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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. -
PRODUCT MONOGRAPH ORCIPRENALINE Orciprenaline Sulphate Syrup House Standard 2 Mg/Ml Β2-Adrenergic Stimulant Bronchodilator AA P
PRODUCT MONOGRAPH ORCIPRENALINE Orciprenaline Sulphate Syrup House Standard 2 mg/mL 2-Adrenergic Stimulant Bronchodilator AA PHARMA INC. DATE OF PREPARATION: 1165 Creditstone Road, Unit #1 April 10, 2014 Vaughan, Ontario L4K 4N7 Control Number: 172362 1 PRODUCT MONOGRAPH ORCIPRENALINE Orciprenaline Sulfate Syrup House Standard 2 mg/mL THERAPEUTIC CLASSIFICATION 2–Adrenergic Stimulant Bronchodilator ACTIONS AND CLINICAL PHARMACOLOGY Orciprenaline sulphate is a bronchodilating agent. The bronchospasm associated with various pulmonary diseases - chronic bronchitis, pulmonary emphysema, bronchial asthma, silicosis, tuberculosis, sarcoidosis and carcinoma of the lung, has been successfully reversed by therapy with orciprenaline sulphate. Orciprenaline sulphate has the following major characteristics: 1) Pharmacologically, the action of orciprenaline sulphate is one of beta stimulation. Receptor sites in the bronchi and bronchioles are more sensitive to the drug than those in the heart and blood vessels, so that the ratio of bronchodilating to cardiovascular effects is favourable. Consequently, it is usually possible clinically to produce good bronchodilation at dosage levels which are unlikely to cause cardiovascular side effects. 2 2) The efficacy of the bronchodilator after both oral and inhalation administration has been demonstrated by pulmonary function studies (spirometry, and by measurement of airways resistance by body plethysmography). 3) Rapid onset of action follows administration of orciprenaline sulphate inhalants, and the effect is usually noted immediately. Following oral administration, the effect is usually noted within 30 minutes. 4) The peak effect of bronchodilator activity following orciprenaline sulphate generally occurs within 60 to 90 minutes, and this activity lasts for 3 to 6 hours. 5) Orciprenaline sulphate taken orally potentiates the action of a bronchodilator inhalant administered 90 minutes later, whereas no additive effect occurs when the drugs are given in reverse order. -
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. -
Us Anti-Doping Agency
2019U.S. ANTI-DOPING AGENCY WALLET CARDEXAMPLES OF PROHIBITED AND PERMITTED SUBSTANCES AND METHODS Effective Jan. 1 – Dec. 31, 2019 CATEGORIES OF SUBSTANCES PROHIBITED AT ALL TIMES (IN AND OUT-OF-COMPETITION) • Non-Approved Substances: investigational drugs and pharmaceuticals with no approval by a governmental regulatory health authority for human therapeutic use. • Anabolic Agents: androstenediol, androstenedione, bolasterone, boldenone, clenbuterol, danazol, desoxymethyltestosterone (madol), dehydrochlormethyltestosterone (DHCMT), Prasterone (dehydroepiandrosterone, DHEA , Intrarosa) and its prohormones, drostanolone, epitestosterone, methasterone, methyl-1-testosterone, methyltestosterone (Covaryx, EEMT, Est Estrogens-methyltest DS, Methitest), nandrolone, oxandrolone, prostanozol, Selective Androgen Receptor Modulators (enobosarm, (ostarine, MK-2866), andarine, LGD-4033, RAD-140). stanozolol, testosterone and its metabolites or isomers (Androgel), THG, tibolone, trenbolone, zeranol, zilpaterol, and similar substances. • Beta-2 Agonists: All selective and non-selective beta-2 agonists, including all optical isomers, are prohibited. Most inhaled beta-2 agonists are prohibited, including arformoterol (Brovana), fenoterol, higenamine (norcoclaurine, Tinospora crispa), indacaterol (Arcapta), levalbuterol (Xopenex), metaproternol (Alupent), orciprenaline, olodaterol (Striverdi), pirbuterol (Maxair), terbutaline (Brethaire), vilanterol (Breo). The only exceptions are albuterol, formoterol, and salmeterol by a metered-dose inhaler when used -
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, -
Etats Rapides
