Biennial Review of 40 CFR Part 503 As Required Under the Clean Water Act Section 405(D)(2)(C)
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Ranking of Substances for Monitoring in Foods, Drinks and Dietary Supplements - Based on Risk and Knowledge Gaps
VKM Report 2019: 13 Ranking of substances for monitoring in foods, drinks and dietary supplements - based on risk and knowledge gaps Scientific Opinion of the Scientific Steering Committee of the Norwegian Scientific Committee for Food and Environment Scientific Opinion of the Scientific Steering Committee of the Norwegian Scientific Committee for Food and Environment 16.09.2019 ISBN: 978-82-8259-329-8 ISSN: 2535-4019 Norwegian Scientific Committee for Food and Environment (VKM) Po 222 Skøyen N – 0213 Oslo Norway Phone: +47 21 62 28 00 Email: [email protected] vkm.no vkm.no/english Cover photo: Brace Suggested citation: VKM, Inger-Lise Steffensen, Christiane Kruse Fæste, Trine Husøy, Helle Katrine Knutsen, Gro Haarklou Mathisen, Robin Ørnsrud, Angelika Agdestein, Johanna Bodin, Edel Elvevoll, Dag O. Hessen, Merete Hofshagen, Åshild Krogdahl, Asbjørn Magne Nilsen, Trond Rafoss, Taran Skjerdal, Gaute Velle, Yngvild Wasteson, Gro-Ingunn Hemre, Vigdis Vandvik, Jan Alexander (2019). Ranking of substances for monitoring in foods, drinks and dietary supplements - based on risk and knowledge gaps. Scientific Opinion of the Scientific Steering Committee of the Norwegian Scientific Committee for Food and Environment. VKM report 2019:13, ISBN: 978-82-8259-329-8, ISSN: 2535-4019. VKM Report 2019: 13 Ranking of substances for monitoring in foods, drinks and dietary supplements - based on risk and knowledge gaps Preparation of the opinion The Norwegian Scientific Committee for Food and Environment (Vitenskapskomiteen for mat og miljø, VKM) appointed a project group to answer the request from the Norwegian Food Safety Authority. The project group consisted of six VKM members and a project leader from the VKM secretariat. -
PACKAGE LEAFLET: INFORMATION for the USER Asacol® 800Mg MR Tablets (Mesalazine) Read All of This Leaflet Carefully Before You S
PACKAGE LEAFLET: INFORMATION FOR THE USER Asacol® 800mg MR tablets (mesalazine) Read all of this leaflet carefully before you start taking this medicine. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Asacol 800mg MR tablets are and what they are used for 2. Before you take Asacol 800mg MR tablets 3. How to take Asacol 800mg MR tablets 4. Possible side effects 5. How to store Asacol 800mg MR tablets 6. Further information 1. WHAT ASACOL 800MG MR TABLETS ARE AND WHAT THEY ARE USED FOR Asacol 800mg MR tablets contain the active substance mesalazine (also known as 5- aminosalicylic acid) which is an anti-inflammatory drug used in the treatment of: • Ulcerative colitis - a disease of the large bowel (colon) and back passage (rectum) in which the lining of the bowel becomes inflamed (red and swollen). Symptoms can include rectal bleeding, frequent diarrhoea and abdominal pain. Asacol 800mg MR tablets act locally in the colon to reduce inflammation and can also prevent further episodes (flares) of ulcerative colitis. • Crohn’s ileo-colitis – a disease affecting the small bowel (terminal ileum) and colon in which the lining of the bowel becomes swollen and sore. -
Information to Users
INFORMATION TO USERS This manuscript has been reproduced from the microfilm master. UMI films the text directly from the original or copy submitted. Thus, some thesis and dissertation copies are in typewriter face, while others may be from any type of computer printer. The quality of this reproduction is dependent upon the quality of the copy submitted. Broken or indistinct print, colored or poor quality illustrations and photographs, print bleedthrough, substandard margins, and improper alignment can adversely affect reproduction. In the unlikely event that the author did not send UMI a complete manuscript and there are missing pages, these will be noted. Also, if unauthorized copyright material had to be removed, a note will indicate the deletion. Oversize materials (e.g., maps, drawings, charts) are reproduced by sectioning the original, beginning at the upper left-hand corner and continuing from left to right in equal