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Basel Arafat, Magdalena Wojsz, Abdullah Isreb, Robert T Forbes, Mohammad Isreb, Waqar Ahmed, Tawfiq Arafat, Mohamed A Alhnan
Fused deposition modelling (FDM) 3D printing has shown the most immediate potential for on-demand dose personalisation to suit particular patient's needs. However, FDM 3D printing often involves employing a relatively large molecular weight thermoplastic polymer and results in extended release pattern. It is therefore essential to fast-track drug release from the 3D printed objects. This work employed an innovative design approach of tablets with unique built-in gaps (Gaplets) with the aim of accelerating drug release...
March 17, 2018: European Journal of Pharmaceutical Sciences
Baixue Yang, Chen Wei, Yang Yang, Qifang Wang, Sanming Li
OBJECTIVE: To evaluate parameters about wettability, water absorption or swelling of excipients in forms of powders or dosage through various methods systematically and explore its correlation with tablet disintegration. MATERIALS AND METHODS: The water penetration and swelling of powders with different proportions of excipients including microcrystalline cellulose (MCC), mannitol, low-substituted hydroxypropyl cellulose (L-HPC), crospolyvinylpyrrolidone (PVPP), carboxymethyl starch sodium (CMS-Na), croscarmellose sodium (CCMC-Na) and magnesium stearate (MgSt) were determined by Washburn capillary rise...
March 20, 2018: Drug Development and Industrial Pharmacy
Ali Akgul, Ayfer Akgul, Mark L Lawrence, Attila Karsi
Edwardsiella ictaluri is a Gram-negative facultative anaerobic rod and the causative agent of enteric septicemia of channel catfish (ESC), which is one of the most prevalent diseases of catfish, causing significant economic losses in the catfish industry. E. ictaluri is resistant to complement system and macrophage killing, which results in rapid systemic septicemia. However, mechanisms of E. ictaluri stress responses under conditions of host environment are not studied well. Therefore, in this work, we report E...
2018: PloS One
Martin Kornecki, Jochen Strube
Productivity improvements of mammalian cell culture in the production of recombinant proteins have been made by optimizing cell lines, media, and process operation. This led to enhanced titers and process robustness without increasing the cost of the upstream processing (USP); however, a downstream bottleneck remains. In terms of process control improvement, the process analytical technology (PAT) initiative, initiated by the American Food and Drug Administration (FDA), aims to measure, analyze, monitor, and ultimately control all important attributes of a bioprocess...
March 16, 2018: Bioengineering
Weinan Guo, Jinyuan Ma, Tianli Pei, Tao Zhao, Sen Guo, Xiuli Yi, Yu Liu, Shiyu Wang, Guannan Zhu, Zhe Jian, Tianwen Gao, Chunying Li, Wenjun Liao, Qiong Shi
Melanoma is the most malignant skin cancer with increasing incidence worldwide. Although innovative therapies such as BRAF inhibitor and immune checkpoint inhibitor have gained remarkable advances, metastatic melanoma remains an incurable disease for its notorious aggressiveness. Therefore, further clarification of the underlying mechanism of melanoma pathogenesis is critical for the improvement of melanoma therapy. Ubiquitination is an important regulatory event for cancer hallmarks and melanoma development, and the deubiquitinating enzymes including ubiquitin-specific peptidase (USP) families are greatly implicated in modulating cancer biology...
March 14, 2018: Journal of Cellular and Molecular Medicine
C Gassner, R Karlsson, F Lipsmeier, J Moelleken
Previously we have introduced two SPR-based assay principles (dual-binding assay and bridging assay), which allow the determination of two out of three possible interaction parameters for bispecific molecules within one assay setup: two individual interactions to both targets, and/or one simultaneous/overall interaction, which potentially reflects the inter-dependency of both individual binding events. However, activity and similarity are determined by comparing report points over a concentration range, which also mirrors the way data is generated by conventional ELISA-based methods So far, binding kinetics have not been specifically considered in generic approaches for activity assessment...
March 6, 2018: Journal of Pharmaceutical and Biomedical Analysis
Quanying Bao, Bryan Newman, Yan Wang, Stephanie Choi, Diane J Burgess
In vitro drug release testing and ex vivo transcorneal drug permeation can provide valuable information on the performance of the Q1/Q2 equivalent ointments prior to any animal studies. Good correlation between in vitro and ex vivo drug release may be indicative of good in vitro and in vivo correlation. Accordingly, it is important to investigate in vitro as well as ex vivo drug release from Q1/Q2 equivalent ophthalmic ointments and evaluate whether a correlation between these release profiles can be established...
