European Journal of Pharmaceutics and Biopharmaceutics This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Dissolvable microneedles in the skin: Determination the impact of barrier disruption and dry skin on dissolution
This study compares the hyaluronic acid-based DMNs penetration, formation of microchannels, dissolution, and diffusion kinetics in intact, barrier-disrupted (tape stripped), and dry (acetone-treated) porcine ear skin ex vivo. After DMNs application, comprehensive investigations including dermoscopy, stereomicroscope, skin hydration, transepidermal water loss (TEWL), optical coherence tomography (OCT), reflectance confocal laser scanning microscopy (RCLSM), confocal Raman micro-spectroscopy (CRM), two-photon tomography combined with fluorescence lifetime imaging (TPT-FLIM), histology, and scanning electron microscopy (SEM) ...
Source: European Journal of Pharmaceutics and Biopharmaceutics - April 24, 2024 Category: Drugs & Pharmacology Authors: Benchaphorn Limcharoen Supason Wanichweacharungruang Marius Kr öger Titiporn Sansureerungsikul Johannes Schleusener Anna Lena Klein Wijit Banlunara Martina C Meinke Maxim E Darvin Source Type: research

A novel simulated media system for in vitro evaluation of bioequivalent intestinal drug solubility
In this study we have compared literature Fa/FeHIF drug solubilities to values measured in a novel in vitro simulated nine media system for either the fasted (Fa9SIF) or fed (Fe9SIF) state. The manuscript contains 129 literature sampled human intestinal fluid equilibrium solubility values and 387 simulated intestinal fluid equilibrium solubility values. Statistical comparison does not detect a difference (Fa/Fe9SIF vs Fa/FeHIF), a novel solubility correlation window enclosed 95% of an additional literature Fa/FeHIF data set and solubility behaviour is consistent with previous physicochemical studies. The Fa/Fe9SIF system t...
Source: European Journal of Pharmaceutics and Biopharmaceutics - April 24, 2024 Category: Drugs & Pharmacology Authors: Qamar Abuhassan Maria In ês Silva Rana Abu-Rajab Tamimi Ibrahim Khadra Hannah K Batchelor Kate Pyper Gavin W Halbert Source Type: research

Engineering pH-sensitive dissolution of lipid-polymer nanoparticles by Eudragit integration impacts plasmid DNA (pDNA) transfection
In this study, biocompatible Eudragit constructs E100 and RS100 were formulated as lipid-polymer nanoparticles loaded with pDNA expressing red fluorescent protein (RFP) as a model therapeutic. Using a facile nanoprecipitation technique, a core-shell structure stabilised by lipid-polyethylene glycol (PEG) surfactant was produced and displayed resistance to ultracentrifugation. Both cationic polymers E100 (pH-sensitive dissolution at 5) and RS100 (pH-insensitive dissolution) produced 150-200 nm sized particles with a small positive surface charge (+3-5 mV) and high pDNA encapsulation efficiencies (EE) of 75-90 %. The dissolu...
Source: European Journal of Pharmaceutics and Biopharmaceutics - April 21, 2024 Category: Drugs & Pharmacology Authors: Diviya Santhanes Huiming Zhang Alex Wilkins Robert John Aitken Anne-Louise Gannon Mingtao Liang Source Type: research

Exosome-Based Macromolecular neurotherapeutic drug delivery approaches in overcoming the Blood-Brain barrier for treating brain disorders
Eur J Pharm Biopharm. 2024 Apr 18:114298. doi: 10.1016/j.ejpb.2024.114298. Online ahead of print.ABSTRACTDelivering drugs to the brain is a complex challenge in medical research, particularly for disorders like Alzheimer's and Parkinson's. The blood-brain barrier restricts the entry of many therapeutic molecules, hindering their effectiveness. Nanoparticles, a potential solution, face issues like toxicity and limited approvals. A new avenue explores the use of small extracellular vesicles (sEVs), i.e., exosomes, as natural carriers for drug delivery. sEVs, tiny structures below 150 nm, show promise due to their minimal imm...
Source: European Journal of Pharmaceutics and Biopharmaceutics - April 20, 2024 Category: Drugs & Pharmacology Authors: Krishna Yadav R Vijayalakshmi Kantrol Kumar Sahu Pavani Sure Kavita Chahal Renu Yadav None Sucheta Akhilesh Dubey Megha Jha Madhulika Pradhan Source Type: research

Spray-drying of PEI-/PPI-based nanoparticles for DNA or siRNA delivery
In this study, we identify optimal spray-drying conditions for PEI-based nanoparticles containing large plasmid DNA or small siRNAs, and further explore the spray-drying of nanoparticles containing chemically modified polymers. Poly(vinyl alcohol) (PVA), but not trehalose or lactose, is particularly well-suited as excipient, retaining or even enhancing transfection efficacies compared to fresh complexes. A big mesh size is critically important as well, while the variation of the spray-drying temperature plays a minor role. Upon spray-drying, microparticles in a ∼ 3.3 - 8.5 µm size range (laser granulometry) are obtained...
Source: European Journal of Pharmaceutics and Biopharmaceutics - April 19, 2024 Category: Drugs & Pharmacology Authors: Sandra Noske Michael Karimov Martin Kr üger Bettina Lilli Alexander Ewe Achim Aigner Source Type: research

