journal
https://read.qxmd.com/read/38857646/biowaiver-monograph-for-immediate-release-solid-oral-dosage-forms-fexofenadine
#1
JOURNAL ARTICLE
Naseem A Charoo, N Selvasudha, Zahira Nala Kath, Bertil Abrahamsson, Rodrigo Cristofoletti, Atsushi Kambayashi, Peter Langguth, Mehul Mehta, Alan Parr, James E Polli, Vinod P Shah, Jennifer Dressman
In this monograph, the potential use of methods based on the Biopharmaceutics Classification System (BCS) framework to evaluate the bioequivalence of solid immediate-release (IR) oral dosage forms containing fexofenadine hydrochloride as a substitute for a pharmacokinetic study in human volunteers is investigated. We assessed the solubility, permeability, dissolution, pharmacokinetics, pharmacodynamics, therapeutic index, bioavailability, drug-excipient interaction, and other properties using BCS recommendations from the ICH, FDA and EMA...
June 8, 2024: Journal of Pharmaceutical Sciences
https://read.qxmd.com/read/38857645/converting-short-acting-insulin-into-thermo-stable-longer-acting-insulin-using-multi-layer-detachable-microneedles
#2
JOURNAL ARTICLE
Theerapat Phoka, Nisha Wanichwecharungruang, Narintorn Dueanphen, Naruchit Thanuthanakhun, Pongtorn Kietdumrongwong, Asada Leelahavanichkul, Supason Wanichwecharungruang
The detachable dissolving microneedles (DDMNs) feature an array of needles capable of being separated from the base sheet during administration. Here they were fabricated to address delivery efficiency and storage stability of insulin. The constructed insulin-DDMN is multi-layered, with 1) a hard tip cover layer; 2) a layer of regular short-acting insulin (RI) mixed with hyaluronic acid (HA) and sorbitol (Sor) which occupies the taper tip region of the needles; 3) a barrier layer situated above the RI layer; and 4) a fast-dissolving layer connecting the barrier layer to the base sheet...
June 8, 2024: Journal of Pharmaceutical Sciences
https://read.qxmd.com/read/38857644/simultaneous-protein-adsorption-and-viscosity-measurement-using-micropillar-enhanced-acoustic-wave-%C3%AE-paw-device-for-pharmaceutical-applications
#3
JOURNAL ARTICLE
Ilia Chiniforooshan Esfahani, Nastaran A Tehrani, Siqi Ji, Hongwei Sun
At the early stages of drug development, the amount of drug materials is rather limited. In this case, viscosity measurement is often postponed to the later stages, where grams of proteins can be produced. Therefore, it is necessary to develop a viscometer capable of measuring the viscosity with high accuracy while requiring low sample volume. This study presents a novel viscosity measurement technique based on measuring the resonance frequency and motional resistance of a micropillar-enhanced acoustic wave (μPAW) device...
June 8, 2024: Journal of Pharmaceutical Sciences
https://read.qxmd.com/read/38857643/physiologically-based-pharmacokinetic-modeling-and-clinical-extrapolation-for-topical-application-of-pilocarpine-on-eyelids-a-comprehensive-study
#4
JOURNAL ARTICLE
Jiaying Lin, Fengjiao Bu, Dan Wu, Pin Jiang, Qingfeng He, Dongsheng Yang, Xiao Zhu, Yixue Wang, Xiaoqiang Xiang
Exploiting a convenient and highly bioavailable ocular drug delivery approach is currently one of the hotspots in the pharmaceutical industry. Eyelid topical application is seen to be a valuable strategy in the treatment of chronic ocular diseases. To further elucidate the feasibility of eyelid topical administration as an alternative route for ocular drug delivery, pharmacokinetic and pharmacodynamic studies of pilocarpine were conducted in rabbits. Besides, a novel physiologically based pharmacokinetic (PBPK) model describing eyelid transdermal absorption and ocular disposition was developed in rabbits...
June 8, 2024: Journal of Pharmaceutical Sciences
https://read.qxmd.com/read/38857642/a-robust-chromatographic-method-for-drug-release-profiling-of-liposomal-doxorubicin-hcl
#5
JOURNAL ARTICLE
Isabelle I Niyonshuti, Savithra Jayaraj, Wenlei Jiang, Thilak Mudalige
Liposomes are excellent drug delivery vehicles for chemotherapeutics as they may change the pharmacokinetics of therapeutic compounds, resulting in altered tissues distribution, and in some cases, reduced cytotoxicity and enhanced distribution and efficacy of the active pharmaceutical ingredient (API) at target tissues. Drug release profiles of liposomal formulations are crucial to support equivalence evaluation and quality control in pre- and post-approval stages. We developed an automated chromatographic method for quantifying the drug release profile of liposomal formulations containing doxorubicin to overcome the shortcomings of currently available methods...
