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European Journal of Pharmaceutics and Biopharmaceutics

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https://www.readbyqxmd.com/read/29792911/prolonged-drug-release-properties-for-orodispersible-films-by-combining-hot-melt-extrusion-and-solvent-casting-methods
#1
Isabell Speer, Maren Preis, Jörg Breitkreutz
Orodispersible films (ODFs) are an advantageous dosage form to accomplish patient convenience and compliance in oral drug delivery. They provide a number of special application features, such as the ease of administration without water and suitability for patients with swallowing problems. However, this promising dosage form has been limited to immediate release formulations so far. The aim of this study was to develop a thin film produced by solvent casting, which is rapidly disintegrating when placed in the mouth, but which provides prolonged drug release characteristics by incorporating drug-loaded matrix particles (MPs)...
May 21, 2018: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29787801/looking-inside-the-black-box-freezing-engineering-to-ensure-the-quality-of-freeze-dried-biopharmaceuticals
#2
Luigi C Capozzi, Roberto Pisano
The freezing step plays a central role in reaching the most stringent requirements of quality, homogeneity and standardization of freeze-dried products. In this paper, a systematic procedure has been proposed to obtain a quantitative estimation of the pore-size variability of lyophilized products resulting from uncontrollable variations of the nucleation temperature. This procedure consisted in collecting the nucleation temperature from a statistically significant number of samples and correlating each nucleation temperature to the corresponding product morphology, using a mathematical model, to obtain a statistical description of the lyophilized product structure...
May 19, 2018: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29787800/the-effect-of-formulation-on-spray-dried-sabin-inactivated-polio-vaccine
#3
Gaurav Kanojia, Rimko Ten Have, Debbie Brugmans, Peter C Soema, Henderik W Frijlink, Jean-Pierre Amorij, Gideon Kersten
The objective of this study was to develop a stable spray dried formulation, containing the three serotypes of Sabin inactivated polio vaccine (sIPV), aiming for minimal loss of native conformation (D-antigen) during drying and subsequent storage. The influence of atomization and drying stress during spray drying on trivalent sIPV was investigated. This was followed by excipient screening, in which monovalent sIPV was formulated and spray dried. Excipient combinations and concentrations were tailored to maximize both the antigen recovery of respective sIPV serotypes after spray drying and storage (T= 40°C and t= 7 days)...
May 19, 2018: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29778525/mucus-penetrating-nanoparticles-promising-drug-delivery-systems-for-the-photodynamic-therapy-of-intestinal-cancer
#4
Juliane Anderski, Laura Mahlert, Dennis Mulac, Klaus Langer
Photodynamic therapy (PDT) is an auspicious therapy approach for the treatment of cancer. Despite its numerous benefits, the drug delivery of the used photosensitizer (PS) to target locations inside the human body remains a main therapy challenge, since the standard intravenous PS injection often causes systemic side-effects. To circumvent this therapy drawback, the oral application represents a promising administration alternative. Especially for the treatment of intestinal cancer it offers the possibility of a local treatment with a reduced likelihood for adverse drug reactions...
May 17, 2018: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29777773/progress-in-formulation-development-and-sterilisation-of-freeze-dried-oligodeoxynucleotide-loaded-gelatine-nanoparticles
#5
Katharina J Geh, Madlen Hubert, Gerhard Winter
Oligodeoxynucleotide (ODN)-loaded gelatine nanoparticles (GNPs) have proven their outstanding potential in the treatment of allergic diseases such as equine asthma and canine atopic dermatitis, which are appropriate models for the corresponding human diseases. To encourage the development of a marketable product, long term stability and sterility needs to be ensured. In this work, we aimed to advance freeze-drying options to stabilise ODN-loaded GNPs. Matrix-assisted laser desorption/ionisation mass spectrometry time-of-flight was implemented as a versatile tool to assess ODN stability...
