(12) Patent Application Publication (10) Pub. No.: US 2013/0034530 A1 Fantz (43) Pub
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(12) Patent Application Publication (10) Pub. No.: US 2006/0110449 A1 Lorber Et Al
US 200601 10449A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2006/0110449 A1 LOrber et al. (43) Pub. Date: May 25, 2006 (54) PHARMACEUTICAL COMPOSITION Publication Classification (76) Inventors: Richard R. Lorber, Scotch Plains, NJ (US); Heribert W. Staudinger, Union, (51) Int. Cl. NJ (US); Robert E. Ward, Summit, NJ A6II 3/473 (2006.01) (US) A6II 3L/24 (2006.01) Correspondence Address: A6IR 9/20 (2006.01) SCHERING-PLOUGH CORPORATION (52) U.S. Cl. ........................... 424/464; 514/290: 514/540 PATENT DEPARTMENT (K-6-1, 1990) 2000 GALLOPNG HILL ROAD KENILWORTH, NJ 07033-0530 (US) (57) ABSTRACT (21) Appl. No.: 11/257,348 (22) Filed: Oct. 24, 2005 The present invention relates to formulations useful for Related U.S. Application Data treating respiratory disorders associated with the production of mucus glycoprotein, skin disorders, and allergic conjunc (60) Provisional application No. 60/622,507, filed on Oct. tivitis while substantially reducing adverse effects associ 27, 2004. Provisional application No. 60/621,783, ated with the administration of non-selective anti-cholin filed on Oct. 25, 2004. ergic agents and methods of use thereof. US 2006/01 10449 A1 May 25, 2006 PHARMACEUTICAL COMPOSITION example, Weinstein and Weinstein (U.S. Pat. No. 6,086,914) describe methods of treating allergic rhinitis using an anti CROSS REFERENCE TO RELATED cholinergic agent with a limited capacity to pass across lipid APPLICATION membranes, such as the blood-brain barrier, in combination with an antihistamine that is limited in both sedating and 0001. This application claims benefit of priority to U.S. -
Optimal Foods
Optimal Foods 1. Almonds: high in monounsaturated and polyunsaturated fats, with 20% of calories coming from protein and dietary fiber. Nutrients include potassium, magnesium, calcium, iron, zinc, vitamin E and an antioxidant flavonoid called amygdlin also known as laetrile. 2. Barley: Like oat bran it is high in beta-glucan fiber which helps to lower cholesterol. Nutrients include copper, magnesium, phosphorous and niacin. 3. Berries : The darker the berry the higher in anti-oxidants. Nutritionally they are an excellent source of flavonoids, especially anthocyanidins, vitamin C and both soluble and insoluble fiber. 4. Brussels Sprouts : Similar to broccoli, and a member of the cabbage family, it contains cancer fighting glucosinolates. Nutritionally it is an excellent source of vitamin C and K, the B vitamins, beta-carotene, potassium and dietary fiber. 5. Carrots: It contains the highest source of proviatamin A carotenes as well as vitamin K, biotin, vitamin C, B6, potassium, thiamine and fiber. 6. Dark Chocolate: It is rich in the flavonoids, similar to those found in berries and apples, that are more easily absorbed than in other foods. It also provides an amino acid called arginine that helps blood vessels to dilate hence regulating blood flow and helping to lower blood pressure. Choose high-quality semisweet dark chocolate with the highest cocoa content that appeals to your taste buds. 7. Dark leafy greens : Kale, arugula, spinach, mustard greens, chard, collards, etc: low calorie, anti-oxidant dense food with carotenes, vitamin C, folic acid, manganese, copper, vitamin E, copper, vitamin B6, potassium, calcium, iron and dietary fiber. Kale is a particularly excellent bioavailable source of calcium while spinach is not. -
Toxicological and Pharmacological Profile of Amanita Muscaria (L.) Lam