June 8, 2024: Journal of Pharmaceutical Sciences
https://read.qxmd.com/read/38852674/microparticles-incorporating-dual-apoptotic-factors-to-inhibit-anti-inflammatory-effects-in-macrophages
#6
JOURNAL ARTICLE
Sean R Simpson, Denzel Middleton, Nicole Rose Lukesh, Md Jahirul Islam, Eric M Bachelder, Kristy M Ainslie
New approaches to treat autoimmune diseases are needed, and we can be inspired by mechanisms in immune tolerance to guide the design of these approaches. Efferocytosis, the process of phagocyte-mediated apoptotic cell (AC) disposal, represents a potent tolerogenic mechanism that we could draw inspiration from to restore immune tolerance to specific autoantigens. ACs engage multiple avenues of the immune response to redirect aberrant immune responses. Two such avenues are: phosphatidylserine on the outer leaflet of the cell and engaging the aryl hydrocarbon receptor (AhR) pathway...
June 7, 2024: Journal of Pharmaceutical Sciences
https://read.qxmd.com/read/38852673/examination-of-particulate-contamination-in-parenteral-injections-and-infusions-following-fluid-withdrawal-utilizing-conventional-needles-and-filter-needles-assessment-of-compliance-and-comparative-analysis
#7
JOURNAL ARTICLE
Roland B van den Berg, Monica Ganesh, Mirjam Crul, Erik B Wilms, Eleonora L Swart, Elsbeth M Westerman
Particulate contamination, the unintentional presence of particles in parenteral fluids, is associated with potential risks such as phlebitis and thrombophlebitis. Recent guidelines recommend the use of filter needles when withdrawing parenteral fluid from vials with a rubber stopper. However, the literature is limited and lacks clarity regarding the advantages of filter needles over conventional needles. The aim of this study was to assess the compliance of parenteral fluids regarding particulate contamination after withdrawing fluid using both conventional needles and filter needles, following the guidelines of European Pharmacopoeia (Ph...
June 7, 2024: Journal of Pharmaceutical Sciences
https://read.qxmd.com/read/38852672/lessons-to-learn-for-3d-printing-of-drug-products-by-semisolid-extrusion-sse
#8
JOURNAL ARTICLE
Weining Sun, Jukka Rantanen, Natalja Genina
Semisolid extrusion (SSE) 3DP technology is emerging due to its simplicity and potential for on-site manufacturing of personalized drug products with tailored functionality (dose, release profile), as well as recognizability (size, shape, color). However, even a minor change in the composition of the ink (the feedstock material) and the printing process parameters can largely influence the outcome of printing. This paper summarizes the recent SSE 3D printing studies, where the important factors affecting the quality of the printed drug products are discussed...
June 7, 2024: Journal of Pharmaceutical Sciences
https://read.qxmd.com/read/38825234/mechanical-characterization-of-vial-strain-during-freezing-and-thawing-operations-using-amorphous-excipients
#9
JOURNAL ARTICLE
Drew Strongrich, Ian Flynn, Bakul Bhatnagar, Evgenyi Shalaev, Serguei Tchessalov
The purpose of this study was to investigate the mechanical stresses and strains acting on pharmaceutical glass tubing vials during freezing and thawing of model pharmaceutical formulations. Strain measurements were conducted inside of a laboratory-scale freeze-dryer using a custom wireless sensor. In both sucrose and trehalose formulations at concentrations between 5-20%, the strain measurements initially increased before peaking in magnitude at temperatures close to the respective glass transition temperatures of the maximally freeze concentrated solutes, Tg'...
May 31, 2024: Journal of Pharmaceutical Sciences
https://read.qxmd.com/read/38815860/identification-and-characterization-of-rotigotine-degradation-products-by-hplc-coupled-dad-and-cad-detectors-and-hrms-through-q-orbitrap-and-electrospray-ionization
#10
JOURNAL ARTICLE
Thamara de Carvalho Mendes, Gil Mendes Viana, Letícia Coli Louvisse de Abreu, Carina de Souza Anselmo, Henrique Marcelo Gualberto Pereira, Antônio Jorge Ribeiro da Silva, Lucio Mendes Cabral, Valeria Pereira de Sousa
Rotigotine (RTG) is a dopamine agonist used in the treatment of Parkinson's disease. As it is susceptible to oxidation, stability studies must be carefully designed for the identification and characterization of all possible degradation products. Here, RTG degradation was evaluated according to the International Conference on Harmonization guidelines under various stress conditions, including acidic and basic hydrolysis, oxidative, metallic, photolytic, and thermal conditions. Additionally, more severe stress conditions were applied to induce RTG degradation...
