially, eight formulations were developed using different synthesis conditions, including polymer proportion, cooling gradient, and final process temperature. These were assessed by several characterization studies. Finally, saturation solubility dissolution profiles and in vitro drug release were also evaluated. Results: A combination of techniques confirmed the compatibility between poloxamer 407 and ivermectin in the solid dispersions. The rate of temperature in the cooling process of synthesis showed a significant impact on the polymer self-assembly, affecting their ability to entrap ivermectin. The optimized solid dispersion comprised ivermectin and poloxamer 407 in a 1:1 w/w ratio prepared by rapid cooling. This decrease in the crystallinity index and the nanometric size of particles of the solid dispersions could explain their ability to improve 1600-fold the aqueous solubility, as well as enhance the drug dissolution and in vitro drug release compared to pure ivermectin. Conclusions: Therefore, it follows that these poloxamer-based solid dispersions are promising alternatives to improve the bioavailability of ivermectin. Full article

(This article belongs to the Special Issue Biomaterials: Pharmaceutical Applications)

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20 pages, 2698 KiB

Open AccessArticle

Rapidly Dissolving Microneedles Incorporating Lidocaine Hydrochloride: A PVP/PVA-Based Approach for Local Anesthesia

by Su Young Jin, Eugene Jae-Jin Park, Sae Min Kwon, Hyoung-Seok Jung and Dong Wuk Kim

Pharmaceutics 2025, 17(9), 1100; https://doi.org/10.3390/pharmaceutics17091100 (registering DOI) - 23 Aug 2025

Background/Objectives: Lidocaine is a widely used local anesthetic, but injections and topical creams are often painful or slow in onset. This study aimed to develop dissolving microneedles incorporating lidocaine hydrochloride for rapid and convenient local anesthesia. Methods: Six formulations were prepared with polyvinylpyrrolidone [...] Read more.

Background/Objectives: Lidocaine is a widely used local anesthetic, but injections and topical creams are often painful or slow in onset. This study aimed to develop dissolving microneedles incorporating lidocaine hydrochloride for rapid and convenient local anesthesia. Methods: Six formulations were prepared with polyvinylpyrrolidone (PVP) and polyvinyl alcohol (PVA) and evaluated for mechanical strength, skin insertion, drug release, and transdermal permeability. Results: Sharp pyramidal microneedles were successfully fabricated, with PVP–PVA mixtures producing stronger needles than single polymers. The optimized F5 formulation showed high strength (>32 N), efficient skin insertion (four parafilm layers), and rapid release (>80% within 15 min). In ex vivo studies, F5 delivered >600 µg/mL lidocaine in 15 min, over three times the therapeutic level and much faster than Emla cream (5%). Conclusions: PVP–PVA microneedles represent a promising platform for painless, rapid local anesthesia, combining the benefits of injections and topical creams while minimizing their drawbacks. Full article

(This article belongs to the Special Issue Dosage Forms in Drug Delivery: State of the Art and Future Perspectives)

32 pages, 1944 KiB

Open AccessReview

Methods of Thermal Analysis as Fast and Reliable Tools for Identification and Quantification of Active Ingredients in Commercially Available Drug Products

by Marek Wesolowski

Pharmaceutics 2025, 17(9), 1099; https://doi.org/10.3390/pharmaceutics17091099 (registering DOI) - 23 Aug 2025

Background/Objectives: Drug products on the pharmaceutical market must meet a number of requirements that guarantee their quality, safety, and efficacy. Accordingly, periodic inspection of the content of active pharmaceutical ingredients (APIs) in marketed drug products is carried out, confirming that they meet [...] Read more.

Background/Objectives: Drug products on the pharmaceutical market must meet a number of requirements that guarantee their quality, safety, and efficacy. Accordingly, periodic inspection of the content of active pharmaceutical ingredients (APIs) in marketed drug products is carried out, confirming that they meet all quality and quantity requirements for a given drug formulation before the expiration date. Therefore, the purpose of this study was to evaluate the suitability of the most commonly used thermal analysis methods, differential thermal analysis (DTA), differential scanning calorimetry (DSC), and thermogravimetric analysis (TGA), in the control of the composition of commercially available drug products. Results: Based on a review of the literature, it was shown that thermal methods can be useful in distinguishing drug products from different manufacturers, which guarantees their usefulness in quality control of finished drug products and detecting drug products from illegal manufacturers. They are also useful as tools for confirming the presence of APIs in dosage forms under investigation. The cited literature also indicates that DSC and TGA methods can be used in the quantification of APIs in marketed drug products and to detect non-compliant drug products. The use of chemometric techniques to interpret thermal data can eliminate the adverse effects of excipients on quantification results. Conclusions: Thermal methods are a good complement to chromatographic and spectroscopic methods, with the particular advantages of not needing any sample pretreatment, low sample weight, and short analysis time. Full article

(This article belongs to the Section Pharmaceutical Technology, Manufacturing and Devices)

26 pages, 925 KiB

Open AccessReview

Comparative Pharmacological and Pharmaceutical Perspectives on Antidiabetic Therapies in Humans, Dogs, and Cats

by Iljin Kim and Jang-Hyuk Yun

Pharmaceutics 2025, 17(9), 1098; https://doi.org/10.3390/pharmaceutics17091098 (registering DOI) - 23 Aug 2025

Background/Objectives: Diabetes mellitus (DM) is an increasingly prevalent endocrine disorder affecting humans and companion animals. Type 1 DM (T1DM) and type 2 DM (T2DM) are well characterized in humans, and canine DM most often resembles T1DM, marked by insulin dependence and β-cell destruction. [...] Read more.

