In-house CHO HCP Platform: a promising approach for HCPs ELISA monitoring
Eur J Pharm Sci. 2023 Nov 27:106656. doi: 10.1016/j.ejps.2023.106656. Online ahead of print.ABSTRACTA key aspect that must be supervised during the development of recombinant therapeutic products is the potential presence of impurities. Residual host cell proteins (HCPs) are a major class of process-related impurities derived from the host organism that even in trace amount have the potential to affect product quality, safety, and efficacy. Therefore, the product purification processes must be optimized to consistently remove as many HCPs as feasible, with the goal of making the product as pure as possible. The workhorse o...
Source: European Journal of Pharmaceutical Sciences - November 29, 2023 Category: Drugs & Pharmacology Authors: Elisa Giordano Barbara Liori Irene Cecchini Roberta Verani Lidia Leone Source Type: research

In-house CHO HCP Platform: a promising approach for HCPs ELISA monitoring
Eur J Pharm Sci. 2023 Nov 27:106656. doi: 10.1016/j.ejps.2023.106656. Online ahead of print.ABSTRACTA key aspect that must be supervised during the development of recombinant therapeutic products is the potential presence of impurities. Residual host cell proteins (HCPs) are a major class of process-related impurities derived from the host organism that even in trace amount have the potential to affect product quality, safety, and efficacy. Therefore, the product purification processes must be optimized to consistently remove as many HCPs as feasible, with the goal of making the product as pure as possible. The workhorse o...
Source: European Journal of Pharmaceutical Sciences - November 29, 2023 Category: Drugs & Pharmacology Authors: Elisa Giordano Barbara Liori Irene Cecchini Roberta Verani Lidia Leone Source Type: research

Development and characterization of a spray-dried inhalable ternary combination for the treatment of Pseudomonas aeruginosa biofilm infection in cystic fibrosis
In conclusion, a ternary drug combination powder with suitable aerosolization, physical stability and antibacterial/antibiofilm properties was prepared by a single spray drying step.PMID:38013123 | DOI:10.1016/j.ejps.2023.106654 (Source: European Journal of Pharmaceutical Sciences)
Source: European Journal of Pharmaceutical Sciences - November 28, 2023 Category: Drugs & Pharmacology Authors: Nasser Alhajj Mohd Fakharul Zaman Raja Yahya Niall J O'Reilly Helen Cathcart Source Type: research

In vitro biodistribution studies on clinically approved FGFR inhibitors ponatinib, nintedanib, erlotinib and an investigational inhibitor KP2692
Eur J Pharm Sci. 2023 Nov 25:106651. doi: 10.1016/j.ejps.2023.106651. Online ahead of print.ABSTRACTBinding towards human serum albumin (HSA) and α1-acid glycoprotein (AGP) of three approved fibroblast growth factor receptor (FGFR) inhibitors ponatinib (PON), nintedanib (NIN) and erdafitinib (ERD), as well as the experimental drug KP2692 was studied by means of spectrofluorometric and UV-visible spectrophotometric methods. Additionally, proton dissociation processes, lipophilicity, and fluorescence properties of these four molecules were investigated in detail. The FGFR inhibitors were predominantly presented in their sin...
Source: European Journal of Pharmaceutical Sciences - November 28, 2023 Category: Drugs & Pharmacology Authors: Orsolya D ömötör Marlene Mathuber Christian R Kowol Source Type: research

Overcoming drug impurity challenges in amorphous solid dispersion with rational development of biorelevant dissolution-permeation method
This study provides a relationship between observed in vitro supersaturation and precipitation behavior of amorphous solid dispersion formulation with in vivo results, on patients, by using the acceptor profile of side-by-side dissolution-permeation apparatus. An in vitro dissolution method, in small volumes, in an apparatus with paddles and dissolution-permeation side-by-side method was developed on the MicroFluxTM apparatus to assess if the differences observed in vitro bears relevance to the bioequivalence outcome in vivo. The former was used to guide the generic drug product development due to high discriminatory stren...
Source: European Journal of Pharmaceutical Sciences - November 28, 2023 Category: Drugs & Pharmacology Authors: T Huzjak O Jakasanovski K Berginc V Pu ž Zajc K K Ž Jeraj B Jankovi ć Source Type: research

