European Journal of Pharmaceutical Sciences 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.

Implementing physics-based digital patient twins to tailor the switch of oral morphine to transdermal fentanyl patches based on patient physiology
This study explores the outcome in terms of pain relief and minute ventilation during opioid therapy. For this, we used physics-based simulations on a virtually-generated population of patients, and we applied the same therapy to all patients. We could show that patients' physiology, such as gender, age, and weight, greatly impact the outcome of the therapy; as such, the correlation coefficient between pain intensity and age is 0.89, and the correlation coefficient between patient's weight and maximum plasma concentration of morphine and fentanyl is -0.98 and -0.97. Additionally, a different combination of the duration of ...
Source: European Journal of Pharmaceutical Sciences - February 15, 2024 Category: Drugs & Pharmacology Authors: Flora Bahrami Ren é Michel Rossi Katelijne De Nys Markus Joerger Milena Cukic Radenkovic Thijs Defraeye Source Type: research

Equivalence assessment of creams with quali-quantitative differences in light of the EMA and FDA regulatory framework
Eur J Pharm Sci. 2024 Feb 12:106726. doi: 10.1016/j.ejps.2024.106726. Online ahead of print.ABSTRACTEMA and FDA are upgrading guidelines on assessing the quality and the equivalence of topically applied drug products for developing copies of originator products and supporting post-marketing variations. For topical products having remarkably similar composition, both EMA and FDA accept the equivalence on the bases of the comparison of rheological properties and in vitro drug release constant (k) and skin permeation flux (J) values, instead of clinical studies. This work aims to evaluate the feasibility to expand this approa...
Source: European Journal of Pharmaceutical Sciences - February 14, 2024 Category: Drugs & Pharmacology Authors: Paola Volont è Umberto M Musazzi Luca Arnaboldi Marco A Ortenzi Antonella Casiraghi Francesco Cilurzo Paola Minghetti Source Type: research

Equivalence assessment of creams with quali-quantitative differences in light of the EMA and FDA regulatory framework
Eur J Pharm Sci. 2024 Feb 12:106726. doi: 10.1016/j.ejps.2024.106726. Online ahead of print.ABSTRACTEMA and FDA are upgrading guidelines on assessing the quality and the equivalence of topically applied drug products for developing copies of originator products and supporting post-marketing variations. For topical products having remarkably similar composition, both EMA and FDA accept the equivalence on the bases of the comparison of rheological properties and in vitro drug release constant (k) and skin permeation flux (J) values, instead of clinical studies. This work aims to evaluate the feasibility to expand this approa...
Source: European Journal of Pharmaceutical Sciences - February 14, 2024 Category: Drugs & Pharmacology Authors: Paola Volont è Umberto M Musazzi Luca Arnaboldi Marco A Ortenzi Antonella Casiraghi Francesco Cilurzo Paola Minghetti Source Type: research

iRGD mediated pH-responsive mesoporous silica enhances drug accumulation in tumors
In this study, we developed a novel drug delivery carrier derived from mesoporous silica, dually modified with the tumor-homing cyclic peptide iRGD (CRGDKGPDC) and the pH-responsive polymer poly(2-ethyl-2-oxazoline) (PEOz) for treating triple-negative breast cancer. The carrier selectively bound to the αvβ3 integrin receptor, which is specifically expressed in MDA-MB-231 breast cancer cells and vessels. Subsequently, it penetrated deep into the tumor parenchyma through NRP-1 receptor-dependent internalization, with the drug-loaded particles releasing drugs rapidly in the acidic cytoplasmic environment. Results indicated ...
Source: European Journal of Pharmaceutical Sciences - February 12, 2024 Category: Drugs & Pharmacology Authors: Xiaoning Wang Guangyang Zhao Mengru Yan Xiaoyan Liang Ning Zhao Tingli Lu Source Type: research

Investigating distributions of inhaled aerosols in the lungs of post-COVID-19 clusters through a unified imaging and modeling approach
CONCLUSIONS: This study revealed unique mechanistic phenotypes of airway resistance and particle deposition in the two post-COVID-19 clusters. The implications of these findings for inhaled drug delivery effectiveness and susceptibility to air pollutants were explored.PMID:38340875 | DOI:10.1016/j.ejps.2024.106724 (Source: European Journal of Pharmaceutical Sciences)
Source: European Journal of Pharmaceutical Sciences - February 10, 2024 Category: Drugs & Pharmacology Authors: Xuan Zhang Frank Li Prathish K Rajaraman Alejandro P Comellas Eric A Hoffman Ching-Long Lin Source Type: research