Background/Objectives: Diabetes mellitus (DM) is an increasingly prevalent endocrine disorder affecting humans and companion animals. Type 1 DM (T1DM) and type 2 DM (T2DM) are well characterized in humans, and canine DM most often resembles T1DM, marked by insulin dependence and β-cell destruction. Conversely, feline DM shares key features with human T2DM, including insulin resistance, obesity-related inflammation, and islet amyloidosis. This review provides a comprehensive comparative analysis of antidiabetic therapies in humans, dogs, and cats, focusing on three core areas: disease pathophysiology, pharmacological and delivery strategies, and translational implications. In human medicine, a wide array of insulin analogs, oral hypoglycemic agents, and incretin-based therapies, including glucagon-like peptide-1 receptor agonists (liraglutide) and sodium-glucose cotransporter-2 inhibitors (empagliflozin), are available. Veterinary treatments remain limited to species-adapted insulin formulations and off-label use of human drugs. Interspecies differences in gastrointestinal physiology, drug metabolism, and behavioral compliance influence therapeutic efficacy and pharmacokinetics. Recent innovations, such as microneedle patches for insulin delivery and continuous glucose monitoring systems, show promise in humans and animals. Companion animals with naturally occurring diabetes serve as valuable models for preclinical testing of novel delivery platforms and long-acting formulations under real-world settings. While these technologies show potential, challenges remain in regulatory approval and behavioral adaptation in animals. Conclusions: Future research should prioritize pharmacokinetic bridging studies, veterinary-specific formulation trials, and device validation in animal models. By highlighting shared and species-specific characteristics of DM pathogenesis and treatment, this review advocates a One Health approach toward optimized antidiabetic therapies that benefit human and veterinary medicine. Full article

(This article belongs to the Section Clinical Pharmaceutics)

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19 pages, 1636 KiB

Open AccessArticle

Assessment of Purple Loosestrife (Lythrum salicaria L.) Extracts from Wild Flora of Transylvania: Phenolic Profile, Antioxidant Activity, In Vivo Toxicity, and Gene Expression Variegation Studies

by Lidia-Ioana Virchea, Cecilia Georgescu, Endre Máthé, Adina Frum, Monica Mironescu, Bence Pecsenye, Robert Nagy, Oana Danci, Maria-Lucia Mureșan, Maria Totan and Felicia-Gabriela Gligor

Pharmaceutics 2025, 17(9), 1097; https://doi.org/10.3390/pharmaceutics17091097 - 22 Aug 2025

Background: Purple loosestrife (Lythrum salicaria L.) is a medicinal plant native to the spontaneous Romanian flora. The aim of this study was to investigate the phenolic profile, total phenolic content (TPC), and antioxidant capacity (AC) of two L. salicaria L. extracts, a [...] Read more.

Background: Purple loosestrife (Lythrum salicaria L.) is a medicinal plant native to the spontaneous Romanian flora. The aim of this study was to investigate the phenolic profile, total phenolic content (TPC), and antioxidant capacity (AC) of two L. salicaria L. extracts, a hydro-methanolic extract (LSmet-1) and a hydro-ethanolic extract (LSeth-2), and their putative toxicity, as well as the effect on eye pigment content in the case of Drosophila melanogaster of an extract derived from LSmet-1 (LSmet-3). To the best of our knowledge, this is the first study to evaluate the influence of L. salicaria L. extracts on cytotoxicity and the expression of genes as determined by eye pigment levels, using a D. melanogaster-based model system. Methods: High-performance liquid chromatography was carried out to investigate the chemical composition of the extracts. Spectrophotometric methods were used to estimate their TPC and AC. Cytotoxicity was evaluated using an in vivo D. melanogaster diet-dependent viability assay and eye pigments of w^m4h males, suitable for position-effect variegation studies, which were quantified by a spectrophotometric method. Results: The results indicated that the main phenolic compounds were gallic acid, resveratrol, and rutin in LSmet-1, whereas in LSeth-2, gallic acid and quercetin were the most relevant. LSmet-1 had a higher TPC compared to LSeth-2. Both extracts exhibited notable efficacy in the applied in vitro antioxidant tests. The viability of flies on normal media increased in a concentration-dependent manner at lower concentrations, with the extract being toxic at higher concentrations. On a high-sugar diet, even lower concentrations were toxic. All tested concentrations influenced the eye pigment content. Conclusions: Our study brings new findings on L. salicaria L. extracts, suggesting the need for further investigation before introducing them in therapy. Full article

(This article belongs to the Special Issue Natural Compounds in Drug Delivery Systems)

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16 pages, 1336 KiB

Open AccessArticle

Impact of Different Drying Processes on the Physico-Chemical Properties of Liquitablet Formulations Containing Lornoxicam

by Csilla Balla-Bartos, Alaa Gamiel, Anett Motzwickler-Németh and Rita Ambrus

Pharmaceutics 2025, 17(9), 1096; https://doi.org/10.3390/pharmaceutics17091096 - 22 Aug 2025

Background: Enhancing bioavailability is the target of most pharmaceutical research; this can be achieved by modifying the physico-chemical characteristics of poorly water-soluble drugs intended for oral administration using different techniques. The preparation of liquitablets by blister molding technique provides an opportunity to [...] Read more.