List of European Pharmacopoeia Reference Standards Effective from 2015/12/24 Order Reference Standard Batch n° Quantity Sale Information Monograph Leaflet Storage Price Code per vial Unit Y0001756 Exemestane for system suitability 1 10 mg 1 2766 Yes +5°C ± 3°C 79 ! Y0001561 Abacavir sulfate 1 20 mg 1 2589 Yes +5°C ± 3°C 79 ! Y0001552 Abacavir for peak identification 1 10 mg 1 2589 Yes +5°C ± 3°C 79 ! Y0001551 Abacavir for system suitability 1 10 mg 1 2589 Yes +5°C ± 3°C 79 ! Y0000055 Acamprosate calcium - reference spectrum 1 n/a 1 1585 79 ! Y0000116 Acamprosate impurity A 1 50 mg 1 3-aminopropane-1-sulphonic acid 1585 Yes +5°C ± 3°C 79 ! Y0000500 Acarbose 3 100 mg 1 See leaflet ; Batch 2 is valid until 31 August 2015 2089 Yes +5°C ± 3°C 79 ! Y0000354 Acarbose for identification 1 10 mg 1 2089 Yes +5°C ± 3°C 79 ! Y0000427 Acarbose for peak identification 3 20 mg 1 Batch 2 is valid until 31 January 2015 2089 Yes +5°C ± 3°C 79 ! A0040000 Acebutolol hydrochloride 1 50 mg 1 0871 Yes +5°C ± 3°C 79 ! Y0000359 Acebutolol impurity B 2 10 mg 1 -[3-acetyl-4-[(2RS)-2-hydroxy-3-[(1-methylethyl)amino] propoxy]phenyl] 0871 Yes +5°C ± 3°C 79 ! acetamide (diacetolol) Y0000127 Acebutolol impurity C 1 20 mg 1 N-(3-acetyl-4-hydroxyphenyl)butanamide 0871 Yes +5°C ± 3°C 79 ! Y0000128 Acebutolol impurity I 2 0.004 mg 1 N-[3-acetyl-4-[(2RS)-3-(ethylamino)-2-hydroxypropoxy]phenyl] 0871 Yes +5°C ± 3°C 79 ! butanamide Y0000056 Aceclofenac - reference spectrum 1 n/a 1 1281 79 ! Y0000085 Aceclofenac impurity F 2 15 mg 1 benzyl[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetate -
Clinical Trial of Orciprenaline in Bradyarrhythmias
100 SINGAPORE MEDICAL JOURNAL Vol. 16, No. 2. June, 1975. CLINICAL TRIAL OF ORCIPRENALINE IN BRADYARRHYTHMIAS By Chin Hock, Lirn, Charles C. S. Toh and Oon Teik, Khoo SYNOPSIS The intravenous and oral forms of orciprenaline was used in the treatment of patients with severe sinus bradycardia, high grade atrio -ventricular block or the sick sinus syndrome. Intra- venous orciprenaline can be used to tide patients over a period of severe bradyarrhythmia, or prior to cardiac pacing. One patient developed ventricular tachycardia following an intravenous bolus of orciprenaline. Oral orciprenaline was used in 23 patients with severe bradyarrhythmia. Two patients responded poorly to it. Saventrine was given sequentially in nine patients. The merits and side effects of both drugs are discussed. INTRODUCTION efficiency of orciprenaline and to compare it with Saventrine in the treatment of complete In 1952, Nathanson and Miller introduced heart block and other forms of bradyarrhyth- isoprenaline for the treatment of heart block and mias. it still has an important role in the treatment of bradyarrhythmias. Nis Innissen and Thompson PHARMACOLOGY (1965) felt that the use of a sustained release form of isoprenaline could reduce the need for Orciprenaline (Alupent*) is a derivative of pacemakers. Intravenous isoprenaline and orci- isoprenaline but it has predominant beta -two prenaline may be used to treat patients with stimulatine effects and is commonly used as a Stokes Adams (S.A.) attacks resulting from very bronchodilator (Bogdan, 1969). However, it has slow ventricular rates in acute myocardial chronotropic and inotropic effects. It stimulates infarction, either alone or prior to cardiac the sino -atrial and atrioventricular nodes and pacing. -
Effects of Glycopyrronium on Lung Hyperinflation in COPD Patients Claudio M Sanguinetti1,2
