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https://www.readbyqxmd.com/read/28092854/biopharmaceutical-characterization-of-praziquantel-cocrystals-and-cyclodextrin-complexes-prepared-by-grinding
#1
Martina Cugovčan, Jasna Jablan, Jasmina Lovrić, Dominik Cinčić, Nives Galić, Mario Jug
Mechanochemical activation using several different co-grinding additives was applied as a green chemistry approach to improve physiochemical and biopharmaceutical properties of praziquantel (PZQ). Liquid assisted grinding with an equimolar amount of citric acid (CA), malic acid (MA), salicylic acid (SA) and tartaric acid (TA) gained in cocrystal formation, which all showed pH-dependent solubility and dissolution rate. However, the most soluble cocrystal of PZQ with MA was chemically unstable, as seen during the stability testing...
January 10, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28091715/highly-sensitive-glycosylamine-labelling-of-o-glycans-using-non-reductive-%C3%AE-elimination
#2
Kenichiro Furuki, Toshimasa Toyo'oka, Kazutoshi Ban
When developing biopharmaceuticals, glycans are the most important posttranslational protein modifications that must be addressed because they affect the between-protein interactions that maintain homeostasis. The glycan profile may be defined as a critical quality attribute of a biopharmaceutical. Comprehensive analysis of protein glycosylation must overcome challenges such as the release, labelling, separation and detection of O-glycans. In contrast, N-glycans can be readily released non-reductively from peptide backbones using an enzyme such as peptide N-glycosidase F...
January 14, 2017: Analytical and Bioanalytical Chemistry
https://www.readbyqxmd.com/read/28090277/anti-quorum-sensing-activity-of-substances-isolated-from-wild-berry-associated-bacteria
#3
Suha M Abudoleh, Adel M Mahasneh
BACKGROUND: Quorum Sensing (QS) is a mechanism used by bacteria to determine their physiological activities and coordinate gene expression based on cell to cell signaling. Many bacterial physiological functions are under the regulation of quorum sensing such as virulence, luminescence, motility, sporulation and biofilm formation. The aim of the present study was to isolate and characterize Quorum Sensing Inhibitory (QSI) substances from epiphytic bacteria residing on wild berries surfaces...
January 2017: Avicenna Journal of Medical Biotechnology
https://www.readbyqxmd.com/read/28088879/the-biopharmaceutical-classification-system-of-excipients
#4
Teófilo Vasconcelos, Sara Marques, Bruno Sarmento
The increasing number of new chemical entities is bringing new challenges to the field of drug delivery. These drugs present bioavailability issues that are frequently associated with intestinal metabolism or efflux mechanisms. Some excipients, particularly surfactants, have demonstrated a capacity to interfere with these mechanisms, improving drug bioavailability. Consequently, these excipients can no longer be considered as inert and should be subject to special considerations from a regulatory perspective...
February 2017: Therapeutic Delivery
https://www.readbyqxmd.com/read/28088541/secretory-pathway-optimization-of-cho-producer-cells-by-co-engineering-of-the-mitosrna-1978-target-genes-cers2-and-tbc1d20
#5
Lisa A Pieper, Michaela Strotbek, Till Wenger, Martin Gamer, Monilola A Olayioye, Angelika Hausser
Chinese Hamster Ovary (CHO) cells are the most commonly used host for the production of biopharmaceuticals. Although transcription and translation engineering strategies have been employed to generate high-producer cell clones, the secretory pathway still remains a bottleneck in cellular productivity. In this study we show that ectopic expression of a human mitochondrial genome-encoded small RNA (mitosRNA-1978) in an IgG expressing CHO cell line strongly improved specific productivity by functioning in a microRNA-like fashion...
