DOCSLIB.ORG

(12) Patent Application Publication (10) Pub. No.: US 2014/0302147 A1 HARTMAN Et Al

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text

Load more

US 20140302147A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2014/0302147 A1 HARTMAN et al. (43) Pub. Date: Oct. 9, 2014 (54) RESPRABLEAGGLOMERATES OF POROUS Publication Classification CARRIER PARTICLES AND MICRONIZED DRUG (51) Int. Cl. A619/16 (2006.01) (71) Applicants: Michael HARTMAN, Millbrae, CA A619/00 (2006.01) (US); Thomas ETARARA, A613 L/40 (2006.01) Burlingame, CA (US); Patrick TEUNG, A613 L/4704 (2006.01) Sunnyvale, CA (US); Jeffry G WEERS, A613 L/58 (2006.01) Belmont, CA (US) (52) U.S. Cl. CPC ........... A61 K9/1617 (2013.01); A61 K3I/4704 (72) Inventors: Michael HARTMAN, Millbrae, CA (2013.01); A61 K3I/58 (2013.01); A61K 31/40 (US); Thomas ETARARA, (2013.01); A61 K9/1682 (2013.01); A61 K Burlingame, CA (US); Patrick TEUNG, 9/0075 (2013.01) Sunnyvale, CA (US); Jeffry G WEERS, USPC ............................ 424/489: 514/312: 514/171 Belmont, CA (US) (57) ABSTRACT Embodiments of the present invention provide a dry powder Assignee: composition comprising porous carrier particles associated (73) NOVARTIS AG, Basel (CH) with one, two, three or more micronized drugs or APIs wherein an ordered mixture between the micronized drug or (21) Appl. No.: 14/202,262 drugs and the carrier particle results, such that the micronized drug or drugs adhere strongly to the carrier particles forming a stable ordered mixture of respirable agglomerates. Embodi (22) Filed: Mar 10, 2014 ments of the present invention further comprise a spray-dry ing process to create the respirable agglomerates. Embodi ments of the present invention further relate to the use of the Related U.S. Application Data dry powder formulation comprising respirable agglomerates (60) Provisional application No. 61/784,842, filed on Mar. for the treatment of a patient having a disease or condition 14, 2013. which is treatable thereby. Patent Application Publication Oct. 9, 2014 Sheet 1 of 7 US 2014/0302147 A1 Patent Application Publication Oct. 9, 2014 Sheet 2 of 7 US 2014/0302147 A1 8 :---------rSingie Capsule Funifornity, Ovivot 105A-7-6 : NvA237 Dose & w (A843 base xx 88: 8; 3. & xx x88: 88 « » « » « » . 8 . » « » - 3. r- - - - - - - - - - . « » vis: 8 Patent Application Publication Oct. 9, 2014 Sheet 3 of 7 US 2014/0302147 A1 Patent Application Publication Oct. 9, 2014 Sheet 4 of 7 US 2014/0302147 A1 A5 im. im actose Biend a. 3 Standard PinoSphere Respirable aggotterate rea 888 4s 2.82 SS 94 . ,34. re PreSep NG Stage EC (a Fig. 4 Patent Application Publication Oct. 9, 2014 Sheet 5 of 7 US 2014/0302147 A1 Asraex S. Mono Corbo -------------------------------------------------------------------------------------------------------------------------------------------------------------- S at 8.8 4.46 2,82 166 94. 8s ,34 r PreSep is Stage ECO a Fig 5 Patent Application Publication Oct. 9, 2014 Sheet 6 of 7 US 2014/0302147 A1 (SunOO) (ISueu Patent Application Publication Oct. 9, 2014 Sheet 7 of 7 US 2014/0302147 A1 (SunOO) (ISueu US 2014/0302147 A1 Oct. 9, 2014 RESPIRABLEAGGLOMERATES OF POROUS interactions can lead to variability in aerosol performance, CARRIER PARTICLES AND MICRONIZED with differences observed for each drug as a mono-compo DRUG nent or in the fixed dose combination, and with differences in dose strength. The complex interactions between the various FIELD OF THE INVENTION formulation components leads to difficulty in meeting the “combination rule', which relates that the in vitro aerosol 0001. The disclosure relates to physically stable and sub performance of each drug should be equivalent for the drug stantially uniform dry powder medicament formulations of alone and in combination. In order to overcome potential one, two, three, or more active ingredients that are useful for issues with meeting the combination rule with lactose blends, pulmonary administration, and in particular for administering Some groups have turned to Sophisticated devices, where medicaments to treat diseases of the lung. blends of each drug in the fixed dose combination is present in its own receptacle, and the two receptacles are aerosolized BACKGROUND concurrently (see for example, Anderson et al., WO 2003/ 0002 Active pharmaceutical ingredients (APIs) that are 061743). useful for treating respiratory diseases are often formulated for administration pulmonarily, to wit: by inhalation, such as SUMMARY OF THE INVENTION with portable inhalers. Pulmonary drug delivery methods and 0008 Accordingly, embodiments of the present invention compositions that effectively provide the pharmaceutical overcome the complexity observed with standard blends of compound at the specific site of action (the lung) potentially coarse lactose and micronized drug by creating ordered mix serve to minimize toxic