sections with small overlaps. Each original is also photographed in one exposure and is included in reduced form at the back of the book. Photographs included in the original manuscript have been reproduced xerographically in this copy. Higher quality 6" x 9" black and white photographic prints are available for any photographs or illustrations appearing in this copy for an additional charge. Contact UMI directly to order. University Microfilms International A Bell & Howell Information Company 300 North Zeeb Road, Ann Arbor, Ml 48106-1346 USA 313/761-4700 800/521-0600 Order Number 9238132 Protein induction and estrogen metabolism in subcellular preparations and tissue slices of the golden Syrian hamster Beleh, Mustapha Ahmed, Ph.D. -
Salofalk®) in an Open Study of 20 Patients with Ankylosing Spondylitis
Efficacy and Safety of Mesalazine (Salofalk®) in an Open Study of 20 Patients with Ankylosing Spondylitis J. CHRISTIAAN van DENDEREN, IRENE E. van der HORST-BRUINSMA, P. DICK BEZEMER, and BEN A.C. DIJKMANS ABSTRACT. Objective. Mesalazine (Salofalk®) was found to be effective and showed low toxicity in patients with inflammatory bowel disease. The association of gut lesions and spondyloarthropathy (SpA) is well known and we studied the efficacy and safety of a relatively high dose of mesalazine in patients with ankylosing spondylitis (AS). Methods. In an open study, mesalazine (3–4 g/day) was prescribed for 24 weeks to 20 patients (aged 18–70 yrs) with active AS, defined as the presence of at least one clinical criterion (morning stiff- ness > 30 min, peripheral synovitis, enthesopathy, or pain score > 2 on a visual analog scale of 10 cm) and one laboratory criterion [erythrocyte sedimentation rate (ESR) > 20 mm/h or C-reactive protein (CRP) > 20 mg/l]. Data on toxicity and disease activity variables (ESR, CRP, BASDAI, BASFI, BASMI, global assessment, and joint count) were obtained at baseline and after 4, 12, and 24 weeks, and analyzed on an intention-to-treat basis. Results. Study patients had a mean age of 41 years, with mean disease duration of 7.9 years and a mean ESR at baseline of 29 mm/h. After a mean of 9.3 weeks (range 2–22), 8 of the 20 patients prematurely stopped the medication because of adverse effects, mainly gastrointestinal complaints. Twelve patients completed the 24 weeks of the study using a mean dose of 3.2 g/day (range 1–4) mesalazine. -
Ononis Spinosa Alleviated Capsaicin-Induced Mechanical
Korean J Pain 2021;34(3):262-270 https://doi.org/10.3344/kjp.2021.34.3.262 pISSN 2005-9159 eISSN 2093-0569 Experimental Research Article Ononis spinosa alleviated capsaicin-induced mechanical allodynia in a rat model through transient receptor potential vanilloid 1 modulation Sahar Majdi Jaffal1, Belal Omar Al-Najjar2,3, and Manal Ahmad Abbas3,4 1Department of Biological Sciences, Faculty of Science, The University of Jordan, Amman, Jordan 2Department of Pharmaceutical Sciences, Faculty of Pharmacy, Al-Ahliyya Amman University, Amman, Jordan 3Pharmacological and Diagnostic Research Center, Al-Ahliyya Amman University, Amman, Jordan 4Department of Medical Laboratory Sciences, Faculty of Allied Medical Sciences, Al-Ahliyya Amman University, Amman, Jordan Received January 2, 2021 Revised April 7, 2021 Background: Transient receptor potential vanilloid 1 (TRPV1) is a non-selective Accepted April 8, 2021 cation channel implicated in pain sensation in response to heat, protons, and cap- saicin (CAPS). It is well established that TRPV1 is involved in mechanical allodynia. Handling Editor: Sang Hun Kim This study investigates the effect of Ononis spinosa (Fabaceae) in CAPS-induced mechanical allodynia and its mechanism of action. Correspondence Methods: Mechanical allodynia was induced by the intraplantar (ipl) injection of 40 Sahar Majdi Jaffal µg CAPS into the left hind paw of male Wistar rats. Animals received an ipl injection Department of Biological Sciences, of 100 µg O. spinosa methanolic leaf extract or 2.5% diclofenac sodium 20 minutes Faculty of Science, The University of before CAPS injection. Paw withdrawal threshold (PWT) was measured using von Jordan, Amman 11942, Jordan Tel: +962787924254 Frey filament 30, 90, and 150 minutes after CAPS injection. -
