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Laszlo Hajba, Eszter Csanky, Andras Guttman
Comprehensive carbohydrate analysis of glycoproteins from human biological samples and biotherapeutics are important from diagnostic and therapeutic points of view. This review summarizes the current state-of-the-art liquid phase separation techniques used in N-glycosylation analysis. The different liquid chromatographic techniques and capillary electrophoresis methods are critically discussed in detail. Miniaturization of these methods is also important to increase throughput and decrease analysis time. The sample preparation and labeling methods for asparagine linked oligosaccharides are also addressed...
November 2, 2016: Analytica Chimica Acta
Arathi Kizhedath, Simon Wilkinson, Jarka Glassey
Biopharmaceuticals, monoclonal antibody (mAb)-based therapeutics in particular, have positively impacted millions of lives. MAbs and related therapeutics are highly desirable from a biopharmaceutical perspective as they are highly target specific and well tolerated within the human system. Nevertheless, several mAbs have been discontinued or withdrawn based either on their inability to demonstrate efficacy and/or due to adverse effects. Approved monoclonal antibodies and derived therapeutics have been associated with adverse effects such as immunogenicity, cytokine release syndrome, progressive multifocal leukoencephalopathy, intravascular haemolysis, cardiac arrhythmias, abnormal liver function, gastrointestinal perforation, bronchospasm, intraocular inflammation, urticaria, nephritis, neuropathy, birth defects, fever and cough to name a few...
October 20, 2016: Archives of Toxicology
Monica R P Rao, Chaitanya Shirsath
Efavirenz is a non-nucleoside reverse transcriptase inhibitor which is chronically prescribed for HIV patients. However, it exhibits solubility-limited bioavailability. Aim of this work was to enhance the solubility and dissolution of the Biopharmaceutical Classification System (BCS) class II drug efavirenz, using beta-cyclodextrin-based nanosponges. Nanosponges have high drug loading capacity and are effective for solubility enhancement. Beta-cyclodextrin was crosslinked with carbonates in different ratios to prepare nanosponges...
October 18, 2016: AAPS PharmSciTech
Ting-Ting Zhao, Ling-Ling Zhu, Meng Chen, Quan Zhou
BACKGROUND: According to prescribing information for Myrtol standardized enteric-coated soft capsules, the medicine should be taken on an empty stomach. Some patients may experience stomach discomfort after oral administration in fasted state and would prefer to take the medicine after a meal. However, there is no literature addressing the effect of meal on absorption of this drug; therefore, it is desirable to explore the feasibility of taking the capsule after a meal from pharmacokinetic perspective...
2016: Patient Preference and Adherence
Irene Krämer, Matthias Blüher, Martin K Kuhlmann, Lutz Heinemann
Following the market authorization of the first insulin biosimilar in 2014, further approvals are to be expected due to patent expiry of several originator insulins. Knowledge of the manufacturing and the characteristics of these pharmaceutical products is important for their rationale and safe use by the physician, the pharmacist and the patient.Biosimilars are not generics, but similar or comparable, yet not identical versions of the originator biopharmaceutical. Marketing authorization in the EU is granted only after passing a stringent procedure...
October 2016: Deutsche Medizinische Wochenschrift
William F Weiss, John P Gabrielson, Wasfi Al-Azzam, Guodong Chen, Darryl L Davis, Tapan K Das, David B Hayes, Damian Houde, Satish K Singh
Characterization of the higher order structure (HOS) of protein-based biopharmaceutical products is an important aspect of their development. Opinions vary about how best to apply biophysical methods, in which contexts to use these methods, and how to use the resulting data to make technical decisions as drug candidates are commercialized [Gabrielson JP, Weiss WF IV. J Pharm Sci. 2015;104(4):1240-1245]. The aim of this commentary is to provide guidance for the development and implementation of a robust and comprehensive HOS characterization strategy...
October 12, 2016: Journal of Pharmaceutical Sciences
Marton Szigeti, Andras Guttman
N-glycan profiling of therapeutic glycoproteins is essential to ensure the activity and efficacy of these promising new-generation drugs. The N-linked glycan moieties of these entities highly affect circulation half-life, immunogenicity and receptor-binding activity as well as physicochemical and thermal stability properties. In addition, more than half of the biopharmaceuticals are glycoproteins representing multibillion dollar worldwide business, further emphasizing the importance of their analysis. In the biomedical field, on the other hand, revealing disease-related glycan structure alterations holds the promise of the discovery of new biomarkers for early diagnostics...
