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Regional lung targeting with a fluticasone/salmeterol aerosol using a bolus breath hold method of the PreciseInhale ® system: A first evaluation in humans
CONCLUSIONS: When one inhaler dose was administered via the PI system, the absorbed dose, expressed as AUC24, was approximately twice as high and the CV was less than half, compared to direct inhalation from the same pMDI. Bolus breath hold targeting of drugs from the same aerosol mixture to the peripheral lung and the central airways showed a difference in their appearance in the systemic circulation. Normalized to the same deposited dose, SMX had a 57% higher Cmax in the peripheral lung compared to the central airways. However, from 6 to 24 h after dosing the systemic concentrations of SMX from both regions were quite si...
Source: European Journal of Pharmaceutical Sciences - March 9, 2024 Category: Drugs & Pharmacology Authors: Per Gerde Carl-Olof Sj öberg Helen B äckroos Joakim Englund Marit Wangheim Helena Litorp Source Type: research

Environmental considerations along the life cycle of pharmaceuticals: Interview study on views regarding environmental challenges, concerns, strategies, and prospects within the pharmaceutical industry
Eur J Pharm Sci. 2024 Mar 7:106743. doi: 10.1016/j.ejps.2024.106743. Online ahead of print.ABSTRACTEnvironmental impacts of medicines arise throughout their entire life cycle. The pharmaceutical industry has a key role in reducing these impacts in early production phases, but currently has limited possibilities to reduce the environmental exposure arising from drug consumption and end-of-life. The aim of this interview study was to explore the current environmental actions within the industry, as well as the views and attitudes toward the strategies to address the environmental challenges and concerns. Semi-structured inte...
Source: European Journal of Pharmaceutical Sciences - March 9, 2024 Category: Drugs & Pharmacology Authors: Sanja Riikonen Johanna Timonen Tiina Sikanen Source Type: research

Open Forum Conference on the ICH M13A Bioequivalence Guideline
Discussion Forum on the ICH M13A draft "Guideline on bioequivalence for immediate-release solid oral dosage forms". This conference was cosponsored by the Arbeitsgemeinschaft Pharmazeutische Verfahrenstechnik (APV) and the Frankfurt Foundation Quality of Medicines. Scientists from academia and industry attended this workshop on May 15, 2023, in Frankfurt/Germany, to discuss the suggested regulations with the European members of the ICH drafting group. The aim of this report is to summarise and highlight the main discussion points such as choice of study population (females and/or males), request for fasted and/or fed studi...
Source: European Journal of Pharmaceutical Sciences - March 7, 2024 Category: Drugs & Pharmacology Authors: Henning Blume Steven Wedemeyer Anne Seidlitz Gerald Beuerle Sandra Klein Erem Bilensoy Source Type: research

The 2-aminoethyl diphenylborinate-based fluorescent method identifies quercetin and luteolin metabolites as substrates of Organic anion transporting polypeptides, OATP1B1 and OATP2B1
Eur J Pharm Sci. 2024 Mar 2:106740. doi: 10.1016/j.ejps.2024.106740. Online ahead of print.ABSTRACTOrganic anion transporting polypeptides (OATPs), OATP1B1 and OATP2B1 are membrane proteins mediating the cellular uptake of chemically diverse organic compounds. OATP1B1 is exclusively expressed in hepatocytes and plays a key role in hepatic detoxification. The ubiquitously expressed OATP2B1 promotes the intestinal absorption of orally administered drugs. Flavonoids are widely found in foods and beverages, and many of them can inhibit OATP function, resulting in food-drug interactions. In our previous work, we have shown that...
Source: European Journal of Pharmaceutical Sciences - March 4, 2024 Category: Drugs & Pharmacology Authors: Hana Kaci Éva Bakos Paul W Needs Paul A Kroon Kate řina Valentová Mikl ós Poór Csilla Özvegy-Laczka Source Type: research

Virtual Special Issue of Nordic POP: Patient-Oriented Products
Eur J Pharm Sci. 2024 Mar 1:106737. doi: 10.1016/j.ejps.2024.106737. Online ahead of print.NO ABSTRACTPMID:38432548 | DOI:10.1016/j.ejps.2024.106737 (Source: European Journal of Pharmaceutical Sciences)
Source: European Journal of Pharmaceutical Sciences - March 3, 2024 Category: Drugs & Pharmacology Authors: Jessica M Rosenholm G øril Eide Flaten Alexandra Teleki Source Type: research

Screening of 16 major drug glucuronides for time-dependent inhibition of nine drug-metabolizing CYP enzymes - detailed studies on CYP3A inhibitors
In conclusion, we identified several glucuronide metabolites with CYP inhibitory properties. Based on detailed experiments, the inactivation of CYP3A by carvedilol may cause clinically significant drug-drug interactions.PMID:38423227 | DOI:10.1016/j.ejps.2024.106735 (Source: European Journal of Pharmaceutical Sciences)
Source: European Journal of Pharmaceutical Sciences - February 29, 2024 Category: Drugs & Pharmacology Authors: Helin ä Kahma Marie-No ëlle Paludetto Mikko Neuvonen Mika Kurkela Anne M Filppula Mikko Niemi Janne T Backman Source Type: research

Microfluidics produced ATRA-loaded PLGA NPs reduced tuberculosis burden in alveolar epithelial cells and enabled high delivered dose under simulated human breathing pattern in 3D printed head models
Eur J Pharm Sci. 2024 Feb 26:106734. doi: 10.1016/j.ejps.2024.106734. Online ahead of print.ABSTRACTTuberculosis, caused by Mycobacterium tuberculosis (Mtb), is second only to COVID-19 as the top infectious disease killer worldwide. Multi-drug resistant TB (MDR-TB) may arise because of poor patient adherence to medications due to lengthy treatment duration and side effects. Delivering novel host directed therapies (HDT), like all trans retinoic acid (ATRA) may help to improve drug regimens and reduce the incidence of MDR-TB. Local delivery of ATRA to the site of infection leads to higher bioavailability and reduced systemi...
Source: European Journal of Pharmaceutical Sciences - February 28, 2024 Category: Drugs & Pharmacology Authors: Ahmad Z Bahlool Brenton Cavanagh Andrew O' Sullivan Ronan MacLoughlin Joseph Keane Mary P O' Sullivan Sally-Ann Cryan Source Type: research

Development and characterization of solid lipid-based formulations (sLBFs) of ritonavir utilizing a lipolysis and permeation assay
In this study, ritonavir loaded solid LBFs (sLBFs) were prepared using solid lipid excipients to investigate whether sLBFs are also capable of improving solubility and permeability. Additionally, the influence of polymeric precipitation inhibitors (PVP-VA and HPMC-AS) on lipolysis triggered supersaturation and precipitation was investigated. One step intestinal digestion and bicompartmental permeation studies using an artificial lecithin-in-dodecane (LiDo) membrane were performed for each formulation. All formulations presented significantly higher solubility (5 to >20-fold higher) during lipolysis and permeation studie...
Source: European Journal of Pharmaceutical Sciences - February 26, 2024 Category: Drugs & Pharmacology Authors: Arne Schulzen Ioannis I Andreadis Christel A S Bergstr öm Julian Quodbach Source Type: research