DOCSLIB.ORG

(12) Patent Application Publication (10) Pub. No.: US 2016/0000709 A1 MORTON (43) Pub

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
(12) Patent Application Publication (10) Pub. No.: US 2016/0000709 A1 MORTON (43) Pub US 2016.000.0709A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2016/0000709 A1 MORTON (43) Pub. Date: Jan. 7, 2016 (54) DRY POWDER INHALER FORMULATIONS A613 L/55 (2006.01) COMPRISING SURFACE-MODIFIED A6M I5/00 (2006.01) KS WITH ANT-ADHERENT A613 L/473 (2006.01) A613 L/35 (2006.01) (71) Applicant: VECTURA LIMITED, CHIPPENHAM A647/26 (2006.01) (GB) A647/12 (2006.01) 469/14 (2006.01) 72) Inventor: DAVID MORTON CHIPPENHAM (72) Inventor (GB) s A613 L/522 (2006.01) (52) U.S. Cl. (21) Appl. No.: 14/823,484 CPC ............... A61K 9/0075 (2013.01); A6IK 9/145 (2013.01); A61 K3I/58 (2013.01); A61 K3I/55 (22) Filed: Aug. 11, 2015 (2013.01); A61 K3I/522 (2013.01); A61 K Related U.S. Application Data 31/473 (2013.01); A61K 31/135 (2013.01); (63) Continuation of application No. 13/085,200, filed on A61K4726 (2013.01); A61K 47/12 (2013.01); Apr. 12, 2011, which is a continuation of application A61M 15/0028 (2013.01); A61M 2202/064 No. 1 1/791,385, filed on Jul. 5, 2007, now abandoned, (2013.01) filed as application No. PCT/GB05/50211 on Nov. 23, 2005. (57) ABSTRACT (30) Foreign Application Priority Data The present invention is concerned with a refinement of the processing of particles that are to form a dry powder formu Nov. 23, 2004 (GB) ................................... O425758.0 lation which is to be administered to the lung using a dry powder inhaler (DPI) device. In particular, the present inven Publication Classification tion provides the processing of particles of active material and (51) Int. Cl. particles of carrier material in the presence of additive mate A6 IK9/00 (2006.01) rial to provide a powder composition which exhibits excellent A6 IK3I/58 (2006.01) powder properties and which is economical to produce. Patent Application Publication Jan. 7, 2016 Sheet 1 of 7 US 2016/0000709 A1 Microporosity of lactose 100 80 s -- SOrbolaC 3.9. 60 -A-MF SOrbolac 40 ... Sorb/MgSt 98/2 -- Sorb/MgSt 95/5 20 O O 20 40 60 80 100 pore diameter (nm) Fig. 1 Patent Application Publication Jan. 7, 2016 Sheet 2 of 7 US 2016/0000709 A1 Patent Application Publication Jan. 7, 2016 Sheet 3 of 7 US 2016/0000709 A1 Patent Application Publication Jan. 7, 2016 Sheet 4 of 7 US 2016/0000709 A1 9 L # eº|| Patent Application Publication Jan. 7, 2016 Sheet 5 of 7 US 2016/0000709 A1 Patent Application Publication Jan. 7, 2016 Sheet 6 of 7 US 2016/0000709 A1 pasniq +900AS :66)3SõJN Patent Application Publication Jan. 7, 2016 Sheet 7 of 7 US 2016/0000709 A1 =Alpeg ·~~~~);0:02 A 2 US 2016/0000709 A1 Jan. 7, 2016 DRY POWDER INHALER FORMULATIONS 0008 FIG. 3, also noted as Table 2, shows the Hosokawa COMPRISING SURFACE-MODIFIED Powder Tester Results for Extra Fine Lactose. PARTICLES WITH ANT-ADHERENT 0009 FIG. 4, also noted as Table 3, shows the Hosokawa ADDITIVES Powder Tester Results for Sorbolac 400 (Cyclomixed). 0010 FIG. 5, also noted as Table 4, shows the Hosokawa RELATED APPLICATIONS Powder Tester Results for Micronised Lactose (Model Drug). 0001. This application is a continuation of U.S. applica 0011 FIG. 6, also noted as Table 5, shows the Hosokawa tion Ser. No. 13/085,200 filed Apr. 12, 2011, which is a Powder Tester Results for SU003 (Conventional “Large” Car continuation of U.S. application Ser. No. 1 1/791,385 filed Jul. rier). 5, 2007, now abandoned which is a United States national 0012 FIG. 7 shows the Zeta potential of Lactose. Lactose/ stage of International Application No. PCT/GB2005/0502.11, Magnesium Stearate that has been Turbula-blended and Lac filed Nov. 23, 2005, which was published as International tose/Magnesium Stearate that has been mechanofused. Publication No. WO 2006/056812, and which claims benefit of United Kingdom Application No. 0425758.0 filed, Nov. DETAILED DESCRIPTION OF THE INVENTION 23, 2004, the entire contents of which are hereby expressly 0013 The drug particles or particles of pharmaceutically incorporated herein by reference thereto. active material (also referred to herein as “active' particles) in the resuspended powder must aerosolise into an ultra-fine FIELD OF THE INVENTION aerosol so that they can be transported to the appropriate target area within the lung. Typically, for lung deposition, the 0002 The present invention is concerned with a refine active particles have a diameter of less than 10 Jums, fre ment of the processing of particles that are to form a dry quently 0.1 to 7 um, 0.1 to 5um, or 0.5 to 5 um. powder formulation which is to be administered to the lung, 0014 For formulations to reach the deep lung or the blood for example