January 11, 2017: Metabolic Engineering
https://www.readbyqxmd.com/read/28072827/comprehensive-n-glycan-profiling-of-cetuximab-biosimilar-candidate-by-np-hplc-and-maldi-ms
#6
Sheng Liu, Wenjie Gao, Yao Wang, Zhenyu He, Xiaojun Feng, Bi-Feng Liu, Xin Liu
Monitoring glycosylation of the mAbs have been emphasized and routinely characterized in biopharmaceutical industries because the carbohydrate components are closely related to the safety, efficacy, and consistency of the antibodies. In this study, the comprehensive glycan profiling of a biosimilar candidate of cetuximab was successfully characterized using Normal phase high-performance liquid chromatography (NP-HPLC) in combination with Matrix assisted laser desorption/ionization mass spectrometry (MALDI-MS)...
2017: PloS One
https://www.readbyqxmd.com/read/28054475/design-and-control-of-integrated-chromatography-column-sequences
#7
Niklas Andersson, Anton Löfgren, Marianne Olofsson, Anton Sellberg, Peter Tiainen, Bernt Nilsson
To increase the productivity in biopharmaceutical production a natural step is to introduce integrated continuous biomanufacturing which leads to fewer buffer and storage tanks, smaller sizes of integrated unit operations and full automation of the operation. The main contribution of this work is to illustrate a methodology for design and control of a downstream process based on integrated column sequences. For small scale production, e.g. pre-clinical studies, integrated column sequences can be implemented on a single chromatography system...
January 5, 2017: Biotechnology Progress
https://www.readbyqxmd.com/read/28054462/optimization-of-biopharmaceutical-downstream-processes-supported-by-mechanistic-models-and-artificial-neural-networks
#8
Silvia M Pirrung, Luuk A M van der Wielen, Ruud F W C Van Beckhoven, Emile J A X van de Sandt, Michel H M Eppink, Marcel Ottens
Downstream process development is a major area of importance within the field of bioengineering. During the design of such a downstream process, important decisions have to be made regarding the type of unit operations as well as their sequence and their operating conditions. Current computational approaches addressing these issues either show a high level of simplification or struggle with computational speed. Therefore, this article presents a new approach that combines detailed mechanistic models and speed-enhancing artificial neural networks...
January 5, 2017: Biotechnology Progress
https://www.readbyqxmd.com/read/28053073/in-vivo-imaging-in-pharmaceutical-development-and-its-impact-on-the-3rs
#9
Barry R Campbell, Dinko Gonzalez Trotter, Catherine D G Hines, Wenping Li, Manishkumar Patel, Weisheng Zhang, Jeffrey L Evelhoch
It is well understood that the biopharmaceutical industry must improve efficiency along the path from laboratory concept to commercial product. In vivo imaging is recognized as a useful method to provide biomarkers for target engagement, treatment response, safety, and mechanism of action. Imaging biomarkers have the potential to inform the selection of drugs that are more likely to be safe and effective. Most of the imaging modalities for biopharmaceutical research are translatable to the clinic. In vivo imaging does not require removal of tissue to provide biomarkers, thus reducing the number of valuable preclinical subjects required for a study...
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28051868/quantifying-risks-of-asparagine-deamidation-and-aspartate-isomerization-in-biopharmaceuticals-by-computing-reaction-free-energy-surfaces
#10
Nikolay V Plotnikov, Satish Kumar Singh, Jason C Rouse, Sandeep Kumar
Early identification of asparagine deamidation and aspartate isomerization degradation sites can facilitate successful development of biopharmaceuticals. Several knowledge-based models have been proposed to assess these degradation risks. In this contribution, we propose a physics-based approach to identify the degradation sites based on the free energy barriers along the pre-chemical conformational step and along the chemical reaction path. These contributions are estimated from classical and QM/MM molecular dynamics simulations...