March 5, 2018: Journal of Controlled Release: Official Journal of the Controlled Release Society
Bahaa E Ali, Ramadan I Al-Shedfat, Mohamed H Fayed, Fars K Alanazi
Development of orodispersible delivery system of high mechanical properties and low disintegration time is a big challenge. The aim of the current work was to assess and optimize the high shear granulation process as a new methodology for development of orodispersible tablets of high quality attributes using design of experiment approach. A two factor, three levels (32), full factorial design was carried out to investigate the main and interaction effects of independent variables, water amount (XI) and granulation time (X2) on the characteristics of granules and final product, tablet...
May 2017: Acta Poloniae Pharmaceutica
Bartosz Urbaniak, Bartlomiej Milanowski, Janina Lulek, Zenon J Kokot
The commercially available coated tablets containing either racemic form of ofloxacin (Tarivid 200 mg, OfloHexal 200 mg and Ofloxacin-Ratiopharm 200 mg) or only levofloxacin S-(-)-isomer (Tavanic 250 mg) were examined. The aim of our study was to establish the kinetics of dissolution rate process of ofloxacin optical isomers (S-(-) and R-(+)-ofloxacin) from solid oral dosage forms using flow-through cell method (USP 4 method). The concentrations of analytes (racemic ofloxacin and its enantiomers) in the samples of tablet extracts as well as in dissolution media (0...
May 2017: Acta Poloniae Pharmaceutica
Lakhan Kanji, Sensen Xu, Afonso Cavaco
One of the sources of poor health outcomes is the lack of compliance with the prescribed treatment plans, often due to communication barriers between healthcare professionals and patients. Pictograms are a form of communication that conveys meaning through its pictorial resemblance to a physical object or an action. Pharmaceutical pictograms are often associated with a better comprehension of treatment regimens, although their use is still subject to limitations. The main goal of this study was to examine the potential understanding of pharmaceutical pictograms by a cultural minority when providing patient information while comparing the effectiveness of two reference systems (United States Pharmacopeia USP and International Pharmacy Federation FIP) for this purpose...
March 5, 2018: Pharmacy (Basel, Switzerland)
Sevil Karaman Erdur, Goktug Demirci, Funda Dikkaya, Mehmet Selim Kocabora, Mustafa Ozsutcu
BACKGROUND: To determine the agreement of central corneal thickness (CCT) measurements taken with ultrasonic pachymetry (USP), spectral domain optical coherence tomography (SD-OCT) and noncontact specular microscopy (NSM). METHODS: A prospective, observational, cross-sectional study was performed in the outpatient ophthalmology clinic. CCT was measured in a total of 147 eyes of 147 consecutive healthy patients with USP, NSM, and SD-OCT. Same examiner performed all examinations...
March 6, 2018: Seminars in Ophthalmology
Pinki Pal, Jay Prakash Pandey, Gautam Sen
The purpose of this study is to fabricate 5-Fluorouracil sustained release matrix based on a novel, nontoxic, eco-friendly modified biopolymer. The sesbania gum based hydrogel has been prepared by microwave assisted method using acrylamide as a monomer and N,N Methylenebisacrylamide as a crosslinker. The crosslink copolymerization has been confirmed by several modern techniques such as FTIR, SEM, XRD, TGA, DSC, elemental analysis etc. The bioactive 5-Fluorouracil has been encapsulated via solvent swelling method and its release rate has been investigated in various pH dissolution medium through USP standard protocol...
March 2, 2018: International Journal of Biological Macromolecules
Javier Giglio, Maia Zeni, Eduardo Savio, Henry Engler
Background: Overexpression of prostatic membrane antigen (PSMA) is associated with the progression and prognosis of prostate cancer. There are numerous studies using this peptide with the68 Ga radionuclide. Previous methods to synthetize18 F-labeled PSMA ligands with complexes [18 F]AlF2+ have been achieved. However, these reported syntheses were performed manually, using small volumes. Therefore it is only possible to have the radiopharmaceutical on a small scale, for use in preclinical studies...
