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COPD: Inhaled Medications Drugs and Delivery 2016

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COPD: Inhaled Medications Drugs and Delivery 2016 Brian W.Carlin, MD, MAACVPR, FAARC, FCCP SleepMedicine and Lung Health Consultants Pittsburgh, Pennsylvania May 2017 Disclosures Consultant/Independent Contractor: AstraZeneca; Boehringer-Ingelheim Pharmaceuticals; Monaghan Medical Corporation; Nonin Medical; Sunovion Pharmaceuticals, Philips Grant/Research Support: Philips Respironics Speakers Bureaus: Boehringer Ingelheim Pharmaceuticals; GlaxoSmithKline; Sunovion Pharmaceuticals 2 Pharmacologic Treatment Options Treatment Options for COPD ICS + LABA and LAMA C LAMA and LABA or D or ICS + LABA and PDE-4 LAMA and PDE-4 or ≥2 or LAMA and LABA LABA and PDE-4 or LAMA and PDE-4 A LAMA B or 1 LABA LAMA and LABA or Exacerbations/y SABA and SAMA 0 mMRC 0-1 mMRC ≥2 CAT <10 CAT ≥10 ICS, inhaled corticosteroid; SABA, short-acting beta2-adrenoceptor agonist; SAMA, short-acting muscarinic antagonist; mMRC = mMRC Breathlessness Scale; CAT = COPD Assessment Test Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2016. www.goldcopd.org. Accessed 3/29/16. 4 Pharmacologic Options Bronchodilators Anti-Inflammatory Short-Acting Long-Acting Inhaled Anticholinergic (SAMA) Anticholinergic (LAMA) ICS + LABA Ipratropium Tiotropium,Tiotropium or aclidinium, or Fluticasone + salmeterol umeclidinium,Aclidinium or glycopyrrolate Budesonide + formoterol Β2-Agonists (SABA) Umeclidinium Fluticasone + vilanterol Β2-Agonists (LABA) Albuterol Salmeterol,Β2-Agonists or formoterol,(LABA) or Oral Levalbuterol arformoterol,Salmeterol, or orindacaterolFormoterol, (ultra), or or Metaproterenol Arformoterol, oorlodaterolIndacaterol (ultra), or PDE-4 Inhibitors Pirbuterol Roflumilast LAMAOlodaterol + LABA SAMA + SABA TiotropiumLAMA + olodaterolLABA Oral Steroids Ipratropium + albuterol UmeclidiniumTiotropium + olodaterol+ vilanterol Prednisone IndacaterolUmeclidinium + glycopyrrolate + vilanterol Methylprednisolone Xanthine Derivative: Theophylline 5 Newer Therapies (continued) Medication/Formulation Class Approved Indication Long-term, once-daily maintenance treatment, Vilanterol/umeclidinium LABA + Dec COPD-related airflow obstruction, including bromide inhalation powder1 LAMA 2013 chronic bronchitis/emphysema Fluticasone furoate/vilanterol ICS + May Once-daily alternative to inhalation powder2 LABA 2013 fluticasone/salmeterol, budesonide/formoterol Aclidinium bromide inhalation July Long-term, twice-daily maintenance treatment, LAMA powder3 2012 COPD-related bronchospasm 1. Anoro Ellipta. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm379057.htm. Accessed 4/4/16. 2. Breo Ellipta. www.fda.gov/newsevents/newsroom/pressannouncements/ucm351664.htm. Accessed 3/29/16.. 3 Tudorza Pressair. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm313052.htm. Accessed 3/29/16. 6 Newer Therapies (continued) Medication/Formulation Class Approved Indication Long-term, once-daily maintenance treatment, Aug Olodaterol inhalation spray1 LABA COPD-related airflow obstruction, including 2014 chronic bronchitis/emphysema Long-term, once-daily maintenance treatment, Umeclidinium bromide April LAMA COPD-related airflow obstruction, including inhalation powder2 2014 chronic bronchitis/emphysema 1. Olodaterol. http://us.boehringer-ingelheim.com/news_events/press_releases/press_release_archive/2014/08-01-14-fda-approves-boehringer-ingelheims-striverdi-respimat-olodaterol-inhalation-spray- maintenance-treatment-copd.html. Accessed 3/29/16. 2. Umeclidinium. www.prnewswire.com/news-releases/gsk-receives-approval-for-incruse-ellipta-umeclidinium-in-the-us-for-the-treatment-of-copd- 257416481.html. Accessed 4/5/16. 