using a dry powder inhaler (DPI) device. In stream via inhalation, the active agent in the formulation must particular, the present invention provides the processing of be in the form of very fine particles, for example, having a particles of active material and particles of carrier material in mass median aerodynamic diameter (MMAD) of less than 10 the presence of additive material to provide a powder com um. It is well established that particles having an MMAD of position which exhibits excellent powder properties and greater than 10 um are likely to impact on the walls of the which is economical to produce. throat and generally do not reach the lung. Particles having an MMAD in the region of 5 to 2 um will generally be deposited BACKGROUND OF THE INVENTION in the respiratory bronchioles whereas particles having an 0003. Inhalation represents a very attractive, rapid and MMAD in the range of 3 to 0.05um are likely to be deposited patient-friendly route for the delivery of systemically acting in the alveoli and to be absorbed into the bloodstream. drugs, as well as for drugs that are designed to act locally on (0015 Preferably, for delivery to the lower respiratory tract the lungs themselves. It is particularly desirable and advan or deep lung, the MMAD of the active particles is not more tageous to develop technologies for delivering drugs to the than 10 um, and preferably not more than more preferably not lungs in a predictable and reproducible manner. more than 3 Jum, and may be less than 2 Jum, less than 1.5um 0004. The key features which make inhalation an exciting or less than 1 Jum. Especially for deep lung or systemic deliv drug delivery route are: rapid speed of onset; improved ery, the active particles may have a size of 0.1 to 3 um or 0.1 patient acceptance and compliance for a non-invasive sys to 2 Jum. temic route; reduction of side effects; product life cycle 0016. Ideally, at least 90% by weight of the active particles extension; improved consistency of delivery; access to new in a dry powder formulation should have an aerodynamic forms of therapy, including higher doses, greater efficiency diameter of not more than 10 um, preferably not more than 5 and accuracy of targeting; and direct targeting of the site of um, more preferably not more than 3 um, not more than 2.5 action for locally administered drugs, such as those used to um, not more than 2.0 um, not more than 1.5um, or even not treat lung diseases such as asthma, COPD, CF or lung infec more than 1.0 um. tions. 0017. When dry powders are produced using conventional 0005. However, the powder technology behind successful processes, the active particles will vary in size, and often this dry powders and DPI products remains a significant technical variation can be considerable. This can make it difficult to hurdle to those wishing to succeed with this route of admin ensure that a high enough proportion of the active particles istration and to exploit the significant product opportunities. are of the appropriate size for administration to the correct Any formulation must have suitable flow properties, not only site. It is therefore desirable to have a dry powderformulation to assist in the manufacture and metering of the powders, but wherein the size distribution of the active particles is as nar also to provide reliable and predictable resuspension and row as possible. For example, the geometric standard devia fluidisation, and to avoid excessive retention of the powder tion of the active particle aerodynamic or Volumetric size within the dispensing device. distribution (Og), is preferably not more than 2, more prefer ably not more than 1.8, not more than 1.6, not more than 1.5, not more than 1.4, or even not more than 1.2. This will BRIEF DESCRIPTION OF THE DRAWINGS improve dose efficiency and reproducibility. 0006 FIG. 1 shows the microporosity of various types of 0018 Fine particles, that is, those with an MMAD of less lactose particles as measured using the Cooker SA 3100 BET than 101. Lum and Smaller, tend to be increasingly thermody system as defined by pore diameter (nm) versus cumulative namically unstable as their surface area to Volume ratio percentage. increases, which provides an increasing Surface free energy 0007 FIG. 2, also noted as Table 1, shows the Hosokawa with this decreasing particle size, and consequently increases Powder Tester Results for Sorbolac 400 (Mechanofused). the tendency of particles to agglomerate and the strength of US 2016/0000709 A1 Jan. 7, 2016 the agglomerate. In the inhaler, agglomeration of fine par collisions it employs. Such variations can lead to increased ticles and adherence of such particles to the walls of the Surface energy and increased cohesiveness and adhesiveness.