side effects, lower dosing require tures of respirable agglomerates comprising Small porous ments, and decrease therapeutic costs. The development of carrier particles and micronized drug. Such systems for pulmonary drug delivery has long been a 0009 Embodiments of the present invention further pro goal of the pharmaceutical industry. vide a method for creating uniform ordered mixtures of respi 0003. Inhalation systems commonly used to deliver drugs rable agglomerates of Small porous particles and micronized locally to the pulmonary air passages are dry powder inhalers drug, comprising preparing a suspension of drug and carrier (DPIs), metered dose inhalers (MDIs), and nebulizers. DPIs in an anti-solvent, followed by removal of the anti-solvent in generally rely entirely on the patients inspiratory efforts to a drying process. introduce a medicament in a dry powder form to the lungs. 00.10 Embodiments of the present invention thus com 0004 To achieve good deposition of aerosolized particles prise a dry powder composition comprising carrier particles in the lungs, the particles should have an aerodynamic diam associated with one, two, three or more micronized drugs or eter in the respirable size range from 1 to 5um. However, fine APIs wherein an ordered mixture between the micronized particles of this size are highly cohesive with poor bulk pow drug or drugs and the carrier particle results, such that the der properties (e.g., poor powder flow, fluidization, and dis micronized drug or drugs adhere strongly to the carrier par persibility). ticles forming stable respirable agglomerates. The carrier 0005 To improve bulk powder properties of dry powder particles are Small and/or porous. aerosols, micronized drug particles are often blended with 0011 Embodiments of the invention comprise a plurality coarse lactose monohydrate carrier particles with a geometric of Small porous carrier particles, together with a plurality of diameter between 50 and 200 um. The blend forms a mixture one or more Small active drug particles which together form with the fine particles adhering to the carrier, and the mixture an ordered mixture of aerodynamically sized, pulmonarily taking on the bulk powder characteristics of the coarse carrier deliverable respirable agglomerates. particles. 0012 Embodiments of the present invention obviate the 0006 Engineered particle blends require a delicate bal need for dispersion of the drug from the carrier during a ance of surface forces. The adhesive force between the drug patients inhalation, and the patient instead inhales the respi and carrier must be strong enough to create an ordered mix rable agglomerates of micronized drug and Small porous car ture that maintains its structure during filling and on storage, rier particles into their lungs. As such, the physicochemical yet weak enough to allow the drug and carrier to separate properties of the drug Substance and its content in the powder during aerosol administration. The adhesive force between become largely irrelevant. This is in contrast to the conven the fine particles and the carrier particles in current marketed tional mixtures of coarse lactose and micronized drug, where products remains high, however, leading to mean lung deliv both the adhesive forces between the drug and carrier, and the ery efficiencies of just 10-30% of the nominal dose, and mean cohesive forces between the micronized drug particles are interpatient variability in lung delivery of approximately critical in the resulting bulk powder properties. Thus, the 30-50%. aerosol performance of the respirable agglomerates of 0007. In practice, the engineered blends of micronized embodiments of the present invention do not depend on a drug adhered to lactose carrier particles do not exist as simple balance of adhesive and cohesive forces between carrier and ordered mixtures. Drug may be stuck to coarse lactose, to fine drug particles, but instead depend only on the cohesive forces lactose, or to itself in large agglomerates. This led some to between the respirable agglomerates. refer to these complex formulations as “multi-particulate 0013 The cohesive forces between small porous carrier nightmares'. The interactions become even more complex for particles are significantly reduced relative to standard fixed dose combinations of two or more drugs. Each drug in micronized drug particles, due to the decreased area of con the combination exhibits a different force of adhesion with tact between particles afforded by the porous particle mor the carrier, and a different dependence of drug dispersion phology, and the hydrophobic nature of the excipients from the carrier with flow rate. In addition, there are addi enriched at the particle Surface. As a result, Small porous tional adhesive forces between the two drugs and between carrier
Recommended publications
  • Asthma/COPD Agents