Pharmacia 67(4): 317–323 DOI 10.3897/pharmacia.67.e56112 Review Article Toxicological and pharmacological profile of Amanita muscaria (L.) Lam. – a new rising opportunity for biomedicine Maria Voynova1, Aleksandar Shkondrov2, Magdalena Kondeva-Burdina1, Ilina Krasteva2 1 Laboratory of Drug metabolism and drug toxicity, Department “Pharmacology, Pharmacotherapy and Toxicology”, Faculty of Pharmacy, Medical University of Sofia, Bulgaria 2 Department of Pharmacognosy, Faculty of Pharmacy, Medical University of Sofia, Bulgaria Corresponding author: Magdalena Kondeva-Burdina ([email protected]) Received 2 July 2020 ♦ Accepted 19 August 2020 ♦ Published 26 November 2020 Citation: Voynova M, Shkondrov A, Kondeva-Burdina M, Krasteva I (2020) Toxicological and pharmacological profile of Amanita muscaria (L.) Lam. – a new rising opportunity for biomedicine. Pharmacia 67(4): 317–323. https://doi.org/10.3897/pharmacia.67. e56112 Abstract Amanita muscaria, commonly known as fly agaric, is a basidiomycete. Its main psychoactive constituents are ibotenic acid and mus- cimol, both involved in ‘pantherina-muscaria’ poisoning syndrome. The rising pharmacological and toxicological interest based on lots of contradictive opinions concerning the use of Amanita muscaria extracts’ neuroprotective role against some neurodegenerative diseases such as Parkinson’s and Alzheimer’s, its potent role in the treatment of cerebral ischaemia and other socially significant health conditions gave the basis for this review. Facts about Amanita muscaria’s morphology, chemical content, toxicological and pharmacological characteristics and usage from ancient times to present-day’s opportunities in modern medicine are presented. Keywords Amanita muscaria, muscimol, ibotenic acid Introduction rica, the genus had an ancestral origin in the Siberian-Be- ringian region in the Tertiary period (Geml et al. -
The Effect of Vitamin Supplementation on Subclinical
molecules Review The Effect of Vitamin Supplementation on Subclinical Atherosclerosis in Patients without Manifest Cardiovascular Diseases: Never-ending Hope or Underestimated Effect? Ovidiu Mitu 1,2,* , Ioana Alexandra Cirneala 1,*, Andrada Ioana Lupsan 3, Mircea Iurciuc 4 , 5 5 2, Ivona Mitu , Daniela Cristina Dimitriu , Alexandru Dan Costache y , Antoniu Octavian Petris 1,2 and Irina Iuliana Costache 1,2 1 Department of Cardiology, Clinical Emergency Hospital “Sf. Spiridon”, 700111 Iasi, Romania 2 1st Medical Department, University of Medicine and Pharmacy “Grigore T. Popa”, 700115 Iasi, Romania 3 Department of Cardiology, University of Medicine, Pharmacy, Science and Technology, 540139 Targu Mures, Romania 4 Department of Cardiology, University of Medicine and Pharmacy “Victor Babes”, 300041 Timisoara, Romania 5 2nd Morpho-Functional Department, University of Medicine and Pharmacy “Grigore T. Popa”, 700115 Iasi, Romania * Correspondence: [email protected] (O.M.); [email protected] (I.A.C.); Tel.: +40-745-279-714 (O.M.) Medical Student, University of Medicine and Pharmacy “Grigore T. Popa”, 700115 Iasi, Romania. y Academic Editors: Raluca Maria Pop, Ada Popolo and Stefan Cristian Vesa Received: 25 March 2020; Accepted: 7 April 2020; Published: 9 April 2020 Abstract: Micronutrients, especially vitamins, play an important role in the evolution of cardiovascular diseases (CVD). It has been speculated that additional intake of vitamins may reduce the CVD burden by acting on the inflammatory and oxidative response starting from early stages of atherosclerosis, when the vascular impairment might still be reversible or, at least, slowed down. The current review assesses the role of major vitamins on subclinical atherosclerosis process and the potential clinical implications in patients without CVD. -
DRIDIETARY REFERENCE INTAKES Thiamin, Riboflavin, Niacin, Vitamin
Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline http://www.nap.edu/catalog/6015.html DIETARY REFERENCE INTAKES DRI FOR Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline A Report of the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes and its Panel on Folate, Other B Vitamins, and Choline and Subcommittee on Upper Reference Levels of Nutrients Food and Nutrition Board Institute of Medicine NATIONAL ACADEMY PRESS Washington, D.C. Copyright © National Academy of Sciences. All rights reserved. Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline http://www.nap.edu/catalog/6015.html NATIONAL ACADEMY PRESS • 2101 Constitution Avenue, N.W. • Washington, DC 20418 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This project was funded by the U.S. Department of Health and Human Services Office of Disease Prevention and Health Promotion, Contract No. 282-96-0033, T01; the National Institutes of Health Office of Nutrition Supplements, Contract No. N01-OD-4-2139, T024, the Centers for Disease Control and Prevention, National Center for Chronic Disease Preven- tion and Health Promotion, Division of Nutrition and Physical Activity; Health Canada; the Institute of Medicine; and the Dietary Reference Intakes Corporate Donors’ Fund. -