Background: Enhancing bioavailability is the target of most pharmaceutical research; this can be achieved by modifying the physico-chemical characteristics of poorly water-soluble drugs intended for oral administration using different techniques. The preparation of liquitablets by blister molding technique provides an opportunity to increase the bioavailability of the drug using an optimal combination of release-facilitating additives. Lornoxicam is an effective non-steroidal anti-inflammatory drug with low water solubility. This study aimed to formulate a novel lornoxicam-containing liquitablets. The effect of different drying techniques on the physico-chemical properties and in vitro dissolution of lornoxicam was investigated. The physical parameters of the tablets were also studied. Methods: The additives applied in the formulation included Tween^® 80, Polyvinylpyrrolidone (PVP K90), Avicel^® PH-102, and sodium bicarbonate. Vacuum-drying and freeze-drying were employed to produce liquitablets. The influence of various drying methods on crystallinity and intra- and interparticle phenomena was investigated. In Vitro dissolution tests were performed at pH 1.2, and a comparison was made between our products and commercial tablets using the pairwise similarity factor model (f2). Results: The liquitablets demonstrated high hydrophilicity and a lower crystallinity of the drug. Freeze-dried liquitablet showed improved dissolution compared to that of the pure drug or the vacuum-dried product. A similarity was observed between our freeze-dried product and the marketed fast-release tablets. Conclusions: This research demonstrates that preparation of liquitablet in combination with freeze-drying has a significantly positive effect in improving the in vitro dissolution rate of lornoxicam. Full article

(This article belongs to the Special Issue Advancements in Tablet Formulation and Technological Innovations in Pharmaceutical Manufacturing)

13 pages, 1103 KiB

Open AccessArticle

Prolonged Gel Delivery to Oral Cavity from a Silicone Tube: In Vivo Assessment

by Suhail Alghanem, Ewelina Dziurkowska, Mateusz Lampkowski, Iwona Ordyniec-Kwaśnica and Małgorzata Sznitowska

Pharmaceutics 2025, 17(9), 1095; https://doi.org/10.3390/pharmaceutics17091095 - 22 Aug 2025

Objectives: This study evaluated the comfort of using silicone tubes installed in the oral cavity as a reservoir for a hydrogel that allows for a slow delivery of the active substance acting locally or systemically. Methods: Perforated silicone tubes 8 cm [...] Read more.

Objectives: This study evaluated the comfort of using silicone tubes installed in the oral cavity as a reservoir for a hydrogel that allows for a slow delivery of the active substance acting locally or systemically. Methods: Perforated silicone tubes 8 cm long with two internal diameters were used: T1 (1.5 mm) and T2 (2.4 mm). The reservoirs were filled with hydrogel placebo formulations: carbomer 1.5% (C), hydroxyethylcellulose 4% (HEC), or hydroxypropylmethylcellulose (hypromellose) 3% (HPMC). Physical parameters of the gel were determined with a viscometer and a texture analyzer. During 4 h of application, the volunteers reported sensory perceptions, and the rate of gel erosion was evaluated. The results were correlated with the viscosity, rheology, and dissolution rate of the gels measured in vitro. Results: Volunteers reported only mild discomfort wearing the device, preferring smaller-sized tubes. The tubes were easy to apply and generally comfortable, with no reports of significant discomfort. Despite similar viscosity and rheology, the polymer type had a significant impact on erosion rate, both in vitro and in vivo. After 4 h of application in vivo, more than 90% of the carbomer gel remained in the tube, while in the case of less cohesive HPMC or HEC gels, this was about 50%. A statistically significant correlation was observed between the in vitro and in vivo mean erosion percentages for the HEC and HPMC gels. Conclusions: This study supports the use of silicone tubes as effective reservoir devices for prolonging the residence time of drug formulations in the oral cavity. Full article

(This article belongs to the Special Issue Development and Optimization of Buccal Films Formulations)

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16 pages, 3851 KiB

Open AccessArticle

Lysozyme Amyloid for Synthetic RNA Delivery

by Benjamin Beluzo, Maytham Ismail, Sergei Chuikov, Venkateshwar G. Keshamouni and Mathumai Kanapathipillai

Pharmaceutics 2025, 17(9), 1094; https://doi.org/10.3390/pharmaceutics17091094 - 22 Aug 2025

Background/Objectives: Lysozyme-based amyloid aggregates offer a promising platform for RNA delivery due to their stability, cationic nature, biocompatibility, and ability to form well-defined structures. In this study, we evaluated their potential as drug carriers, focusing on the delivery of polyinosinic–polycytidylic acid (Poly(I:C)), [...] Read more.

