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https://www.readbyqxmd.com/read/28737679/modernization-of-enoxaparin-molecular-weight-determination-using-homogeneous-standards
#1
Katelyn M Arnold, Stephen J Capuzzi, Yongmei Xu, Eugene N Muratov, Kevin Carrick, Anita Y Szajek, Alexander Tropsha, Jian Liu
Enoxaparin is a low-molecular weight heparin used to treat thrombotic disorders. Following the fatal contamination of the heparin supply chain in 2007-2008, the U.S. Pharmacopeia (USP) and U.S. Food and Drug Administration (FDA) have worked extensively to modernize the unfractionated heparin and enoxaparin monographs. As a result, the determination of molecular weight (MW) has been added to the monograph as a measure to strengthen the quality testing and to increase the protection of the global supply of this life-saving drug...
July 22, 2017: Pharmaceuticals
https://www.readbyqxmd.com/read/28737403/validation-of-dissolution-testing-with-biorelevant-media-an-orbito-study
#2
James Mann, Jennifer B Dressman, Karin Rosenblatt, Lee Ashworth, Uwe Muenster, Kerstin Frank, Paul Hutchins, James Williams, Lukas Klumpp, Kristina Wielockx, Philippe Berben, Patrick Augustijns, Rene Holm, Michael Hofmann, Sanjaykumar Patel, Stefania Beato, Krista Ojala, Irena Tomaszewska, Jean-Luc Bruel, James Butler
BACKGROUND: Dissolution testing with biorelevant media has become widespread in the pharmaceutical industry as a means of better understanding how drugs and formulations behave in the gastrointestinal tract. Until now, however, there have been few attempts to gauge the reproducibility of results obtained with these methods. PURPOSE: The aim of this study was to determine the inter-laboratory reproducibility of biorelevant dissolution testing, using the paddle apparatus (USP 2)...
July 24, 2017: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/28733333/method-development-for-container-closure-integrity-evaluation-via-headspace-gas-ingress-by-using-frequency-modulation-spectroscopy
#3
Ken G Victor, Lauren Levac, Michael Timmins, James Veale
USP <1207.1> Section 3.5 states that "A deterministic leak test method having the ability to detect leaks at the product's maximum allowable leakage limit is preferred when establishing the inherent integrity of a container-closure system." Ideally, container closure integrity (CCI) of parenteral packaging would be evaluated by measuring a physical property that is sensitive to the presence of any package defect that breaches package integrity by increasing its leakage above its maximum allowable leakage limit (MALL)...
July 20, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28733332/demonstration-of-the-maintaining-the-validated-state-of-a-system-used-to-generate-water-for-injection-by-thermocompression
#4
Alberto Leyva, Iriac Bisquet, Tania de la Cruz, Leoner Del Arco, Joel Ríos, Rodolfo Valdés, Sonny Robles, Fabian Ugarte, Manuel Montané
Water for injection is used in multiple applications in Biopharmaceutical industry. Regarding this, several methods have been use to generate water with this high quality. Within them, the thermos-compression distillation method has been widely employed. Though, reports on the maintenance of the qualification and validation status of thermo-compression systems used for water for injection generation are non-existent in the scientific literature. Therefore, this paper sought to give evidences on continue process verification of a system used for water for injection generation during two years analyzing the level of conductivity, nitrate, total organic carbon (TOC), endotoxins and microbiology in 1284 water samples...
July 20, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28732917/ultrasound-assisted-pectic-polysaccharide-extraction-and-its-characterization-from-waste-heads-of-helianthus-annus
#5
K Ponmurugan, Naif Abdullah Al-Dhabi, J Prakash Maran, K Karthikeyan, I Ganesh Moothy, N Sivarajasekar, J Jony Blessing Manoj
The main aim of this current work is to extract pectin from waste heads of Helianthus annus by ultrasound and optimize the process variables (ultrasound power (USP), pH, time of sonication (TS) and ratio of solid to liquid (RSL) on maximal recovery of pectin using central composite statistical experimental design. In addition to that, extracted pectin at optimal condition was characterized and compared with commercial pectin. The optimal extraction process condition was USP of 375w, pH of 3.2, TS of 32min and RSL of 1:15g/ml...