    Asthma/COPD Agents

    Quick Reference Drug List: Asthma/COPD Agents each State Health Plan has compiled a list of available products used to treat this condition. This reference will help identify preferred products, in addition to some P limitations or step-therapies when a product requires a prior authorization. Any non-PDL product will require the trial and failure of two PDL agents be documented on a prior authorization review. Generic products are preferred. Prior Authorizations should be sent to Envolve Pharmacy Solutions: Prior Authorization Phone: 866-399-0928 Prior Authorization Fax: 866-399-0929 MEDICAID DRUG INGREDIENT DOSAGE PDL LIMITS & NAME FORM/STRENGTH STATUS RESTRICTIONS Short Acting Beta Adrenergic Agonists (SABA) Albuterol Albuterol Sulfate Neb Sol: 0.63 mg/3ml, Yes QL: 375ml per 30 Sulfate 1.25mg/3ml, 0.083% day (0.63mg/3ml and (2.5mg/3ml), 0.5% 1/25mg/3ml only); (2.5mg/0.5ml) QL: 12.5 ml per day Syr: 2 mg/5ml (0.083% only); Tabs: 2mg, 4 mg ER Tabs: 4 mg, 8 mg Alupent® Metaproterenol Syr: 10 mg/5 mL Yes QL: 30ml per day Tabs: 10 mg, 20 mg (syrup only) Brethine® Terbutaline Tabs: 2.5 mg, 5mg Yes None ProAir HFA® Albuterol sulfate Aero sol: 90 mcg/act Yes QL: 8.5gm per fill, 17gm per 30 days ProAir Albuterol sulfate Aero sol: 90 mcg/act Yes AL: At least 4 years Respiclick® old up to 18 years old Proventil Albuterol sulfate Aero sol: 90 mcg/act No PA Required HFA® Ventolin Albuterol Sulfate Aero sol: 90 mcg/act Yes QL: 8gm per fill, HFA® 36gm per 30 days Xopenex® Levalbuterol Neb sol: 0.31mg/3ml, No PA Required 0.63mg/3ml, 1.25mg/0.5ml, 1.25mg/3ml
  • Dosing Time Matters