2017: Methods in Molecular Biology
Tongkai Chen, Chuwen Li, Ye Li, Yi Xiang, Simon Ming Yuen Lee, Ying Zheng
Schisantherin A (SA) is a promising anti-Parkinsonism Chinese herbal medicine but with poor water solubility and challenges to be delivered to the brain. We formulated SA as nanocrystals (SA-NC), aiming to improve its solubility, pharmacokinetic profile and thus provide a potential therapeutic agent for the treatment of Parkinson's disease (PD). The rod-shaped SA-NC had a particle size of ~160 nm with 33.3% drug loading, and the nanocrystals exhibited a fast dissolution rate in vitro. The intact drug nanocrystals could be internalized into Madin-Darby canine kidney (MDCK) cells, which were followed by rapid intracellular release, and most of the drug was transported to the basolateral side in its soluble form...
October 14, 2016: Molecular Pharmaceutics
Cinzia Pagano, Maria Cristina Tiralti, Luana Perioli
OBJECTIVES: Folic acid (FA) is an important source for the prevention of many diseases. However, its use is limited because the very low solubility (<10 mg/l particularly in the gastric environment) responsible for the incomplete adsorption of the administered dose. This study proposes a technological strategy to overcome this problem enhancing FA dissolution rate by means of a formulation able to make completely bioavailable the whole administered dose. METHODS: Folic acid was intercalated in the layered double hydroxides (LDHs) MgAl-LDH and ZnAl-LDH...
October 13, 2016: Journal of Pharmacy and Pharmacology
Nambin Yim, Chulhee Choi
Extracellular vesicles (EVs) are natural carriers of biomolecules that play central roles in cell-to-cell communications. Based on this, there have been many attempts to use EVs as therapeutic drug carriers. Various macromolecules, from chemical reagents to nucleic acids, were successfully loaded into EVs; however, loading of proteins with high molecular weight has been huddled with several problems. Purification of recombinant proteins is expensive and time consuming, and easily results in modification of proteins by physical or chemical forces...
October 13, 2016: BMB Reports
John Joseph Milne
Separation science continues to occupy the central position in the overall strategy for the downstream processing and purification of therapeutic protein products for human use. Increasing product titers from mammalian cell culture and new emerging classes of biopharmaceuticals has presented a challenge to the industry to identify ways of improving the robustness and economics of chromatography processes. In commercial manufacturing, there is always a need to increase the scale of the chromatography operations which are typically developed and optimized in small-scale laboratory experiments...
2017: Methods in Molecular Biology
Fabiano Luiz Heggendorn, Gabriela Cristina de Carvalho Silva, Elisama Azevedo Cardoso, Helena Carla Castro, Lúcio Souza Gonçalves, Eliane Pedra Dias, Viviane de Oliveira Freitas Lione, Márcia Teresa Soares Lutterbach
This study assessed the cell viability of the inoculation vehicle of BACCOR (a combination of sulfate-reducing bacteria plus a culture media for bacteria), a biopharmaceutical product under development for dental use as aid in fractured endodontic file removal from the root canal. Different culture media for bacteria were evaluated: modified Postgate E (MCP-E mod), Modified Postgate E without Agar-agar (MCP-E w/Ag), Postgate C with Agar-agar (MCP-C Ag) and Postgate C without Agar-agar (MCP-C w/Ag). Cytotoxicity was quantified by the MTT test, exposing L929 and Vero cell lines to the vehicles over 24 h...
2016: Dental Materials Journal
Xiaoxia Yang, John Duan, Jeffrey Fisher
A previously presented physiologically-based pharmacokinetic model for immediate release (IR) methylphenidate (MPH) was extended to characterize the pharmacokinetic behaviors of oral extended release (ER) MPH formulations in adults for the first time. Information on the anatomy and physiology of the gastrointestinal (GI) tract, together with the biopharmaceutical properties of MPH, was integrated into the original model, with model parameters representing hepatic metabolism and intestinal non-specific loss recalibrated against in vitro and in vivo kinetic data sets with IR MPH...
2016: PloS One
Henrik Aronsson, Petter Larsson, Sandra Bains
Higher plants have been used in medicine throughout human history. While traditional medicinal uses relied on compounds produced naturally by plants, recent advances have enabled the use of plant-based factories to produce diverse agents including pharmaceuticals, antibiotics, and vaccines. The genes responsible for the production of these substances can be either transiently expressed in plants or integrated into their nuclear genome or plastid genome (plastome) by genetic transformation. This review focuses on the application of plastid transformation of higher plants to produce biopharmaceuticals for human applications that are neither antibiotics nor vaccines...
