Corrigendum to "Does nonlinear blood-brain barrier transport matter for (lower) morphine dosing strategies?" [European Journal of Pharmaceutical Sciences 187 (2023) 106482]
Eur J Pharm Sci. 2024 Mar 14:106736. doi: 10.1016/j.ejps.2024.106736. Online ahead of print.NO ABSTRACTPMID:38490876 | DOI:10.1016/j.ejps.2024.106736 (Source: European Journal of Pharmaceutical Sciences)
Source: European Journal of Pharmaceutical Sciences - March 15, 2024 Category: Drugs & Pharmacology Authors: Berfin G ülave Divakar Budda Mohammed Aa Saleh Jg Coen van Hasselt Elizabeth Cm de Lange Source Type: research

Effects of omitting titanium dioxide from the film coating of a pharmaceutical tablet - an industrial case study of attempting to comply with EU regulation 2022/63
Eur J Pharm Sci. 2024 Mar 13:106750. doi: 10.1016/j.ejps.2024.106750. Online ahead of print.ABSTRACTRecently, concerns have been raised about the safety of titanium dioxide (TiO2), a commonly used component of pharmaceutical film coatings. The European Union has recently prohibited the application of this material in the food industry, and it is anticipated that the same will happen in the pharmaceutical industry. For this reason, pharmaceutical manufacturers have to consider the possible impact of removing TiO2 from the film coating of tablets. In this paper, we present a case study of a commercially produced tablet where...
Source: European Journal of Pharmaceutical Sciences - March 15, 2024 Category: Drugs & Pharmacology Authors: Dori án László Galata Melinda Sinka L ázárné Dorottya Kiss-Kov ács Gerg ő Fülöp Barnab ás Dávid Botond Bog áti M áté Ficzere Orsolya P éterfi Brigitta Nagy Gy örgy Marosi Zsombor Krist óf Nagy Source Type: research

Corrigendum to "Does nonlinear blood-brain barrier transport matter for (lower) morphine dosing strategies?" [European Journal of Pharmaceutical Sciences 187 (2023) 106482]
Eur J Pharm Sci. 2024 Mar 14:106736. doi: 10.1016/j.ejps.2024.106736. Online ahead of print.NO ABSTRACTPMID:38490876 | DOI:10.1016/j.ejps.2024.106736 (Source: European Journal of Pharmaceutical Sciences)
Source: European Journal of Pharmaceutical Sciences - March 15, 2024 Category: Drugs & Pharmacology Authors: Berfin G ülave Divakar Budda Mohammed Aa Saleh Jg Coen van Hasselt Elizabeth Cm de Lange Source Type: research

Effects of omitting titanium dioxide from the film coating of a pharmaceutical tablet - an industrial case study of attempting to comply with EU regulation 2022/63
Eur J Pharm Sci. 2024 Mar 13:106750. doi: 10.1016/j.ejps.2024.106750. Online ahead of print.ABSTRACTRecently, concerns have been raised about the safety of titanium dioxide (TiO2), a commonly used component of pharmaceutical film coatings. The European Union has recently prohibited the application of this material in the food industry, and it is anticipated that the same will happen in the pharmaceutical industry. For this reason, pharmaceutical manufacturers have to consider the possible impact of removing TiO2 from the film coating of tablets. In this paper, we present a case study of a commercially produced tablet where...
Source: European Journal of Pharmaceutical Sciences - March 15, 2024 Category: Drugs & Pharmacology Authors: Dori án László Galata Melinda Sinka L ázárné Dorottya Kiss-Kov ács Gerg ő Fülöp Barnab ás Dávid Botond Bog áti M áté Ficzere Orsolya P éterfi Brigitta Nagy Gy örgy Marosi Zsombor Krist óf Nagy Source Type: research

Corrigendum to "Does nonlinear blood-brain barrier transport matter for (lower) morphine dosing strategies?" [European Journal of Pharmaceutical Sciences 187 (2023) 106482]
Eur J Pharm Sci. 2024 Mar 14:106736. doi: 10.1016/j.ejps.2024.106736. Online ahead of print.NO ABSTRACTPMID:38490876 | DOI:10.1016/j.ejps.2024.106736 (Source: European Journal of Pharmaceutical Sciences)
Source: European Journal of Pharmaceutical Sciences - March 15, 2024 Category: Drugs & Pharmacology Authors: Berfin G ülave Divakar Budda Mohammed Aa Saleh Jg Coen van Hasselt Elizabeth Cm de Lange Source Type: research