May 28, 2024: Journal of Pharmaceutical Sciences
https://read.qxmd.com/read/38810881/impact-of-post-manufacturing-handling-of-protein-based-biologic-drugs-on-product-quality-and-user-centricity
#11
REVIEW
Elia Cappelletto, Stanley C Kwok, Lea Sorret, Nathalie Fuentes, Annette Medina, Stephen Burleigh, Jonas Fast, Isla S Mackenzie, Anna Millqvist Fureby, Mattias Paulsson, Marie Wahlgren, Ulla Elofsson, Angela Flynn, Giorgia Miolo, Lina Nyström, Patrizia Polverino De Laureto, Giorgia De Paoli
This article evaluates the current gaps around the impact of post-manufacturing processes on the product qualities of protein-based biologics, with a focus on user centricity. It includes the evaluation of the regulatory guidance available, describes a collection of scientific literature and case studies to showcase the impact of post-manufacturing stresses on product and dosing solution quality. It also outlines the complexity of clinical handling and the need for communication, and alignment between drug providers, healthcare professionals, users, and patients...
May 27, 2024: Journal of Pharmaceutical Sciences
https://read.qxmd.com/read/38801974/development-of-new-nanoniosome-carriers-for-vorinostat-evaluation-of-anticancer-efficacy-in-vitro
#12
JOURNAL ARTICLE
R Nazari-Vanani, Z Kayani, K Karimian, M R Ajdari, H Heli
Vorinostat (VST) is a chemotherapeutic agent administrated for various types of cancers. However, it suffers from side effects and chemoresistance that reduce its application. Different nanoniosomes comprised Span 20, 60, 65 and 80 were prepared by the thin film hydration method and loaded with VST. The nanoniosomes were physicochemically characterized using particle size analysis and field emission scanning electron microscopy. The best formulation that was prepared using Span 65 (VST-NN-S65) included vesicle size of 127 nm with a narrow size distribution...
May 25, 2024: Journal of Pharmaceutical Sciences
https://read.qxmd.com/read/38801973/microfluidic-stress-device-to-decouple-the-synergistic-effect-of-shear-and-interfaces-on-antibody-aggregation
#13
JOURNAL ARTICLE
Michael S Gerlt, Eduard M Meier, Fabian Dingfelder, Dominik Zürcher, Marius Müller, Paolo Arosio
Protein denaturation and aggregation resulting from the effects of interfacial stress that can be enhanced by flow and shear stress pose significant challenges in the production of therapeutic proteins such as monoclonal antibodies. The influence of flow on protein stability is closely intertwined with interfacial effects. In this study, we have developed a microfluidic device capable of exposing low volume (< 320 μL) protein solutions to highly uniform shear. To disentangle the synergistic impact of flow and interfaces on protein aggregation, we fabricated two devices composed of different materials, namely poly(methyl methacrylate) (PMMA) and stainless steel...
May 25, 2024: Journal of Pharmaceutical Sciences
https://read.qxmd.com/read/38801972/genistein-chitosan-derivative-nanoparticles-for-targeting-and-enhancing-the-anti-breast-cancer-effect-of-tamoxifen-in-vitro
#14
JOURNAL ARTICLE
Yang Xing, Weiguang Shen, Chuan Sun, Ruyi Wang, Bo Fan, Guixian Liang
Tamoxifen (TAM) is a classical anti-estrogenic drug that antagonizes estrogen by competitively binding to estrogen receptor α (ERα). However, drug resistance to TAM remains a significant challenge in breast cancer treatment. In this study, we aimed to design an actively targeted drug delivery system to enhance the proliferation inhibitory effects of TAM on ER positive breast cancer cells. Herein, chitosan (CS) was modified with genistein (GEN) to obtain the actively targeted GEN-CS. The TAM-loaded nanoparticles (TAM-GEN-CS-NPs) were constructed using an ionic-crosslinking method, with GEN-CS as the carrier material and sodium tripolyphosphate (TPP) as the crosslinking agent...
May 25, 2024: Journal of Pharmaceutical Sciences
https://read.qxmd.com/read/38796157/miscibility-of-amorphous-solid-dispersions-a-rheological-and-solid-state-nmr-spectroscopy-study
#15
JOURNAL ARTICLE
Sichen Song, Jianchao Xu, Zhenxuan Chen, Changquan Calvin Sun, Eric J Munson, Ronald A Siegel
Miscibility is critical in the prediction of stability against crystallization of amorphous solid dispersions (ASDs) in the solid state. However, currently available approaches for its determination are limited by both theoretical and practical considerations. Recently, a rheological approach guided by the polymer overlap concentration (c*) has been proposed for miscibility quantification of ASDs [J. Pharm. Sci., 112 (2023) 204-212] and shown to be useful in predicting both accelerated and long term physical stability without the presence of moisture...
