Journals European Journal of Pharmaceut...

European Journal of Pharmaceutics and Biopharmaceutics
Mariia Nesterkina, Iryna Kravchenko, Anna K H Hirsch, Claus-Michael Lehr
Responsive and adaptive soft-matter systems represent an advanced category of materials with potential applications in drug delivery. Among these, liquid crystals (LCs) emerge as multifunctional anisotropic scaffolds capable of reacting to temperature, light, electric or magnetic fields. Specifically, the ordering and physical characteristics of thermotropic LCs are primarily contingent on temperature as an external stimulus. This comprehensive review aims to bridge a notable gap in the biomedical application of thermotropic mesogens by exclusively focusing on drug delivery...
May 25, 2024: European Journal of Pharmaceutics and Biopharmaceutics
Daniela Stadler, Constanze Helbig, Klaus Wuchner, Jürgen Frank, Klaus Richter, Andrea Hawe, Tim Menzen
Lentiviral vectors (LVVs) are used as a starting material to generate chimeric antigen receptor (CAR) T cells. Therefore, LVVs need to be carefully analyzed to ensure safety, quality, and potency of the final product. We evaluated orthogonal and complementary analytical techniques for their suitability to characterize particulate matter (impurities and LVVs) in pharmaceutical LVV materials at development stage derived from suspension and adherent manufacturing processes. Microfluidic resistive pulse sensing (MRPS) with additional manual data fitting enabled the assessment of mode diameters for particles in the expected LVV size range in material from adherent production...
May 24, 2024: European Journal of Pharmaceutics and Biopharmaceutics
Ambra Massei, Nunzia Falco, Davide Fissore
Over the past three decades, there was a remarkable growth in the approval of antibody-based biopharmaceutical products. These molecules are notably susceptible to the stresses occurring during drug manufacturing, often leading to structural alterations. A key concern is thus the ability to detect and comprehend these alterations caused by processes, such as aggregation, fragmentation, oxidation levels, as well as the change in protein concentration throughout the process steps, potentially resulting in out-of-spec products...
May 23, 2024: European Journal of Pharmaceutics and Biopharmaceutics
Sergey P Verevkin, Kseniya V Zherikova
The development of pharmaceutical formulations and the optimisation of drug synthesis are not possible without knowledge of thermodynamics. At the same time, the quantity and quality of the available data is not at a level that meets modern requirements. A convenient diagnostic approach is desirable to assess the quality of available experimental thermodynamic data of drugs. A comprehensive set of available data on phase transitions of profens family drugs was analysed using new complementary measurements and structure-property correlations...
May 23, 2024: European Journal of Pharmaceutics and Biopharmaceutics
Dorota Danielak, Maciej Gajda, Tomasz Bołtromiuk, Katarzyna Sulikowska, Bartłomiej Kubiak, Michał Romański
Mathematical models that treat the fed stomach content as a uniform entity emptied with a constant rate may not suffice to explain pharmacokinetic profiles recorded in clinical trials. In reality, phenomena such as the Magenstrasse or chyme areas of different pH and viscosity, play an important role in the intragastric drug dissolution and its transfer to the intestine. n this study, we investigated the data gathered in the bioequivalence trial between an immediate-release tablet (Reference) and an orally dispersible tablet (Test) with a poorly soluble weak base drug administered with or without water after a high-fat high-calorie breakfast...
May 23, 2024: European Journal of Pharmaceutics and Biopharmaceutics
Mohamed A M Kamal, Justine Bassil, Brigitta Loretz, Anna K H Hirsch, Sangeun Lee, Claus-Michael Lehr
Antimicrobial resistance is becoming more prominent day after day due to a number of mechanisms by microbes, especially the sophisticated biological barriers of bacteria, especially in Gram-negatives. There, the lipopolysaccharides (LPS) layer is a unique component of the outer leaflet of the outer membrane which is highly impermeable and prevents antibiotics from passing passively into the intracellular compartments. Biodynamers, a novel class of dynamically bio-responsive polymers, may open new perspectives to overcome this particular barrier by accommodating various secondary structures and form supramolecular structures in such bacterial microenvironments...
May 23, 2024: European Journal of Pharmaceutics and Biopharmaceutics
Dorota Pawlowska, Nicole Erdmann, Manuela Folz, Andreas Langner, Bodo Dobner, Christian Wölk, Gerald Brezesinski
Ionizable lipids are a class of pharmaceutical excipients with a main application in lipid nanoparticles for nucleic acid delivery. New ionizable lipids are needed to tune characteristics of lipid-based nucleic acid delivery systems, e.g. stability, nucleic acid loading capacity and binding strength, as well as bio-distribution. Herein, we present the synthesis of three novel ionizable lipids as putative excipients for lipid-based nucleic acid delivery systems. Langmuir monolayer experiments with classical surface pressure/area isotherm evaluation were used to understand the self-assembly behavior of the lipids...