Load more

Recommended publications
  • WO 2012/148799 Al 1 November 2012 (01.11.2012) P O P C T
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2012/148799 Al 1 November 2012 (01.11.2012) P O P C T (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 9/107 (2006.01) A61K 9/00 (2006.01) kind of national protection available): AE, AG, AL, AM, A 61 47/10 (2006.0V) AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, (21) International Application Number: DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, PCT/US2012/034361 HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, (22) International Filing Date: KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, 20 April 2012 (20.04.2012) MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SC, SD, (25) Filing Language: English SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, (26) Publication Language: English TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: (84) Designated States (unless otherwise indicated, for every 61/480,259 28 April 201 1 (28.04.201 1) US kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, (71) Applicant (for all designated States except US): BOARD UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, OF REGENTS, THE UNIVERSITY OF TEXAS SYS¬ TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, TEM [US/US]; 201 West 7th St., Austin, TX 78701 (US).
    [Show full text]
  • 2019 Instrumentation and Consumable Catalog 2 INSTRUMENTATION and CONSUMABLE CATALOG
    PRODUCT CATALOG 2019 Instrumentation and Consumable Catalog 2 INSTRUMENTATION AND CONSUMABLE CATALOG Resolvex® A200 Part Numbers: A200 96: 253-1160 Resolvex® A200 96 Resolvex A200 Standalone work station for automated sample preparation. The compact benchtop offers the one stop solution for automating sample preparation utilizing creation of multiple work flows, and programmable dispensing of up to 11 solvents. Along with its innovative positive pressure system leading to clean samples, improving accuracy, throughput and enhancing the Life time of your analytical instrument. The A200 comes with an easy to use touch screen interface allowing for easy set up of multiple work flows. In addition the light curtain safety feature will release gas pressure when manifold is activated to prevent any injuries. INSTRUMENTATION AND CONSUMABLE CATALOG 3 Resolvex® A100 Part Numbers: A100 96: 253-0019 A100 48: 253-0014 Resolvex® A100 Standalone work station for automated sample preparation. The compact benchtop offers the one stop solution for automating sample preparation utilizing creation of multiple work flows, and programmable dispensing of up to 11 solvents. Along with its innovative positive pressure system leading to clean samples, improving accuracy, throughput and enhancing the Life time of your analytical instrument. The A100 comes in 96 and 4 configuration allowing for for automated Work Flow solutions in multiple SPE formats. 4 INSTRUMENTATION AND CONSUMABLE CATALOG Resolvex® M10 96/M10 96 XT/M10 48 Part Numbers: M10 96 XT: 288-0006 M10 96: 288-0001 M10 48: 289-0004 Resolvex® M10 Standalone work station for Positive Pressure solid phase extraction. The manual Resolvex M10 48 and 96 are positive pressure manifold for 1, 3, and 6 ml cartridges, or 1ml 96 well plates.
