Active Pharmaceutical Ingredient (API) CAS Number 1,4 Butanediol
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(12) United States Patent (10) Patent No.: US 7,871,995 B2 Bunschoten Et Al
US00787 1995 B2 (12) United States Patent (10) Patent No.: US 7,871,995 B2 Bunschoten et al. (45) Date of Patent: *Jan. 18, 2011 (54) DRUG DELIVERY SYSTEM COMPRISINGA (52) U.S. Cl. ....................................... 514/171; 514/182 TETRAHYDROXYLATED ESTROGEN FOR (58) Field of Classification Search ................. 514/171, USE IN HORMONAL CONTRACEPTION 514f182 See application file for complete search history. (75) Inventors: Evert Johannes Bunschoten, Heesch (NL); Herman Jan Tijmen Coelingh (56) References Cited Bennink, Driebergen (NL); Christian U.S. PATENT DOCUMENTS Franz Holinka, New York, NY (US) 3,440,320 A 4, 1969 Sackler et al. O O 3,797.494. A 3, 1974 Zaffaroni (73) Assignee: Pantarhei Bioscience B.V., Al Zeist 4,460.372 A 7/1984 Campbell et al. (NL) 4,573.996 A 3/1986 Kwiatek et al. 4,624,665 A 1 1/1986 Nuwayser (*) Notice: Subject to any disclaimer, the term of this 4,722,941 A 2f1988 Eckert et al. patent is extended or adjusted under 35 4,762,717 A 8/1988 Crowley, Jr. U.S.C. 154(b) by 1233 days. 4.937,238 A 6, 1990 Lemon 5,063,507 A 1 1/1991 Lindsey et al. This patent is Subject to a terminal dis- 5,130,137 A 7/1992 Crowley, Jr. claimer. 5,211,952 A 5/1993 Spicer et al. 5,223,261 A 6/1993 Nelson et al. 5,340,584 A 8/1994 Spicer et al. (21) Appl. No.: 10/478,357 5,340,585 A 8/1994 Pike et al. 1-1. 5,340,586 A 8, 1994 Pike et al. -
(Trulicity) Pen and the Semaglutide (Ozempic) Pen
Protocol H9X-MC-B021(b) Crossover Study Comparing Dulaglutide (Trulicity) Pen and the Semaglutide (Ozempic) Pen NCT03724981 Approval Date: 30-Nov-2018 H9X-MC-B021(b) Clinical Protocol Page 1 Protocol H9X-MC-B021(b): Crossover Study Comparing the Dulaglutide (Trulicity) Pen and the Semaglutide (Ozempic) Pen Confidential Information The information contained in this document is confidential and is intended for the use of clinical investigators. It is the property of Eli Lilly and Company or its subsidiaries and should not be copied by or distributed to persons not involved in the clinical investigation of dulaglutide (LY2189265), unless such persons are bound by a confidentiality agreement with Eli Lilly and Company or its subsidiaries. Note to Regulatory Authorities: This document may contain protected personal data and/or commercially confidential information exempt from public disclosure. Eli Lilly and Company requests consultation regarding release/redaction prior to any public release. In the United States, this document is subject to Freedom of Information Act (FOIA) Exemption 4 and may not be reproduced or otherwise disseminated without the written approval of Eli Lilly and Company or its subsidiaries. Dulaglutide (LY2189265) Eli Lilly and Company Indianapolis, Indiana USA 46285 Protocol Electronically Signed and Approved by Lilly on 07 Aug 2018 Amendment (a) Electronically Signed and Approved by Lilly on 11 Sep 2018 Amendment (b) Electronically Signed and Approved by Lilly on date below Approval Date: 30-Nov-2018 GMT LY2189265 H9X-MC-B021(b) Clinical Protocol Page 2 Table of Contents Section Page Protocol H9X-MC-B021(b): Crossover Study Comparing the Dulaglutide (Trulicity) Pen and the Semaglutide (Ozempic) Pen ............................................................1 Table of Contents........................................................................................................................2 1. -
The Comparison of the Effect Between Alginate-Based Raft-Forming Liquid and Alginate Liquid on Gastroesophageal Reflux Disease and Gastric Ulcer in Rats
Online - 2455-3891 Vol 10, Issue 12, 2017 Print - 0974-2441 Research Article THE COMPARISON OF THE EFFECT BETWEEN ALGINATE-BASED RAFT-FORMING LIQUID AND ALGINATE LIQUID ON GASTROESOPHAGEAL REFLUX DISEASE AND GASTRIC ULCER IN RATS HAKIM BANGUN1*, ANAYANTI ARIANTO1, RIRIN ASTYA1, GONTAR A SIREGAR2 1Department of Pharmaceutical Technology, Faculty of Pharmacy, Nanomedicine Center, University of Sumatera Utara, Jl. Tri Dharma No. 5, Kampus USU, Medan, Indonesia. 