2018: EJNMMI Radiopharm Chem
A Le Fouler, A Hamy, J Barbieux, V Souday, P Bigot, P Le Naoures, R Jaouen, C Brochard, Aurélien Venara
PURPOSE: For survivors of perineal gangrene (PG), quality of life and functional prognosis of pelvic functions are probably overestimated. The aim of this study was to report long-term anal and urinary sphincter dysfunctions, sexual sequelae, and patients' quality of life after treatment of perineal gangrene. METHODS: This retrospective observational study was conducted in one university hospital over 16 years. Seventy-three patients experienced PG; 22 were subject to long-term follow-up...
March 2, 2018: International Journal of Colorectal Disease
Sandra Stein, Tobias Auel, Wiebke Kempin, Malte Bogdahn, Werner Weitschies, Anne Seidlitz
Sustained intravitreal dexamethasone (DX) administration with the FDA and EMA approved Ozurdex® implant is indicated for the treatment of macular edema and non-infectious uveitis. Since drug release after intravitreal application cannot be determined in vivo in human eyes, the characterization of drug release in vitro in addition to animal models is of great importance. The aim of this study was to provide information about the influence of the test method on the in vitro drug release from intravitreal model implants...
February 25, 2018: European Journal of Pharmaceutics and Biopharmaceutics
Zachary N Warnken, Hugh D C Smyth, Daniel A Davis, Steve Weitman, John G Kuhn, Robert O Williams
Effective targeting of nasal spray deposition could improve local, systemic, and CNS drug delivery, however, this has proven to be difficult due anatomical features of the nasal cavity including the nasal valve and turbinate structures. Furthermore, nasal cavity geometries and dimensions vary between individuals based on differences in their age, gender and ethnicity. The effect of patient-specific administration parameters was evaluated for their ability to overcome the barriers to targeted nasal drug delivery...
February 27, 2018: Molecular Pharmaceutics
S F M Chastin, M L Dontje, D A Skelton, I Čukić, R J Shaw, J M R Gill, C A Greig, C R Gale, I J Deary, G Der, P M Dall
BACKGROUND: Sedentary behaviour is a public health concern that requires surveillance and epidemiological research. For such large scale studies, self-report tools are a pragmatic measurement solution. A large number of self-report tools are currently in use, but few have been validated against an objective measure of sedentary time and there is no comparative information between tools to guide choice or to enable comparison between studies. The aim of this study was to provide a systematic comparison, generalisable to all tools, of the validity of self-report measures of sedentary time against a gold standard sedentary time objective monitor...
February 26, 2018: International Journal of Behavioral Nutrition and Physical Activity
John W Honour, E Conway, R Hodkinson, F Lam
The metabolites of cortisol, and the intermediates in the pathways from cholesterol to cortisol and the adrenal sex steroids can be analysed in a single separation of steroids by gas chromatography (GC) coupled to MS to give a urinary steroid profile (USP). Steroids individually and in profile are now commonly measured in plasma by liquid chromatography (LC) coupled with MS/MS. The steroid conjugates in urine can be determined after hydrolysis and derivative formation and for the first time without hydrolysis using GC-MS, GC-MS/MS and liquid chromatography with mass spectrometry (LC-MS/MS)...
February 23, 2018: Journal of Steroid Biochemistry and Molecular Biology
Balázs Klencsár, Carlos Sánchez, Lieve Balcaen, José Todolí, Frederic Lynen, Frank Vanhaecke
A systematic evaluation of four different ICP sample introduction systems to be used in the context of metabolite profiling of chlorine-containing pharmaceuticals via HPLC-ICP-MS was carried out using diclofenac and its major metabolite, 4'-hydroxy-diclofenac, as model compounds. The strict requirements for GMP validation of chromatographic methods in the pharmaceutical industry were adhered to in this context. The final aim of this investigation is an extension of the applicability and validatability of HPLC-ICP-MS in the field of pharmaceutical R&D...
February 19, 2018: Journal of Pharmaceutical and Biomedical Analysis
Munair Badshah, Hanif Ullah, Abdur Rahman Khan, Shaukat Khan, Joong Kon Park, Taous Khan
The current study was designed to prepare surface modified BC matrices loaded with model drugs selected on the basis of their aqueous solubility, i.e., poorly water soluble famotidine and highly water soluble tizanidine. Fourier transform infrared (FT-IR) spectroscopy, X-ray diffraction (XRD), scanning electron microscopy (SEM) and thermogravimetric analysis (TGA) confirmed the successful drug loading and thermal stability of the BC matrices. In-vitro dissolution studies using USP type-II dissolution apparatus showed that most of the drug was released in 0...
February 22, 2018: International Journal of Biological Macromolecules
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