Bioequivalence risk assessment of oral formulations containing racemic ibuprofen through a chiral physiologically based pharmacokinetic model of ibuprofen enantiomers
Eur J Pharm Biopharm. 2024 Apr 17:114293. doi: 10.1016/j.ejpb.2024.114293. Online ahead of print.ABSTRACTThe characterization of the time course of ibuprofen enantiomers can be useful in the selection of the most sensitive analyte in bioequivalence studies. Physiologically based pharmacokinetic (PBPK) modelling and simulation represents the most efficient methodology to virtually assess bioequivalence outcomes. In this work, we aim to develop and verify a PBPK model for ibuprofen enantiomers administered as a racemic mixture with different immediate release dosage forms to anticipate bioequivalence outcomes based on differ...
Source: European Journal of Pharmaceutics and Biopharmaceutics - April 19, 2024 Category: Drugs & Pharmacology Authors: Javier Reig-L ópez Marina Cuquerella-Gilabert Enrique Band ín-Vilar Matilde Merino-Sanju án V íctor Mangas-Sanjuán Alfredo Garc ía-Arieta Source Type: research

Transcriptomic and western blot characterisation of the human CLEFF4 clone, a new rapid cell line replacement for the Caco2 model
Eur J Pharm Biopharm. 2024 Apr 17:114291. doi: 10.1016/j.ejpb.2024.114291. Online ahead of print.ABSTRACTThe CLEFF4 sub clone from stock late passage Caco2 cells has a unique property of being able to develop polarised cell monolayers with high P-gp expression and tight junctions much quicker than the original cell line. Instead of being useful for transport studies 21-24 days after initiating culture, the CLEFF4 cell line matures in 5-6 days with tight junctions surpassing that of 3 week old Caco2 cells in that time frame [1]. This has enabled the CLEFF4 cell line to provide measures of apparent permeability for potential...
Source: European Journal of Pharmaceutics and Biopharmaceutics - April 19, 2024 Category: Drugs & Pharmacology Authors: Andrew Crowe Source Type: research

Assessment of change in the basic variants composition of trastuzumab during dilution in saline for administration
Eur J Pharm Biopharm. 2024 Apr 16:114295. doi: 10.1016/j.ejpb.2024.114295. Online ahead of print.ABSTRACTPostproduction handling of drug products during preparation or clinical use may affect the structure and efficacy of the drug and perhaps remain unnoticed. Since chemical modifications can impact the product's structure, stability, and biological activity, this study investigates the impact of elevated temperature and subtle shift in pH on the drug product post-dilution in saline. The mAb sample diluted in saline for administration was stressed at elevated temperature and slightly acidic pH condition. Extended stability...
Source: European Journal of Pharmaceutics and Biopharmaceutics - April 18, 2024 Category: Drugs & Pharmacology Authors: Surbhi Gupta Christian Sch öneich Anurag S Rathore Source Type: research

A potent bioreducible ionizable lipid nanoparticle enables siRNA delivery for retinal neovascularization inhibition
Eur J Pharm Biopharm. 2024 Apr 16:114296. doi: 10.1016/j.ejpb.2024.114296. Online ahead of print.ABSTRACTSmall interfering RNA (siRNA) is emerging as a promising treatment for retinal neovascularization due to its specific inhibition of the expression of target genes. However, the clinical translation of siRNA drugs is hindered by the efficiency and safety of delivery vectors. Here, we describe the properties of a new bioreducible ionizable lipid nanoparticle (LNP) 2N12H, which is based on a rationally designed novel ionizable lipid called 2N12B. 2N12H exhibited degradation in response to the mimic cytoplasmic glutathione ...
Source: European Journal of Pharmaceutics and Biopharmaceutics - April 18, 2024 Category: Drugs & Pharmacology Authors: Xiaowen Cao Lili Su Hao Chen Source Type: research

Why Perfluorocarbon nanoparticles encounter bottlenecks in clinical translation despite promising oxygen carriers?
Eur J Pharm Biopharm. 2024 Apr 16:114292. doi: 10.1016/j.ejpb.2024.114292. Online ahead of print.ABSTRACTArtificial Oxygen Carriers (AOCs) have emerged as ground-breaking biomedical solutions, showcasing tremendous potential for enhancing human health and saving lives. Perfluorocarbon (PFC)-based AOCs, in particular, have garnered significant interest among researchers, leading to numerous clinical trials since the 1980 s. However, despite decades of exploration, the success rate has remained notably limited. This comprehensive review article delves into the landscape of clinical trials involving PFC compounds, shedding li...
Source: European Journal of Pharmaceutics and Biopharmaceutics - April 18, 2024 Category: Drugs & Pharmacology Authors: Anindita De Jun-Pil Jee Young-Joon Park Source Type: research

Mini-tablets current use and future opportunities - An APV course on manufacturing, packaging, characterization and use of minitablets
This article provides an overview on the topics presented and discussed during the course.PMID:38636884 | DOI:10.1016/j.ejpb.2024.114294 (Source: European Journal of Pharmaceutics and Biopharmaceutics)
Source: European Journal of Pharmaceutics and Biopharmaceutics - April 18, 2024 Category: Drugs & Pharmacology Authors: Susanne Page Timo Rode J örg Breitkreutz Leonie Wagner-Hattler Source Type: research

Formulation study of PLGA in situ films for topical delivery of salicylates
In this study, a non-commercial poly(lactic-co-glycolic acid) (PLGA) was chosen to formulate an FFS containing salicylic acid (SA) and methyl salicylate (MS). This unique combination is advantageous from a therapeutic point of view, as it enabled modified salicylate release. It is beneficial from a technological perspective too, because it improved thermal, rheological, and adhesive properties of the in situ film. DSC revealed complete dissolution of SA and good miscibility of MS with the polymer. MS also ensures optimal viscoelastic and adhesive properties of the film, leading to prolonged and sustained drug release. The ...
Source: European Journal of Pharmaceutics and Biopharmaceutics - April 13, 2024 Category: Drugs & Pharmacology Authors: Eva Snejdrova Jan Loskot Andrea Veris Petr Kastner Rudolf Andrys Source Type: research