May 23, 2024: Journal of Pharmaceutical Sciences
https://read.qxmd.com/read/38796156/characterization-of-therapeutic-antibody-charge-heterogeneity-under-stress-conditions-by-microfluidic-capillary-electrophoresis-coupled-with-mass-spectrometry
#16
JOURNAL ARTICLE
Zhijie Wu, Hongxia Wang, Xueqing Zhao, Chao Gong, Sarah Sidnam, Borja Cantero-Tubilla, Bojana Nedjic-Dugic, Meinuo Li, Jikang Wu, Yue Su, Yu Huang, Haibo Qiu, Ning Li
Therapeutic antibodies are a major class of biopharmaceutics that are applied in disease treatment because of their many advantages, including high specificity and high affinity to molecular targets. Between their production and administration, therapeutic antibodies are exposed to multiple stress conditions. Forced degradation and stress stability studies are conducted to simulate the risk of degradation and the effects of these stresses, thereby enhancing understanding of the drug product to support strategies to mitigate the impact from stressed conditions...
May 23, 2024: Journal of Pharmaceutical Sciences
https://read.qxmd.com/read/38796155/mechanistic-investigation-of-enzyme-triggered-release-from-a-xyloglucan-matrix-tablet-for-controlled-colonic-drug-delivery
#17
JOURNAL ARTICLE
Viviane Doggwiler, Michael Lanz, Georg Lipps, Georgios Imanidis
The objective of this study was to investigate the mechanisms underlying drug release from a controlled colonic release (CCR) tablet formulation based on a xyloglucan polysaccharide matrix and identify the factors that control the rate of release for the purpose of fundamentally substantiating the concept and demonstrating its robustness for colonic drug delivery. Previous work demonstrated in vitro limited release of 5-aminosalicylic acid (5-ASA) and caffeine from these tablets in small intestinal environment and significant acceleration of release by xyloglucanase, an enzyme of the colonic microbiome...
May 23, 2024: Journal of Pharmaceutical Sciences
https://read.qxmd.com/read/38796154/first-in-human-predictions-of-hepatic-clearance-for-drugs-with-the-well-stirred-model-comparative-assessment-between-models-of-fraction-unbound-based-either-on-the-free-drug-hypothesis-albumin-facilitated-hepatic-uptake-or-dynamic-binding-kinetics
#18
JOURNAL ARTICLE
Patrick Poulin
The well-stirred model (WSM) is commonly used to predict the hepatic clearance in vivo (CLH ) of drugs. The necessary intrinsic clearance of the unbound drug (CLint-in vitro-unbound ) is generated in the in vitro assays in the presence of microsomes or hepatocytes but in the absence of plasma proteins. The value of CLint-in vitro-unbound can be extrapolated with the fraction unbound determined in vitro in plasma (fup ) if the fraction unbound in vivo in liver is the same. However, this approach resulted to a systematic underprediction bias of CLH ...
May 23, 2024: Journal of Pharmaceutical Sciences
https://read.qxmd.com/read/38796153/drug-leachable-interaction-product-evaluation-in-prefilled-syringe-of-ganirelix-acetate-injection
#19
JOURNAL ARTICLE
Dinesh Mule, Sachin Chaturvedi, Devendra Badgujar, Sree Teja Paritala, Nitish Sharma, Ravi P Shah
The concept of extractables and leachable has introduced in a new era for identifying potential impurities in drug products. Pharmaceutical packaging materials encompass a variety of polymers due to their appealing properties for storing the drug product. However, numerous chemical species may leach into the drug product from these polymers, posing significant health hazards in the public domain. Identifying such leachable is crucial for assessing safety and addressing toxicological concerns. Acrylic acids are commonly used materials for adhering needles to the barrel in pre-filled syringes...
May 23, 2024: Journal of Pharmaceutical Sciences
https://read.qxmd.com/read/38777176/advanced-chemical-and-imaging-methods-for-studying-structure-morphology-and-excipients-solid-state-transformations-in-pharmaceutical-multiparticulate-formulations
#20
JOURNAL ARTICLE
Elizabeth J Legge, Mark Stewart, Lourdes Contreras, Hannah Zhang, Dimitrios Tsikritsis, Natalie A Belsey, Mark McAllister, John Richard Murphy, Ken Mingard, Caterina Minelli
The formulation of paediatric medicines faces significant challenges to meet the requirements for safe and accurate administration, while maintaining a suitable taste. Multiparticulate formulations have a strong potential to address these challenges because they combine dose flexibility with ease of administration. Understanding the stability of multiparticulate formulations over storage as a function of time and environmental parameters, such as humidity and temperature, is important to manage their commercialisation and use...
May 20, 2024: Journal of Pharmaceutical Sciences
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