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pharmaceutical development and technology

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https://www.readbyqxmd.com/read/29160839/inkjet-printing-of-drug-loaded-mesoporous-silica-nanoparticles-a-platform-for-drug-development
#1
Henrika Wickström, Ellen Hilgert, Johan O Nyman, Diti Desai, Didem Şen Karaman, Thomas de Beer, Niklas Sandler, Jessica M Rosenholm
Mesoporous silica nanoparticles (MSNs) have shown great potential in improving drug delivery of poorly water soluble (BCS class II, IV) and poorly permeable (BCS class III, IV) drugs, as well as facilitating successful delivery of unstable compounds. The nanoparticle technology would allow improved treatment by reducing adverse reactions of currently approved drugs and possibly reintroducing previously discarded compounds from the drug development pipeline. This study aims to highlight important aspects in mesoporous silica nanoparticle (MSN) ink formulation development for digital inkjet printing technology and to advice on choosing a method (2D/3D) for nanoparticle print deposit characterization...
November 21, 2017: Molecules: a Journal of Synthetic Chemistry and Natural Product Chemistry
https://www.readbyqxmd.com/read/29159694/urinary-excretion-of-ciprofloxacin-after-administration-of-extended-release-tablets-in-healthy-volunteers-swellable-drug-polyelectrolyte-matrix-versus-bilayer-tablets
#2
M L Guzmán, C B Romañuk, M F Sanchez, L C Luciani Giacobbe, L P Alarcón-Ramirez, F D Battistini, F L Alovero, A F Jimenez-Kairuz, R H Manzo, María Eugenia Olivera
This paper builds on a previous paper in which new ciprofloxacin extended-release tablets were developed based on a ciprofloxacin-based swellable drug polyelectrolyte matrix (SDPM-CIP). The matrix contains a molecular dispersion of ciprofloxacin ionically bonded to the acidic groups of carbomer, forming the polyelectrolyte-drug complex CB-CIP. This formulation showed that the release profile of the ciprofloxacin bilayer tablets currently commercialised can be achieved with a simpler strategy. Thus, since ciprofloxacin urine concentrations are associated with the clinical cure of urinary tract infections, the goal of this work was to compare the urinary excretion of SDPM-CIP tablets with those of the CIPRO XR® bilayer tablets...
November 20, 2017: Drug Delivery and Translational Research
https://www.readbyqxmd.com/read/29158704/a-quality-by-design-approach-for-the-development-of-lyophilized-liposomes-with-simvastatin
#3
Alina Porfire, Dana Maria Muntean, Lucia Rus, Bianca Sylvester, Ioan Tomuţă
Lyophilization is used to ensure an increased shelf-life of liposomes, by preserving them in dry state, more stable than the aqueous dispersions. When stored as aqueous systems, the encapsulated drugs are released and the liposomes might aggregate or fuse. The aim of this study was to develop and optimize a lyophilized formulation of simvastatin (SIM) loaded into long circulating liposomes using the Quality by Design (QbD) approach. Pharmaceutical development by QbD aims to identify characteristics that are critical for the final product quality, and to establish how the critical process parameters can be varied to consistently produce a product with the desired characteristics...
November 2017: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
https://www.readbyqxmd.com/read/29150808/monitoring-enzymatic-degradation-of-emerging-contaminants-using-a-chip-based-robotic-nano-esi-ms-tool
#4
Lara F Stadlmair, Thomas Letzel, Johanna Graßmann
Up to now, knowledge of enzymes capable of degrading various contaminants of emerging concern (CEC) is limited, which is especially due to the lack of rapid screening methods. Thus, a miniaturized high-throughput setup using a chip-based robotic nanoelectrospray ionization system coupled to mass spectrometry has been developed to rapidly screen enzymatic reactions with environmentally relevant CECs. Three laccases, two tyrosinases, and two peroxidases were studied for their ability to transform ten pharmaceuticals and benzotriazole...