Development of Mesalazine Microspheres for Colon Targeting
International Journal of Applied Pharmaceutics ISSN- 0975-7058 Vol 9, Issue 4, 2017 Original Article DEVELOPMENT OF MESALAZINE MICROSPHERES FOR COLON TARGETING KATTA RAJESH, R. DEVESWARAN *, S. BHARATH, B. V. BASAVARAJ Department of Pharmaceutics, Faculty of Pharmacy, M. S. Ramaiah University of Applied Sciences, Bangalore 560054 Email: [email protected] Received: 28 Jan 2017, Revised and Accepted: 14 Jun 2017 ABSTRACT Objective: The present work was aimed at preparation of mesalazine microspheres by a non-aqueous solvent evaporation method using eudragit S 100 and eudragit L 100 as pH dependent polymers for colon targeting. Methods: The ratio of drug to polymer was varied and the effect of formulation variables revolutions per minute (RPM) (1000, 1500, 2000 and 2500) and concentration of span 80 (1%, 1.5%, 2% and 2.5%) were studied. Prepared microspheres were evaluated for particle size, percent drug entrapment, granular analysis, in vitro drug release studies, Fourier transformed infrared spectroscopy (FT-IR) Differential Scanning Calorimetry (DSC), X-ray diffraction (XRD) and scanning electron microscopy (SEM) studies. Results: Particle size has decreased and percent drug entrapment had increased with increase in RPM in all formulations. When the span 80 concentration increased, the particle size of the microsphere formulations increased and percent drug entrapment decreased in eudragit S 100 microspheres; whereas in eudragit L 100 microspheres, as the concentration of span 80 increased, the particle size of the microsphere formulations decreased. The prepared microspheres sustained the drug release over a period of 12 h. Conclusion: Thus eudragit S 100 and eudragit L 100 microspheres could constitute a promising approach for colon-specific and sustained delivery of mesalazine for the treatment of inflammatory bowel disease. -
Recent Advances in Mesalamine Colonic Delivery Systems Mohammad F
Bayan and Bayan Future Journal of Pharmaceutical Sciences (2020) 6:43 Future Journal of https://doi.org/10.1186/s43094-020-00057-7 Pharmaceutical Sciences REVIEW Open Access Recent advances in mesalamine colonic delivery systems Mohammad F. Bayan* and Rana F. Bayan Abstract Background: Increased attention has been focused on the continuous development and improvement of mesalamine colonic specific delivery systems, for the effective treatment of inflammatory bowel diseases; thus enhancing therapeutic efficacy and reducing potential side effects. Mesalamine is a class IV drug, according to the Biopharmaceutics Classification System, used usually to treat inflammation associated with colon related diseases such as Crohn’s disease and ulcerative colitis. Main text An ideal colon targeting system aims to deliver a therapeutic agent, selectively and effectively, to the colon. This system should ideally retain the drug release in the upper GI tract (stomach and small intestine); while trigger the drug release in the colon. Several approaches have been used to fabricate formulations to achieve a colon specific delivery of mesalamine such as; time dependent, pH responsive, enzymatic/microbial responsive and ultrasound mediated approaches. This overview outlines the recent advances in mesalamine-colon delivery approaches for the potential treatment of ulcerative colitis and Crohn’ disease. Conclusion: A combined pH-time dependent delivery system can improve mesalamine colonic drug delivery via employing carriers capable of retarding mesalamine release in the stomach and delivering it at predetermined time points after entering the intestine. The existence of specific enzymes, produced by various anaerobic bacteria present in the colon advocates the advantage of designing enzyme sensitive systems and combining it with pH- time dependent system to improve mesalamine colonic delivery. -
PHYTOSTEROLS, PHYTOSTANOLS and THEIR ESTERS Chemical and Technical Assessment
