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US 20140094438A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2014/0094438 A1 Mitchell (43) Pub. Date: Apr. 3, 2014 (54) COMPOSITIONS AND METHODS FOR THE A63/37 (2006.01) TREATMENT OF PAN A63L/25 (2006.01) A613 L/4402 (2006.01) (71) Applicant: GM Pharmaceuticals, Inc., Arlington, A613 L/495 (2006.01) TX (US) A63L/09 (2006.01) A63L/045 (2006.01) (72) Inventor: Odes W. Mitchell, Arlington, TX (US) A613 L/60 (2006.01) A 6LX3 L/505 (2006.01) (73) Assignee: GM Pharmaceuticals, Inc., Arlington, TX (US (52) U.S. Cl. (US) CPC ............... A61 K3I/616 (2013.01); A61K3I/60 (2013.01); A61 K3I/522 (2013.01); A61 K (21) Appl. No.: 14/043,722 31/194 (2013.01); A61K 31/137 (2013.01); 1-1. A6 IK3I/505 (2013.01); A61 K3I/4402 (22)22) FileFiled: Oct.Cl. 1, 2013 (2013.01); A61 K3I/495 (2013.01);s A61 K Related U.S. Application Data 3 1/09 (2013.01); A61K3I/045 (2013.01); A6 IK31/125 (2013.01) (60) Provisional application No. 61/708,533, filed on Oct. USPC ....... 514/161; 562/471; 560/193: 514/263.31 1, 2012. (57) ABSTRACT Publication Classification The claimed invention relates to compositions that may be in (51) Int. Cl. a form of a liquid, Solid, gel, cream or gel capsule comprising A6 IK3I/66 (2006.01) an analgesic, and methods for administering these composi A6 IK3I/522 (2006.01) tions for treatment of patients suffering from various forms of A6 IK3I/94 (2006.01) pain. US 2014/0094438 A1 Apr. 3, 2014 COMPOSITIONS AND METHODS FOR THE 0009. In another embodiment of the present invention, the TREATMENT OF PAIN compositions may comprise an analgesic/antipyretic from one or more of the group consisting of acetaminophen, CROSS-REFERENCES TO RELATED buprenorphine, butorphanol, codeine, dextropropoxyphene. APPLICATIONS dihydrocodeine, fentanyl, diamorphine (Heroin), hydroc odone, hydromorphone, ketobemidone, morphine, nalbu 0001. This Application claims the benefit under 35 U.S.C. phine, oxycodone, oxymorphone, pentazocine, pethidine, S119(e) of U.S. Provisional Patent Application No. 61/708, tramadol, diflunisal, ethenzamide, aminophenaZone, 533 filed Oct. 1, 2012, which is incorporated herein by refer metamizole, phenazone, phenacetin, Ziconotide, tetrahydro ence in its entirety as if fully set forth herein. cannabinol, acetylsalicylic acid, choline salicylate, magne sium salicylate, sodium salicylate, ibuprofen, naproxen and FIELD OF THE INVENTION ketoprofen. 0002 The present invention relates to compositions com 0010. In another embodiment of the present invention, the prising an analgesic that may be in the form of a liquid, gel. compositions may comprise an analgesic adjunct from one or cream, tablet or gel capsules, and methods for administering more of the group consisting of S (+)-ketamine, metoclopra these compositions for treatment of patients suffering from mide, ciramadol, sulfentanil, caffeine and remifentanil. various forms of pain. (0011. The compositions of the present invention may be administered to the patient for oral use and may be in the form BACKGROUND OF THE INVENTION of an elixir, syrup and/or suspension according to an indi 0003 Pain is an unpleasant sensation with a wide range in vidual patient's preferences. In another embodiment of the severity that can be localized or prevalent throughout the present invention, the compositions may further comprise a body. Pain is affected by nerve stimulation that carries flavorant. impulses to the brain and is a symptom of an underlying 0012. In certain embodiments of the invention, the com disease, disorder, or physical injury. positions of the claimed invention may be administered to the 0004. It is estimated that 100 million Americans currently patient as a tablet, gel, cream