Safety Assessment of Panthenol, Pantothenic Acid, and Derivatives As Used in Cosmetics
Safety Assessment of Panthenol, Pantothenic Acid, and Derivatives as Used in Cosmetics Status: Scientific Literature Review for Public Comment Release Date: February 2, 2017 Panel Meeting Date: April 10-11, 2017 All interested persons are provided 60 days from the above date to comment on this safety assessment and to identify additional published data that should be included or provide unpublished data which can be made public and included. Information may be submitted without identifying the source or the trade name of the cosmetic product containing the ingredient. All unpublished data submitted to CIR will be discussed in open meetings, will be available at the CIR office for review by any interested party and may be cited in a peer-reviewed scientific journal. Please submit data, comments, or requests to the CIR Director, Dr. Lillian J. Gill. The 2017 Cosmetic Ingredient Review Expert Panel members are: Chair, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V. Belsito, M.D.; Ronald A. Hill, Ph.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; James G. Marks, Jr., M.D., Ronald C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The CIR Director is Lillian J. Gill, D.P.A. This safety assessment was prepared by Laura N. Scott, Scientific Writer/Analyst. © Cosmetic Ingredient Review 1620 L Street, NW, Suite 1200 ♢ Washington, DC 20036-4702 ♢ ph 202.331.0651 ♢ fax 202.331.0088 ♢ [email protected] INTRODUCTION This assessment reviews the safety of Panthenol, Pantothenic Acid and 5 of their derivatives as used in cosmetic formulations. -
LYSOVIT® (B-Complex+Lysine)
Lysovit/LPD/PK-02 LYSOVIT® (B-Complex+Lysine) 1. NAME OF THE MEDICINAL PRODUCT LYSOVIT® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION LYSOVIT® Syrup 120 ml Description Each 5 ml contains: Thiamine HCl 4.16 mg Riboflavin USP 1.66 mg Pyridoxine HCl 1 mg Niacinamide USP 18 mg D-Panthenol USP 2.5 mg Cyanocobalamin USP 8.33 mcg Ascorbic Acid USP 75 mg Inositol USP 5 mg Lysine Monohydrochloride USP 33.33 mg 3. PHARMACEUTICAL FORM Syrup 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS 1. For maintenance of health and to meet the extra energy needs of growing children. 2. Increases appetite and helps in recovery from illnesses. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Children: 1 teaspoonful daily or as prescribed by the physician Adults: One to two teaspoonsful daily. Shake well before use. Thiamine Benefits: Thiamine is recommended for digestive problems including poor appetite, ulcerative colitis, and ongoing diarrhea. People take thiamine for conditions related to low levels of thiamine (thiamine deficiency syndromes), including beriberi and inflammation of the nerves (neuritis) associated with pellagra or pregnancy.4 1 Lysovit/LPD/PK-02 Thiamine - Daily Recommended Dietary Allowance (RDA): In adults, 1-2 mg of thiamine per day is commonly used. Infants 0-6 months, 0.2 mg Infants 7-12 months, 0.3 mg Children 1-3 years, 0.5 mg Children 4-8 years, 0.6 mg Boys 9-13 years, 0.9 mg Men 14 years and older, 1.2 mg4 Girls 9-13 years, 0.9 mg Women 14-18 years, 1 mg Women over 18 years, 1.1 mg Pregnant women, 1.4 mg Breast-feeding women, 1.5 mg Riboflavin Benefits: Riboflavin had a direct impact on maintenance of good brain function. -
Water-Soluble Vitamins: B-Complex and Vitamin C Fact Sheet No