November 17, 2017: Analytical and Bioanalytical Chemistry
https://www.readbyqxmd.com/read/29139266/-effect-of-fluidized-bed-technology-on-micromeritics-properties-of-leonurus-herba-extract
#5
Yan Du, Qi-Zhi Yi, Yao-Kun Xiong, Lan-Ping Xu
Based on different binders, the Leonurus Herba extract powders were fluidized and modified. The physical properties such as hygroscopicity, flowability, filling property and compression property were studied by various micromeritics methods before and after modification. The results showed that the physical properties of Leonurus Herba extract were close to those of microcrystalline cellulose, and its comprehensive flow index was between 61-75. Fluidization process can improve hygroscopicity, so the moisture absorption indexes of the samples were significantly lower than those of the original Leonurus Herba extract samples...
August 2017: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
https://www.readbyqxmd.com/read/29137663/patent-landscape-of-neglected-tropical-diseases-an-analysis-of-worldwide-patent-families
#6
Folahanmi Tomiwa Akinsolu, Vitor Nobre de Paiva, Samuel Santos Souza, Orsolya Varga
BACKGROUND: "Neglected Tropical Diseases" (NTDs) affect millions of people in Africa, Asia and South America. The two primary ways of strategic interventions are "preventive chemotherapy and transmission control" (PCT), and "innovative and intensified disease management" (IDM). In the last 5 years, phenomenal progress has been achieved. However, it is crucial to intensify research effort into NTDs, because of the emerging drug resistance. According to the World Health Organization (WHO), the term NTDs covers 17 diseases, namely buruli ulcer, Chagas disease, dengue, dracunculiasis, echinococcosis, trematodiasis, human African trypanosomiasis, leishmaniasis, leprosy, lymphatic filariasis, onchocerciasis, rabies, schistosomiasis, soil-transmitted helminthes, taeniasis, trachoma, and yaws...
November 14, 2017: Globalization and Health
https://www.readbyqxmd.com/read/29136894/si-traceable-calibration-free-analysis-for-the-active-concentration-of-g2-epsps-protein-using-surface-plasmon-resonance
#7
Ping Su, Zhangjing He, Liqing Wu, Liang Li, Kangle Zheng, Yi Yang
Active proteins play important roles in the function regulation of human bodies and attract much interest for use in pharmaceuticals and clinical diagnostics. However, the lack of primary methods to analyze active proteins means there is currently no metrology standard for active protein measurement. In recent years, calibration-free concentration analysis (CFCA), which is based on surface plasmon resonance (SPR) technology, has been proposed to determine the active concentration of proteins that have specific binding activity with a binding partner without any higher order standards...
February 1, 2018: Talanta
https://www.readbyqxmd.com/read/29134556/process-optimization-and-particle-engineering-of-micronized-drug-powders-via-milling
#8
REVIEW
A Brunaugh, H D C Smyth
Process control and optimization is a critical aspect of process analytical technology (PAT), quality by design (QbD), and the implementation of continuous manufacturing procedures. While process control and optimization techniques have been utilized in other manufacturing industries for decades, the pharmaceutical industry has only recently begun to adopt these procedures. Micronization, particularly milling, is a generally low-yield, high-energy consumption process that is well suited for a process optimization mindset...
November 13, 2017: Drug Delivery and Translational Research
https://www.readbyqxmd.com/read/29133873/coordinative-alignment-of-chiral-molecules-to-control-over-the-chirality-transfer-in-spontaneous-resolution-and-asymmetric-catalysis
#9
Zhengqiang Xia, Xu Jing, Cheng He, Xiaoge Wang, Chunying Duan
The production and availability of enantiomerically pure compounds that spurred the development of chiral technologies and materials are very important to the fine chemicals and pharmaceutical industries. By coordinative alignment of enantiopure guests in the metal‒organic frameworks, we reported an approach to control over the chirality of homochiral crystallization and asymmetric transformation. Synthesized by achiral triphenylamine derivatives, the chirality of silver frameworks was determined by the encapsulated enantiopure azomethine ylides, from which clear interaction patterns were observed to explore the chiral induction principles...