PHYTOSTEROLS, PHYTOSTANOLS AND THEIR ESTERS Chemical and Technical Assessment 1 Prepared by Richard Cantrill, Ph.D., reviewed by Yoko Kawamura, Ph.D., for the 69th JECFA 1. Summary Phytosterols and phytostanols, also referred to as plant sterols and stanols, are common plant and vegetable constituents and are therefore normal constituents of the human diet. They are structurally related to cholesterol, but differ from cholesterol in the structure of the side chain. Commercially, phytosterols are isolated from vegetable oils, such as soybean oil, rapeseed (canola) oil, sunflower oil or corn oil, or from so-called "tall oil", a by-product of the manufacture of wood pulp. These sterols can be hydrogenated to obtain phytostanols. Both phytosterols- and stanols, which are high melting powders, can be esterified with fatty acids of vegetable (oil) origin. The resulting esters are liquid or semi-liquid materials, having comparable chemical and physical properties to edible fats and oils, enabling supplementation of various processed foods with phytosterol- and phytostanol esters. The most common phytosterols and phytostanols are sitosterol (3β-stigmast-5-en-3ol; CAS Number 83- 46-5), sitostanol (3β,5α-stigmastan-3-ol; CAS Number 83-45-4), campesterol (3β-ergost-5-en-3-ol; CAS Number 474-62-4), campestanol (3β,5α-ergostan-3-ol; CAS Number 474-60-2), stigmasterol (3β- stigmasta-5,22-dien-3-ol; CAS Number 83-48-7) and brassicasterol (3β-ergosta-5,22-dien-3-ol; CAS Number 474-67-9). Each commercial source has its own typical composition. Dietary intake of phytosterols ranges from 150-400 mg /day in a typical western diet. -
Physicochemical Compatibility Investigation of Mesalazine and Folic Acid Using Chromatographic and Thermoanalytical Techniques
pharmaceuticals Article Physicochemical Compatibility Investigation of Mesalazine and Folic Acid Using Chromatographic and Thermoanalytical Techniques Mario-Livio Jeliˇci´c,Edvin Brusaˇc , Daniela Amidži´cKlari´c , Biljana Nigovi´c , Sabina Keser and Ana Mornar * Faculty of Pharmacy and Biochemistry, University of Zagreb, A. Kovaˇci´ca1, 10000 Zagreb, Croatia; [email protected] (M.-L.J.); [email protected] (E.B.); [email protected] (D.A.K.); [email protected] (B.N.); [email protected] (S.K.) * Correspondence: [email protected]; Tel.: +385-1-481-8288 Received: 16 July 2020; Accepted: 7 August 2020; Published: 8 August 2020 Abstract: Inflammatory bowel disease is a common name for Crohn’s disease and ulcerative colitis. These inflammatory states cause damage in the sidewalls of the gastrointestinal tract, resulting in malabsorption of food and vitamins. Folic acid (Vitamin B9) is often associated with inflammatory bowel diseases since reduced overall folate concentration in the human body may lead to the development of colorectal cancer and megaloblastic anaemia. However, its deficiency is easily compensated by taking an additional folic acid pill during regular therapy. At the moment, there are no studies that have examined the compatibility of folic acid with 5-aminosalicylate drugs used in the treatment of inflammatory bowel diseases. In this work, differential scanning calorimetry, forced degradation studies, isothermal stress testing and dissolution stability testing were used to determine the stability of folic acid and one of the most commonly used 5-aminosalicylates, mesalazine, when present in the same solution or blend. To monitor the assay of folic acid, mesalazine and nine of its related impurities, a single HPLC method was developed. -
A Novel Microbial Zearalenone Transformation Through Phosphorylation
toxins Article A Novel Microbial Zearalenone Transformation through Phosphorylation Yan Zhu 1, Pascal Drouin 2 , Dion Lepp 1, Xiu-Zhen Li 1, Honghui Zhu 1, Mathieu Castex 2 and Ting Zhou 1,* 1 Guelph Research and Development Centre, Agriculture and Agri-Food Canada, Guelph, ON N1G 5C9, Canada; [email protected] (Y.Z.); [email protected] (D.L.); [email protected] (X.-Z.L.); [email protected] (H.Z.) 2 Lallemand Inc., Montréal, QC H1W 2N8, Canada; [email protected] (P.D.); [email protected] (M.C.) * Correspondence: [email protected]; Tel.: +1-226-217-8084; Fax: +1-519-829-2600 Abstract: Zearalenone (ZEA) is a mycotoxin widely occurring in many agricultural commodities. In this study, a purified bacterial isolate, Bacillus sp. S62-W, obtained from one of 104 corn silage samples from various silos located in the United States, exhibited activity to transform the mycotoxin ZEA. A novel microbial transformation product, ZEA-14-phosphate, was detected, purified, and identified by HPLC, LC-MS, and NMR analyses. The isolate has been identified as belonging to the genus Bacillus according to phylogenetic analysis of the 16S rRNA gene and whole genome alignments. The isolate showed high efficacy in transforming ZEA to ZEA-14-phosphate (100% transformation within 24 h) and possessed advantages of acid tolerance (work at pH = 4.0), working under a broad range of temperatures (22–42 ◦C), and a capability of transforming ZEA at high concentrations (up to 200 µg/mL). In addition, 23 Bacillus strains of various species were tested for their ZEA phosphorylation activity. -