    [Show full text]
  • Screening of 300 Drugs in Blood Utilizing Second Generation
    Forensic Screening of 300 Drugs in Blood Utilizing Exactive Plus High-Resolution Accurate Mass Spectrometer and ExactFinder Software Kristine Van Natta, Marta Kozak, Xiang He Forensic Toxicology use Only Drugs analyzed Compound Compound Compound Atazanavir Efavirenz Pyrilamine Chlorpropamide Haloperidol Tolbutamide 1-(3-Chlorophenyl)piperazine Des(2-hydroxyethyl)opipramol Pentazocine Atenolol EMDP Quinidine Chlorprothixene Hydrocodone Tramadol 10-hydroxycarbazepine Desalkylflurazepam Perimetazine Atropine Ephedrine Quinine Cilazapril Hydromorphone Trazodone 5-(p-Methylphenyl)-5-phenylhydantoin Desipramine Phenacetin Benperidol Escitalopram Quinupramine Cinchonine Hydroquinine Triazolam 6-Acetylcodeine Desmethylcitalopram Phenazone Benzoylecgonine Esmolol Ranitidine Cinnarizine Hydroxychloroquine Trifluoperazine Bepridil Estazolam Reserpine 6-Monoacetylmorphine Desmethylcitalopram Phencyclidine Cisapride HydroxyItraconazole Trifluperidol Betaxolol Ethyl Loflazepate Risperidone 7(2,3dihydroxypropyl)Theophylline Desmethylclozapine Phenylbutazone Clenbuterol Hydroxyzine Triflupromazine Bezafibrate Ethylamphetamine Ritonavir 7-Aminoclonazepam Desmethyldoxepin Pholcodine Clobazam Ibogaine Trihexyphenidyl Biperiden Etifoxine Ropivacaine 7-Aminoflunitrazepam Desmethylmirtazapine Pimozide Clofibrate Imatinib Trimeprazine Bisoprolol Etodolac Rufinamide 9-hydroxy-risperidone Desmethylnefopam Pindolol Clomethiazole Imipramine Trimetazidine Bromazepam Felbamate Secobarbital Clomipramine Indalpine Trimethoprim Acepromazine Desmethyltramadol Pipamperone
    [Show full text]
  • L:\0901 with Peru\0901PHARMAPPX.Wpd
    Harmonized Tariff Schedule of the United States (2009) (Rev. 1) Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE Harmonized Tariff Schedule of the United States (2009) (Rev. 1) 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. ABACAVIR 136470-78-5 ACEXAMIC ACID 57-08-9 ABAFUNGIN 129639-79-8 ACICLOVIR 59277-89-3 ABAMECTIN 65195-55-3 ACIFRAN 72420-38-3 ABANOQUIL 90402-40-7 ACIPIMOX 51037-30-0 ABAPERIDONE 183849-43-6 ACITAZANOLAST 114607-46-4 ABARELIX 183552-38-7 ACITEMATE 101197-99-3 ABATACEPT 332348-12-6 ACITRETIN 55079-83-9 ABCIXIMAB 143653-53-6 ACIVICIN 42228-92-2 ABECARNIL 111841-85-1 ACLANTATE 39633-62-0 ABETIMUS 167362-48-3 ACLARUBICIN 57576-44-0 ABIRATERONE 154229-19-3 ACLATONIUM NAPADISILATE 55077-30-0 ABITESARTAN 137882-98-5 ACODAZOLE 79152-85-5 ABLUKAST 96566-25-5 ACOLBIFENE 182167-02-8 ABRINEURIN 178535-93-8 ACONIAZIDE 13410-86-1 ABUNIDAZOLE 91017-58-2 ACOTIAMIDE 185106-16-5 ACADESINE 2627-69-2 ACOXATRINE 748-44-7 ACAMPROSATE 77337-76-9 ACREOZAST 123548-56-1 ACAPRAZINE 55485-20-6
    [Show full text]
  • Info on Skin Testing
    Information on Skin Testing *Please review 1 week prior to testing* Your Doctor has ordered an allergy test for you. Your appointment has been made for: ___________________________________ at _______________________AM/PM at our (date) (time) _ Foulkstone / Limestone / Glasgow _ office. Skin tests are a method of testing for allergic reactions to substances, or allergens, in the environment. Our practice utilizes a test that involves no needles! We use a prick method which involves a series of small plastic applicators that carry a specific antigen which is placed on your arms. The types of allergens we test for include weeds, trees, grasses, molds, animal dander, dust mites and some foods. The testing will take 45 minutes. Please remember to wear comfortable clothing with short sleeves. Reactions can consist of itchy eyes, nose or throat, nasal congestion, runny nose, tightness in the throat or chest, wheezing, lightheadedness, hives or anaphylactic shock. Although this is very rare, our staff is fully prepared with emergency equipment and a physician is always on site. To ensure accurate testing results, certain medicines should be stopped 5 days prior to testing, although you should not stop medicines without talking to your prescribing physician. Medications that interfere with testing include but are not limited to: Antihistamines are medicines used to treat allergies, nausea, and dizziness. Many are found in over the counter cold medicines. They include, but are not limited to: ALAVERT / CLARITIN (LORATIDINE) DRAMAMINE (DIMENHYDRINATE)