Background/Objectives: Lysozyme-based amyloid aggregates offer a promising platform for RNA delivery due to their stability, cationic nature, biocompatibility, and ability to form well-defined structures. In this study, we evaluated their potential as drug carriers, focusing on the delivery of polyinosinic–polycytidylic acid (Poly(I:C)), an immunostimulatory synthetic RNA. To validate RNA delivery capability and rule out the possibility that observed effects arose from the lysozyme–Poly(I:C) complex itself, small interfering RNA (siRNA) was also used to verify that the successful delivery of intact and functional RNA was the cause of the observed effects. Methods: The aggregates were characterized by particle size, zeta potential, morphology, and RNA encapsulation efficiency. Results: In vitro studies using RAW 264.7 macrophage-like cells demonstrated that Poly(I:C)-loaded aggregates improved RNA uptake and triggered significant immune activation without inducing toxicity. To further confirm the potential of lysozyme amyloids in RNA delivery, GFP siRNA-loaded aggregates were evaluated in A549-GFP cells. A notable decrease in GFP expression, confirmed through confocal microscopy and flow cytometry, confirmed successful intracellular delivery. Conclusions: These results highlight the potential of lysozyme amyloids as non-viral vectors for RNA delivery, with promising applications in immunotherapy. Full article

(This article belongs to the Special Issue Innovative Viral and Non-Viral Vectors for Drug Delivery, Vaccine Development, Therapeutic Applications and Diagnosis)

19 pages, 4767 KiB

Open AccessArticle

Efficacy of Phlomis crinita Extract-Loaded Nanostructured Formulation in Accelerating Wound Healing

by Tahsine Kosksi, Paola Bustos-Salgado, Arem Selmi, Marwa Rejeb, Nawres Debbabi, Lupe Carolina Espinoza, Lilian Sosa, Joaquim Suñer-Carbó, Mohamed Ali Lassoued, Leila Chekir-Ghedira and Ana Cristina Calpena

Pharmaceutics 2025, 17(9), 1093; https://doi.org/10.3390/pharmaceutics17091093 - 22 Aug 2025

Background/Objectives: Recent advancements in innovative drug delivery nanosystems have significantly impacted wound healing, particularly through the incorporation of natural products. This study aimed to develop and characterize a Phlomis crinita extract-loaded nanostructured formulation (PCE-NF) as a topical therapy for skin wounds. Methods [...] Read more.

Background/Objectives: Recent advancements in innovative drug delivery nanosystems have significantly impacted wound healing, particularly through the incorporation of natural products. This study aimed to develop and characterize a Phlomis crinita extract-loaded nanostructured formulation (PCE-NF) as a topical therapy for skin wounds. Methods: This study involved the incorporation of P. crinita extract in a nanoemulsion by the high-energy emulsification method. This formulation was subjected to physicochemical and biopharmaceutical characterization, and a physical stability study over 30 days. Biocompatibility, tolerability, and irritant effects were assessed, while the wound healing potential was evaluated using in vitro skin models of fibroblasts and keratinocytes. Results: PCE-NF showed a homogeneous appearance with nanometric-sized spherical droplets of 212.27 nm and Newtonian behavior. This formulation showed a sustained release of its majority component (luteonin 7-(6″-acetylglucoside)), which followed a hyperbolic kinetic while showing high permeation, through healthy human skin, with 22.01 µg after 27 h. There were no cytotoxic effects of PCE-NF with improvements in skin barrier function and hydration levels. The wound healing potential of PCE-NF at 3.125 µg/mL was evidenced by enhanced cell migration and accelerated wound closure in 3T3-L1 and HaCaT cells, with values of 94.24 and 92.41%, respectively. Conclusions: These results suggest that this formulation could be used as an effective wound healing treatment. Full article

(This article belongs to the Special Issue Advances in Drug Delivery Systems for the Treatment of Chronic Wound Healing)

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16 pages, 5759 KiB

Open AccessArticle

Mechanisms of Self-Assembly of Giant Unilamellar Vesicles in the Army Liposome Formulation (ALF) Family of Vaccine Adjuvants

by Calin Nicolescu, Essie Komla, Mangala Rao, Gary R. Matyas and Carl R. Alving

Pharmaceutics 2025, 17(9), 1092; https://doi.org/10.3390/pharmaceutics17091092 - 22 Aug 2025

Background/Objectives: Army Liposome Formulation with QS21 (ALFQ) is a vaccine adjuvant formulation consisting of liposomes that contain saturated zwitterionic and anionic phospholipids, 55 mol% cholesterol, and small molar amounts of monophosphoryl lipid A (MPLA) and QS21 saponin as adjuvants. A unique aspect of [...] Read more.

Background/Objectives: Army Liposome Formulation with QS21 (ALFQ) is a vaccine adjuvant formulation consisting of liposomes that contain saturated zwitterionic and anionic phospholipids, 55 mol% cholesterol, and small molar amounts of monophosphoryl lipid A (MPLA) and QS21 saponin as adjuvants. A unique aspect of ALFQ is that after addition of QS21 to nanoliposomes (<100 nm), the liposomes self-assemble through fusion to form giant (≥1000 nm) unilamellar vesicles (GUVs). The purpose of this study was to introduce and investigate new intermediate structures in the fusion process that we term tethered incomplete microspheres (TIMs), which were discovered by us incidentally as structures that were visible by phase contrast microscopy. Methods: Differential centrifugation; phase contrast microscopy; confocal microscopy of vesicles or TIMs which contain fluorescent chromophores linked to phospholipids or cholesterol; ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) analysis of lipid components of liposomes and TIMs; and dynamic light scattering were all used for the characterization of TIMS. Results and Conclusions: (A) Sizes of TIMs range from overall aggregated structural sizes of ~1 µm to mega sizes of ≥200 µm. (B) Stable TIM structures occur when a fusion process is stopped by depletion of a fusogenic lipid during an evolving fusing of a lipid bilayer membrane. (C) TIMs consist of long-term stable (>2 years), but also metastable, tightly aggregated tear-drop or spherical incomplete GUVs tethered to visible masses of underlying vesicles that are not individually visible. (D) The TIMs and GUVs all contain phospholipid and cholesterol (when present) as bulk lipids. (E) Lyophilized liposomes lacking QS21 saponin, but which still contain MPLA (ALF55lyo), also self-assemble to form GUVs and TIMs. (F) Cholesterol is a required component in nanoliposomes for generation of GUVs and TIMs by addition of QS21. (G) Cholesterol is not required for production of GUVs and TIMs in ALFlyo, but cholesterol greatly reduces and narrows the polydisperse vesicle distribution. Full article

