Appendix on Tariff Elimination Schedule for Mercosur
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More Than Expectorant: New Scientific Data on Ambroxol in the Context of the Treatment of Bronchopulmonary Diseases
Mini Review iMedPub Journals Journal of Intensive and Critical Care 2017 www.imedpub.com ISSN 2471-8505 Vol. 3 No. 3: 37 DOI: 10.21767/2471-8505.100096 More than Expectorant: New Scientific Data Manuel Plomer1* and 2 on Ambroxol in the Context of the Treatment Justus de Zeeuw of Bronchopulmonary Diseases 1 Medical Affairs CHC Germany, Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, D-65926, Frankfurt am Main, Deutschland, German Abstract 2 Medical Specialist for Internal Medicine, Pneumology and Sleep Medicine, Background:Ambroxol has been established for decades in the treatment of Cologne, Germany, German acute and chronic respiratory diseases. A reassessment of the benefit-risk was conducted recently. Objective: What new scientific data, relevant for the treatment of *Corresponding author: bronchopulmonary diseases, were published in the last decade? Dr. Manuel Plomer Method: Systematic literature search via http://www.pubmed.gov with the search term “ambroxol”, covering the publication period from 2006 to 2015. Non- [email protected] relevant publications were excluded manually. Medical Manager, Medical Affairs CHC Results: 64 relevant publications could be identified covering both, clinical and Germany, Sanofi-Aventis Deutschland GmbH, preclinical research. Industriepark Höchst, D-65926 Frankfurt am Conclusion: The traditional indication of ambroxol as an expectorant is confirmed Main, Germany. but new results revealed a better understanding of the various mechanisms of action of ambroxol and the benefits for special patient populations. The Tel: 49 69 305 36803 available data suggest the use of ambroxol as an adjuvant in anti-infective therapy, particularly in case of infections with biofilm-producing pathogens. Lung- protective properties are discussed in both infants and severely ill adult patients. -
European Journal of Scientific Exploration Vol 3 №2 2020
EUROPEAN JOURNAL OF SCIENTIFIC EXPLORATION VOL 3 №2 2020 Determination of Oligomer Content in Benzonatate Drug Substance by HPLC Lakshmi Narasimha Rao Katakam 1 Santhosh Kumar Ettaboina 2 Thirupathi Dongala 2 1Saptalis Pharmaceuticals LLC, New York, USA 2Aurex Pharmaceuticals Inc, East Windsor, USA Abstract. A reverse-phase liquid chromatographic method has developed and validated to determine oligomer content in Benzonatate Drug substances. This method has a separation of relatively few monomer units, which constitutes an oligomer with a minimum adequate chromatographic resolution of 1.0 from each of the subject component peaks. The separation achieved using Phenomenex Luna C18 (250 X 4.6 mm) 5 µm column at a flow rate of 1.0 ml/min with an isocratic elution method. The mobile phase consisting of 0.25% Ammonium formate buffer and methanol in the ratio 350:650 (v/v), respectively. The Oligomer compounds detection carried out at UV 310 nm, and the LC method validated as per the current ICH Q2 guidelines. The method is effectively validated and proved to be precise, specific, linear, robust, and rugged to quantitate oligomer content in Benzonatate drug substance. Key words: benzonatate (BNZ), oligomers, HPLC, method validation. Introduction Benzonatate (BNZ) is an oral antitussive drug used to relieve and suppress cough in patients older than ten years of age (Oligomer Wikipedia, 2020). Currently, BNZ is the only non-narcotic antitussive available as a prescription drug. The chemical structure resembles that of the anesthetic agents in the para-amino-benzoic acid class (such as procaine and tetracaine), BNZ exhibits anesthetic or numbing action. BNZ also inhibits the transmission of impulses of the cough reflex in the medulla's vagal nuclei (Tessalon, 2020). -
Tibolone Has Anti-Inflammatory Effects in Estrogen-Deficient