Development and characterization of a spray-dried inhalable ternary combination for the treatment of Pseudomonas aeruginosa biofilm infection in cystic fibrosis
In conclusion, a ternary drug combination powder with suitable aerosolization, physical stability and antibacterial/antibiofilm properties was prepared by a single spray drying step.PMID:38013123 | DOI:10.1016/j.ejps.2023.106654 (Source: European Journal of Pharmaceutical Sciences)
Source: European Journal of Pharmaceutical Sciences - November 28, 2023 Category: Drugs & Pharmacology Authors: Nasser Alhajj Mohd Fakharul Zaman Raja Yahya Niall J O'Reilly Helen Cathcart Source Type: research

In vitro biodistribution studies on clinically approved FGFR inhibitors ponatinib, nintedanib, erlotinib and an investigational inhibitor KP2692
Eur J Pharm Sci. 2023 Nov 25:106651. doi: 10.1016/j.ejps.2023.106651. Online ahead of print.ABSTRACTBinding towards human serum albumin (HSA) and α1-acid glycoprotein (AGP) of three approved fibroblast growth factor receptor (FGFR) inhibitors ponatinib (PON), nintedanib (NIN) and erdafitinib (ERD), as well as the experimental drug KP2692 was studied by means of spectrofluorometric and UV-visible spectrophotometric methods. Additionally, proton dissociation processes, lipophilicity, and fluorescence properties of these four molecules were investigated in detail. The FGFR inhibitors were predominantly presented in their sin...
Source: European Journal of Pharmaceutical Sciences - November 28, 2023 Category: Drugs & Pharmacology Authors: Orsolya D ömötör Marlene Mathuber Christian R Kowol Source Type: research

Overcoming drug impurity challenges in amorphous solid dispersion with rational development of biorelevant dissolution-permeation method
This study provides a relationship between observed in vitro supersaturation and precipitation behavior of amorphous solid dispersion formulation with in vivo results, on patients, by using the acceptor profile of side-by-side dissolution-permeation apparatus. An in vitro dissolution method, in small volumes, in an apparatus with paddles and dissolution-permeation side-by-side method was developed on the MicroFluxTM apparatus to assess if the differences observed in vitro bears relevance to the bioequivalence outcome in vivo. The former was used to guide the generic drug product development due to high discriminatory stren...
Source: European Journal of Pharmaceutical Sciences - November 28, 2023 Category: Drugs & Pharmacology Authors: T Huzjak O Jakasanovski K Berginc V Pu ž Zajc K K Ž Jeraj B Jankovi ć Source Type: research

A pH-Sensitive Silica Nanoparticles for Colon-Specific Delivery and Controlled Release of Catechin: Optimization of Loading Efficiency and In Vitro Release Kinetics
Eur J Pharm Sci. 2023 Nov 24:106652. doi: 10.1016/j.ejps.2023.106652. Online ahead of print.ABSTRACTCatechin is a naturally occurring flavonoid of the flavan-3-ol subclass with numerous biological functions; however, these benefits are diminished due to several factors, including low water solubility and degradation in the stomach's harsh environment. So, this study aimed to develop an intelligent catechin colon-targeting delivery system with a high loading capacity. This was done by coating surface-decorated mesoporous silica nanoparticles with a pH-responsive enteric polymer called Eudragit®-S100. The pristine wormlike ...
Source: European Journal of Pharmaceutical Sciences - November 26, 2023 Category: Drugs & Pharmacology Authors: Abdulsalam M Kassem May Almukainzi Tarek M Faris Ahmed H Ibrahim Walid Anwar Ibrahim A Elbahwy Farid R El-Gamal Mohamed F Zidan Mohamed A Akl Ahmed M Abd-ElGawad Abdelsamed I Elshamy Mohammed Elmowafy Source Type: research

A pH-Sensitive Silica Nanoparticles for Colon-Specific Delivery and Controlled Release of Catechin: Optimization of Loading Efficiency and In Vitro Release Kinetics
Eur J Pharm Sci. 2023 Nov 24:106652. doi: 10.1016/j.ejps.2023.106652. Online ahead of print.ABSTRACTCatechin is a naturally occurring flavonoid of the flavan-3-ol subclass with numerous biological functions; however, these benefits are diminished due to several factors, including low water solubility and degradation in the stomach's harsh environment. So, this study aimed to develop an intelligent catechin colon-targeting delivery system with a high loading capacity. This was done by coating surface-decorated mesoporous silica nanoparticles with a pH-responsive enteric polymer called Eudragit®-S100. The pristine wormlike ...
Source: European Journal of Pharmaceutical Sciences - November 26, 2023 Category: Drugs & Pharmacology Authors: Abdulsalam M Kassem May Almukainzi Tarek M Faris Ahmed H Ibrahim Walid Anwar Ibrahim A Elbahwy Farid R El-Gamal Mohamed F Zidan Mohamed A Akl Ahmed M Abd-ElGawad Abdelsamed I Elshamy Mohammed Elmowafy Source Type: research