May 16, 2018: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29777772/improving-maraviroc-oral-bioavailability-by-formation-of-solid-drug-nanoparticles
#6
Alison C Savage, Lee M Tatham, Marco Siccardi, Trevor Scott, Manoli Vourvahis, Andrew Clark, Steve P Rannard, Andrew Owen
Oral drug administration remains the preferred approach for treatment of HIV in most patients. Maraviroc (MVC) is the first in class co-receptor antagonist, which blocks HIV entry into host cells. MVC has an oral bioavailability of approximately 33%, which is limited by poor permeability as well as affinity for CYP3A and several drug transporters. While once-daily doses are now the favoured option for HIV therapy, dose-limiting postural hypotension has been of theoretical concern when administering doses high enough to achieve this for MVC (particularly during coadministration of enzyme inhibitors)...
May 16, 2018: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29775665/use-of-computational-fluid-dynamics-for-improving-freeze-dryers-design-and-process-understanding-part-1-modelling-the-lyophilisation-chamber
#7
Antonello A Barresi, Valeria Rasetto, Daniele L Marchisio
This manuscript shows how computational models, mainly based on Computational Fluid Dynamics (CFD), can be used to simulate different parts of an industrial freeze-drying equipment and to properly design them; in particular, the freeze-dryer chamber and the duct connecting the chamber with the condenser, with the valves and vanes eventually present are analysed in this work. In Part 1, it will be shown how CFD can be employed to improve specific designs, to perform geometry optimization, to evaluate different design choices and how it is useful to evaluate the effect on product drying and batch variance...
May 15, 2018: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29753774/facile-fabrication-of-microparticles-with-ph-responsive-macropores-for-small-intestine-targeted-drug-formulation
#8
Bahman Homayun, Chengmeng Sun, Ankit Kumar, Carlo Montemagno, Hyo-Jick Choi
Oral drugs present the most convenient, economical, and painless route for self-administration. Despite commercialization of multiple technologies relying on micro- and nanocrystalline drugs, research on microparticles (MPs) based oral biopharmaceuticals delivery systems has still not culminated well enough in commercial products. This is largely due to the drugs being exposed to the destabilizing environment during MP synthesis process, and partly because of complicated process conditions. Hence, we developed a solvent swelling-evaporation method of producing pH-responsive MPs with micron-sized macropores using poly(methacrylic acid-co-ethyl acrylate) in 1:1 ratio (commercial name: Eudragit® L100-55 polymer)...
May 10, 2018: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29746910/determination-of-the-dried-product-resistance-variability-and-its-influence-on-the-product-temperature-in-pharmaceutical-freeze-drying
#9
Bernadette Scutellà, Ioan Cristian Trelea, Erwan Bourlès, Fernanda Fonseca, Stephanie Passot
During the primary drying step of the freeze-drying process, mass transfer resistance strongly affects the product temperature, and consequently the final product quality. The main objective of this study was to evaluate the variability of the mass transfer resistance resulting from the dried product layer (Rp ) in a manufacturing batch of vials, and its potential effect on the product temperature, from data obtained in a pilot scale freeze-dryer. Sublimation experiments were run at -25 °C and 10 Pa using two different freezing protocols: with spontaneous or controlled ice nucleation...
May 7, 2018: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29738819/use-of-computational-fluid-dynamics-for-improving-freeze-dryers-design-and-process-understanding-part-2-condenser-duct-and-valve-modelling
#10
Daniele L Marchisio, Miquel Galan, Antonello A Barresi
This manuscript shows how computational models, mainly based on Computational Fluid Dynamics (CFD), can be used to simulate different parts of an industrial freeze-drying equipment and to properly design them; in particular in this part the duct connecting the chamber with the condenser, with its valves, is considered, while the chamber design and its effect on drying kinetics have been investigated in Part 1. Such an approach allows a much deeper process understanding and assessment of the critical aspects of lyophilisation...