October 1, 2017: Carbohydrate Polymers
https://www.readbyqxmd.com/read/28714756/study-of-the-influence-of-coating-methods-on-lipid-spheres-manufactured-on-rotor-fluidized-bed-process
#6
Pascale Gauthier, Jean-Michel Cardot, Erick Beyssac, Jean-Marc Aiache
Different previous works have shown that various kinds of spheres can be manufactured by rotor granulation in a 'single pot process' using a lipid base: Hydrogenated Castor Oil. This single pot technology is based on wet granulation where all components are placed in powder form in the rotor bowl; then, they are continuously suspended in a fluidized air, with a tangentially sprayed liquid solution. This process allows the granulation and sphere manufacture during the same time. Previous experiments have studied the influence of the formulation and the manufacturing process parameters on spheres in term of feasibility and dissolution properties...
July 17, 2017: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/28713028/the-effect-of-fusarium-culmorum-infection-and-deoxynivalenol-don-application-on-proteome-response-in-barley-cultivars-chevron-and-pedant
#7
Klára Kosová, Jana Chrpová, Jiří Šantrůček, Radovan Hynek, Lenka Štěrbová, Pavel Vítámvás, Jana Bradová, Ilja Tom Prášil
Fusarium head blight (FHB) disease adversely affects grain quality and final yield in small-grain cereals including barley. In the present study, the effect of an artificial infection with Fusarium culmorum and an application of deoxynivalenol (DON) on barley spikes of cultivars Chevron and Pedant during flowering was investigated at grain mid-dough stage (BBCH 73) 10days after pathogen inoculation (10 dai). Proteomic analysis using a two-dimensional differential gel electrophoresis (2D-DIGE) technique coupled with LC-MS/MS investigated 98 protein spots revealing quantitative or qualitative differences between the experimental variants...
July 13, 2017: Journal of Proteomics
https://www.readbyqxmd.com/read/28705037/saffron-and-its-derivatives-crocin-crocetin-and-safranal-a-patent-review
#8
Maryam Rameshrad, Bibi Marjan Razavi, Hossein Hosseinzadeh
Saffron and its main components have traditionally been used as pharmaceutical agents. Current experimental research projects have also exhibited their applications in a wide spectrum of disorder treatments. Area covered: This review covers the demonstrated findings and patents on therapeutic/pharmaceutical properties of saffron and related derivatives, since 2000 to bold their outstanding merit on human health. An extensive literature review was performed in USP Patent, Patentscope, Espacenet and Google Patent in the field of CNS, cardiovascular, urogenital, dermatological and inflammatory disorders...
July 13, 2017: Expert Opinion on Therapeutic Patents
https://www.readbyqxmd.com/read/28701375/spata2-regulates-the-activation-of-ripk1-by-modulating-linear-ubiquitination
#9
Ran Wei, Lily Wen Xu, Jianping Liu, Yanxia Li, Pei Zhang, Bing Shan, Xiaojuan Lu, Lihui Qian, Zheming Wu, Kangyun Dong, Hong Zhu, Lifeng Pan, Junying Yuan, Heling Pan
Stimulation of cells with TNFα leads to the formation of the TNF-R1 signaling complex (TNF-RSC) to mediate downstream cellular fate decision. Activation of the TNF-RSC is modulated by different types of ubiquitination and may lead to cell death, including apoptosis and necroptosis, in both RIPK1-dependent and RIPK1-independent manners. Spata2 (spermatogenesis-associated 2) is an adaptor protein recruited into the TNF-RSC to modulate the interaction between the linear ubiquitin chain assembly complex (LUBAC) and the deubiquitinase CYLD (cylindromatosis)...
June 1, 2017: Genes & Development
https://www.readbyqxmd.com/read/28687156/-description-of-a-clinical-typology-specific-to-men-whose-urinary-symptoms-require-anticholinergic-treatment
#10
J-N Cornu, A Descazeaud, E Chartier-Kastler, R Bourouina
OBJECTIVES: To describe, using cluster analysis methods, the existence of a clinical typology specific to men, who are responding or not to anticholinergic treatment, and identify predictive factors associated with treatment success. METHODS: An observational study was conducted in consecutive male patients who were prescribed anticholinergics for the first time. Sociodemographic data, patient characteristics, urinary symptom profile (USP) questionnaire, Ditrovie scale and symptom severity were assessed at inclusion and after 3 months of treatment...