Regulatory Peptides 179 (2012) 55–60 Contents lists available at SciVerse ScienceDirect Regulatory Peptides journal homepage: www.elsevier.com/locate/regpep Tibolone has anti-inflammatory effects in estrogen-deficient female rats on the natriuretic peptide system and TNF-alpha Ana Raquel Santos de Medeiros a,b, Aline Zandonadi Lamas b, Izabela Facco Caliman b, Polyana L. Meireles Dalpiaz b, Luciana Barbosa Firmes c, Gláucia Rodrigues de Abreu b, Margareth Ribeiro Moysés b, Elenice Moreira Lemos d, Adelina Martha dos Reis c, Nazaré Souza Bissoli b,⁎ a Biological and Health Sciences, Federal Institute of Espírito Santo, Vila Velha, ES, Brazil b Department of Physiological Sciences, Federal University of Espírito Santo, Vitória, ES, Brazil c Department of Physiology and Biophysics, Federal University of Minas Gerais, Belo Horizonte, MG, Brazil d Center of Infectious Diseases, Federal University of Espírito Santo, Vitória, ES, Brazil article i nfo abstract Article history: Cardiovascular and immune system abnormalities have been reported in females with estrogen deficiency. Received 25 April 2012 To control these disorders in post-menopausal women, hormone replacement therapy (HRT) has been Received in revised form 10 August 2012 used. Tibolone has been used as a HRT, but the effects of tibolone on the natriuretic peptide system have Accepted 29 August 2012 not been determined. We investigated the effects of tibolone on the natriuretic peptide system and Available online 10 September 2012 pro-inflammatory cytokines in ovariectomized (OVX) rats. Female rats were divided into four groups: SHAM, OVX, OVX treated with 17β-estradiol (OVX+E: 14 days) and OVX treated with tibolone (OVX+T: Keywords: Ovariectomy 14 days) beginning 21 days after ovariectomy. -
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. -
Pharmaceutical Manufacturing Formulations Liquid Products V () L UME Sarfaraz K
HANDBOOK OF Pharmaceutical Manufacturing Formulations Liquid Products V () L UME Sarfaraz K. Niazi CRC PRESS Boca Raton London New York Washington, D.C. Table of Contents PART I Regulatory and Manufacturing Guidance 1 Chapter 1 Current Good Manufacturing Practice Considerations in Liquid Manufacturing 3 I. Introduction 3 II. Facilities 3 III. Equipment 3 IV. Raw Materials 4 V. Compounding 4 VI. Microbiological Quality 4 VII. Oral Suspensions 5 VIII. Product Specifications 5 IX. Process Validation 5 X. Stability 5 XI. Packaging 6 Chapter 2 Stability Testing of New Drug Substances and Products 7 I. Introduction 7 II. Drug Substance 7 A. General Case 8 B. Drug Substances Intended for Storage in a Refrigerator 8 C. Drag Substances Intended for Storage in a Freezer 8 D. Drug Substances Intended for Storage below -20°C 9 HI. Drag Product 10 A. General Case •' B. Drag Products Packaged in Impermeable Containers 11 C. Drag Products Packaged in Semipermeable Containers 11 D. Drag Products Intended for Storage in a Refrigerator 12 E. Drag Products Intended for Storage in a Freezer 13 F. Drag Products Intended for Storage below -20"C 13 IV Glossary 14 References 1() Chapter 3 Container Closure Systems '7 I. Introduction '7 A. Definitions '7 B. Current Good Manufacturing Practice, the Consumer Product Safety Commission, and Requirements on Containers and Closures 17 C. Additional Considerations 17 II. Qualification and Quality Control of Packaging Components 18 A. Description 21 B. Information about Suitability 21 C. Stability Data (Packaging Concerns) 22 D. Inhalation Drag Products 23 E. Injection and Ophthalmic Drag Products 23 F. -
Research Article
Volume 8, Issue 2, May – June 2011; Article-004 ISSN 0976 – 044X Research Article SPECTROPHOTOMETRIC SIMULTANEOUS ANALYSIS OF AMBROXOL HYDROCHLORIDE, GUAIFENESIN AND TERBUTALINE SULPHATE IN LIQUID DOSAGE FORM (SYRUP) Ritu Kimbahune*, Sunil K, Prachi Kabra, Kuldeep Delvadiya, Sanjay Surani Department of Quality Assurance, Nargund College of Pharmacy, Dattatreyanagar, Bangalore - 560 085, India. Accepted on: 06-03-2011; Finalized on: 28-05-2011. ABSTRACT This study proposes a method for simultaneous estimation of Ambroxol HCl, Guaifenesin and Terbutaline sulphate in syrup form. The study was done by combining three spectrophotometric methods viz use of specific absorbance [A 1%, 1cm], second order derivative and colorimetry. Absorption of Guaifenesin and Terbutaline sulphate were found to be zero at 307.5nm, thus enabling the measurement of Ambroxol HCl, using specific absorbance in zero order spectrum. Applying the second order derivative, the amplitude of Guaifenesin was measured at 279.4nm, while Ambroxol HCl and Terbutaline sulphate were at zero cross point. For colorimetric measurement of Terbutaline Sulphate, a colored substance was obtained by coupling the oxidized product of Terbutaline sulphate with 4-aminoantipyrine and its absorption was measured at 550nm. The proposed method was statistically validated in accordance with ICH guidelines and results were found to be satisfactory for accuracy, precision and specificity. Keywords: Ambroxol HCl, Guaifenesin and Terbutaline sulphate, second order derivative, colorimetric method. INTRODUCTION TBS as an individual drug or in combination, either in pure or in pharmaceutical forms as well as in biological Ambroxol hydrochloride (AB) [trans-4-[(2-amino-3,5- fluids and tissues. Literature survey reveals that there is dibromobenzyl)amino]cyclohexanol hydrochloride] is a no single spectrophotometric analysis reported for the semi-synthetic derivative of vasicine obtained from Indian determination of AB, GF and TBS simultaneously in liquid shrub Adhatodavasica. -