    [Show full text]
  • Tricyclic Antidepressants Versus
    Jørgensen et al. Syst Rev (2021) 10:227 https://doi.org/10.1186/s13643-021-01789-0 PROTOCOL Open Access Tricyclic antidepressants versus ‘active placebo’, placebo or no intervention for adults with major depressive disorder: a protocol for a systematic review with meta-analysis and Trial Sequential Analysis Caroline Kamp Jørgensen1* , Sophie Juul1,2,3, Faiza Siddiqui1, Marija Barbateskovic1, Klaus Munkholm4, Michael Pascal Hengartner5, Irving Kirsch6, Christian Gluud1 and Janus Christian Jakobsen1,7 Abstract Background: Major depressive disorder is a common psychiatric disorder causing great burden on patients and societies. Tricyclic antidepressants are frequently used worldwide to treat patients with major depressive disorder. It has repeatedly been shown that tricyclic antidepressants reduce depressive symptoms with a statistically signifcant efect, but the efect is small and of questionable clinical importance. Moreover, the benefcial and harmful efects of all types of tricyclic antidepressants have not previously been systematically assessed. Therefore, we aim to investigate the benefcial and harmful efects of tricyclic antidepressants versus ‘active placebo’, placebo or no intervention for adults with major depressive disorder. Methods: This is a protocol for a systematic review with meta-analysis that will be reported as recommended by Pre- ferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols, bias will be assessed with the Cochrane Risk of Bias tool—version 2, our eight-step procedure will be used to assess if the thresholds for clinical signifcance are crossed, Trial Sequential Analysis will be conducted to control random errors and the certainty of the evidence will be assessed with the Grading of Recommendations Assessment, Development and Evaluation approach.
    [Show full text]
  • Stembook 2018.Pdf
    The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances FORMER DOCUMENT NUMBER: WHO/PHARM S/NOM 15 WHO/EMP/RHT/TSN/2018.1 © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances. Geneva: World Health Organization; 2018 (WHO/EMP/RHT/TSN/2018.1). Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data.
    [Show full text]
  • Antidepressant Treatment for Postnatal Depression
    This is a repository copy of Antidepressant treatment for postnatal depression. White Rose Research Online URL for this paper: https://eprints.whiterose.ac.uk/163986/ Version: Published Version Article: Brown, Jennifer Valeska Elli orcid.org/0000-0003-0943-5177, Wilson, Claire A., Ayre, Karyn et al. (5 more authors) (2020) Antidepressant treatment for postnatal depression. Cochrane Database of Systematic Reviews. CD013560. ISSN 1469-493X https://doi.org/10.1002/14651858.CD013560 Reuse Items deposited in White Rose Research Online are protected by copyright, with all rights reserved unless indicated otherwise. They may be downloaded and/or printed for private study, or other acts as permitted by national copyright laws. The publisher or other rights holders may allow further reproduction and re-use of the full text version. This is indicated by the licence information on the White Rose Research Online record for the item. Takedown If you consider content in White Rose Research Online to be in breach of UK law, please notify us by emailing [email protected] including the URL of the record and the reason for the withdrawal request. [email protected] https://eprints.whiterose.ac.uk/ Cochrane Library Cochrane Database of Systematic Reviews Antidepressant treatment for postnatal depression (Protocol) Brown JVE, Wilson CA, Ayre K, South E, Molyneaux E, Trevillion K, Howard LM, Khalifeh H Brown JVE, Wilson CA, Ayre K, South E, Molyneaux E, Trevillion K, Howard LM, Khalifeh H. Antidepressant treatment for postnatal depression. Cochrane Database of Systematic Reviews 2020, Issue 3. Art. No.: CD013560. DOI: 10.1002/14651858.CD013560. www.cochranelibrary.com Antidepressant treatment for postnatal depression (Protocol) Copyright © 2020 The Cochrane Collaboration.