    Dosing Time Matters

    bioRxiv preprint doi: https://doi.org/10.1101/570119; this version posted March 21, 2019. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under aCC-BY-NC-ND 4.0 International license. Dosing Time Matters 1 2,3 4,5,6 1* Marc D. Ruben ,​ David F. Smith ,​ Garret A. FitzGerald ,​ and John B. Hogenesch ​ ​ ​ ​ 1 Division​ of Human Genetics, Center for Chronobiology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, 240 Albert Sabin Way, Cincinnati, OH, 45229 2 Divisions​ of Pediatric Otolaryngology and Pulmonary and Sleep Medicine, Cincinnati Children’s Hospital Medical Center, 3333 Burnet Ave, Cincinnati, OH 45229 3 Department​ of Otolaryngology-Head and Neck Surgery, University of Cincinnati School of Medicine, 231 Albert Sabin Way, Cincinnati, OH, 45267 4 Department​ of Systems Pharmacology and Translational Therapeutics, at the University of Pennsylvania Perelman School of Medicine, Philadelphia, PA 19104 USA 5 Department​ of Medicine, at the University of Pennsylvania Perelman School of Medicine, Philadelphia, PA 19104 USA 6 ​ Institute for Translational Medicine and Therapeutics (ITMAT), at the University of Pennsylvania Perelman School of Medicine, Philadelphia, PA 19104 USA *Corresponding Author. Email: [email protected] Abstract Trainees in medicine are taught to diagnose and administer treatment as needed; time-of-day is rarely considered. Yet accumulating evidence shows that ~half of human genes and physiologic functions follow daily rhythms. Circadian medicine aims to incorporate knowledge of these rhythms to enhance diagnosis and treatment.
  • Spirometry Protocol and Software Training Handout

    Spirometry Protocol and Software Training Handout

    SPIROMETRY PROTOCOL AND SOFTWARE TRAINING HANDOUT Spirometry Protocol Key Points in Performing Spirometry ▪ Always demonstrate the maneuver ▪ Prompt the participant to BLAST out the air ▪ Continue by having the participant PUSH out the air ▪ Continue until the balloon bursts or at least six seconds Getting ready to do Spirometry Subjects will be instructed to not use any bronchodilator medicines for at least 4 hours prior to the appointment (in the case of salmeterol [Serevent] or Fomoterol (foradil)or Tritoprium (Spiriva) avoid for 12 hours prior to the test). Bronchodilator medicines include: Short acting bronchodilators Albuterol (ventolin, proventil, airet, volmax tablet) Levalbuterol (xopenex) Metaproterenol (alupent) Pirbuterol (maxair) Terbutaline (brethaire, brethine, bricanyl) Isoetharine (bronkosol) Ipratropium (atrovent) Ipratropium and albuterol combination (Combivent) Isoproteranol (isuprel) Primatine 1 CHW Educational Protocols – Spirometry Protocol and Software Training Handout Bitolterol (tornalate) Long acting bronchodilator Salmeterol (serevent) Fomoterol (foradil) Tritoprium (Spiriva) Bronchodilators should be avoided because they can affect the spirometry results. If the patient is having symptoms from asthma and needs to use the medicine, ask that the medicine be used 4 hours before the visit, so that the next dose is due during the visit. Patients can then do the spirometry and then the patient can take the medicine after the test is completed. When scheduling the follow-up spirometry visit, if at all possible, try to make the visit at the same time as the initial baseline visit. 1. Preparing the Computer 1. Check to see if the time and date on the lower right hand corner is current. If the date and time is NOT, the spirometer will NOT sync with the computer or the Easy One software.
  • Separation of Β-Receptor Blockers and Analogs by Capillary Liquid Chromatography