Water-Soluble Vitamins: B-Complex and Vitamin C Fact Sheet No. 9.312 Food and Nutrition Series|Health by L. Bellows and R. Moore* What are Vitamins? and their influence is felt in many parts of Quick Facts Vitamins are essential nutrients found the body. They function as coenzymes that • B-complex vitamins and in foods. They perform specific and vital help the body obtain energy from food. The vitamin C are water-soluble functions in a variety of body systems, and B vitamins are also important for normal are crucial for maintaining optimal health. appetite, good vision, and healthy skin, vitamins that are not stored The two different types of vitamins nervous system, and red blood cell formation. in the body and must be are fat-soluble vitamins and water-soluble Thiamin: Vitamin B1 replaced each day. vitamins. Fat-soluble vitamins — vitamins What is Thiamin. Thiamin, or vitamin B1, • These vitamins are easily A, D, E and K — dissolve in fat before they helps to release energy from foods, promotes destroyed or washed out are absorbed in the bloodstream to carry out normal appetite, and is important in during food storage and their functions. Excesses of these vitamins maintaining proper nervous system function. are stored in the liver, and are not needed Food Sources for Thiamin. Sources preparation. every day in the diet. For more information include peas, pork, liver, and legumes. Most • The B-complex group is on fat-soluble vitamins, see fact sheet 9.315 commonly, thiamin is found in whole grains found in a variety of foods: Fat-Soluble Vitamins: A, D, E, and K. -
Nutrition in Addiction Recovery
Many Hands Sustainability Center 411 Sheldon Road Barre, MA 01005 http://manyhandssustainabilitycenter.org Nutrition in Addiction Recovery by Rebecca Place Miller, Science Writer May 2010 Table of Contents I. Introduction II. What is Addiction? III. Addiction in the Brain Neurotransmitters: Chemical Messengers An Imbalanced Brain Recovery Foods for Neurotransmitters Summary of Abused Substances and Health Problems IV. Addiction in the Body Hypoglycemia Adrenal Fatigue Allergies/Sensitivities Leaky Gut Yeast/Candida Problems V. Common Nutritional Deficiencies Carbohydrates Protein Fats Vitamins and Minerals Nutritional Supplements VI. Eating in Recovery What to Eat What Not to Eat When to Eat Can Food Work in Recovery? VII. List of Resources VIII. References 1 I. Introduction Making the connection between addiction and nutrition: a literature review. This document has been prepared by Many Hands Sustainability Center (MHSC) as part of its Nutritional Many Hands Sustainability Center, Education and Job-Training Program, a program that located in Barre, Massachusetts, is a nonprofit educational center estab- offers former prisoners recovering from drug and lished in 2007 to educate about alcohol addiction an opportunity to develop job skills, sustainable living, organic farming, learn about all aspects of organic farming, and become and good nutrition. The Center is an educated about proper nutrition and healthier lifestyle outgrowth of Many Hands Organic choices. Farm, which since 1984 has offered over 300 educational workshops on food/nutrition and organic farming This document has been prepared to educate people and has helped launch a number of about how drugs and alcohol can disrupt the normal successful farm education programs functioning of the body and how better nutrition can across Massachusetts. -
021876Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 021876Orig1s000 PHARMACOLOGY REVIEW(S) MEMO FOOD AND DRUG ADMINISTRATION Division of Reproductive and Urologic Products Center for Drug Evaluation and Research Date: April 5, 2013 From: Kimberly Hatfield, Ph.D. Toxicologist To: NDA 21876 Subject: Changes to nonclinical scientific bridge and labeling for NDA 21876 (Diclegis) Scientific bridge: NDA 21876 has been submitted as a 505(b)(2) application for the drug product Diclegis (combination of doxylamine succinate and pyridoxine hydrochloride), with nonclinical evidence supporting the safety of Diclegis being based on the Agency’s determination of safety for the Reference Listed Drug (RLD), Bendectin® (NDA 10-598). The nonclinical scientific bridge between Diclegis and the RLD Bendectin® has been revised since submission of the initial nonclinical NDA review. It now states: The bridge for reliance on the nonclinical data generated with Bendectin (10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride) to support the NDA for Diclegis (10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride) is based on: 1) in vivo delayed release, 2) similar pharmacodynamic characteristics, and 3) in vitro dissolution based on Diclectin (a Canadian approved drug product containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride) manufactured at (b) (4) and 4) chemical criteria for doxylamine succinate and pyridoxine hydrochloride defined in the US Pharmacopeia e.g., composition, structure, molecular weight and chemical characteristics. Refer also to the clinical pharmacology memo further elaborating on the scientific bridge submitted by CAPT E. Dennis Bashaw, PharmD. Labeling changes: During label negotiations, a change in Section 13 Carcinogenesis, Mutagenesis and Impairment of Fertility was made. -