2Department of Internal Medicine, Faculty of Medicine, University of Sumatera Utara, Jl Dr. T. Mansyur No. 5, Kampus USU, Medan, Indonesia. Email: [email protected] Received: 04 July 2017, Revised and Accepted: 16 August 2017 ABSTRACT Objective: The objective of the study was to compare the effect between alginate (Alg)-based raft-forming and Alg liquid on healing gastroesophageal reflux disease (GERD) and gastric ulcer in rats. Methods: Each of the 18 fasted rats was given 1 ml acidified pepsin. Then, rats were divided into three groups. Each group consisted of six rats. Group 1 (negative control) was orally given 1 ml distilled water, Group 2 was given 1 ml Alg-based raft-forming liquid, and Group 3 was given 1 ml Alg liquid. Then, the abdomen of rats was incised under anesthesia with ketamine, and then both their pylorus and the forestomach were ligated to form gastric reflux. After 4 hrs, all rats were killed with chloroform and their esophagus and stomach were examined macroscopically and microscopically (histopathology). Results: On macroscopic observation, all of the Group 1 rats (negative control) showed esophageal lesions and gastric lesions. Four rats of Group 2 (given Alg-based raft-forming) showed no esophageal lesion and two more rats showed a slight lesion, but all of the tested rats showed gastric lesions. -
RAFT FORMING SYSTEM a REVIEW Bhavsar Dhaval Niranjanbhai*, Varde Neha Mahendrakumar, C
View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Journal of Drug Delivery and Therapeutics (JDDT) Bhavsar et al Journal of Drug Delivery & Therapeutics; 2012, 2(5), 123-128 123 Available online at http://jddtonline.info REVIEW ARTICLE ADVANCES IN GRDDS: RAFT FORMING SYSTEM A REVIEW Bhavsar Dhaval Niranjanbhai*, Varde Neha Mahendrakumar, C. Sini Surendran, Shah Viral H, Upadhyay UM Dept. of pharmaceutics, Sigma Institute of Pharmacy, Bakrol, Vadodara(Gujarat), India *Corresponding Author’s Ph: +91-9725512814, Email id: [email protected] Received 06 June 2012; Review Completed 26 Aug 2012; Accepted 26 Aug 2012, Available online 15 Sep 2012 ABSTRACT: In recent years several advancements has been made in research and development of Gastro retentive drug delivery system to overcome the drawback of non-site specificity when drug administered orally. In order to understand various physiological difficulties to achieve gastric retention, we have summarized important factors controlling gastric retention time. We have reviewed various gastro retentive approaches designed and developed until now i.e. floating drug dosage systems (FDDS), swelling or expanding systems, mucoadhesive systems, high density system, Raft forming system, magnetic systems. Among these systems, the review summarizes the special focus on raft forming approach which comes under floating drug delivery system. Raft system incorporates alginate gels which have carbonate components react with gastric acid causes bubbles and this enables floating. Finally, Evaluation, advantages, disadvantages, future potential and marketed preparation of raft forming approach in gastro retentive drug delivery systems were covered. Key words-Advances in GRDDS, Raft forming system, alginic acid, gaviscon, INTRODUCTION: Conventional oral delivery is widely used in 4) Drugs with a narrow window of absorption E.g. -
List of Union Reference Dates A
Active substance name (INN) EU DLP BfArM / BAH DLP yearly PSUR 6-month-PSUR yearly PSUR bis DLP (List of Union PSUR Submission Reference Dates and Frequency (List of Union Frequency of Reference Dates and submission of Periodic Frequency of submission of Safety Update Reports, Periodic Safety Update 30 Nov. 2012) Reports, 30 Nov. -
Cell Surface Mobility of GABAB Receptors Saad Bin
Cell surface mobility of GABAB receptors Saad Bin Hannan September 2011 A thesis submitted in fulfilment of the requirements for the degree of Doctor of Philosophy of the University College London Department of Neuroscience, Physiology, and Pharmacology University College London Gower Street London WC1E 6BT UK Declaration ii ‘I, Saad Hannan confirm that the work presented in this thesis is my own. Where information has been derived from other sources, I confirm that this has been indicated in the thesis.' ____________________ Saad Hannan September 2011 To Ammu, Abbu, Polu Abstract ivi Abstract Type-B γ-aminobutyric acid receptors (GABABRs) are important for mediating slow inhibition in the central nervous system and the kinetics of their internalisation and lateral mobility will be a major determinant of their signalling efficacy. Functional GABABRs require R1 and R2 subunit co-assembly, but how heterodimerisation affects the trafficking kinetics of GABABRs is unknown. Here, an α- bungarotoxin binding site (BBS) was inserted into the N-terminus of R2 to monitor receptor mobility in live cells. GABABRs are internalised via clathrin- and dynamin- dependent pathways and recruited to endosomes. By mutating the BBS, a new technique was developed to differentially track R1a and R2 simultaneously, revealing the subunits internalise as heteromers and that R2 dominantly-affects constitutive internalisation of GABABRs. Notably, the internalisation profile of R1aR2 heteromers, but not R1a homomers devoid of their ER retention motif (R1ASA), is similar to R2 homomers in heterologous systems. The internalisation of R1aASA was slowed to that of R2 by mutating a di-leucine motif in the R1 C-terminus, indicating a new role for heterodimerisation, whereby R2 subunits slow the internalization of surface GABABRs. -