(This article belongs to the Special Issue Advanced Liposomes for Drug Delivery, 2nd Edition)

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34 pages, 4867 KiB

Open AccessReview

Polymeric Nanoparticles for Targeted Lung Cancer Treatment: Review and Perspectives

by Devesh U. Kapoor, Sonam M. Gandhi, Sambhavi Swarn, Basant Lal, Bhupendra G. Prajapati, Supang Khondee, Supachoke Mangmool, Sudarshan Singh and Chuda Chittasupho

Pharmaceutics 2025, 17(9), 1091; https://doi.org/10.3390/pharmaceutics17091091 - 22 Aug 2025

Lung cancer remains a foremost cause of cancer-related impermanence globally, demanding innovative and effective therapeutic strategies. Polymeric nanoparticles (NPs) have turned up as a promising transport system for drugs due to their biodegradability, biocompatibility, and capability to provide controlled and targeted release of [...] Read more.

Lung cancer remains a foremost cause of cancer-related impermanence globally, demanding innovative and effective therapeutic strategies. Polymeric nanoparticles (NPs) have turned up as a promising transport system for drugs due to their biodegradability, biocompatibility, and capability to provide controlled and targeted release of therapeutic agents. This review offers a thorough examination of different polymeric NP platforms, such as chitosan, gelatin, alginate, poly (lactic acid), and polycaprolactone, highlighting their mechanisms, formulations, and applications in the treatment of lung cancer. These NPs facilitate the delivery of chemotherapeutic agents, gene therapies, and immune modulators, with enhanced bioavailability and reduced systemic toxicity. Additionally, advanced formulations such as ligand-conjugated, stimuli-responsive, and multifunctional NPs demonstrate improved tumor-specific accumulation and cellular uptake. The review also discusses quantum dots, magnetic and lipid-based NPs, and green-synthesized metallic polymeric hybrids, emphasizing their potential in theranostics and combination therapies. Preclinical studies show promising results, yet clinical translation faces challenges; for example, large-scale production, long-term toxicity, and regulatory hurdles. Overall, polymeric NPs represent a powerful platform for advancing personalized lung cancer therapy, with future prospects rooted in multifunctional, targeted, and patient-specific nanomedicine. Full article

(This article belongs to the Special Issue Nanoparticle-Mediated Targeted Drug Delivery Systems)

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27 pages, 27757 KiB

Open AccessArticle

Continuous Processing Strategies for Amorphous Solid Dispersions of Itraconazole: Impact of Polymer Selection and Manufacturing Techniques

by Madhuri M. Kshirsagar, Bandoo C. Chatale, Sathish Dyawanapelly, Lalitkumar K. Vora and Purnima D. Amin

Pharmaceutics 2025, 17(9), 1090; https://doi.org/10.3390/pharmaceutics17091090 - 22 Aug 2025

Background: The limited aqueous solubility of BCS Class II drugs, exemplified by itraconazole (ITR), continues to hinder their bioavailability and therapeutic performance following oral administration. The present study investigated the development of amorphous solid dispersions (ASDs) of ITR via continuous manufacturing technologies, [...] Read more.

Background: The limited aqueous solubility of BCS Class II drugs, exemplified by itraconazole (ITR), continues to hinder their bioavailability and therapeutic performance following oral administration. The present study investigated the development of amorphous solid dispersions (ASDs) of ITR via continuous manufacturing technologies, such as hot melt extrusion (HME) and spray drying (SD), to improve drug release. Methods: Polymer selection was guided by Hansen solubility parameter (HSP) analysis, film casting, and molecular modeling, leading to the identification of aminoalkyl methacrylate copolymer type A (Eudragit^® EPO), polyvinyl caprolactam–polyvinyl acetate–polyethylene glycol graft copolymer (Soluplus^®), and hypromellose acetate succinate HG (AQOAT^® AS-HG) as suitable carriers. ASDs were prepared at drug-to-polymer ratios of 1:1, 1:2, and 2:1. Comprehensive characterization was performed using ATR-FTIR, NMR, DSC, PXRD, SEM, PLM, and contact angle analysis. Results: HME demonstrated higher process efficiency, solvent-free operation, and superior dissolution enhancement compared to SD. Optimized HME-based ASDs were formulated into tablets. The ITR–Eudragit^® EPO formulation achieved 95.88% drug release within 2 h (Weibull model, R² > 0.99), while Soluplus^® and AQOAT^® AS-HG systems achieved complete release, best described by the Peppas–Sahlin model. Molecular modeling confirmed favorable drug–polymer interactions, correlating with the formation of stable complex and enhanced release performance. Conclusions: HME-based continuous manufacturing provides a scalable and robust strategy for improving the oral delivery of poorly water-soluble drugs. Integrating predictive modeling with experimental screening enables the rational design of ASD formulations with optimized dissolution behavior, offering potential for improved therapeutic outcomes in BCS Class II drug delivery. Full article

(This article belongs to the Special Issue Advances in Hot Melt Extrusion Technology)

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24 pages, 2946 KiB

Open AccessArticle

Comparative In Vitro Deposition Analysis of Formoterol, Glycopyrronium, and Tiotropium Delivered via Capsule-Based DPI

by Adam Sikora, Joanna Chałupka, Kinga Lewandowska, Paulina Drapińska and Michał Piotr Marszałł

Pharmaceutics 2025, 17(9), 1089; https://doi.org/10.3390/pharmaceutics17091089 - 22 Aug 2025

Dry powder inhalers (DPIs) are the mainstay in the treatment of obstructive pulmonary diseases. However, the performance of DPI formulations is highly dependent on the used inhaler device and the patient’s inspiratory effort. This study aimed to evaluate and compare the aerosolization behavior [...] Read more.