Non-Pharmacologic Therapies and Airway Clearance Techniques in Bronchiectasis
Division of Pulmonary, Critical Care and Sleep Medicine NON-PHARMACOLOGIC THERAPIES AND AIRWAY CLEARANCE TECHNIQUES IN BRONCHIECTASIS Ashwin Basavaraj, MD, FCCP Associate Director, NYU Bronchiectasis Program NTM Patient Education Program DC 11/24/2019 October 30, 2019 Financial Disclosure • Insmed - Consultant, Advisory Board (Active) • Hill-Rom – Consultant, Principal investigator on a clinical trial (Active) • COPD foundation grant on airway clearance 2 Division of Pulmonary, Critical Care and Sleep Medicine DC 11/24/2019 Case presentation • 66 year-old female with a history of prior pneumonia 15 years ago presents with productive cough. • She has mild shortness of breath. No fevers, no hemoptysis. She has gained two pounds over the year. • No other prior medical history, and currently not taking any medications • Initial workup including autoimmune serologies and quantitative immunoglobulin levels were negative. • You check AFB, bacterial and fungal sputum cultures. • She has 2 out 3 cultures positive for MAC. 3 Division of Pulmonary, Critical Care and Sleep Medicine DC 11/24/2019 4 Division of Pulmonary, Critical Care and Sleep Medicine DC 11/24/2019 What’s the next best step in management? A) Start 3 drug antibiotic therapy for MAC B) Initiate airway clearance with nebulized hypertonic saline and a positive expiratory pressure device C) Start antibiotics for MAC and initiate airway clearance D) Closely monitor without initiation of treatment 5 Division of Pulmonary, Critical Care and Sleep Medicine DC 11/24/2019 GOALS OF AIRWAY CLEARANCE Short term goals Long term goals • Provide more effective sputum • Reduce further airway damage by clearance that improves ventilation halting the vicious cycle • Reduce cough and breathlessness • Reduce pulmonary exacerbations • Improve quality of life O’Neill, et al. -
Management of Breathlessness in Patients with Life Limiting Disease
MANAGEMENT OF BREATHLESSNESS IN PATIENTS WITH LIFE LIMITING DISEASE Helen Armstrong Dr Helen Bonwick Dr Clare Jeffries Dr Martin Ledson Dr Kate Marley Mrs Sue Oakes CURRENT STANDARDS AND GUIDELINES • Current standards and guidleines • Literature review – pharmacological and non- pharmacological • Audit results • Proposed new standards and guidelines • Current management of cough Guidelines Non pharmacological options (Level 4 ) • These are important and should not be overlooked. They may be used alone or in conjunction with medication. • They include – Reassurance and explanation – Use of fan or cool air across face – Adequate positioning of the patient to aid breathing – Breathing exercises and relaxation training – Advice on modifying lifestyle – Acupuncture, aromatherapy and reflexology Guidelines Pharmacological options Benzodiazepines (Level 3) • Benzodiazepines may be useful especially if there is coexisting anxiety and/or fear. • Lorazepam is suggested for episodes of paroxysmal breathlessness. Dose: 0.5mg-1mg sublingually as required (max dose 4mg daily). • In patients unable to tolerate oral medication or those in the dying phase, subcutaneous Midazolam 2.5mg-5mg as required may be appropriate. If effective this can be incorporated into a 24hour subcutaneous infusion via syringe driver. Guidelines Nebulised Medication (Level 4)/(Level 1) NB: The first medication of any nebulised medication, including saline, must be monitored for adverse effect such as bronchospasm. • Nebulised non opioids – Nebulised sodium chloride 0.9% may help as a mucolytic. Consider trial for 24hours. Dose: 5ml via a nebuliser 4 hourly as required. – A trial of nebulised bronchodilator should be considered if there is evidence of airways obstruction (Level 4) commonly prescribed bronchdilators are Salbutamol and Ipratropium Bromide. -
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. -
Bahrain-Pharma-1444108170.Pdf