7 Newer Therapies Medication/ Class Approved Indication Formulation Indacaterol + LAMA + Oct Long-term maintenance treatment of airflow glycopyrrolate LABA 2015 obstruction in patients with COPD inhalation powder1 Glycopyrrolate Oct Stand-alone, long-term maintenance treatment of LAMA inhalation powder2 2015 airflow obstruction in patients with COPD Long-term, once-daily from start of maintenance Tiotropium/olodaterol LAMA + April treatment, COPD-related airflow obstruction, inhalation spray3,4 LABA 2015 including chronic bronchitis/emphysema 1. UTIBRON™ NEOHALER® [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2016. http://www.pharma.us.novartis.com/product/pi/pdf/utibron.pdf. 2. Seebri TM NeohalerR [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2016. http://pharma.us.novartis.com/product/pi/pdf/seebri.pdf. 3. Tiotropium/olodaterol. www.boehringer- ingelheim.com/news/news_releases/press_releases/2015/20_may_2015_copd.html. Accessed 3/29/16. 4. Stiolto [package insert]. Ridgefield, CT: Boehringer Ingleheim; 2015. 8 Adverse Effects of Therapy . Anticholinergics . Dry mouth, urinary retention, glaucoma . Beta2-agonists . Tachycardia, palpitations, premature ventricular contractions, tremors, hypokalemia . Inhaled corticosteroids . Dysphonia, thrush, systemic effects (bruising, bone density, cataract), pneumonia, local irritation Harvey RA, et al. Pharmacology (Lippincott’s Illustrated Reviews Series). 5th ed. Baltimore, MD: Lippincott Williams & Wilkins; 2012. 9 Most COPD Patients Do Not Receive Recommended Treatment Patients not receiving recommended maintenance therapy LAAC, long-acting anticholinergic; SAAC, short-acting anticholinergic; Ach, inhaled anticholinergic Make B et al. Int J Chron Obstruct Pulmon Dis. 2012;7:1-9. 10 INHALED DRUG DEPOSITION . Patient inhalational flow . Aerosol velocity . Inhaled drug particle size Delivery Devices Inhaler Use Fink, Respir Care 2005 14 Inhaler Use Fink, Respir Care 2005 Inhaler Use Fink, Respir Care 2005 16 Inhaler Use Fink, Respir Care 2005 17 Inhaler Use Fink, Respir Care 2005 Factors That Determine Selection of Delivery System Clinical efficacy Cognitive/ Disease severity dexterity issues Need for combination Lifestyle/ therapy preference Cost Ease of use Portability Photo credit: www.humana.com 19 Inhaler Devices Available United States Diskus® MDI Handihaler® Aerolizer™ Twisthaler® Pressair® Ellipta® Flexhaler® Respimat® Spacer Devices 20 Inhaler Devices Available United States Small-Volume Nebulizer • Select a medication delivery system/regimen that is aligned with treatment goals, patient abilities and preferences; consider costs • Train patients on proper device technique; reinforce training at each visit 21 pMDI . HFA driven, breath-actuated . Advantages . Portable, compact . Disadvantages . Requires coordination . Shaken prior to use . Oropharyngeal deposition 22 DPI . Single, multidose . Advantages . Portable, compact . No spacer required . Disadvantages . Inspiratory flow dependent . Poor dose reproducibility 23 Soft mist . Single, multidose . Advantages . Portable, compact . No spacer required . Disadvantages . Newer model of use 24 Nebulizers . Jet, vibrating mesh, ultrasonic . Advantages . Propellant free . Slow velocity aerosol . Disadvantages . Bulky . Power sources . Frequent cleaning 25 Individualizing Inhaled Therapy1,2 . Good hand-breath coordination required for MDIs . May not be suitable for elderly, confused, those with hand conditions (e.g., arthritis) . Dry-powder inhalers (DPIs) do not require coordination of actuation, inhalation; easier to use than MDIs . Breath actuation may be difficult in patients with poor inspiratory effort . Avoid changing inhaler types for individual patients 1. Vincken W et al. Prim Care Respir. 2010;19(1):10-20. 2. De Coster DA et al. Curr Respir Care Rep. 2014;3:121-132. 