    [Show full text]
  • Beta Blockers Herbs
    Accredited Asthma, Allergy, & Food Intolerance Center • 1009B Dupont Square North • Louisville, KY • 40207 • Phone (502)895 -3330 • Fax (502)895-3356 IMPORTANT LIST OF MEDICATIONS TO AVOID - REVIEW IMMEDIATELY ANTIHISTAMINES ANTIHISTAMINES (CONT.) TRICYCLIC ANTIDEPRESSANTS **STOP 10 days PRIOR TO TESTING** **STOP 2 DAYS or 48 Hours PRIOR TO TESTING** **STOP 10 days PRIOR TO TESTING** GENERIC NAME BRAND NAME GENERIC NAME BRAND NAME **Please contact the ordering physician Azelastine Astelin Acrivastine Semprex-D before stopping these medications.** Azelastine Optivar Olopatadine Pataday Cetirizine Zyrtec GENERIC NAME BRAND NAME Chlorcyclizine HCl Ahist Amitriptyline Elavil Chlorcyclizine HCl Stahist Medications for Dizziness/Motion Amitriptyline Endep Chlorpheniramine Aller-Chlor Sickness Amitriptyline Etrafon Chlorpheniramine Chlo-Amine **STOP 10 DAYS PRIOR TO TESTING** Amitriptyline Laroxyl Chlorpheniramine Chlorphen GENERIC NAME BRAND NAME Amitriptyline Limbitrol Chlorpheniramine Chlor-Trimeton Meclizine Hydrochloride Antivert Amitriptyline Tryptizol Chlorpheniramine C.P.M. Meclizine Dramamine Amitriptyline Vanatrip Chlorpheniramine Effidac-24 Amitriptylinoxide Ambivalon Chlorpheniramine Ridraman Amitriptylinoxide Amioxid Cimetidine Tagamet Amitriptylinoxide Equilibrin Clemastine Allerhist-1 BETA BLOCKERS Amoxampine Asendin Clemastine Contac 12 Hour Allergy **DO NOT TAKE these medications the MORNING Butriptyline Evadyne Clemastine Tavist-1 OF your appointment** Clomipramine Anafranil Cyproheptadine Periactin GENERIC NAME BRAND NAME
    [Show full text]
  • PDF of Clinical Laboratory Fee Schedule CY 2015 Updates
    WASHINGTON BEAT Challenges in Laboratory Coding 2015 KATHLEEN HANSEN ABBREVIATIONS: CLFS – Clinical Laboratory Fee their use are published in the fall. Schedule, CPT - Current Procedural Terminology, AMA - American Medical Association, CMS - Center Reimbursement amounts are published near the end of for Medicare and Medicaid Services, HCPCS – the year with the new Clinical Laboratory Fee Schedule Healthcare Common Procedure Coding System, NGS - (CLFS). Reimbursement amounts for the CLFS are Next Generation Sequencing, MAC - Medicare determined using one of two methodologies: crosswalk Administrative Contractor, Mopath – molecular or gap fill. Crosswalk matches the new code with an Downloaded from pathology, MUE - Medically Unlikely Edit existing code that is deemed to be of similar cost to perform, and assigns that same reimbursement to the INDEX TERMS: CPT coding, molecular pathology, new code. Gap fill assumes that the new code is drug screening, immunohistochemical stains sufficiently different from existing codes to need its own reimbursement determination. Each Medicare http://hwmaint.clsjournal.ascls.org/ Clin Lab Sci 2015;28(1):3 contractor decides what its reimbursement will be based on its determination of the cost to perform the test. Kathleen Hansen, MLS(ASCP)CM, Advisor, ASCLS These different amounts are used for a year, after which Government Affairs Committee, Laboratory Administra- Medicare reviews and assigns an amount on the CLFS. tion Consultant, Fairview Health Services, Minneapolis, The laboratory community has traditionally been more MN comfortable with the crosswalk method since the gap fill method can lead to very different reimbursements in Address for Correspondence: Kathleen Hansen, different contractor jurisdictions, and amounts may not MLS(ASCP)CM, 2309 Beverly Road, St.