July 4, 2017: Progrès en Urologie
https://www.readbyqxmd.com/read/28684363/investigation-of-multiphase-multicomponent-aerosol-flow-dictating-pmdi-spacer-interactions
#11
Saurabh Sarkar, S Prasad Peri, Bodhisattwa Chaudhuri
The use of Pressurized metered dose inhalers (pMDIs) for the treatment of asthma and other chronic obstructive pulmonary diseases is frequently associated with breath-actuation synchronization problems and poor pulmonary delivery, particularly amongst the pediatric and geriatric population groups. Spacers, or Valved Holding Chambers (VHCs), are frequently used to address these problems. However, the performance of spacers with different pMDIs is also highly variable and needs to be investigated. The purpose of the current study is to develop a computational fluid dynamics (CFD) model which can characterize multiphase multicomponent aerosol flow issuing from a commercial suspension-based pMDI into a spacer...
July 4, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28681525/selective-spectrofluorimetric-method-for-determination-of-lisinopril-in-pharmaceutical-preparations-and-in-presence-of-hydrochlorothiazide-application-to-content-uniformity-testing
#12
Sayed M Derayea, Khalid M Badr El-Din, Fatma F Mohammed
A novel sensitive and cost-effective spectrofluorimetric method has been developed and validated for determination of lisinopril (an angiotensin converting enzyme inhibitor) in its pure form and pharmaceutical preparations. The method is based on the reaction of the drug with ninhydrin and phenylacetaldehyde in buffered medium (pH 7.0) to form a highly fluorescent product measured at 460 nm after excitation at 390 nm. Different experimental parameters were optimized and calibration curve was constructed...
July 6, 2017: Luminescence: the Journal of Biological and Chemical Luminescence
https://www.readbyqxmd.com/read/28680812/new-reporter-gene-assays-for-detecting-natural-and-synthetic-molting-hormone-agonists-using-yeasts-expressing-ecdysone-receptors-of-various-insects
#13
Sayoko Ito-Harashima, Mai Matsuura, Masanobu Kawanishi, Yoshiaki Nakagawa, Takashi Yagi
Synthetic nonsteroidal ecdysone agonists, a class of insect growth regulators (IGRs), target the ecdysone receptor (EcR), which forms a heterodimer with ultraspiracle (USP) to transactivate ecdysone response genes. These compounds have high binding affinities to the EcR-USP complexes of certain insects and their toxicity is selective for certain taxonomic orders. In the present study, we developed reporter gene assay (RGA) systems to detect molting hormone (ecdysone) activity by introducing EcR-USP cDNA and a bacterial lacZ reporter gene into yeast...
July 2017: FEBS Open Bio
https://www.readbyqxmd.com/read/28673094/screening-of-anionic-modified-polymers-in-terms-of-stability-disintegration-and-swelling-behavior
#14
F Laffleur, M Ijaz, C Menzel
This study aimed to screen the stability, disintegration and swelling behavior of chemical modified anionic polymers. Investigated polymers were well-known and widely used staples of the pharmaceutical and medical field, namely, alginate (AL), carboxymethyl cellulose (CMC), polycarbophil (PC) and hyaluronic acid (HA). On the basis of amide bond formation between the carboxylic acid moieties of anionic polymers and the primary amino group of the modification ligand cysteine (CYS), the modified polymers were obtained...
July 4, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28671624/effect-of-polymers-on-the-physicochemical-properties-and-biological-performance-of-fenoprofen-calcium-dihydrate-triacetyl-%C3%AE-cyclodextrin-complex
#15
Hussein O Ammar, Tarek S Makram, Shaimaa Mosallam
BACKGROUND: Fenoprofen calcium dehydrate (FCD) is counted as a non-steroidal, anti-inflammatory, anti-arthritic drug. FCD is slightly water soluble. It is indicated for mild pain relief, where the suggested dosage is 200 mg orally every 4 to 6 h. AIM: Reduce dissolution efficiency, reach an extended therapeutic effect and reduce the frequency of the drug side effects. METHOD: Combination of the co-evaporated drug:triacetyl-β-cyclodextrin complex prepared in a ratio of 1:3 and either of two polymers-hydroxylpropylmethyl cellulose (HPMC) or ethyl cellulose (EC)-in the same formulation...