Water-mediated phase transformations of posaconazole: An intricate jungle of crystal forms
Eur J Pharm Sci. 2024 Feb 7;195:106722. doi: 10.1016/j.ejps.2024.106722. Online ahead of print.ABSTRACTPosaconazole is a broad-spectrum antifungal agent exhibiting rich polymorphism. Up to now, a total of fourteen different crystal forms have been reported, sometimes with an ambiguous nomenclature, but less is known about their properties and stability relationships. Investigating the solid-state of a drug compound is essential to identify the most stable form under working conditions and to prevent the risk of undesired solid-phase transformations under processing and storage. In this paper, we study posaconazole polymorp...
Source: European Journal of Pharmaceutical Sciences - February 9, 2024 Category: Drugs & Pharmacology Authors: Matteo Guidetti Rolf Hilfiker Martin Kuentz Annette Bauer-Brandl Fritz Blatter Source Type: research

Safety, tolerability, pharmacokinetics and neutrophil elastase inhibitory effects of Sivelestat: A randomized, double-blind, placebo-controlled single- and multiple-dose escalation study in Chinese healthy subjects
CONCLUSION: Sivelestat was safe and well tolerated with appropriate pharmacokinetic parameters, which provided support for more diverse dosing regimen in clinical application.CLINICAL TRIAL REGISTRATION: www.chinadrugtrials.org.cn identifier is CTR20210072.PMID:38336251 | DOI:10.1016/j.ejps.2024.106723 (Source: European Journal of Pharmaceutical Sciences)
Source: European Journal of Pharmaceutical Sciences - February 9, 2024 Category: Drugs & Pharmacology Authors: Kun Li Lingfang Dong Shan Gao Jingying Zhang Yinghua Feng Li Gu Jie Yang Xing Liu Yaqin Wang Zhenkun Mao Dandan Jiang Zhengchao Xia Guoliang Zhang Jingwen Tang Peizhi Ma Wei Zhang Source Type: research

Effects of H < sub > 2 < /sub > S-donor ascorbic acid derivative and ischemia/reperfusion-induced injury in isolated rat hearts
In conclusion, the designed water soluble H2S releasing ascorbic acid derivative, BM-164, showed better cardiac protection against ischemia/reperfusion-induced injury compared to the untreated and ascorbic acid treated hearts, respectively.PMID:38331005 | DOI:10.1016/j.ejps.2024.106721 (Source: European Journal of Pharmaceutical Sciences)
Source: European Journal of Pharmaceutical Sciences - February 8, 2024 Category: Drugs & Pharmacology Authors: Bence T ánczos Vir ág Vass Erzs ébet Szabó Mikl ós Lovas Rasha Ghanem Kattoub Ilona Bereczki Anik ó Borbás P ál Herczegh Árpád Tósaki Source Type: research

The role of partial area under the curve and maximum concentrations in assessing the bioequivalence of long-acting injectable formulation of exenatide_A sensitivity analysis
Eur J Pharm Sci. 2024 Feb 3;195:106718. doi: 10.1016/j.ejps.2024.106718. Online ahead of print.ABSTRACTTo ensure therapeutic equivalence between the long-acting injectable (LAI) products, additional PK metrics other than Cmax and AUC were considered necessary. However, regarding the selection of additional PK metrics for bioequivalence (BE) assessment of exenatide LAI, a discrepancy existed between EMA's and USFDA's product-specific guidance. The EMA recommends that both the maximum plasma concentration in the initial-release phase (Cmax,1) and the extended-release phase (Cmax,2) should be determined. Nevertheless, the USF...
Source: European Journal of Pharmaceutical Sciences - February 5, 2024 Category: Drugs & Pharmacology Authors: Hong-Jaan Wang Li-Feng Hsu Source Type: research

Predicting the intrinsic membrane permeability of Caco-2/MDCK cells by the solubility-diffusion model
Eur J Pharm Sci. 2024 Feb 2;195:106720. doi: 10.1016/j.ejps.2024.106720. Online ahead of print.ABSTRACTMembrane permeability is one of the main determinants for the absorption, distribution, metabolism and excretion of compounds and is therefore of crucial importance for successful drug development. Experiments with artificial phospholipid membranes have shown that the intrinsic membrane permeability (P0) of compounds is well-predicted by the solubility-diffusion model (SDM). However, using the solubility-diffusion model to predict the P0 of biological Caco-2 and MDCK cell membranes has proven unreliable so far. Recent pub...
Source: European Journal of Pharmaceutical Sciences - February 4, 2024 Category: Drugs & Pharmacology Authors: Carolin Dahley Tim B öckmann Andrea Ebert Kai-Uwe Goss Source Type: research