Investigation into the Impact of Proton Pump Inhibitors on Sertraline Transport across the Blood-Brain Barrier
In this study, PPIs were further found to inhibit the mRNA and protein expression of brain BCRP. To sum up, the findings of this study revealed that PPIs could enhance the brain distribution and antidepressant effect of sertraline, which may be attributed to the inhibition of BCRP expression at the BBB by PPIs.PMID:38006986 | DOI:10.1016/j.ejps.2023.106653 (Source: European Journal of Pharmaceutical Sciences)
Source: European Journal of Pharmaceutical Sciences - November 25, 2023 Category: Drugs & Pharmacology Authors: Yumeng Xiao Wenwen Xu Dandan Niu Zhuowei Quan Ling Wang Source Type: research

The use of polymorphic state modifiers in solid lipid microparticles: The role of structural modifications on drug release performance
This study investigates the correlation between the structural and release properties of solid lipid microparticles (MPs) of tristearin containing 5 % w/w of four different liquid additives used as crystal modifiers: isopropyl myristate (IM), ethyl oleate (EO), oleic acid (OA) and medium chain triglycerides (MCT). All additives accelerated the conversion of the unstable α-form of tristearin, formed after the MPs manufacturing, to the stable β-polymorph and the transformation was completed within 24 h (for IM and EO) or 48 h (for OA and MCT). The kinetic of polymorphic transition at 25 °C was investigated by simultaneous...
Source: European Journal of Pharmaceutical Sciences - November 23, 2023 Category: Drugs & Pharmacology Authors: Serena Bertoni Elena Simone Stefano Sangiorgi Beatrice Albertini Nadia Passerini Source Type: research

The use of polymorphic state modifiers in solid lipid microparticles: the role of structural modifications on drug release performance
This study investigates the correlation between the structural and release properties of solid lipid microparticles (MPs) of tristearin containing 5% w/w of four different liquid additives used as crystal modifiers: isopropyl myristate (IM), ethyl oleate (EO), oleic acid (OA) and medium chain triglycerides (MCT). All additives accelerated the conversion of the unstable α-form of tristearin, formed after the MPs manufacturing, to the stable β-polymorph and the transformation was completed within 24 h (for IM and EO) or 48 h (for OA and MCT). The kinetic of polymorphic transition at 25°C was investigated by simultaneous s...
Source: European Journal of Pharmaceutical Sciences - November 23, 2023 Category: Drugs & Pharmacology Authors: Serena Bertoni Elena Simone Stefano Sangiorgi Beatrice Albertini Nadia Passerini Source Type: research

The use of polymorphic state modifiers in solid lipid microparticles: the role of structural modifications on drug release performance
This study investigates the correlation between the structural and release properties of solid lipid microparticles (MPs) of tristearin containing 5% w/w of four different liquid additives used as crystal modifiers: isopropyl myristate (IM), ethyl oleate (EO), oleic acid (OA) and medium chain triglycerides (MCT). All additives accelerated the conversion of the unstable α-form of tristearin, formed after the MPs manufacturing, to the stable β-polymorph and the transformation was completed within 24 h (for IM and EO) or 48 h (for OA and MCT). The kinetic of polymorphic transition at 25°C was investigated by simultaneous s...
Source: European Journal of Pharmaceutical Sciences - November 23, 2023 Category: Drugs & Pharmacology Authors: Serena Bertoni Elena Simone Stefano Sangiorgi Beatrice Albertini Nadia Passerini Source Type: research

Fibrous matrices facilitate pleurocidin killing of wound associated bacterial pathogens
Eur J Pharm Sci. 2023 Nov 20:106648. doi: 10.1016/j.ejps.2023.106648. Online ahead of print.ABSTRACTConventional wound infection treatments neither actively promote wound healing nor address the growing problem of antibacterial resistance. Antimicrobial peptides (AMPs) are natural defense molecules, released from host cells, which may be rapidly bactericidal, modulate host-immune responses, and/or act as endogenous mediators for wound healing. However, their routine clinical use has hitherto been hindered due to their instability in the wound environment. Here we describe an electrospun carrier system for topical applicati...
Source: European Journal of Pharmaceutical Sciences - November 22, 2023 Category: Drugs & Pharmacology Authors: Celia Ramos Kairi Lorenz Marta Putrin š Charlotte K Hind Andres Meos Ivo Laidm äe Tanel Tenson J Mark Sutton A James Mason Karin Kogermann Source Type: research