Sanguinetti Multidisciplinary Respiratory Medicine 2014, 9:19 http://www.mrmjournal.com/content/9/1/19 REVIEW Open Access The lungs need to be deflated: effects of glycopyrronium on lung hyperinflation in COPD patients Claudio M Sanguinetti1,2 Abstract Chronic obstructive pulmonary disease (COPD) is characterized by persistent airflow limitation caused by bronchial alterations, small airways disease and parenchymal destruction. In patients with COPD the structural and functional lung alterations can progress more or less rapidly from the initial small airways disease to an overt COPD where a severe expiratory flow limitation takes place. In these conditions, lung hyperinflation develops characterized by increase in functional residual capacity (FRC) and decrease in inspiratory capacity (IC). Thus, IC is an easy and reliable index to monitor lung hyperinflation and to assess the efficacy of bronchodilator drugs. When FRC increases, tidal volume (VT) is located in a more flatted upper part of the P –V curve of the respiratory system and respiratory muscles must sustain a greater elastic workload. Furthermore, due to inadequate time for expiration, there is a positive alveolar pressure at the end of expiration (PEEPi). This represents a further elastic workload for the inspiratory muscles. This impairment of ventilatory mechanics generates dyspnea that in most severely compromised patients occurs also for small efforts causing activity limitation and worst health-related quality of life (HRQoL). Due to these respiratory alterations, bronchodilators are the cornerstone of the long-term treatment of COPD in order to decrease airways resistances, lung hyperinflation and exacerbation rate, and improve patient’s symptoms, exercise tolerance and health status. -
Effects of Replacing Oxitropium with Tiotropium on Pulmonary Function in Patients with COPD: a Randomized Study
View metadata, citation and similar papers at core.ac.uk ARTICLE IN PRESS brought to you by CORE provided by Elsevier - Publisher Connector Respiratory Medicine (2007) 101, 476–480 Effects of replacing oxitropium with tiotropium on pulmonary function in patients with COPD: A randomized study Cristoforo IncorvaiaÃ, Gian Galeazzo Riario-Sforza, Chiara Pravettoni, Natale Dugnani, Fulvia Paterniti, Laura Pessina, Mario Fumagalli Unit of Pulmonary Rehabilitation, ICP Hospital, via Bignami 1, Viale Molise 69, Milan, Italy Received 3 February 2006; accepted 6 July 2006 KEYWORDS Summary COPD; Background: Inhaled bronchodilators are first line drugs in the treatment of chronic Pulmonary function; obstructive pulmonary disease (COPD). Tiotropium bromide is a recently introduced long- Drug treatment; acting anticholinergic agent able to reduce dyspnoea and COPD exacerbations and to Anticholinergics; improve pulmonary function and quality of life. We designed a study to compare the short- Tiotropium; term efficacy of tiotropium bromide with that of oxitropium bromide in improving Oxitropium pulmonary function in patients with COPD. Methods: Eighty patients were randomized either to continue oxitropium 800 mcg/day or to receive tiotropium 18 mcg/day. Seventy-six (39 in the tiotropium and 37 in the oxitropium group) completed the study. Plethysmography was performed at baseline and after 72 h in all patients. The changes in functional parameters in the two groups were compared by the Mann–Whitney U-test. Results: There were no differences between the two groups regarding age (72.5 vs. 74.2 years), male/female ratio (25/14 vs. 23/14) and pulmonary function at baseline. The changes in spirometric parameters were significantly greater in tiotropium- than in oxitropium-treated patients: mean forced expiratory volume in 1 s (FEV1) increased significantly by 15% vs. -
Ep 2626065 A1
(19) TZZ Z_T (11) EP 2 626 065 A1 (12) EUROPEAN PATENT APPLICATION published in accordance with Art. 153(4) EPC (43) Date of publication: (51) Int Cl.: A61K 31/137 (2006.01) A61K 31/135 (2006.01) 14.08.2013 Bulletin 2013/33 A61K 31/4704 (2006.01) A61K 31/58 (2006.01) A61K 31/56 (2006.01) A61K 9/12 (2006.01) (2006.01) (2006.01) (21) Application number: 11827927.2 A61K 9/14 A61P 11/06 (86) International application number: Date of filing: 01.02.2011 (22) PCT/CN2011/070883 (87) International publication number: WO 2012/041031 (05.04.2012 Gazette 2012/14) (84) Designated Contracting States: (72) Inventor: WU, Wei-hsiu AL AT BE BG CH CY CZ DE DK EE ES FI FR GB Taipei GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO Taiwan (TW) PL PT RO RS SE SI SK SM TR (74) Representative: Patentanwaltskanzlei WILHELM (30) Priority: 28.09.2010 