July 3, 2017: Pharmaceutics
https://www.readbyqxmd.com/read/28666964/developing-quantitative-in-vitro-in-vivo-correlation-ivivc-for-fenofibrate-immediate-release-formulations-with-the-biphasic-dissolution-partition-test-method
#16
Hao Xu, Yi Shi, Socrates Vela, Patrick Marroum, Ping Gao
This study is to evaluate three fenofibrate formulations including Fournier® 200 mg capsule, Lipidil® 145 mg tablet, and a clinical HME 160 mg tablet by an in vitro biphasic method. Key experimental parameters were evaluated including the selection of biorelevant media, the USP IV flowrate and the USP paddle speed. Varying the hydrodynamic condition resulted in a significant impact on FEN concentration time profiles in both aqueous and octanol phases for these formulations. In vivo pharmacokinetic profiles of the HME tablet, the Lipidil tablet and Fournier capsule under the fasting and low fat fed states are reported...
June 27, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28666884/bioinspired-coupled-helical-coils-for-soft-tissue-engineering-of-tubular-structures-improved-mechanical-behavior-of-tubular-collagen-type-i-templates
#17
H P Janke, J Bohlin, R M L M Lomme, S M Mihaila, J Hilborn, W F J Feitz, E Oosterwijk
The design of constructs for tubular tissue engineering is challenging. Most biomaterials need to be reinforced with supporting structures such as knittings, meshes or electrospun material to comply with the mechanical demands of native tissues. In this study, coupled helical coils (CHCs) were manufactured to mimic collagen fiber orientation as found in nature. Monofilaments of different commercially available biodegradable polymers were wound and subsequently fused, resulting in right-handed and left-handed polymer helices fused together in joints where the filaments cross...
June 27, 2017: Acta Biomaterialia
https://www.readbyqxmd.com/read/28666555/life-cycle-management-of-analytical-methods
#18
REVIEW
Maria Kristina Parr, Alexander H Schmidt
In modern process management, the life cycle concept gains more and more importance. It focusses on the total costs of the process from invest to operation and finally retirement. Also for analytical procedures an increasing interest for this concept exists in the recent years. The life cycle of an analytical method consists of design, development, validation (including instrumental qualification, continuous method performance verification and method transfer) and finally retirement of the method. It appears, that also regulatory bodies have increased their awareness on life cycle management for analytical methods...
June 17, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28660092/novel-hplc-analysis-of-hydrocortisone-in-conventional-and-controlled-release-pharmaceutical-preparations
#19
Ofosua Adi-Dako, Samuel Oppong Bekoe, Kwabena Ofori-Kwakye, Enoch Appiah, Paul Peprah
An isocratic sensitive and precise reverse phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the determination and quantification of hydrocortisone in controlled-release and conventional (tablets and injections) pharmaceutical preparations. Chromatographic separation was achieved on an ODS (C18), 5 μm, 4.6 × 150 mm, with an isocratic elution using a freshly prepared mobile phase of composition methanol : water : acetic acid (60 : 30 : 10, v/v/v) at a flow rate of 1...
2017: Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28658352/premaxilla-an-independent-bone-that-can-base-therapeutics-for-middle-third-growth
#20
Mariana Trevizan, Alberto Consolaro
Premaxilla, in its early descriptions, had the participation of Goethe. In our face, in a certain period of growth and development processes, premaxilla is an independent and, then, a semi-independent bone to finally be totally integrated to the maxilla. Formation of the premaxilla acts as a stabilization element inside the facial skeleton comparable to the cornerstone of a Roman arch and is closely related to the development of human face and its abnormal growth with characteristic malformations. Until when the premaxillary-maxillary suture remains open and offers opportunities to orthopedically influence facial growth to exert influence over facial esthetics and function? Contact with preliminary results in 1183 skulls from anatomic museums at USP, Unicamp and Unifesp led us to question therapeutic perspectives and its clinical applicability...
March 2017: Dental Press Journal of Orthodontics
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