Pharmacological Agents Currently in Clinical Trials for Disorders in Neurogastroenterology
Pharmacological agents currently in clinical trials for disorders in neurogastroenterology Michael Camilleri J Clin Invest. 2013;123(10):4111-4120. https://doi.org/10.1172/JCI70837. Clinical Review Esophageal, gastrointestinal, and colonic diseases resulting from disorders of the motor and sensory functions represent almost half the patients presenting to gastroenterologists. There have been significant advances in understanding the mechanisms of these disorders, through basic and translational research, and in targeting the receptors or mediators involved, through clinical trials involving biomarkers and patient responses. These advances have led to relief of patients’ symptoms and improved quality of life, although there are still significant unmet needs. This article reviews the pipeline of medications in development for esophageal sensorimotor disorders, gastroparesis, chronic diarrhea, chronic constipation (including opioid-induced constipation), and visceral pain. Find the latest version: https://jci.me/70837/pdf Review Pharmacological agents currently in clinical trials for disorders in neurogastroenterology Michael Camilleri Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Mayo Clinic, Rochester, Minnesota, USA. Esophageal, gastrointestinal, and colonic diseases resulting from disorders of the motor and sensory functions represent almost half the patients presenting to gastroenterologists. There have been significant advances in under- standing the mechanisms of these disorders, through basic and translational research, and in targeting the recep- tors or mediators involved, through clinical trials involving biomarkers and patient responses. These advances have led to relief of patients’ symptoms and improved quality of life, although there are still significant unmet needs. This article reviews the pipeline of medications in development for esophageal sensorimotor disorders, gastropa- resis, chronic diarrhea, chronic constipation (including opioid-induced constipation), and visceral pain. -
Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017
Q UO N T FA R U T A F E BERMUDA PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2017 BR 111 / 2017 The Minister responsible for health, in exercise of the power conferred by section 48A(1) of the Pharmacy and Poisons Act 1979, makes the following Order: Citation 1 This Order may be cited as the Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017. Repeals and replaces the Third and Fourth Schedule of the Pharmacy and Poisons Act 1979 2 The Third and Fourth Schedules to the Pharmacy and Poisons Act 1979 are repealed and replaced with— “THIRD SCHEDULE (Sections 25(6); 27(1))) DRUGS OBTAINABLE ONLY ON PRESCRIPTION EXCEPT WHERE SPECIFIED IN THE FOURTH SCHEDULE (PART I AND PART II) Note: The following annotations used in this Schedule have the following meanings: md (maximum dose) i.e. the maximum quantity of the substance contained in the amount of a medicinal product which is recommended to be taken or administered at any one time. 1 PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2017 mdd (maximum daily dose) i.e. the maximum quantity of the substance that is contained in the amount of a medicinal product which is recommended to be taken or administered in any period of 24 hours. mg milligram ms (maximum strength) i.e. either or, if so specified, both of the following: (a) the maximum quantity of the substance by weight or volume that is contained in the dosage unit of a medicinal product; or (b) the maximum percentage of the substance contained in a medicinal product calculated in terms of w/w, w/v, v/w, or v/v, as appropriate. -
Tanibirumab (CUI C3490677) Add to Cart