    Separation of Β-Receptor Blockers and Analogs by Capillary Liquid Chromatography

    ORIGINAL ARTICLES College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, China Separation of b-receptor blockers and analogs by Capillary Liquid Chromatography (CLC) and Pressurized Capillary Electrochromatography (pCEC) using a vancomycin chiral stationary phase column Zhongyi Chen, Su Zeng, Tongwei Yao Received September 15, 2006, accepted October 28, 2006 Tongwei Jao, Department of Pharmaceutical Analysis and Drug Metabolism, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, 310031, China [email protected] Pharmazie 62: 585–592 (2007) doi: 10.1691/ph.2007.8.6194 Enantiomeric separation of chiral pharmaceuticals was carried out by means of in capillary liquid chroma- tography (CLC) and pressurized capillary electrochromatography (pCEC) using a vancomycin chiral sta- tionary phase (CSP). A 100 mm I.D. fused-silica capillary was packed with 5 mm diameter silica particles modified with vancomycin. Enantiomeric resolution of fifteen b-receptor blockers and analogs was stu- died by polar organic CLC mode and reversed-phase pCEC mode using mobile phases containing methanol-isopropanol-acetic acid-triethylamine and TEAA buffer-methanol, respectively. Several factors affecting chiral separation were investigated in both CLC and pCEC mode. Good enantiomeric resolution was achieved by CLC mode for propranolol, celiprolol, esmolol, bisoprolol, atenolol, metoprolol and car- teolol using methanol-isopropanol-acetic acid-triethylamine (70 : 30 : 0.05 : 0.05, v/v/v/v) as mobile phase and for clenbuterol, bambuterol, terbutaline, and salbutamol using methanol-isopropanol-acetic acid- triethylamine (50 : 50 : 0.05 : 005 or 50 : 50: 0.025 : 0.05, v/v/v/v) as mobile phase. The baseline was achieved by pCEC mode for the separation of esmolol, bisoprolol, atenolol, metoprolol, carteolol in the mobile phase containing MeOH-0.05%TEAA (pH 7.0) (90 : 10, v/v) (–10 kV), and that of propranolol and celiprolol in the mobile phase containing MeOH-0.025%TEAA (pH 7.0) (90 : 10, v/v)(–10 kV).
  • Clenbuterol Human Effects the Effect of Clenbuterol in Humans Is Researched Through Examining the History and Regulations of the Drug

    Clenbuterol Human Effects the Effect of Clenbuterol in Humans Is Researched Through Examining the History and Regulations of the Drug

    Clenbuterol Human Effects The effect of clenbuterol in humans is researched through examining the history and regulations of the drug. Specifically, Alberto Contador’s case is considered. Tag Words: Clenbuterol; drugs; Beta-2 Agonist; Effects; Thermogenic; Fat; Harmful; Authors: Jessie Yeh, Horace Lau, Danielle Lovisone with Julie M. Fagan, Ph.D. Summary (written by Danielle Lovisone) As a sympathomimetic and Beta-2 agonist, clenbuterol have several deleterious effects on the human body. The drug acts as a thermogenic stimulant, increasing lean muscle mass and respiratory efficiency while reducing fat. Cases on clenbuterol, including animal tests and human occurrences, support these unnatural and potentially harmful effects. With this, athletes and body builders have recently increased their use of the drug. Particularly, Alberto Contador has recently been targeted for having traces of clenbuterol in a urine drug test. Contador claims, instead of doping, this trace amount was unknowingly received from ingesting beef in Spain during the 2010 Tour de France. Although clenbuterol is banned in most areas of the world, this explanation seems plausible because the drug is poorly regulated by organizations such as the FDA. To examine Contador’s case further, our group compiled research on clenbuterol to ultimately hypothesize that Contador received this trace amount from contaminated beef. Our findings were submitted to the World Anti-Doping Agency as part of our Service Project. Video Link Class project 2010 fall: www.youtube.com/watch?v=ZTeJiBvbLhA The Issue: Clenbuterol The Effects of Clenbuterol on the Human Body By Jessie Yeh What is Clenbuterol? Clenbuterol is a chemical compound closely resembling the structure of an amine.
  • Validation of New Analytical Methodology for Determining Fenoterolhydrobromide by HPLC: Application in Pharmaceutical Products

    Validation of New Analytical Methodology for Determining Fenoterolhydrobromide by HPLC: Application in Pharmaceutical Products