    [Show full text]
  • (12) United States Patent (10) Patent No.: US 7,560,544 B2 Webber Et Al
    USOO756.0544B2 (12) United States Patent (10) Patent No.: US 7,560,544 B2 Webber et al. (45) Date of Patent: Jul. 14, 2009 (54) 3.5-DISUBSITITUTED AND 2003.01.00764 A1 5/2003 Bonket al. 3,5,7-TRISUBSTITUTED-3H-OXAZOLO AND 2003,01628.06 A1 8, 2003 Dellaria et al. 3H-THIAZOLO4,5-DIPYRIMIDIN-2-ONE 2003/0176458 A1 9, 2003 Dellaria et al. COMPOUNDS AND PRODRUGS THEREOF 2003/0186949 A1 10, 2003 Dellaria et al. 2003. O195209 A1 10, 2003 Dellaria et al. (75) Inventors: Stephen E. Webber, San Diego, CA S-8. A. 1929 St.oberts etet al. al. (US); Gregory J. Haley, Del Mar, CA 2005, 0004144 A1 1/2005 Carson et al. (US); Joseph R. Lennox, San Diego, CA (US); Alan X. Xiang, San Diego, CA FOREIGN PATENT DOCUMENTS (US); Erik J. Rueden, Santee, CA (US) EP O 882 727 9, 1998 EP 1 035 123 9, 2000 (73) Assignee: Anadys Pharmaceuticals, Inc., San EP 1043 021 10, 2000 Diego, CA (US) EP 1386,923 A1 2, 2004 WO WO-89/05649 6, 1989 Notice: Subject to any disclaimer, the term of this WO WO-92, 16215 10, 1992 (*) WO WO-94,07904 4f1994 patent is extended or adjusted under 35 WO WO-94, 17043 8, 1994 U.S.C. 154(b) by 119 days. WO WO-94.17090 8, 1994 WO WO-98, 17279 4f1998 (21) Appl. No.: 11/304,691 WO WO-03/045968 6, 2003 (22) Filed: Dec. 16, 2005 OTHER PUBLICATIONS Vippagunta et al. Advanced Drug Delivery Reviews 48 (2001)3-26.* (65) Prior Publication Data Lugemwaetal.
    [Show full text]
  • Esketamine for the Treatment of Treatment-Resistant Depression: Effectiveness and Value
    Esketamine for the Treatment of Treatment-Resistant Depression: Effectiveness and Value Evidence Report May 9, 2019 Prepared for ©Institute for Clinical and Economic Review, 2019 The University of Illinois at Chicago College of ICER Staff and Consultants Pharmacy’s Center for Pharmacoepidemiology and Pharmacoeconomic Research* Steven J. Atlas, MD, MPH Daniel R. Touchette, PharmD, MA Associate Professor of Medicine Professor of Pharmacy Harvard Medical School, Boston Assistant Director, Center for Pharmacoepidemiology Director, Practice Based Research & Quality and Pharmacoeconomic Research Improvement University of Illinois at Chicago Division of General Internal Medicine Massachusetts General Hospital, Boston Nicole Boyer, PhD Research Fellow Foluso Agboola, MBBS, MPH University of Chicago Director, Evidence Synthesis Institute for Clinical and Economic Review Brian Talon, PharmD PhD Student University of Illinois at Chicago Katherine Fazioli Senior Research Assistant Bob G. Schultz, PharmD Institute for Clinical and Economic Review PhD Student and Research Fellow University of Illinois at Chicago Varun M. Kumar, MBBS, MPH, MSc Associate Director of Health Economics Institute for Clinical and Economic Review *The role of the University of Illinois at Chicago College of Ellie Adair, MPA Pharmacy’s Center for Pharmacoepidemiology and Program Manager Pharmacoeconomic Research is limited to the development of the cost-effectiveness model, and the resulting ICER reports do not Institute for Clinical and Economic Review necessarily represent the views of the UIC. David Rind, MD Chief Medical Officer Institute for Clinical and Economic Review Steve Pearson, MD, MSc President Institute for Clinical and Economic Review Date of Publication: May 9, 2019 Steven Atlas served as the lead author for the report.
    [Show full text]