May 22, 2024: European Journal of Pharmaceutics and Biopharmaceutics
Shu-Yin Liu, Hui Chen, Feng Zhou, Jian-Ping Zheng, Jian-Tao Zhang
Orodispersible films (ODFs) have emerged as an advanced and patient-friendly delivery system due to ease of administration, improved patient compliance, quick release and taste-masking of active pharmaceutical ingredients. This research reports the preparation of the ODF containing eugenol and borax (EB-ODF) by a solvent casting technique for treating mouth ulcers. The EB-ODF consisted of Kollidon® VA 64 and hydroxypropyl methylcellulose (HPMC-K250) as the film formers where eugenol and borax were loaded...
May 22, 2024: European Journal of Pharmaceutics and Biopharmaceutics
Sanjeevini Babu Reddiar, Mohammad Abdallah, Ian K Styles, Olivia O Müllertz, Natalie L Trevaskis
Peptides, despite their therapeutic potential, face challenges with undesirable pharmacokinetic (PK) properties and biodistribution, including poor oral absorption and cellular uptake, and short plasma elimination half-lives. Lipidation of peptides is a common strategy to improve their physicochemical and PK properties, making them viable drug candidates. For example, the plasma half-life of peptides has been extended via conjugation to lipids that are proposed to promote binding to serum albumin and thus protect against rapid clearance...
May 22, 2024: European Journal of Pharmaceutics and Biopharmaceutics
Lirong Nie, Ziwei Zheng, Ruiqi Chen, Shulong Liang, Pengkun Fu, Siqi Wu, Zhepeng Liu, Chao Wang
In this work, a novel erythrocyte-shaped electrospraying nanoparticle (EENP) was designed and constructed by tri-axial electrospraying technique with PEG as the outer layer, PLGA as the middle drugs (paclitaxel [PTX] and osimertinib [OSI]) carrier layer and air as the inner layer. The prepared EENP were characterized and evaluated based on their spectral and morphological attributes. After the PTX/OSI ratio and process optimization, the EENP has inspiring features, including nanoscale size, erythrocyte morphology with a concave disk shape, and satisfactory drug loading (DL) and encapsulation efficiency (EE)...
May 22, 2024: European Journal of Pharmaceutics and Biopharmaceutics
Xianzhi Liu, Luyan Shen, Lin Zhou, Wencheng Wu, Guang Liang, Yunjie Zhao, Wenqi Wu
Developing co-amorphous systems is an attractive strategy to improve the dissolution rate of poorly water-soluble drugs. Various co-formers have been investigated. However, previous studies revealed that it is a challenge to develop satisfied acidic co-formers, e.g., acidic amino acids showed much poorer co-former properties than neutral and basic amino acids. Only a few acidic co-formers have been reported, such as aspartic acid, glutamic acid, and some other organic acids. Thus, this study aims to explore the possibility of adenosine monophosphate and adenosine diphosphate used as acidic co-formers...
May 18, 2024: European Journal of Pharmaceutics and Biopharmaceutics
Rasha M Elkanayati, Alaa Y Darwesh, Iman Taha, Honghe Wang, Prateek Uttreja, Sateesh Kumar Vemula, Walter G Chambliss, Michael A Repka
The study endeavors the fabrication of extended-release adipic acid (APA) buccal films employing a quality by design (QbD) approach. The films intended for the treatment of xerostomia were developed utilizing hot-melt extrusion technology. The patient-centered quality target product profile was created, and the critical quality attributes were identified accordingly. Three early-stage formulation development trials, complemented by risk assessment aligned the formulation and process parameters with the product quality standards...
May 18, 2024: European Journal of Pharmaceutics and Biopharmaceutics
W Pula, R Ganugula, E Esposito, M N V Ravi Kumar, M Arora
Functional polymer-lipid hybrid nanoparticles (H-NPs) are a promising class of nanocarriers that combine the benefits of polymer and lipid nanoparticles, offering biocompatibility, structural stability, high loading capacity, and, most importantly, superior surface functionalization. Here, we report the synthesis and design of highly functional H-NPs with specificity toward the transferrin receptor (TfR), using a small molecule ligand, gambogic acid (GA). A fluorescence study revealed the molecular orientation of H-NPs, where the lipid-dense core is surrounded by a polymer exterior, functionalized with GA...
May 18, 2024: European Journal of Pharmaceutics and Biopharmaceutics
Sankha Bhattacharya, Amit Page, Prafull Shinde
Aggressive colon cancer treatment poses significant challenges. This study investigates the potential of innovative carbohydrate-based nanoparticles for targeted Capecitabine (CTB) delivery. CTB nanoparticles were synthesized by conjugating CTB with potato starch and chitosan using ultrasonication, hydrolysis, and ionotropic gelation. Characterization included drug loading, rheology, Surface-Enhanced Raman Spectroscopy (SERS), Fourier-Transform Infrared Spectroscopy (FTIR), Differential Scanning Calorimetry (DSC), X-ray Diffraction (XRD), and Thermogravimetric Analysis (TGA)...