    Artigo Original/Original Article Validation of new analytical methodology for determining fenoterolhydrobromide by HPLC: application in pharmaceutical products Validação de uma nova metodologia analítica para determinação de bromidrato de fenoterol por CLAE: aplicações em produtos farmacêuticos RIALA6/1475 *Helena Miyoco YANO1, Fernanda Fernandes FARIAS1, Marcelo Beiriz DEL BIANCO1, Pedro Lopez GARCIA2 *Endereço para correspondência: 1Núcleo de Ensaios Físicos e Químicos em Medicamentos, Centro de Medicamentos, Cosméticos e Saneantes, Instituto Adolfo Lutz, Av. Doutor Arnaldo, 355, CEP: 01246-902, São Paulo, SP, Brasil. E-mail: [email protected] 2Departamento de Farmácia, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, São Paulo, SP, Brasil. Recebido: 31.10.2011- Aceito para publicação: 20.04.2012 RESUMO Bromidrato de fenoterol é um agente agonista adrenérgico β2-seletivo utilizado para tratamento de asma e doenças pulmonares crônicas obstrutivas. A metodologia analítica por cromatografia líquida de alta eficiência (CLAE) foi desenvolvida e validada para a determinação quantitativa de bromidrato de fenoterol. A condição analítica empregada incluiu coluna em fase reversa C18 (150 mm × 3,9 mm d.i., 5 µm) Thermo®, fase móvel composta de mistura de acetonitrila e água (30:70, v/v) com 0,1% de trietilamina e pH ajustado para 5,0 com ácido fórmico, vazão de 1,0 mL.min-1 e detecção em UV a 276 nm. A faixa de linearidade foi de 0,025 a 0,15 mg.mL-1; a curva analítica mostrou coeficiente de correlação > 0,999. O limite de detecção (LD) foi de 0,003 mg.mL-1 e o limite de quantificação de 0,012 mg.mL-1.
  • Ep 2560611 B1

    Ep 2560611 B1

    (19) TZZ Z___T (11) EP 2 560 611 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 9/00 (2006.01) 03.01.2018 Bulletin 2018/01 (86) International application number: (21) Application number: 11719211.2 PCT/EP2011/056227 (22) Date of filing: 19.04.2011 (87) International publication number: WO 2011/131663 (27.10.2011 Gazette 2011/43) (54) "PROCESS FOR PROVIDING PARTICLES WITH REDUCED ELECTROSTATIC CHARGES" VERFAHREN ZUR BEREITSTELLUNG VON PARTIKELN MIT REDUZIERTEN ELEKTROSTATISCHEN LADUNGEN PROCÉDÉ DE PRÉPARATION DE PARTICULES AYANT DES CHARGES ÉLECTROSTATIQUES RÉDUITES (84) Designated Contracting States: • GUCHARDI ET AL: "Influence of fine lactose and AL AT BE BG CH CY CZ DE DK EE ES FI FR GB magnesium stearate on low dose dry powder GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO inhaler formulations", INTERNATIONAL PL PT RO RS SE SI SK SM TR JOURNAL OF PHARMACEUTICS, ELSEVIER BV, NL LNKD- DOI:10.1016/J.IJPHARM.2007.06.041, (30) Priority: 21.04.2010 EP 10160565 vol. 348, no. 1-2, 19 December 2007 (2007-12-19), pages 10-17, XP022393884, ISSN: 0378-5173 (43) Date of publication of application: • ELAJNAF A ET AL: "Electrostatic 27.02.2013 Bulletin 2013/09 characterisation of inhaled powders: Effect of contact surface and relative humidity", (73) Proprietor: Chiesi Farmaceutici S.p.A. EUROPEAN JOURNAL OF PHARMACEUTICAL 43100 Parma (IT) SCIENCES, ELSEVIER, AMSTERDAM, NL LNKD- DOI:10.1016/J.EJPS.2006.07.006, vol. 29, no. 5, 1 (72) Inventors: December 2006 (2006-12-01), pages 375-384, • COCCONI, Daniela XP025137181, ISSN: 0928-0987 [retrieved on I-43100 Parma (IT) 2006-12-01] • MUSA, Rossella • CHAN ET AL: "Dry powder aerosol drug I-43100 Parma (IT) delivery-Opportunities for colloid and surface scientists", COLLOIDS AND SURFACES.
  • Difference Between Patient-Reported Side Effects of Ciclesonide Versus fluticasone Propionate