January 4, 2017: Journal of Physical Chemistry. B
https://www.readbyqxmd.com/read/28041968/medicines-for-pediatric-patients-biopharmaceutical-developmental-and-regulatory-considerations
#11
David P Elder, René Holm, Martin Kuentz
This commentary reflects current developments in pediatric medicine. The underpinning legislation in both Europe and the US has led to the initiation of an increased number of clinical trials in the pediatric population, but there are still a number of outstanding issues within this field. These include the differences in the physiology between adults and the very heterogeneous nature of pediatric patients. There is an ongoing scientific debate on the applicability of a Pediatric Biopharmaceutical Classification System (PBCS) to define when waivers for bioequivalence studies can be supported by in vitro dissolution...
December 29, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28035627/supramolecular-cocrystals-of-gliclazide-synthesis-characterization-and-evaluation
#12
Renu Chadha, Dimpy Rani, Parnika Goyal
PURPOSE: To prepare the supramolecular cocrystals of gliclazide (GL, a BCS class II drug molecule) via mechanochemical route, with the goal of improving physicochemical and biopharmaceutical properties. METHODS: Two cocrystals of GL with GRAS status coformers, sebacic acid (GL-SB; 1:1) and α-hydroxyacetic acid (GL-HA; 1:1) were screened out using liquid assisted grinding. The prepared cocrystals were characterized using thermal and analytical techniques followed by evaluation of antidiabetic activity and pharmacokinetic parameters...
December 29, 2016: Pharmaceutical Research
https://www.readbyqxmd.com/read/28033667/metformin-loaded-alginate-nanoparticles-as-an-effective-antidiabetic-agent-for-controlled-drug-release
#13
Sandeep Kumar, Gaurav Bhanjana, Ritesh Kumar Verma, Dinesh Dhingra, Neeraj Dilbaghi, Ki-Hyun Kim
OBJECTIVES: Present modalities for the diagnosis and treatment of diabetes still suffer from certain limitations such as erratic absorption, need of high dose, poor sensitivity or specificity, resistance, substantial morbidity and mortality, long-term complications, and patient-to-patient variability with lifetime treatment. METHODS: This study focused on the development of a water-in-oil-in-water metformin nanoemulsion as an effective method in diabetes treatment...
December 29, 2016: Journal of Pharmacy and Pharmacology
https://www.readbyqxmd.com/read/28032948/effect-of-peg-architecture-on-the-hybridization-thermodynamics-and-protein-accessibility-of-pegylated-oligonucleotides
#14
Fei Jia, Xueguang Lu, Xuyu Tan, Dali Wang, Xueyan Cao, Ke Zhang
PEGylation is an attractive approach to modifying oligonucleotides intended for therapeutic purposes. PEG conjugation reduces protein interactions with the oligonucleotide, and helps to overcome their intrinsic biopharmaceutical shortcomings, such as poor enzymatic stability, rapid body clearance, and unwanted immunostimulation. However, the effect of PEG architecture and the manner in which the PEG component interferes with the hybridization of the oligonucleotide remain poorly understood. In this study, we systematically compare the hybridization thermodynamics and protein accessibility of several DNA conjugates involving linear, Y-shaped, and brush-type PEG...
December 29, 2016: Angewandte Chemie
https://www.readbyqxmd.com/read/28032517/integrating-biopharmaceutics-risk-assessment-and-in-vivo-absorption-model-in-formulation-development-of-bcs-class-i-drug-using-the-qbd-approach
#15
Naseem A Charoo, Rodrigo Cristofoletti, Sun K Kim
OBJECTIVE: Clinically relevant critical quality attributes (CQA's) were identified for the development of generic drug products containing fluconazole and potential design spaces relevant to the clinical application of the drug candidate was explored. SIGNIFICANCE: A simplified scoring system for the biopharmaceutics risk assessment roadmap (BioRAM) is proposed to guide product development. METHODS: Factorial design of experiments was employed to study the effect of formulation and process variables on CQA's...