26 Types of Inhaler Errors 1. Device care and preparation 2. Exhalation before use 3. Timing 4. Coordination with device 5. Flow rate errors 6. Completing inhalation/breath hold 7. After care (ie, rinsing/gargling) • Extremely high rate of device technique errors with use of chronic inhaled medications • Incorrect technique poorly perceived by patient; must be assessed by HCPs 27 Increasing Patient Adherence to COPD Treatment Adherence to Medications: Poor . 167 patients with COPD . LABA: 54% adherencea . ICS: 40% adherence . Patients more adherent when they perceive clinician as a lung disease expert aAdherence measured by electronic pharmacy records to assess adherence, defined as medication possession ratio ≥0.80 Cecere LM et al. COPD. 2012;9:251-258. 29 Barriers to Treatment Adherence . Inadequate education about COPD, therapy1 . Perceived burden of medication regimen1,2 . Device difficult to use3 . Depressed mood3 . Medication-related cost3 . Adverse effects3 1. Laforest L et al. Prim Care Resp J. 2010;19(2):148-154. 2. George J et al. Chest. 2005;128(5):3198-3204. 3. Restrepo RD et al. Int J COPD. 2008;3(3):371-384. 30 Features of Devices . pMDIs(pressurized metered-dose inhalers) . DPIs (dry powder inhalers) . Soft-mist inhaler . Nebulizers 31 Systematic Review of Errors in Inhaler Use Sanchis, CHEST 2016 (in press) 32 Systematic Review of Errors in Inhaler Use Sanchis, CHEST 2016 . 144 articles (n = 54354 patients) . MDI errors . Co-ordination (45%) . Speed and/or depth of inspiration (44%) . No post-inhalation breath-hold (46%) . DPI errors . Incorrect preparation (28%) . No full expiration before inhalation (46%) . No post-inhalation breath hold (37%) 33 Systematic Review of Errors in Inhaler Use Sanchis, CHEST 2016 . Prevalence (technique) . Correct 31% (33-40%) . Acceptable 41% (36-47%) . Poor 31% (27-36%) 34 EFFECTIVENESS OF INTERVENTIONS Press et al, Annals ATS 2016 . Evaluate the relative effects of two educational strategies in adults hospitalized with asthma/COPD . Teach to goal . Brief verbal instruction . Randomized trial
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  • The Organic Chemistry of Drug Synthesis

    The Organic Chemistry of Drug Synthesis

    The Organic Chemistry of Drug Synthesis VOLUME 2 DANIEL LEDNICER Mead Johnson and Company Evansville, Indiana LESTER A. MITSCHER The University of Kansas School of Pharmacy Department of Medicinal Chemistry Lawrence, Kansas A WILEY-INTERSCIENCE PUBLICATION JOHN WILEY AND SONS, New York • Chichester • Brisbane • Toronto Copyright © 1980 by John Wiley & Sons, Inc. All rights reserved. Published simultaneously in Canada. Reproduction or translation of any part of this work beyond that permitted by Sections 107 or 108 of the 1976 United States Copyright Act without the permission of the copyright owner is unlawful. Requests for permission or further information should be addressed to the Permissions Department, John Wiley & Sons, Inc. Library of Congress Cataloging in Publication Data: Lednicer, Daniel, 1929- The organic chemistry of drug synthesis. "A Wiley-lnterscience publication." 1. Chemistry, Medical and pharmaceutical. 2. Drugs. 3. Chemistry, Organic. I. Mitscher, Lester A., joint author. II. Title. RS421 .L423 615M 91 76-28387 ISBN 0-471-04392-3 Printed in the United States of America 10 987654321 It is our pleasure again to dedicate a book to our helpmeets: Beryle and Betty. "Has it ever occurred to you that medicinal chemists are just like compulsive gamblers: the next compound will be the real winner." R. L. Clark at the 16th National Medicinal Chemistry Symposium, June, 1978. vii Preface The reception accorded "Organic Chemistry of Drug Synthesis11 seems to us to indicate widespread interest in the organic chemistry involved in the search for new pharmaceutical agents. We are only too aware of the fact that the book deals with a limited segment of the field; the earlier volume cannot be considered either comprehensive or completely up to date.