Dry powder inhalers (DPIs) are the mainstay in the treatment of obstructive pulmonary diseases. However, the performance of DPI formulations is highly dependent on the used inhaler device and the patient’s inspiratory effort. This study aimed to evaluate and compare the aerosolization behavior of three commercially available capsule-based DPI medications—formoterol (Foradil^®), glycopyrronium (Seebri^® Breezhaler), and tiotropium (Spiriva^®)—delivered using three different capsule-based inhalers (Aerolizer, Breezhaler, and Handihaler), under varying flow conditions. Methods: The aerodynamic performance of each formulation–inhaler combination was assessed using the Next-Generation Impactor (NGI) and Dosage Unit Sampling Apparatus (DUSA) methodology. Fine particle dose (FPD) and aerodynamic particle size distribution (APSD) were determined at fixed flow rates of 15, 30, 60, and 100 L/min, as well as at inhaler-specific flow rates corresponding to a 4 kPa pressure drop. Chromatographic quantification of active ingredients was performed using validated HPLC methods specific to each drug. Results: The FPD values increased consistently with higher flow rates across all tested formulations and inhalers. At a 4 kPa pressure drop, Aerolizer and Breezhaler achieved significantly higher FPDs compared to Handihaler. Notably, in some instances, non-dedicated inhalers produced greater respirable fractions than the originally intended devices. APSD profiles revealed that drug deposition shifted toward smaller NGI stages at higher inspiratory flows, supporting enhanced deep lung delivery potential under optimal conditions. Conclusions: Device resistance, capsule orientation, and piercing mechanics substantially influence drug aerosolization. Although non-dedicated inhalers may offer improved FPDs in vitro, clinical use should adhere to approved drug–device combinations, as these have been validated for efficacy and safety under real-world conditions. Full article

(This article belongs to the Special Issue Inhaled Advances: Emerging Trends in Pulmonary Drug Delivery)

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45 pages, 1496 KiB

Open AccessReview

Integrating Graphene Oxide and Mesenchymal Stem Cells in 3D-Printed Systems for Drug Delivery and Tissue Regeneration

by Igor Soares Gianini Grecca, Vitor Fernando Bordin Miola, Júlia Carolina Ferreira, Thiago Rissato Vinholo, Laira Mireli Dias da Silva, Paulo Gabriel Friedrich Totti, Silvia Helena Soares Gianini, Maricelma da Silva Soares de Souza, Juliana da Silva Soares de Souza, Adriano Cressoni Araújo, Elen Landgraf Guiguer, Caio Sérgio Galina Spilla, Marcelo Dib Bechara, Domingos Donizeti Roque, Eliana de Souza Bastos Mazuqueli Pereira and Karina Torres Pomini

Pharmaceutics 2025, 17(8), 1088; https://doi.org/10.3390/pharmaceutics17081088 - 21 Aug 2025

Mesenchymal stem cells (MSCs) represent a promising strategy in the field of regenerative medicine due to their multipotent differentiation capacity and immunomodulatory properties. The interaction of these cells with the extracellular matrix (ECM) and biomaterials, notably graphene oxide (GO), has proven decisive in [...] Read more.

Mesenchymal stem cells (MSCs) represent a promising strategy in the field of regenerative medicine due to their multipotent differentiation capacity and immunomodulatory properties. The interaction of these cells with the extracellular matrix (ECM) and biomaterials, notably graphene oxide (GO), has proven decisive in modulating cell behavior, with the potential to optimize tissue regeneration processes. This review was conducted using the MEDLINE, Scopus, and Cochrane databases, covering studies published between 2018 and 2025, from which seven studies met the inclusion criteria, with an emphasis on in vitro and in vivo investigations regarding the association between GO and MSCs. The main findings demonstrate that GO, particularly when conjugated with polymers such as poly(L-lactic acid) (PLLA), enhances cell adhesion, stimulates proliferation, and promotes the osteogenic differentiation of MSCs, in addition to positively modulating intracellular signaling pathways. However, significant gaps remain in understanding the mechanisms and safety of GO’s therapeutic use in association with MSCs. Therefore, this review reinforces the need for further studies to deepen the characterization of the bioactive properties of GO-MSCs, aiming to enable safer and more effective clinical applications. Full article

(This article belongs to the Special Issue Cutting-Edge 3D Printing Technology for Drug Delivery and Tissue Engineering)

35 pages, 2860 KiB

Open AccessReview

An Update on Novel Drug Delivery Systems for the Management of Glaucoma

by Harshilkumar S. Jani, Ketan Ranch, Radhika Pandya, Yashkumar Patel, Sai H. S. Boddu, Amit K. Tiwari, Shery Jacob and Haya Khader Ahmad Yasin

Pharmaceutics 2025, 17(8), 1087; https://doi.org/10.3390/pharmaceutics17081087 - 21 Aug 2025

Glaucoma is recognized as a chronic optic neuropathy marked by progressive optic nerve degeneration, loss of retinal ganglion cells (RGCs, the neurons responsible for transmitting visual information from the eye to the brain), disruptions in optic disc blood supply, and changes in glial [...] Read more.