Fill Type of Competition S. No BP Brand Name Therapeutical Class Potency Generic Name/Composition Volume Dosage Name,company, retail price form Each 5 ml contents: Samol 120 ml Salbutamol Sulphate 2mg Salbutamol 1 Anti-Asthmatic agent (Bronchodilator) Each 5ml contains Acefylline piperazine 125mg Pifalin 100 ml Acefylline Piperazine 2 (125mg/5ml) Acefylline Piperazine 45mg, Diphenhydramine Dephicef 100 ml Acefylline Piperazine + Diphenhydramine 3 8mg/5ml Ammonium Chloride 100.00mg , Sodium Clomadrin 100 ml Citrate 60.00mg, Ephedrine HCl 7.00mg, Ammonium Chloride + Sodium Citrate + Ephedrine HCl + Chlorpheniramine Maleate 4 Chlorpheniramine Maleate 2.00mg/5ml Each 5 ml contents: Ambroxol HCl eq. to 100 ml Ambroxol 15mg 5 Ambrol Ambroxol HCl Each 5 ml contents: Ambroxol HCl eq. to Cough and Cold 100 ml Syrup 6 Ambroxol 30mg 7 Dextron 100 ml 15mg/5 ml Dextromethorphan Hbr 8 Gufosil 100 ml 100mg/5 ml Guaifenesin 9 Proligen 120 ml 1.25mg + 30mg/5 ml Triprolodin HCl + Pseudoephedrine HCl 10 Tripodil 120 ml 1.25mg + 30mg + 10mg/5 ml Triprolodin HCL + Pseudoephedrine HCl + Dextromethorphan Hbr 11 Tripogin 120 ml 1.25mg + 30mg + 100 mg/5 ml Triprolodin HCL + Pseudoephedrine HCl + Guaifenesin 12 Dexotrin 120 ml 1.25mg +10mg + 7.5mg + 50mg/5 ml Triprolodin HCL + Pseudoephedrine HCl + Dextromethorphan Hbr + Guaifenesin Wild cherry (Prunus serotina) + (myroxylon balsamum) + Mallow (Malva Sylvestris) + Welcosin 120 ml 60mg + 18.75mg + 7.5mg + 7.5mg / 5ml 13 Marshnallow (Althaea officinalis) 14 Ivosil 100 ml Each 5 ml contents: Ivy leaf 15 Hexobim 100 ml 4mg/5mlIvy leaves dried extract (4-8:1, 100%) 100 mg Bromhexine HCl Carbocisteine 2% and 5% (i.e. -
Interventions for Cough in Cancer (Review)
Interventions for cough in cancer (Review) Molassiotis A, Bailey C, Caress A, Brunton L, Smith J This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2010, Issue 9 http://www.thecochranelibrary.com Interventions for cough in cancer (Review) Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 PLAINLANGUAGESUMMARY . 2 BACKGROUND .................................... 2 OBJECTIVES ..................................... 3 METHODS ...................................... 3 RESULTS....................................... 5 DISCUSSION ..................................... 7 AUTHORS’CONCLUSIONS . 8 ACKNOWLEDGEMENTS . 8 REFERENCES ..................................... 9 CHARACTERISTICSOFSTUDIES . 13 DATAANDANALYSES. 33 APPENDICES ..................................... 33 HISTORY....................................... 40 CONTRIBUTIONSOFAUTHORS . 41 DECLARATIONSOFINTEREST . 41 SOURCESOFSUPPORT . 41 DIFFERENCES BETWEEN PROTOCOL AND REVIEW . .... 41 NOTES........................................ 41 Interventions for cough in cancer (Review) i Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [Intervention Review] Interventions for cough in cancer Alex Molassiotis1, Chris Bailey2, Ann Caress1, Lisa Brunton1, Jacky Smith3 1School of Nursing, Midwifery & Social Work, University of Manchester, Manchester, UK. -
Medicines Regulations 1984 (SR 1984/143)
Reprint as at 1 August 2011 Medicines Regulations 1984 (SR 1984/143) David Beattie, Governor-General Order in Council At the Government House at Wellington this 5th day of June 1984 Present: His Excellency the Governor-General in Council Pursuant to section 105 of the Medicines Act 1981, and, in the case of Part 3 of the regulations, to section 62 of that Act, His Excellency the Governor-General, acting on the advice of the Minister of Health tendered after consultation with the organisations and bodies that ap- peared to the Minister to be representatives of persons likely to be substantially affected, and by and with the advice and consent of the Executive Council, hereby makes the following regulations. Contents Page 1 Title and commencement 5 Note Changes authorised by section 17C of the Acts and Regulations Publication Act 1989 have been made in this reprint. A general outline of these changes is set out in the notes at the end of this reprint, together with other explanatory material about this reprint. These regulations are administered by the Ministry of Health. 1 Reprinted as at Medicines Regulations 1984 1 August 2011 2 Interpretation 5 Part 1 Classification of medicines 3 Classification of medicines 11 Part 2 Standards 4 Standards for medicines, related products, medical 11 devices, cosmetics, and surgical dressings 5 Pharmacist may dilute medicine in particular case 12 6 Colouring substances [Revoked] 12 Part 3 Advertisements 7 Advertisements not to claim official approval 12 8 Advertisements for medicines 13 9 Advertisements