Nutrition Journal of Parenteral and Enteral
Journal of Parenteral and Enteral Nutrition http://pen.sagepub.com/ Micronutrient Supplementation in Adult Nutrition Therapy: Practical Considerations Krishnan Sriram and Vassyl A. Lonchyna JPEN J Parenter Enteral Nutr 2009 33: 548 originally published online 19 May 2009 DOI: 10.1177/0148607108328470 The online version of this article can be found at: http://pen.sagepub.com/content/33/5/548 Published by: http://www.sagepublications.com On behalf of: The American Society for Parenteral & Enteral Nutrition Additional services and information for Journal of Parenteral and Enteral Nutrition can be found at: Email Alerts: http://pen.sagepub.com/cgi/alerts Subscriptions: http://pen.sagepub.com/subscriptions Reprints: http://www.sagepub.com/journalsReprints.nav Permissions: http://www.sagepub.com/journalsPermissions.nav >> Version of Record - Aug 27, 2009 OnlineFirst Version of Record - May 19, 2009 What is This? Downloaded from pen.sagepub.com by Karrie Derenski on April 1, 2013 Review Journal of Parenteral and Enteral Nutrition Volume 33 Number 5 September/October 2009 548-562 Micronutrient Supplementation in © 2009 American Society for Parenteral and Enteral Nutrition 10.1177/0148607108328470 Adult Nutrition Therapy: http://jpen.sagepub.com hosted at Practical Considerations http://online.sagepub.com Krishnan Sriram, MD, FRCS(C) FACS1; and Vassyl A. Lonchyna, MD, FACS2 Financial disclosure: none declared. Preexisting micronutrient (vitamins and trace elements) defi- for selenium (Se) and zinc (Zn). In practice, a multivitamin ciencies are often present in hospitalized patients. Deficiencies preparation and a multiple trace element admixture (containing occur due to inadequate or inappropriate administration, Zn, Se, copper, chromium, and manganese) are added to par- increased or altered requirements, and increased losses, affect- enteral nutrition formulations. -
The Real Deal on Brain Health Supplements: GCBH Recommendations on Vitamins, Minerals, and Other Dietary Supplements Background: About GCBH and Its Work
The Real Deal on Brain Health Supplements: GCBH Recommendations on Vitamins, Minerals, and Other Dietary Supplements Background: About GCBH and its Work The Global Council on Brain Health (GCBH) is an independent collaborative of scientists, health professionals, scholars and policy experts from around the world who are working in areas of brain health related to human cognition. The GCBH focuses on brain health relating to people’s ability to think and reason as they age, including aspects of memory, perception and judgment. The GCBH is convened by AARP with support from Age UK to offer the best possible advice about what older adults can do to maintain and improve their brain health. GCBH members gather to discuss specific lifestyle habits that may impact people’s brain health as they age, with the goal of providing evidence-based recommendations for people to consider incorporating into their lives. Many people across the globe are interested in learning that it is possible to influence their own brain health and in finding out what can be done to maintain their brain health as they age. We aim to be a trustworthy source of information, basing recommendations on current evidence supplemented by a consensus of experts from a broad array of disciplines and perspectives. Supplements and Brain Health Members of the GCBH met in Washington, D.C., to address the about dietary supplements and brain health, provides a topic of dietary supplements and brain health for people age glossary of terms used in the document and lists resources 50 and older. Throughout the discussion, experts examined the for additional information.