    Difference Between Patient-Reported Side Effects of Ciclesonide Versus fluticasone Propionate

    View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Elsevier - Publisher Connector Respiratory Medicine (2010) 104, 1825e1833 available at www.sciencedirect.com journal homepage: www.elsevier.com/locate/rmed Difference between patient-reported side effects of ciclesonide versus fluticasone propionate Thys van der Molen a, Juliet M. Foster a,b, Manfred Caeser c,e, Thomas Mu¨ller c, Dirkje S. Postma d,* a Department of General Practice, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands b Woolcock Institute of Medical Research, 431 Glebe Point Rd, Glebe NSW 2037, Sydney, Australia c Nycomed GmbH, Byk-Gulden-Straße 2, 78467 Konstanz, Konstanz, Germany d Department of Pulmonary Diseases, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands Received 18 January 2010; accepted 26 May 2010 Available online 2 July 2010 KEYWORDS Summary Adverse events; Rationale: Patient-reported outcomes provide new insights into the dynamics of asthma Inhaled corticosteroid management. Further to asthma control and quality of life, self-reported side effects of treat- questionnaire; ment can be assessed with the validated Inhaled Corticosteroid Questionnaire (ICQ). ICQ; Objectives: To compare patient-reported side effects between the inhaled corticosteroids Patient-reported ciclesonide and fluticasone propionate. outcomes Methods: Patients with moderate or moderate-to-severe asthma, pre-treated with a constant dose and type of medication, were randomized in three separate studies: 1) once daily cicle- sonide 320 mg(n Z 234) or twice daily fluticasone propionate 200 mg(n Z 240); 2) twice daily ciclesonide 320 mg(n Z 255) or twice daily fluticasone propionate 375 mg(n Z 273); and 3) twice daily ciclesonide 320 mg(n Z 259) or twice daily fluticasone propionate 500 mg (n Z 244).
  • ADD/ADHD: Strattera • Allergy/Anti-Inflammatories

    ADD/ADHD: Strattera • Allergy/Anti-Inflammatories

    EXAMPLES OF PERMITTED MEDICATIONS - 2015 ADD/ADHD: Strattera Allergy/Anti-Inflammatories: Corticosteroids, including Decadron, Depo-Medrol, Entocort, Solu-Medrol, Prednisone, Prednisolone, and Methylprednisolone Anesthetics: Alcaine, Articadent, Bupivacaine HCI, Chloroprocaine, Citanest Plain Dental, Itch-X, Lidocaine, Marcaine, Mepivacaine HCI, Naropin, Nesacaine, Novacain, Ophthetic, Oraqix, Paracaine, Polocaine, Pontocaine Hydrochloride, PrameGel, Prax, Proparacaine HCI, Ropivacaine, Sarna Ultra, Sensorcaine, Synera, Tetracaine, Tronothane HCI, and Xylocaine Antacids: Calci-Chew, Di-Gel, Gaviscon, Gelusil, Maalox, Mintox Plus, Mylanta, Oyst-Cal 500, Rolaids, and Tums Anti-Anxiety: Alprazolam, Atarax, Ativan, Buspar, Buspirone HCI, Chlordiazepoxide HCI, Clonazepam, Chlorazepate Dipotassium, Diastat, Diazepam, Hydroxyzine, Klonopin, Librium, Lorazepam, Niravam, Tranxene T-tab, Valium, Vistaril, and Xanax Antibiotics: Acetasol HC, Amoxil, Ampicillin, Antiben, Antibiotic-Cort, Antihist, Antituss, Avelox, Ceftazidime, Ceftin, Cefuroxime Axetil, Ceptaz, Cleocin, Cloxapen, Cortane-B Aqueous, Cortic, Cresylate, Debrox, Doryx, EarSol-HC, Fortaz, Gantrisin, Mezlin, Moxifloxacin, Neotic, Otocain, Principen, Tazicef, Tazidime, Trioxin, and Zyvox Anti-Depressants: Adapin, Anafranil, Asendin, Bolvidon, Celexa, Cymbalata, Deprilept, Effexor, Elavil, Lexapro, Luvox, Norpramin, Pamelor, Paxil, Pristiq, Prozac, Savella, Surmontil, Tofranil, Vivactil, Wellbutrin, Zoloft, and Zyban Anti-Diabetics: Actos, Amaryl, Avandia, Glipizide, Glucophage,
  • Title 16. Crimes and Offenses Chapter 13. Controlled Substances Article 1