December 29, 2016: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28027919/physicochemical-characterisation-and-investigation-of-the-bonding-mechanisms-of-api-titanate-nanotube-composites-as-new-drug-carrier-systems
#16
Barbara Sipos, Klára Pintye-Hódi, Zoltán Kónya, András Kelemen, Géza Regdon, Tamás Sovány
Titanate nanotube (TNT) has recently been explored as a new carrier material for active pharmaceutical ingredients (API). The aim of the present work was to reveal the physicochemical properties of API-TNT composites, focusing on the interactions between the TNTs and the incorporated APIs. Drugs belonging to different Biopharmaceutical Classification System (BCS) classes were loaded into TNTs: diltiazem hydrochloride (BCS I.), diclofenac sodium (BCS II.), atenolol (BCS III.) and hydrochlorothiazide (BCS IV...
December 24, 2016: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28026957/comparison-of-avidin-neutravidin-and-streptavidin-as-nanocarriers-for-efficient-sirna-delivery
#17
Akshay Jain, Ashutosh Barve, Zhen Zhao, Wei Jin, Kun Cheng
Protein-based drug delivery carrier has been one of the most employed modalities in the biopharmaceuticals. In this study, we have compared avidin and its two analogues, neutravidin and streptavidin, as nanocarriers for the delivery of biotin-labeled siRNA with the help of biotinylated cholesterol (targeting ligand) and protamine (condensing agent). These proteins have similar binding affinity to biotin but substantially difference in their physical and chemical characteristics. Here, we have shown how these characteristics affect the size, cellular uptake and activity of the avidin-based siRNA nanocomplex...
December 27, 2016: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/28026825/transformation-of-medicinal-plants-using-agrobacterium-tumefaciens
#18
Katarzyna Bandurska, Agnieszka Berdowska, Małgorzata Król
For many years attempts are made to develop efficient methods for transformation of medicinal plants via Agrobacterium tumefaciens. It is a soil bacteria which possess a natural ability to infect plants in places of injures which results in arise of cancerous growths (crown gall). This is possible thanks a transfer of fragment of Ti plasmid into plant cells and stable integration with a plant genome. Efficiency of medicinal plant transformation depends on many factors for example: Agrobacterium strain, methods and procedures of transformation as well as on plant species, type and age of the explants and regeneration conditions...
December 20, 2016: Postȩpy Higieny i Medycyny Doświadczalnej
https://www.readbyqxmd.com/read/28025919/amcp-partnership-forum-enabling-the-exchange-of-clinical-and-economic-information-pre-fda-approval
#19
(no author information available yet)
: Current federal laws and FDA regulations have significantly restricted the sharing of clinical and health economic information on biopharmaceuticals that have yet to receive FDA approval. Over the past several years, organizations that make health care coverage decisions, including those that set copayments, premiums, and formulary placement, have expressed a need for receiving this information before approval, as long as appropriate safeguards exist to prevent this information from reaching unintended entities...
January 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28025072/enhancing-biopharmaceutical-attributes-of-phospholipid-complex-loaded-nanostructured-lipidic-carriers-of-mangiferin-systematic-development-characterization-and-evaluation
#20
Rajneet Kaur Khurana, Arvind K Bansal, Sarwar Beg, Andrea Julie Burrow, O P Katare, Kamalinder K Singh, Bhupinder Singh
Mangiferin (Mgf), largely expressed out from the leaves and stem bark of Mango, is a potent antioxidant. However, its in vivo activity gets tremendously reduced owing to poor aqueous solubility and inconsistent gastrointestinal absorption, high hepatic first-pass metabolism and high P-gp efflux. The current research work, therefore, was undertaken to overcome the biopharmaceutical hiccups by developing the Mgf-phospholipid complex (PLCs) loaded in nanostructured lipidic carriers (NLCs). The PLCs and NLCs were prepared using refluxing, solvent evaporation and hot emulsification technique, respectively with three molar ratios of Mgf and Phospholipon 90G, i...
December 23, 2016: International Journal of Pharmaceutics
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