November 13, 2017: Scientific Reports
https://www.readbyqxmd.com/read/29132232/embedded-multimaterial-extrusion-bioprinting
#10
Marco Rocca, Alessio Fragasso, Wanjun Liu, Marcel A Heinrich, Yu Shrike Zhang
Embedded extrusion bioprinting allows for the generation of complex structures that otherwise cannot be achieved with conventional layer-by-layer deposition from the bottom, by overcoming the limits imposed by gravitational force. By taking advantage of a hydrogel bath, serving as a sacrificial printing environment, it is feasible to extrude a bioink in freeform until the entire structure is deposited and crosslinked. The bioprinted structure can be subsequently released from the supporting hydrogel and used for further applications...
November 1, 2017: SLAS Technology
https://www.readbyqxmd.com/read/29128423/amorphous-solid-dispersions-and-nanocrystal-technologies-for-poorly-water-soluble-drug-delivery-an-update
#11
Scott V Jermain, Chris Brough, Robert O Williams
Poor water-solubility remains a typical property of drug candidates in pharmaceutical development pipelines today. Various processes have been developed to increase the solubility, dissolution rate, and bioavailability of these active ingredients belonging to biopharmaceutical classification system (BCS) II and IV classifications. Since the early 2000s, nanocrystal delivery and amorphous solid dispersions are more established techniques to overcome the limitations of poorly-water soluble drugs in FDA available products...
November 8, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/29124963/relevance-and-bio-catalytic-strategies-for-the-kinetic-resolution-of-ketoprofen-towards-dexketoprofen
#12
María Victoria Toledo, Laura Estefanía Briand
This review presents the most relevant investigations concerning the biocatalytic kinetic resolution of racemic ketoprofen to dexketoprofen for the last 22 years. The advantages related to the administration of the dex-enantiomer in terms of human health, the so called "chiral switch" in the pharmaceutical industry and the sustainability of biotransformations have been the driving forces to develop innovative technology to obtain dexketoprofen. In particular, the kinetic resolution of racemic ketoprofen through enantiomeric esterification and hydrolysis using lipases as biocatalysts are thoroughly revised and commented upon...
November 10, 2017: Critical Reviews in Biotechnology
https://www.readbyqxmd.com/read/29119921/design-and-delivery-of-therapeutic-sirnas-application-to-mers-coronavirus
#13
Sayed Sartaj Sohrab, Sherif Aly El-Kafrawy, Zeenat Mirza, Mohammad Amjad Kamal, Esam Ibraheem Azhar
BACKGROUND: The MERS-CoV is a novel human coronavirus causing respiratory syndrome since April 2012. The replication of MERS-CoV is mediated by ORF 1ab and viral gene activity can be modulated by RNAi approach. The inhibition of virus replication has been documented in cell culture against multiple viruses by RNAi approach. Currently, very few siRNA against MERS-CoV have been computationally designed and published. METHODS: In this review, we have discussed the computationally designing and delivery of potential siRNAs...
November 8, 2017: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/29114685/nanoscale-considerations-responsible-for-diverse-macroscopic-phase-behavior-in-monosubstituted-isobutyl-poss-poly-ethylene-oxide-blends
#14
Yavuz Caydamli, Erol Yildirim, Jialong Shen, Xiaomeng Fang, Melissa A Pasquinelli, Richard J Spontak, Alan E Tonelli
Nanocomposites prepared by incorporating functionalized polyhedral oligomeric silsesquioxane (POSS) into polymer matrices afford a wide range of versatile hybrid materials for use in technologies ranging from cosmetics and pharmaceuticals to sensors and batteries. Here, we investigate the phase behavior of nanocomposites composed of poly(ethylene oxide) (PEO) and monosubstituted isobutyl POSS (iPOSS) modified with different functional moieties. Microscopic analyses of blends containing these iPOSS variants reveal the existence of different macroscopic morphologies and surface topologies...