May 5, 2018: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29738716/corrigendum-to-an-insight-of-in-vitro-transport-of-pegylated-non-ionic-surfactant-vesicles-nsvs-across-the-intestinal-polarized-enterocyte-monolayers-eur-j-pharm-biopharm-127-2018-432-442
#11
Rosita Primavera, Paola Palumbo, Christian Celia, Felisa Cilurzo, Benedetta Cinque, Elisabetta Carata, Maria Carafa, Donatella Paolino, Maria Grazia Cifone, Luisa Di Marzio
No abstract text is available yet for this article.
May 5, 2018: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29733952/ph-sensitive-prodrug-conjugated-polydopamine-for-nir-triggered-synergistic-chemo-photothermal-therapy
#12
Huaihong Zhanga, Yu Sun, Rong Hung, Hui Cang, Zhaosheng Cai, Baiwang Sun
Combination of chemotherapy with photothermal therapy (PTT) demonstrate highly desirable for efficient medical treatment of tumor. At present works, camptothecin (CPT)-containing polymeric prodrug (PCPT) were fabricated by polymerization of a pH-sensitive camptothecin (CPT) prodrug monomer and MPC using reversible addition-fragmentation transfer (RAFT) strategy. The pH-sensitive polymeric prodrug was tethered onto surface of polydopamine (PDA) nanoparticles by amidation chemistry for combination of chemotherapy with photothermal therapy...
May 4, 2018: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29733951/bioinspired-co-crystals-of-imatinib-providing-enhanced-kinetic-solubility
#13
Maude Reggane, Johannes Wiest, Marco Saedtler, Cornelius Harlacher, Marcus Gutmann, Sven H Zottnick, Philippe Piechon, Ina Dix, Klaus Müller-Buschbaum, Ulrike Holzgrabe, Lorenz Meinel, Bruno Galli
Realizing the full potential of co-crystals enhanced kinetic solubility demands a comprehensive understanding of the mechanisms of dissolution, phase conversion, nucleation and crystal growth, and of the complex interplay between the active pharmaceutical ingredient (API), the coformer and co-existing forms in aqueous media. One blueprint provided by nature to keep poorly water-soluble bases in solution is the complexation with phenolic acids. Consequently, we followed a bioinspired strategy for the engineering of co-crystals of a poorly water-soluble molecule - Imatinib - with a phenolic acid, syringic acid (SYA)...
May 4, 2018: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29733950/recent-advances-in-carrier-mediated-nose-to-brain-delivery-of-pharmaceutics
#14
REVIEW
Vassilis Bourganis, Olga Kammona, Aleck Alexopoulos, Costas Kiparissides
Central nervous system (CNS) disorders (e.g., multiple sclerosis, Alzheimer's disease, etc.) represent a growing public health issue, primarily due to the increased life expectancy and the aging population. The treatment of such disorders is notably elaborate and requires the delivery of therapeutics to the brain in appropriate amounts to elicit a pharmacological response. However, despite the major advances both in neuroscience and drug delivery research, the administration of drugs to the CNS still remains elusive...
May 4, 2018: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29733949/influence-of-extended-dwell-time-during-pre-and-main-compression-on-the-properties-of-ibuprofen-tablets
#15
E Peeters, A F T Silva, M Fonteyne, T De Beer, C Vervaet, J P Remon
The low melting point, poor flow, physico-mechanical properties (particle size distribution, shape, particle surface roughness) and deformation mechanism of ibuprofen in combination with its high dose in tablets all contribute to the problems observed during the compaction of ibuprofen-based formulations. Since ibuprofen is plastically and elastically deforming, the rate of compaction plays an important role in both the final tablet properties and the risk of capping, laminating and sticking to the punches...
May 4, 2018: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29733948/predictive-models-of-lyophilization-process-for-development-scale-up-tech-transfer-and-manufacturing
#16
Tong Zhu, Ehab M Moussa, Madeleine Witting, Deliang Zhou, Kushal Sinha, Mario Hirth, Martin Gastens, Sherwin Shang, Nandkishor Nere, Shubha Chetan Somashekar, Alina Alexeenko, Feroz Jameel
Scale-up and technology transfer of lyophilization processes remains a challenge that requires thorough characterization of the laboratory and larger scale lyophilizers. In this study, computational fluid dynamics (CFD) was employed to develop computer-based models of both laboratory and manufacturing scale lyophilizers in order to understand the differences in equipment performance arising from distinct designs. CFD coupled with steady state heat and mass transfer modeling of the vial were then utilized to study and predict independent variables such as shelf temperature and chamber pressure, and response variables such as product resistance, product temperature and primary drying time for a given formulation...