In vitro and in ovo photodynamic efficacy of nebulized curcumin-loaded tetraether lipid liposomes prepared by DC as stable drug delivery system
In this study, we used curcumin as a natural photosensitizer in photodynamic therapy and encapsulated it in liposomes consisting of stabilizing tetraether lipids aiming for a pulmonary drug delivery system against lung cancer. The liposomes with either hydrolyzed glycerol-dialkyl-glycerol tetraether (hGDGT) in different ratios or hydrolyzed glycerol-dialkyl-nonitol tetraether (hGDNT) were prepared by dual centrifugation (DC), an innovative method for liposome preparation. The liposomes' physicochemical characteristics before and after nebulization and other nebulization characteristics confirmed their suitability. Morpholo...
Source: European Journal of Pharmaceutical Sciences - March 12, 2024 Category: Drugs & Pharmacology Authors: Lena Bender Eduard Preis Konrad H Engelhardt Muhammad Umair Amin Abdallah M Ayoub Damiano Librizzi Valeri Roschenko Jan Schulze Behrooz H Yousefi Jens Schaefer Udo Bakowsky Source Type: research

Distribution and suitability of pulmonary surfactants as a vehicle for topically applied antibodies in healthy and SARS-CoV-2 infected rodent lungs
Eur J Pharm Sci. 2024 Mar 10:106744. doi: 10.1016/j.ejps.2024.106744. Online ahead of print.ABSTRACTThe use of natural pulmonary surfactants (PS) as a drug delivery vehicle for biologics is a more recent therapeutic modality. Herein, we tested different contents of PS regarding their physicochemical properties under stress conditions. The PS content of 12.25 mg/ml (Formulation B) showed desired properties such as an isotonic osmolality ∼300 mOsm/kg and an acceptable viscosity of 8.61 cSt, being lower than in commercially available PS solutions. Formulation B passed the specifications of surface lowering capacities of >...
Source: European Journal of Pharmaceutical Sciences - March 12, 2024 Category: Drugs & Pharmacology Authors: Lea-Adriana Barlang Isabelle Deimel Bj örn-Patrick Mohl Claudia Blaurock Anne Balkema-Buschmann Kristina Weinbender Brian Hess Helena Obernolte Olivia M Merkel Andreas Popp Source Type: research

Application of bootstrap f < sub > 2 < /sub > to dissolution data from biorelevant media and evidence of the conservative nature of bootstrap f < sub > 2 < /sub >
The objective was to compare outcomes from bootstrap f2 and f2 (i.e. not-bootstrapped f2) using a large set of in vitro dissolution data. Non-parametric bootstrapping was performed on the 104 profile comparisons that did not meet the percent coefficient of variation (CV%) criteria to use average dissolution data. Bootstrap f2 was taken as the lower 90 % confidence interval of bootstrapped samples. There was concordance between bootstrap f2 and f2 in 92 of the 104 comparisons (88 %). There were no false positives. However, 12 % were false negative. Inspection of these discordance pairs suggests that bootstrap f2 serves as a...
Source: European Journal of Pharmaceutical Sciences - March 12, 2024 Category: Drugs & Pharmacology Authors: Raqeeb Jamil James E Polli Source Type: research

In vitro and in ovo photodynamic efficacy of nebulized curcumin-loaded tetraether lipid liposomes prepared by DC as stable drug delivery system
In this study, we used curcumin as a natural photosensitizer in photodynamic therapy and encapsulated it in liposomes consisting of stabilizing tetraether lipids aiming for a pulmonary drug delivery system against lung cancer. The liposomes with either hydrolyzed glycerol-dialkyl-glycerol tetraether (hGDGT) in different ratios or hydrolyzed glycerol-dialkyl-nonitol tetraether (hGDNT) were prepared by dual centrifugation (DC), an innovative method for liposome preparation. The liposomes' physicochemical characteristics before and after nebulization and other nebulization characteristics confirmed their suitability. Morpholo...
Source: European Journal of Pharmaceutical Sciences - March 12, 2024 Category: Drugs & Pharmacology Authors: Lena Bender Eduard Preis Konrad H Engelhardt Muhammad Umair Amin Abdallah M Ayoub Damiano Librizzi Valeri Roschenko Jan Schulze Behrooz H Yousefi Jens Schaefer Udo Bakowsky Source Type: research

Distribution and suitability of pulmonary surfactants as a vehicle for topically applied antibodies in healthy and SARS-CoV-2 infected rodent lungs
Eur J Pharm Sci. 2024 Mar 10:106744. doi: 10.1016/j.ejps.2024.106744. Online ahead of print.ABSTRACTThe use of natural pulmonary surfactants (PS) as a drug delivery vehicle for biologics is a more recent therapeutic modality. Herein, we tested different contents of PS regarding their physicochemical properties under stress conditions. The PS content of 12.25 mg/ml (Formulation B) showed desired properties such as an isotonic osmolality ∼300 mOsm/kg and an acceptable viscosity of 8.61 cSt, being lower than in commercially available PS solutions. Formulation B passed the specifications of surface lowering capacities of >...
Source: European Journal of Pharmaceutical Sciences - March 12, 2024 Category: Drugs & Pharmacology Authors: Lea-Adriana Barlang Isabelle Deimel Bj örn-Patrick Mohl Claudia Blaurock Anne Balkema-Buschmann Kristina Weinbender Brian Hess Helena Obernolte Olivia M Merkel Andreas Popp Source Type: research