5/17/2018 NCI Metathesaurus Contains Exact Match Begins With Name Code Property Relationship Source ALL Advanced Search NCIm Version: 201706 Version 2.8 (using LexEVS 6.5) Home | NCIt Hierarchy | Sources | Help Suggest changes to this concept Tanibirumab (CUI C3490677) Add to Cart Table of Contents Terms & Properties Synonym Details Relationships By Source Terms & Properties Concept Unique Identifier (CUI): C3490677 NCI Thesaurus Code: C102877 (see NCI Thesaurus info) Semantic Type: Immunologic Factor Semantic Type: Amino Acid, Peptide, or Protein Semantic Type: Pharmacologic Substance NCIt Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor tyrosine kinase expressed by endothelial cells, while VEGF is overexpressed in many tumors and is correlated to tumor progression. PDQ Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor -
PHARMACEUTICAL APPENDIX to the TARIFF SCHEDULE 2 Table 1
Harmonized Tariff Schedule of the United States (2020) Revision 19 Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE Harmonized Tariff Schedule of the United States (2020) Revision 19 Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 2 Table 1. This table enumerates products described by International Non-proprietary Names INN which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service CAS registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. -
The Inhaled Steroid Ciclesonide Blocks SARS-Cov-2 RNA Replication by Targeting Viral
bioRxiv preprint doi: https://doi.org/10.1101/2020.08.22.258459; this version posted August 24, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder. All rights reserved. No reuse allowed without permission. 1 The inhaled steroid ciclesonide blocks SARS-CoV-2 RNA replication by targeting viral 2 replication-transcription complex in culture cells 3 4 Shutoku Matsuyamaa#, Miyuki Kawasea, Naganori Naoa, Kazuya Shiratoa, Makoto Ujikeb, Wataru 5 Kamitanic, Masayuki Shimojimad, and Shuetsu Fukushid 6 7 aDepartment of Virology III, National Institute of Infectious Diseases, Tokyo, Japan 8 bFaculty of Veterinary Medicine, Nippon Veterinary and Life Science University, Tokyo, Japan 9 cDepartment of Infectious Diseases and Host Defense, Gunma University Graduate School of 10 Medicine, Gunma, Japan 11 dDepartment of Virology I, National Institute of Infectious Diseases, Tokyo, Japan. 12 13 Running Head: Ciclesonide blocks SARS-CoV-2 replication 14 15 #Address correspondence to Shutoku Matsuyama, [email protected] 16 17 Word count: Abstract 149, Text 3,016 bioRxiv preprint doi: https://doi.org/10.1101/2020.08.22.258459; this version posted August 24, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder. All rights reserved. No reuse allowed without permission. 18 Abstract 19 We screened steroid compounds to obtain a drug expected to block host inflammatory responses and 20 MERS-CoV replication. Ciclesonide, an inhaled corticosteroid, suppressed replication of MERS-CoV 21 and other coronaviruses, including SARS-CoV-2, the cause of COVID-19, in cultured cells. The 22 effective concentration (EC90) of ciclesonide for SARS-CoV-2 in differentiated human bronchial 23 tracheal epithelial cells was 0.55 μM. -
Poster Session III, December 6, 2017
Neuropsychopharmacology (2017) 42, S476–S652 © 2017 American College of Neuropsychopharmacology. All rights reserved 0893-133X/17 www.neuropsychopharmacology.org Poster Session III a high-resolution research tomograph (HRRT), and struc- Palm Springs, California, December 3–7, 2017 tural (T1) MRI using a 3-Tesla scanner. PET data analyses were carried out using the validated 2-tissue compartment Sponsorship Statement: Publication of this supplement is model to determine the total volume of distribution (VT) of sponsored by the ACNP. [18F]FEPPA. Individual contributor disclosures may be found within the Results: Results show significant inverse associations (con- abstracts. Part 1: All Financial Involvement with a pharma- trolling for rs6971 genotype) between neuroinflammation ceutical or biotechnology company, a company providing (VTs) and cortical thickness in the right medial prefrontal clinical assessment, scientific, or medical products or compa- cortex [r = -.562, p = .029] and the left dorsolateral nies doing business with or proposing to do business with prefrontal cortex [r = -.629, p = .012](p values are not ACNP over past 2 years (Calendar Years 2014–Present); Part 2: corrected for multiple comparisons). No significant associa- Income Sources & Equity of $10,000 per year or greater tions were found with surface area. (Calendar Years 2014 - Present): List those financial relation- Conclusions: These results, while preliminary, suggest links ships which are listed in part one and have a value greater than between the microglial activation/neuroinflammation and $10,000 per year, OR financial holdings that are listed in part cortical thickness in the dorsolateral prefrontal cortex and one and have a value of $10,000 or greater as of the date of medial prefrontal cortex in AD patients.