May 4, 2018: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29730261/acid-degradable-lactobionic-acid-modified-soy-protein-nanogels-crosslinked-by-ortho-ester-linkage-for-efficient-antitumor-in-vivo
#17
Xu Cheng, Jiejie Qin, Xin Wang, Qian Zha, Weijing Yao, Shengxiang Fu, Rupei Tang
It remains a crucial challenge to achieve efficient cellular uptake and intracellular drug release in tumor cells for the nanoscale drug delivery systems. Herein, acid-degradable nanogels were prepared by cross-linking methacrylated soy protein with an acid-labile ortho ester cross-linker (NG1), and then modified with lactobionic acid (LA) to give tumor-targeted nanogels (NG2). Both NG1 and NG2 displayed excellent stability in neutral environment, while showed pH-triggered degradation behaviors under mildly acidic conditions resulting from the breakage of ortho ester bonds...
May 3, 2018: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29730260/inner-layer-embedded-contact-lenses-for-ph-triggered-controlled-ocular-drug-delivery
#18
Qiang Zhu, Chang Liu, Zheng Sun, Xiaofei Zhang, Ning Liang, Shirui Mao
Contact lenses (CLs) are ideally suited for controlled ocular drug delivery, but are limited by short release duration, poor storage stability and low drug loading. In this study, we present a novel inner layer-embedded contact lens capable of pH-triggered extended ocular drug delivery with good storage stability. Blend film of ethyl cellulose and Eudragit S100 was used as the inner layer, while pHEMA hydrogel was used as outer layer to fabricate inner layer-embedded contact lens. Using diclofenac sodium(DS) as a drug model, influence of polymer ratio in the blend film, EC viscosity, drug/polymer ratio, inner layer thickness and outlayer thickness of pHEMA hydrogel on drug release behavior was studied and optimized for daily use...
May 3, 2018: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29730259/on-the-needle-clogging-of-staked-in-needle-pre-filled-syringes-mechanism-of-liquid-entering-the-needle-and-solidification-process
#19
M De Bardi, R Müller, C Grünzweig, D Mannes, P Boillat, M Rigollet, F Bamberg, T A Jung, K Yang
Staked-in-needle prefilled syringes (SIN-PFS) are widely used for the parenteral administration of drug product solutions. During stability studies, clogging of the injection needle was observed in syringes filled with concentrated antibody solution. A prerequisite for this phenomenon is that liquid has entered the needle. In this study, we characterized the mechanism causing the entry and movement of liquid in the needle using neutron imaging without manipulating the container closure integrity of the syringe...
May 3, 2018: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29730258/a-combination-of-interdisciplinary-analytical-tools-for-evaluation-of-multi-layered-coatings-on-medical-grade-stainless-steel-for-biomedical-applications
#20
Uroš Maver, Klodian Xhanari, Marko Žižek, Dorota Korte, Lidija Gradišnik, Mladen Franko, Matjaž Finšgar
In this comprehensive study several analytical techniques were used in order to evaluate multi--layered biomedical surface coatings composed of a drug (diclofenac) and a polymer (chitosan). Such a thorough examination is of paramount importance in order to assure safety and prove efficiency of potential biomedical materials already at the in vitro level, hence leading to their potentially faster introduction to clinical trials. For the first time a novel technique based on thermal diffusivity and conductivity measurement (photothermal beam deflection spectroscopy - BDS) was employed in order to analyse in a non-destructive way the thickness of respective layers, together with their thermal diffusivity and conductivity...
May 3, 2018: European Journal of Pharmaceutics and Biopharmaceutics
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