Glaucoma is recognized as a chronic optic neuropathy marked by progressive optic nerve degeneration, loss of retinal ganglion cells (RGCs, the neurons responsible for transmitting visual information from the eye to the brain), disruptions in optic disc blood supply, and changes in glial cell activation. It ranks as the second most prevalent cause of irreversible visual impairment worldwide and is a resultant of increased intraocular pressure (IOP). Addressing this condition proves complex due to the inherent hindrances posed by ocular barriers, which curtail the entry of drugs into the eye. Diverse carriers such as inorganic nanoparticles, polymeric nanocarriers, hydrogels, and contact lens-based systems with distinct physical and chemical attributes are being studied for drug delivery. They have shown enhanced ocular drug bioavailability through higher penetration across ocular tissues, prolonged retention in the precorneal space, sustained drug release, and targeted delivery to specific tissues. These ingenious delivery systems can be deployed through various administration routes—intravitreal or periocular injections or systemic administration—enabling the drugs to reach affected areas, aiding in the regeneration of compromised optical nerves. This review presents a comprehensive exploration of contemporary strides in ocular delivery formulations pertaining to glaucoma. This encompasses an examination of various nanocarrier typologies, delivery routes, in vitro and in vivo effectiveness, clinical applicability, and a forward-looking perspective into potential future developments. Full article

(This article belongs to the Special Issue Novel Approaches to Drug Delivery in Ophthalmic Disorders)

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39 pages, 2665 KiB

Open AccessReview

The Potential of Amphiphilic Cyclodextrins as Carriers for Therapeutic Purposes: A Short Overview

by Ramona Daniela Pârvănescu, Marius Păpurică, Ionica Oana Alexa, Cristina Adriana Dehelean, Codruța Șoica, Elena Alina Moacă, Adriana Ledeți, Mirela Voicu, Dorina Coricovac and Cristina Trandafirescu

Pharmaceutics 2025, 17(8), 1086; https://doi.org/10.3390/pharmaceutics17081086 - 21 Aug 2025

Cyclodextrins, since their discovery in the late 19th century, have gained tremendous interest in biomedical research, beginning with their recognition as safe pharmaceutical excipients, and continuing with exploiting their potential for enhancing the therapeutic response of active pharmaceutical ingredients, and also to be [...] Read more.

Cyclodextrins, since their discovery in the late 19th century, have gained tremendous interest in biomedical research, beginning with their recognition as safe pharmaceutical excipients, and continuing with exploiting their potential for enhancing the therapeutic response of active pharmaceutical ingredients, and also to be used as drugs for specific medical purposes. This review presents an integrative perspective on amphiphilic cyclodextrins, the manuscript being divided into two parts, one devoted to the properties of amphiphilic cyclodextrins, while the second one is dedicated to their biomedical applications, with an emphasis on cancer therapy. Full article

(This article belongs to the Special Issue Recent Insights Concerning the Use of Supramolecular Systems for Biomedical Applications)

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16 pages, 1525 KiB

Open AccessArticle

Physiologically Based Pharmacokinetic Modeling to Assess Perpetrator and Victim Cytochrome P450 2C Induction Risk

by Marina Slavsky, Aniruddha Sunil Karve and Niresh Hariparsad

Pharmaceutics 2025, 17(8), 1085; https://doi.org/10.3390/pharmaceutics17081085 - 21 Aug 2025

Background: Accurate assessment of CYP2C induction-mediated drug–drug interactions (DDIs) remains a challenge, despite the importance of CYP2C enzymes in drug metabolism. Limitations in available models and scarce clinical induction data have hampered quantitative preclinical DDI risk evaluation. Methods: In this study, the authors [...] Read more.

Background: Accurate assessment of CYP2C induction-mediated drug–drug interactions (DDIs) remains a challenge, despite the importance of CYP2C enzymes in drug metabolism. Limitations in available models and scarce clinical induction data have hampered quantitative preclinical DDI risk evaluation. Methods: In this study, the authors utilized an all-human hepatocyte triculture system to capture CYP2C induction using the perpetrators rifampicin, efavirenz, carbamazepine, and apalutamide. In vitro induction parameters were quantified by measuring changes in both mRNA and enzyme activities for CYP2C8, CYP2C9, and CYP2C19. These induction parameters, along with CYP-specific intrinsic clearance (CL_int) for the victim compounds, were incorporated into a physiologically based pharmacokinetic (PBPK) model, and pharmacokinetics (PK) of known CYP2C substrates were predicted with and without co-administration of perpetrator compounds using clinical dosing regimens. The results were quantitatively compared with the currently utilized mechanistic static modeling (MSM) approach and the reported clinical DDI outcomes. Results: By incorporating the measured f_m of CYP2C substrates into PBPK modeling, we observed a lower propensity to over- or underpredict the exposure of these substrates as victims of CYP2C induction-based DDIs when co-administered with known perpetrators, which resulted in an excellent correlation to observed clinical outcomes. The MSM approach predicted the CYP3A4 induction-based DDI risk accurately but could not capture CYP2C induction with similar precision. Conclusions: Overall, this is the first study that demonstrates the utility of PBPK modeling as a complementary approach to MSM for CYP2C induction-based DDI risk assessment. Full article