October 4, 2016: Mini Reviews in Medicinal Chemistry
Leïla Zerkoune, Sylviane Lesieur, Jean-Luc Putaux, Luc Choisnard, Annabelle Gèze, Denis Wouessidjewe, Borislav Angelov, Corinne Vebert-Nardin, James Doutch, Angelina Angelova
Soft mesoporous hierarchically structured particles were created by the self-assembly of an amphiphilic deep cavitand cyclodextrin βCD-nC10 (degree of substitution n = 7.3), with a nanocavity grafted by multiple alkyl (C10) chains on the secondary face of the βCD macrocycle through enzymatic biotransesterification, and the nonlamellar lipid monoolein (MO). The effect of the non-ionic dispersing agent polysorbate 80 (P80) on the liquid crystalline organization of the nanocarriers and their stability was studied in the context of vesicle-to-cubosome transition...
September 13, 2016: Soft Matter
Eric Yang, Jan Welink, Stephanie Cape, Eric Woolf, Jens Sydor, Christopher James, Dina Goykhman, Mark Arnold, Neil Addock, Ronald Bauer, Michael Buonarati, Eugene Ciccimaro, Raj Dodda, Christopher Evans, Fabio Garofolo, Nicola Hughes, Rafiq Islam, Corey Nehls, Amanda Wilson, Chad Briscoe, Mark Bustard, Laura Coppola, Stephanie Croft, Dieter Drexler, Luca Ferrari, Daniela Fraier, Rand Jenkins, John Kadavil, Lloyd King, Wenkui Li, Gustavo Mendes Lima Santos, Adrien Musuku, Ragu Ramanathan, Yoshiro Saito, Natasha Savoie, Scott Summerfield, Rachel Sun, Nilufer Tampal, Steve Vinter, Jason Wakelin-Smith, Qin Yue
The 2016 10(th) Workshop on Recent Issues in Bioanalysis (10(th) WRIB) took place in Orlando, Florida with participation of close to 700 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event - A Full Immersion Week of Bioanalysis including Biomarkers and Immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecule analysis involving LCMS, hybrid LBA/LCMS, and LBA approaches, with the focus on biomarkers and immunogenicity...
October 7, 2016: Bioanalysis
Lisa Murray, Antonio Arias, Jibin Li, Sid Bhoopathy, Ismael J Hidalgo
To improve the quality of pharmaceutical products in their markets, several Latin American countries have begun to require that new generic products demonstrate bioequivalence against innovator or reference products. However, given the number of products involved, it is not feasible to rely on clinical studies to comply with this requirement. Instead, it makes sense to adopt or develop strategies that are appropriate to the characteristics of the region. To streamline drug development and accelerate patients' access to quality drug products, 15 years ago the United States Food and Drug Administration (FDA) decided to grant exemptions from clinical bioequivalence studies (i...
August 2016: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
Iftekhar Mahmod, Tasneem Ahmad, Najia Mansoor, S M Sharib
The objective of this study was to evaluate the predictive performances of allometric models and a physiologically based pharmacokinetic model (PBPK) to predict clearance of glucuronidated drugs in neonates (≤3 months of age). From the literature, clearance values for 9 drugs (glucuronidated) for neonates and adults were obtained. Three allometric models were used to predict clearances of these glucuronidated drugs. A PBPK model was developed using the physicochemical, biopharmaceutical, and metabolic properties together with known pediatric physiology and enzymatic ontogeny...
October 4, 2016: Journal of Clinical Pharmacology
Joana Martir, Talia Flanagan, James Mann, Nikoletta Fotaki
OBJECTIVES: This review focuses on the recommended strategies for the oral administration of paediatric medicines with food in the context of their biopharmaceutical properties. KEY FINDINGS: Acceptability of oral medicines in young patients is more challenging than in adult patients. Mixing oral dosage forms with foods and drinks is sometimes suggested to administer a specific dose and enhance compliance in the paediatric population. In this review, the strategies for the co-administration of paediatric medicines with food and drinks are discussed...
October 5, 2016: Journal of Pharmacy and Pharmacology
Maryam Pourhajibagher, Abbas Bahador
BACKGROUND: Periodontitis is a polymicrobial, chronic, and degenerative disease that can lead to destruction of the teeth-supporting tissues and eventually to loss of teeth. Aggregatibacter actinomycetemcomitans is predominantly associated with periodontal diseases. Outer membrane protein (Omp) 100 is a more important virulence factor of A. actinomycetemcomitans due to the effect of adhesion and invasion into human gingival epithelial cells. Attachment of A. actinomycetemcomitans inhibition is significant in the treatment process...
September 30, 2016: Photodiagnosis and Photodynamic Therapy
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