May 17, 2024: European Journal of Pharmaceutics and Biopharmaceutics
Shu Li, Magdy M Abdelquader, Gavin P Andrews, David S Jones
Therapeutic deep eutectic solvents (THEDES) have been attracting increasing attention in the pharmaceutical literature as a promising enabling technology capable of improving physicochemical and biopharmaceutical properties for difficult-to-deliver drug compounds. The current literature has explored amide local anaesthetics and carboxylic acid nonsteroidal anti-inflammatories (NSAIDs) as commonly used THEDES formers for their active hydrogen-bonding functionality. However, little is known about what happens within the "deep eutectic" region where a range of binary compositions present simply as a liquid with no melting events detectable across experimentally achievable conditions...
May 16, 2024: European Journal of Pharmaceutics and Biopharmaceutics
Shuang-Shuang Zhang, Jia-Hui Yu, Si-Si Jiang, Lun Wang, Jiong Chen, Jiao Long, Shuang-Xi Gu, Hui Li
P-glycoprotein (P-gp) overexpressed mutidrug resistance (MDR) is currently a key factor limiting the effectiveness of breast cancer chemotherapy. Systemic administration based on P-gp-associated mechanism leads to severe toxic side effects. Here, we designed a T7 peptide-modified mixed liposome (T7-MLP@DTX/SchB) that, by active targeting co-delivering chemotherapeutic agents and P-gp inhibitors, harnessed synergistic effects to improve the treatment of MDR breast cancer. This study established drug-resistant cell models and animal models...
May 15, 2024: European Journal of Pharmaceutics and Biopharmaceutics
Maximilian Meudt, Julia Baumeister, Boris Mizaikoff, Sybille Ebert, Frank Rosenau, Michaela Blech, Fabian Higel
N-glycosylation in the Fc part is a (critical) quality attribute of therapeutic antibodies and Fc-containing biotherapeutics, that impacts their stability, immunogenicity, pharmacokinetics, and effector functions. Current glycosylation analysis methods focus on the absolute amounts of glycans, neglecting the apparent glycan distribution over the entirety of proteins. The combination of the two Fc N-glycans, herein referred to as glyco-pair, therefore remains unknown, which is a major drawback for N-glycan impact assessment...
May 15, 2024: European Journal of Pharmaceutics and Biopharmaceutics
Abdelrahman R Said, Gihan F Asaad, Marwa E Shabana, Alaa S Sayed, Dalia H Elfeky, Hager Mohamed Ali, Amal Adel Abdelfattah, Hussein M El-Husseiny, Walaa A El-Dakroury
This study introduces two innovative nanocarrier systems to improve oral drug delivery. Desosomes and desimicelles combine Deep eutectic solvent (DES) with vesicular or micellar nanosystems, respectively. These novel nanosystems integrate the DES solubilization potency for administering drugs with low aqueous solubility and the vesicular and micellar systems to bypass physiological barriers and improve poor drug bioavailability. Lornoxicam (LRX) is a BCS class II anti-inflammatory with limited aqueous solubility and rapid clearance...
May 15, 2024: European Journal of Pharmaceutics and Biopharmaceutics
Maria João Ramalho, Érica Serra, Jorge Lima, Joana Angélica Loureiro, Maria Carmo Pereira
Glioblastoma (GBM) is a highly deadly brain tumor that does not respond satisfactorily to conventional treatment. The non-alkylating agent gemcitabine (GEM) has been proposed for treating GBM. It can overcome MGMT protein-mediated resistance, a major limitation of conventional therapy with the alkylating agent temozolomide (TMZ). However, GEM's high systemic toxicity and poor permeability across the blood-brain barrier (BBB) pose significant challenges for its delivery to the brain. Thus, mucoadhesive poly(lactic-co-glycolic acid) (PLGA) nanoparticles (NPs) coated with chitosan (CH), suitable for intranasal GEM delivery, were proposed in this work...
May 15, 2024: European Journal of Pharmaceutics and Biopharmaceutics
Hiromasa Uchiyama, Katsuhiko Minoura, Erina Yamada, Kenta Ando, Ryoji Yamauchi, Akihito Nakanishi, Mahamadou Tandia, Kazunori Kadota, Yuichi Tozuka
We previously reported that α-glycosylated naringin (naringin-G), synthesized by enzyme-catalyzed transglycosylation, can enhance the solubility of poorly water-soluble compounds without surface-active property. However, the solubilization mechanism has not been fully elucidated. In this study, the solubilization mechanism of naringin-G was investigated using nuclear magnetic resonance (NMR) spectroscopy, and its application in skin formulations was further investigated. 1 H NMR and dynamic light scattering measurements at various concentrations confirmed the self-assembled nanostructures of naringin-G above a critical aggregation concentration of approximately 2...
May 14, 2024: European Journal of Pharmaceutics and Biopharmaceutics
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