Cannabis Impurities Standards
CANNABIS IMPURITIES STANDARDS Cannabis impurity and terpene mixtures lgcstandards.com LGC Quality | ISO 9001 | ISO/IEC 17025 | ISO 17034/ISO Guide 34 | ISO 17043 WE’RE MEETING YOUR STATE’S STANDARDS For cannabis impurity testing Dr. Ehrenstorfer offers a broad range of state-by-state cannabis impurity standards as well as a full list of terpenes to meet your state’s requirements. We manufacture standards for the analysis of pesticide, solvent, heavy metal, mycotoxin, bacteria and growth regulator residues and an extensive list of terpenes. Our cannabis product group features mixes to meet the current needs for cannabis impurity testing in most states. State regulations frequently change. Our catalog is updated as new regulations are implemented, so check back often for the latest version. All of our Dr. Ehrenstorfer™ brand mixes are manufactured in accordance with ISO 17034 requirements. If none of our stock standards suit your needs, we will manufacture a custom standard to your specifications. Please let us know if you have questions or would like to discuss your specific requirements. We are here to help. Email: [email protected] Order online at: lgcstandards.com Prefer to speak to someone in the US?: +1 603 622 7660 Additional sales office contact details are listed at the back. CONTENTS Table of contents Introduction Pesticides and growth regulators California 1 Canada 3 Colorado 6 Nevada 6 Oregon 7 Single Component Pesticide Solutions 15 Neat Pesticides 15 Residual solvents California 18 Cannabis Spiking Mix 22 Butane/Ethanol -
Mesalazine Improves Replication Fidelity in Cultured Colorectal Cells
Priority Report Mesalazine Improves Replication Fidelity in Cultured Colorectal Cells Christoph Gasche,1 Ajay Goel,2 Loki Natarajan,3 and C. Richard Boland2 1Department of Medicine 4, Division of Gastroenterology and Hepatology, Medical University Vienna, Vienna, Austria; 2Baylor University Medical Center, Dallas, Texas; and 3Biostatistics, Cancer Center, University of California, San Diego, California Abstract cancer is, however, derived from aspirin, acetylsalicylic acid, Epidemiologic studies indicate that mesalazine has chemo- which is structurally similar to mesalazine. The molecular preventive effects in inflammatory bowel disease–associated mechanisms by which aspirin and other nonsteroidal anti- colorectal cancer. Most of our general understanding of inflammatory drugs exert chemopreventive effects in colon chemoprevention in colorectal cancer is, however, derived cancer are complex and a matter of ongoing debate. Besides from aspirin, which is structurally similar to mesalazine. the well-established effects on cyclooxygenase, aspirin and Herein we determined the influence of aspirin and mesala- nonsteroidal anti-inflammatory drugs are thought to mediate their antineoplastic properties by other mechanisms including zine on replication fidelity in cultured colorectal cells. Flow n cytometry was used for quantitation of mutation rates at a inhibition of nuclear factor B (4). Another possible target for the activity of nonsteroidal anti-inflammatory drugs is the (CA)13 microsatellite in HCT116 cells (mismatch repair deficient) and HCT116+chr3 cells (mismatch repair profi- improvement of DNA replication. The fidelity of DNA replication cient) that had been stably transfected with pIREShyg2- is a product of polymerase accuracy, its proofreading activity, EGFP/CA13, an enhanced green fluorescence protein–based and the proficiency of the postreplicational mismatch repair plasmid, and cultured in the absence or presence of various system (5).