    Title 16. Crimes and Offenses Chapter 13. Controlled Substances Article 1

    TITLE 16. CRIMES AND OFFENSES CHAPTER 13. CONTROLLED SUBSTANCES ARTICLE 1. GENERAL PROVISIONS § 16-13-1. Drug related objects (a) As used in this Code section, the term: (1) "Controlled substance" shall have the same meaning as defined in Article 2 of this chapter, relating to controlled substances. For the purposes of this Code section, the term "controlled substance" shall include marijuana as defined by paragraph (16) of Code Section 16-13-21. (2) "Dangerous drug" shall have the same meaning as defined in Article 3 of this chapter, relating to dangerous drugs. (3) "Drug related object" means any machine, instrument, tool, equipment, contrivance, or device which an average person would reasonably conclude is intended to be used for one or more of the following purposes: (A) To introduce into the human body any dangerous drug or controlled substance under circumstances in violation of the laws of this state; (B) To enhance the effect on the human body of any dangerous drug or controlled substance under circumstances in violation of the laws of this state; (C) To conceal any quantity of any dangerous drug or controlled substance under circumstances in violation of the laws of this state; or (D) To test the strength, effectiveness, or purity of any dangerous drug or controlled substance under circumstances in violation of the laws of this state. (4) "Knowingly" means having general knowledge that a machine, instrument, tool, item of equipment, contrivance, or device is a drug related object or having reasonable grounds to believe that any such object is or may, to an average person, appear to be a drug related object.
  • COVID-19 Evidence Bulletin 8

    COVID-19 Evidence Bulletin 8

    COVID-19 Evidence Bulletin 8 Public Health England PHE International Epidemiology Daily Evidence Digest – 22nd April 2020 – 21st April 2020 – 20th April 2020 NICE COVID-19 rapid guideline: acute myocardial injury [NG171] Published 23rd April The purpose of this guideline is to help healthcare professionals who are not cardiology specialists identify and treat acute myocardial injury and its cardiac complications in adults with known or suspected COVID-19 but without known pre-existing cardiovascular disease. COVID-19 rapid guideline: gastrointestinal and liver conditions treated with drugs affecting the immune response [NG172] Published 23rd April The purpose of this guideline is to maximise the safety of children and adults who have gastrointestinal or liver conditions treated with drugs affecting the immune response during the COVID 19 pandemic. It also aims to protect staff from infection and enable services to make the best use of NHS resources. COVID-19 rapid guideline: managing symptoms (including at the end of life) in the community Published 3rd April, Last updated 22nd April NHS England Specialty Guides: Clinical guide for acute kidney injury in hospitalised patients with COVID-19 outside the intensive care unit during the coronavirus pandemic (22nd April - updated) Management of palliative care in hospital during the coronavirus pandemic (22nd April – updated) Department of Health and Social Care Medicines that cannot be parallel exported from the UK (22nd April) 33 medicines have been added to the parallel export list and the
  • The Inhaled Steroid Ciclesonide Blocks SARS-Cov-2 RNA Replication by Targeting Viral

    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.