(This article belongs to the Special Issue Development of Physiologically Based Pharmacokinetic (PBPK) Modeling)

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25 pages, 3433 KiB

Open AccessArticle

Exploring miRNA Research in Colorectal Cancer: Insights from a Bibliometric Analysis

by Emanuele Piccinno, Michelangelo Aloisio, Viviana Scalavino, Francesco Russo, Gianluigi Giannelli, Davide Guido and Grazia Serino

Pharmaceutics 2025, 17(8), 1084; https://doi.org/10.3390/pharmaceutics17081084 - 21 Aug 2025

Background/Objectives: Despite advances in diagnosis and treatment, colorectal cancer (CRC) remains one of the most prevalent and challenging malignancies worldwide. The dysregulation of microRNAs (miRNAs) has emerged as a critical factor in CRC onset, progression, and therapeutic resistance. This study aims to [...] Read more.

Background/Objectives: Despite advances in diagnosis and treatment, colorectal cancer (CRC) remains one of the most prevalent and challenging malignancies worldwide. The dysregulation of microRNAs (miRNAs) has emerged as a critical factor in CRC onset, progression, and therapeutic resistance. This study aims to provide an overview of global research trends on miRNAs in CRC, (i) identifying the most studied miRNAs, (ii) exploring under-investigated areas, and (iii) highlighting emerging themes and potential future directions. Methods: To assess the evolution of the global miRNA–CRC research trends, we conducted a bibliometric analysis of 828 CRC–miRNA-focused articles published between 2008 and 2024, sourced from the Scopus database. Bibliometric mapping was performed using the R/Bibliometrix package and by leveraging a customized Python-based pipeline, which is useful for extracting and validating miRNA identifiers (miRNA IDs) based on the miRBase database. This miRNA ID-related approach enabled us to systematically identify the most frequently studied miRNAs over time while highlighting underexplored miRNA. Results: The analysis revealed a substantial and accelerating publication growth rate, delineating three major phases in CRC–miRNA research. China emerged as the leading contributor in terms of the publication volume. miR-21, miR-34a, and miR-195-5p were among the most frequently studied miRNAs, underscoring their relevance to CRC biology and therapy. Keyword and citation analyses identified key thematic areas, such as cell proliferation, epithelial–mesenchymal transition, and chemoresistance, especially to oxaliplatin and 5-fluorouracil. Emerging research frontiers included ferroptosis, ceRNA networks, and exosome-mediated miRNA transport. An analysis of the collaborations indicated strong intra-national collaborations, with room for expanding international research networks. Conclusions: This study provides an in-depth bibliometric landscape of the CRC-related miRNA research by highlighting influential studies and journals while identifying gaps and underexplored topics. These insights offer valuable guidance for future translational and clinical research on this topic. Full article

(This article belongs to the Special Issue Recent Advances in Gastrointestinal Disease: Insights into Drug Delivery and Cellular and Molecular Mechanisms for Therapy)

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4 pages, 152 KiB

Open AccessEditorial

From Data to Dose: Diversity in Therapeutic Drug Monitoring and Pharmacokinetics-Based Individualization of Drug Therapy

by Gellert Balazs Karvaly and Barna Vásárhelyi

Pharmaceutics 2025, 17(8), 1083; https://doi.org/10.3390/pharmaceutics17081083 - 21 Aug 2025

In the past few years, interest in therapeutic drug monitoring (TDM) and the pharmacokinetics-based individualization of drug therapy has gained increased impetus [...] Full article

(This article belongs to the Special Issue Therapeutic Drug Monitoring and Pharmacokinetics-Based Individualization of Drug Therapy, 2nd Edition)

15 pages, 1023 KiB

Open AccessReview

Stimuli-Responsive, Cell-Mediated Drug Delivery Systems: Engineering Smart Cellular Vehicles for Precision Therapeutics

by Samson Sitheni Mashele

Pharmaceutics 2025, 17(8), 1082; https://doi.org/10.3390/pharmaceutics17081082 - 21 Aug 2025

Stimuli-responsive, cell-mediated drug delivery systems represent a dynamic interface between biological functionality and engineered control. Leveraging the inherent targeting properties of erythrocytes, immune cells, stem cells, and exosomes, these systems offer a promising strategy for precise therapeutic delivery. In this review, we provide [...] Read more.

Stimuli-responsive, cell-mediated drug delivery systems represent a dynamic interface between biological functionality and engineered control. Leveraging the inherent targeting properties of erythrocytes, immune cells, stem cells, and exosomes, these systems offer a promising strategy for precise therapeutic delivery. In this review, we provide a comprehensive analysis of the design principles and biological underpinnings of stimuli-responsive carriers that release payloads in response to endogenous triggers (e.g., pH, redox, enzymatic activity) or external stimuli (e.g., light, ultrasound, magnetic fields). We further examine current strategies for loading and functionalizing cellular carriers, highlight key therapeutic applications across oncology and regenerative medicine, and assess translational progress and regulatory challenges. This review underscores the emerging clinical potential of intelligent cell-based delivery vehicles and outlines future directions for their optimization and implementation. Full article

(This article belongs to the Special Issue Cell-Mediated Delivery Systems)

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