November 8, 2017: Soft Matter
https://www.readbyqxmd.com/read/29113803/demonstration-of-pharmaceutical-tablet-coating-process-by-injection-molding-technology
#15
Vibha Puri, David Brancazio, Eranda Harinath, Alexander R Martinez, Parind M Desai, Keith D Jensen, Jung-Hoon Chun, Richard D Braatz, Allan S Myerson, Bernhardt L Trout
We demonstrate the coating of tablets using an injection molding (IM) process that has advantage of being solvent free and can provide precision coat features. The selected core tablets comprising 10% w/w griseofulvin were prepared by an integrated hot melt extrusion-injection molding (HME-IM) process. Coating trials were conducted on a vertical injection mold machine. Polyethylene glycol and polyethylene oxide based hot melt extruded coat compositions were used. Tablet coating process feasibility was successfully demonstrated using different coating mold designs (with both overlapping and non-overlapping coatings at the weld) and coat thicknesses of 150 and 300 μm...
November 4, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/29110507/regulatory-landscapes-for-biomarkers-and-diagnostic-tests-qualification-approval-and-role-in-clinical-practice
#16
William B Mattes, Federico Goodsaid
While the term 'biomarker' is relatively new, the concept is millennia old. However, with the introduction of new technologies to discover potential biomarkers comes the need to assess their utility and veracity for any given use. This is particularly true for the use of biomarkers to support regulatory decisions in medical product development. Hence the US Food and Drug Administration has developed processes for the qualification of biomarkers and other medical product development tools, processes that are underscored by recent legislation (i...
January 1, 2017: Experimental Biology and Medicine
https://www.readbyqxmd.com/read/29105745/the-emerging-role-of-digital-technologies-in-early-clinical-development
#17
Rajesh Krishna
Pharmaceutical development is witnessing an increase in the use of digital technologies in the delivery of pharmaceutical substances, data generation, and data interpretation. These digital technologies offer the valuable benefits of speed, enhanced integration with various other components, visualization of a continuum, and improving precision of delivery or measurement. The adoption of these opportunities in early clinical development has been slow and sparse. This commentary analyzes these benefits, including the socialization and adoption of such practices...
November 6, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29102700/melt-extrusion-with-poorly-soluble-drugs-an-integrated-review
#18
Michael A Repka, Suresh Bandari, Venkata Raman Kallakunta, Anh Q Vo, Haley McFall, Manjeet B Pimparade, Ajinkya M Bhagurkar
Over the last few decades, hot melt extrusion (HME) has emerged as a successful technology for a broad spectrum of applications in the pharmaceutical industry. As indicated by multiple publications and patents, HME is mainly used for the enhancement of solubility and bioavailability of poorly soluble drugs. This review is focused on the recent reports on the solubility enhancement via HME and provides an update for the manufacturing/scaling up aspects of melt extrusion. In addition, drug characterization methods and dissolution studies are discussed...
November 2, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/29100099/synthesis-of-chiral-amines-using-redox-biocatalysis
#19
REVIEW
Gideon Grogan
Chiral amines feature in a large number of small molecule pharmaceuticals, and thus methods for their asymmetric synthesis are of considerable interest. Biocatalytic approaches have come to the fore in recent years as these offer advantages of superior atom economy, mild reaction conditions and excellent stereoselectivity. Advances in redox cofactor process technology have meant that oxidoreductase enzymes in particular now have growing potential as industrial catalysts for amine formation. In this review we survey recent developments in the discovery and application of oxidoreductase enzymes for amine production, including Monoamine Oxidases (MAOs), engineered and natural Amine Dehydrogenases (AmDHs), Imine Reductases (IREDs) and Reductive Aminases (RedAms), in addition to their application in enzyme cascades...
October 31, 2017: Current Opinion in Chemical Biology
https://www.readbyqxmd.com/read/29098942/how-can-a-policy-foster-local-pharmaceutical-production-and-still-protect-public-health-lessons-from-the-health-industry-complex-in-brazil
#20
Elize Massard da Fonseca
The global health community is increasingly advocating for the local production of pharmaceuticals in developing countries as a way to promote technology transfer, capacity building and improve access to medicines. However, efforts to advance drug manufacturing in these countries revive an old dilemma of fostering technological development versus granting access to social services, such as healthcare. This paper explores the case of Brazil, a country that has developed large-scale health-inspired industrial policies, but is, yet, little understood...
November 3, 2017: Global Public Health
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