CN 201010502339 & BECK Prinzenstrasse 13 (71) Applicant: Intech Biopharm Ltd. 80639 München (DE) Taipei (TW) (54) COMPOUND COMPOSITION FOR INHALATION USED FOR TREATING ASTHMA (57) An inhaled pharmaceutical composition con- tric way as a controller. The eccentric way control therapy tains primary active ingredients of beta2- agonist and cor- could create a low blood concentration period during the ticosteroids.The pharmaceuticalcompositions disclosed day and minimize the acute tolerance phenomenon (or in the present invention are to be inhaled by a patient so called tachyphylaxis) for bronchodilator - beta2-ago- when needed as a reliever, or administrated in an eccen- nists in treating asthma or other obstructive respiratory disorders. -
5 August 2004 Version
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product. Before prescribing any product mentioned in this Register, healthcare professionals should consult prescribing information for the product approved in their country. Study No.: SAM 30020 Title: Efficacy and tolerability of the salmeterol/fluticasone 50/100 mcg combination Diskus, inhaled once daily in the evening, in comparison to the p.r.n. inhalation from the reproterol/sodium cromoglycate 0.5/ 1 mg combination MDI, as initial therapy for patients with mild asthma – a multicentre, randomised, open, parallel trial Rationale: The reproterol/sodium cromoglycate 0.5/ 1 mg combination is still widely used for the treatment of mild asthmatics. Usually, patients inhale the combination product from an MDI, and they adjust the dosage according to their asthma symptoms. Anti-inflammatory medication with an inhaled corticosteroid such as fluticasone is an alternative therapeutic option, and long-acting beta agonists can be used as bronchodilatory treatment. The study aimed to investigate whether the efficacy of the salmeterol/fluticasone 50/100-mcg combination (SFC), inhaled from the Diskus once daily in the evening, is superior to that of the PRN inhalation of the reproterol/sodium cromoglycate 0.5/ 1 mg combination (RS) from the metered dose inhaler. Phase: IV Study Period: 13 June 2002 to 27 June 2003 Study Design: This randomised, prospective, open, parallel group study had a total duration of ten weeks. There were two study periods: a run-in period of two weeks, and a treatment period of 8 weeks. -
That Had Torte I Una Altra Manian Literatura
THAT HAD TORTE I USUNA 20180016601A1ALTRA MANIAN LITERATURA UNA ( 19) United States (12 ) Patent Application Publication ( 10) Pub . No. : US 2018 / 0016601 A1 Qi et al. ( 43 ) Pub . Date: Jan . 18 , 2018 ( 54 ) METHODS FOR MODULATING GENOME C12N 15 / 10 (2006 .01 ) EDITING A6IK 38 / 46 ( 2006 .01 ) A61K 31 /365 (2006 .01 ) ( 71) Applicants: The Board of Trustees of the Leland A61K 31/ 63 ( 2006 .01 ) Stanford Junior University , Palo Alto , A61K 31 /513 ( 2006 . 01 ) CA (US ) ; The J . David Gladstone A61K 31 /505 ( 2006 .01 ) Institutes , a Testamentary Trust C12Q 1 / 68 ( 2006 .01 ) established under the Will of J . David C12N 9 / 22 ( 2006 . 01 ) Glads, San Francisco , CA ( US) ; The (52 ) U . S . CI. Regents of the University of CPC . .. - . C12N 15/ 907 ( 2013 .01 ) ; C12Q 1 /68 California , Oakland , CA (US ) ( 2013 . 01 ) ; C12Q 1 /44 ( 2013 .01 ) ; C12N 15 / 1024 (2013 .01 ) ; C12N 9 /22 ( 2013. 01 ) ; ( 72 ) Inventors : Lei S . Qi, Palo Alto , CA (US ) ; Sheng A61K 31/ 365 ( 2013 . 01) ; A61K 31 /63 Ding , Orinda , CA ( US ) ; Chen Yu , San ( 2013 .01 ) ; A61K 31/ 513 ( 2013 . 01 ) ; A61K Francisco , CA (US ) 31/ 505 ( 2013. 01 ) ; A61K 38 /465 (2013 . 01 ) (57 ) ABSTRACT ( 21 ) Appl. No. : 15 / 649, 304 Provided herein are methods and kits for modulating (22 ) Filed : Jul. 13 , 2017 genome editing of target DNA . The invention includes using small molecules that enhance or repress homology - directed Related U . S . Application Data repair (HDR ) and / or nonhomologous end joining (NHEJ ) (63 ) Continuation of application No . PCT /US2016 / repair of double - strand breaks in a target DNA sequence .