Small molecules modified mesoporous silica nanoparticles orally deliver indomethacin with synergistic effect
Eur J Pharm Sci. 2024 Feb 1;195:106719. doi: 10.1016/j.ejps.2024.106719. Online ahead of print.ABSTRACTMolecularly functional drug delivery systems possessed huge potentials to realize novel drug administration. To explore small molecules modified drug delivery, a series of small molecules modified mesoporous silica nanoparticles (L-Mal-MSNs, D-Mal-MSNs) were established by grafting small molecules. Poorly water-soluble indomethacin (IMC) was chosen to load into these small molecules modified carriers as well as corresponding control carrier, and further to study characteristics and delivery effects of drug loaded carriers...
Source: European Journal of Pharmaceutical Sciences - February 3, 2024 Category: Drugs & Pharmacology Authors: Shiliang Yin Lin Cai Xuan Li Kai Lin Xianbao Shi Hong Zhang Lijie Wang Jing Li Source Type: research

Management of oxidative stress for cell therapy through combinational approaches of stem cells, antioxidants, and photobiomodulation
Eur J Pharm Sci. 2024 Jan 30:106715. doi: 10.1016/j.ejps.2024.106715. Online ahead of print.ABSTRACTOver the recent decades, stem cell-based therapies have been considered as a beneficial approach for the treatment of various diseases. In these types of therapies, the stem cells and their products are used as treating agents. Despite the helpful efficacy of stem cell-based therapies, there may be challenges. Oxidative stress (OS) is one of these challenges that can decrease the therapeutic properties of stem cells. Therefore, it seems that employing strategies for the reduction of OS in combination with stem cell therapy c...
Source: European Journal of Pharmaceutical Sciences - February 1, 2024 Category: Drugs & Pharmacology Authors: Rezvan Asgari Yasaman Zandi Mehran Hans Micheal Weber Micheal Weber Sayed Ali Golestanha Mohammah Hossein Kazerouni Farzad Panahi Pantea Mohammadi Kamran Mansouri Source Type: research

A remodeled ivermectin polycaprolactone-based nanoparticles for inhalation as a promising treatment of pulmonary inflammatory diseases
Eur J Pharm Sci. 2024 Jan 30;195:106714. doi: 10.1016/j.ejps.2024.106714. Online ahead of print.ABSTRACTIn recent years, ivermectin (IVM), an antiparasitic drug of low water solubility and poor oral bioavailability, has shown a profound effect on inflammatory mediators involved in diseases, such as acute lung injury, lung fibrosis, and COVID-19. In order to maximize drug bioavailability, polymeric nanoparticles can be delivered through nebulizers for pulmonary administration. The aim of this study was to prepare IVM-loaded polycaprolactone (PCL) nanoparticles (NPs) by solvent evaporation method. Box-Benkhen design (BBD) wa...
Source: European Journal of Pharmaceutical Sciences - February 1, 2024 Category: Drugs & Pharmacology Authors: Sabaa Wafiq Mohammed Nagia Ahmed El-Megrab Azza A Hasan Eman Gomaa Source Type: research

Evaluation of omadacycline dosing regimens in Chinese using population pharmacokinetic-pharmacodynamic analysis
CONCLUSIONS: In conclusion, the approved regimen for China achieved adequate target attainment for all pathogens typically associated with these infections. The higher oral exposure observed in Asians may enhance efficacy without affecting safety or tolerability.PMID:38295963 | DOI:10.1016/j.ejps.2024.106713 (Source: European Journal of Pharmaceutical Sciences)
Source: European Journal of Pharmaceutical Sciences - January 31, 2024 Category: Drugs & Pharmacology Authors: Kun Wang Yusong Zhu Fengyan Xu Lucy Liu Lichuan Liu Mengling Shi Jing Nie Harald Reinhart Jing Liu Yuying Gao Xia Pu Source Type: research

Methotrexate-loaded hyaluronan-modified liposomes integrated into dissolving microneedles for the treatment of psoriasis
Eur J Pharm Sci. 2024 Jan 28;195:106711. doi: 10.1016/j.ejps.2024.106711. Online ahead of print.ABSTRACTMethotrexate (MTX) is a first-line drug in treating psoriasis because of its strong anti-proliferation and anti-inflammatory effects. However, systemic administration of MTX will lead to many side effects, such as gastrointestinal irritation, liver and kidney toxicity, etc. Herein, we developed liposome-loaded microneedles (MNs) system to improve transdermal efficiency, which was used to overcome the problems of low transdermal efficiency and poor therapeutic effect of traditional transdermal drug delivery methods. Hyalu...
Source: European Journal of Pharmaceutical Sciences - January 30, 2024 Category: Drugs & Pharmacology Authors: Shulin Shen Xi Zheng Xu Dong Min Fang Aiqun Wan Tong Zhu Qingliang Yang Jing Xie Qinying Yan Source Type: research