Application of Bootstrap f < sub > 2 < /sub > to Dissolution Data From Biorelevant Media and Evidence of the Conservative Nature of Bootstrap f < sub > 2 < /sub >
The objective was to compare outcomes from bootstrap f2 and f2 (i.e. not-bootstrapped f2) using a large set of in vitro dissolution data. Non-parametric bootstrapping was performed on the 104 profile comparisons that did not meet the percent coefficient of variation (CV%) criteria to use average dissolution data. Bootstrap f2 was taken as the lower 90% confidence interval of bootstrapped samples. There was concordance between bootstrap f2 and f2 in 92 of the 104 comparisons (88%). There were no false positives. However, 12% were false negative. Inspection of these discordance pairs suggests that bootstrap f2 serves as a co...
Source: European Journal of Pharmaceutical Sciences - March 12, 2024 Category: Drugs & Pharmacology Authors: Raqeeb Jamil James E Polli Source Type: research

In vitro and in ovo photodynamic efficacy of nebulized curcumin-loaded tetraether lipid liposomes prepared by DC as stable drug delivery system
In this study, we used curcumin as a natural photosensitizer in photodynamic therapy and encapsulated it in liposomes consisting of stabilizing tetraether lipids aiming for a pulmonary drug delivery system against lung cancer. The liposomes with either hydrolyzed glycerol-dialkyl-glycerol tetraether (hGDGT) in different ratios or hydrolyzed glycerol-dialkyl-nonitol tetraether (hGDNT) were prepared by dual centrifugation (DC), an innovative method for liposome preparation. The liposomes' physicochemical characteristics before and after nebulization and other nebulization characteristics confirmed their suitability. Morpholo...
Source: European Journal of Pharmaceutical Sciences - March 12, 2024 Category: Drugs & Pharmacology Authors: Lena Bender Eduard Preis Konrad H Engelhardt Muhammad Umair Amin Abdallah M Ayoub Damiano Librizzi Valeri Roschenko Jan Schulze Behrooz H Yousefi Jens Schaefer Udo Bakowsky Source Type: research

Distribution and suitability of pulmonary surfactants as a vehicle for topically applied antibodies in healthy and SARS-CoV-2 infected rodent lungs
Eur J Pharm Sci. 2024 Mar 10:106744. doi: 10.1016/j.ejps.2024.106744. Online ahead of print.ABSTRACTThe use of natural pulmonary surfactants (PS) as a drug delivery vehicle for biologics is a more recent therapeutic modality. Herein, we tested different contents of PS regarding their physicochemical properties under stress conditions. The PS content of 12.25 mg/ml (Formulation B) showed desired properties such as an isotonic osmolality ∼300 mOsm/kg and an acceptable viscosity of 8.61 cSt, being lower than in commercially available PS solutions. Formulation B passed the specifications of surface lowering capacities of >...
Source: European Journal of Pharmaceutical Sciences - March 12, 2024 Category: Drugs & Pharmacology Authors: Lea-Adriana Barlang Isabelle Deimel Bj örn-Patrick Mohl Claudia Blaurock Anne Balkema-Buschmann Kristina Weinbender Brian Hess Helena Obernolte Olivia M Merkel Andreas Popp Source Type: research

Application of Bootstrap f < sub > 2 < /sub > to Dissolution Data From Biorelevant Media and Evidence of the Conservative Nature of Bootstrap f < sub > 2 < /sub >
The objective was to compare outcomes from bootstrap f2 and f2 (i.e. not-bootstrapped f2) using a large set of in vitro dissolution data. Non-parametric bootstrapping was performed on the 104 profile comparisons that did not meet the percent coefficient of variation (CV%) criteria to use average dissolution data. Bootstrap f2 was taken as the lower 90% confidence interval of bootstrapped samples. There was concordance between bootstrap f2 and f2 in 92 of the 104 comparisons (88%). There were no false positives. However, 12% were false negative. Inspection of these discordance pairs suggests that bootstrap f2 serves as a co...
Source: European Journal of Pharmaceutical Sciences - March 12, 2024 Category: Drugs & Pharmacology Authors: Raqeeb Jamil James E Polli Source Type: research

Population Pharmacokinetic/Pharmacodynamic Modeling of H018, a Selective JAK1 Inhibitor, in Healthy Chinese Volunteers
Eur J Pharm Sci. 2024 Mar 9:106747. doi: 10.1016/j.ejps.2024.106747. Online ahead of print.ABSTRACTH018 is an orally administered, selective, small-molecule inhibitor of Janus kinase 1 (JAK1) made for the treatment of rheumatoid arthritis. A population pharmacokinetic/pharmacodynamic analysis was conducted to characterize the pharmacokinetic and pharmacodynamic profile of H018 and its active metabolite using data from 48 healthy Chinese volunteers who received a single dose of 10-160 mg of H018 in a phase I clinical study. A two-compartment model with delayed absorption and linear elimination adequately described the pharm...
Source: European Journal of Pharmaceutical Sciences - March 11, 2024 Category: Drugs & Pharmacology Authors: Yuchen Qu Wenjia Zhou Meng Wang Quanying Zhang Mei Su Jie Pan Source Type: research