or gel capsules. suffer with pain. Clinical complaints due to pain come in 0013. In another embodiment of the present invention, the many varieties. Such complaints may be due to such ailments compositions may be substantially free of other added active as arthritis, back pain, neuropathy, or a headache. ingredients. The other added active ingredient may comprise 0005. A headache, also known as cephalalgia, ranks an antihistamine, such as one or more of the group consisting amongst the most common clinical pain complaints and can of diphenhydramine, cyproheptadine hydrochloride, bro be caused from a wide variety of physiological effects. Such mpheneramine, hydroxyzine, chloropheniramine, pyril causes range from hormonal changes, muscle tension in the amine maleate, pyrilamine tannate, acepromazine, back of the neck, or from dehydration. Because headaches aceprometazine, alimemazine, alimemazine tartrate, amoxy come in many forms, they may be treated or prevented by dramine camsilate, antazoline chlorhydrate, antazoline mesi various methods. These methods may include maintaining a late, antazoline phosphate, astemizole, azatadine dimaleate, healthy lifestyle, reducing stress or making use of various azelastine hydrochloride, bamipine hydrochloride, benac medications. Such medications can be antianxiety drugs, tyzine hydrochloride, bretylium tosilate, bromazine hydro antidepressants or nonsteroidal anti-inflammatories chloride, brompheniramine maleate, buclizine dihydrochlo (NSAIDs). However, when these drugs are ineffective or not ride, bufexamac, carbinoxamine maleate acid, cetiedil citrate, possible to use due to allergic reactions, other drug combina cetirizine dihydrochloride, chlorcyclizine hydrochloride, tions may be prescribed. chlorphenamine maleate, chlorphenoxamine hydrochloride, chlorprothixene hydrochloride, cinnarizine, clemastine SUMMARY OF THE INVENTION fumarate, clemizole hexachlorophenate, clemizole penicil line, clemizole undecylenate, clocinizine dihydrochloride. 0006 An embodiment of the invention is directed to a clofedanol, clofenetamine hydrochloride, cyclizine hydro composition comprising an analgesic/antipyretic compound. chloride, dexchlorpheniramine maleate, di (acefylline) In certain embodiments of the invention, the composition diphenhydramine, difencloxazine, dimelazine hydrochlo further comprises an analgesic adjunct or an antihistamine. ride, dimenhydrinate, dimethoxanate hydrochloride, cimeto Embodiments of the invention provide for the composition as tiazine mesilate, diphenhydramine hydrochloride, diphenhy a liquid, solid, gel/cream, tablet or gel capsule. dramine mesilate, diphenylpyraline hydrochloride, diprocqualone camsilate, dixyrazine, doxylamine succinate, DETAILED DESCRIPTION OF EXEMPLARY eprozinol dihydrochloride, etodroxizine dimaleate, etyben EMBODIMENTS Zatropine bromhydrate, etybenzatropine hydrochloride, 0007. The present invention provides compositions and etymemazine hydrochloride, fenethazine hydrochloride, methods of using the compositions for the therapeutic treat fenoxazoline hydrochloride, fenpentadiol, flunarizine hydro ment of pain. Specifically, the present invention comprises a chloride, flupentixol decanoate, flupentixol dihydrochloride, composition of an analgesic/antipyretic either with or without histapyrrodine hydrochloride, hydroxyzine dihydrochloride, an analgesic adjunct and either with or without an antihista hydroxyzine embonate, indoramine hydrochloride, mine, where said composition is in the form of a liquid, Solid isothipendyl hydrochloride, ketotifene fumarate, levocabas or gel/cream. tine hydrochloride, levomepromazine, levomepromazine 0008. As used herein, the term “analgesic/antipyretic' hydrochloride, levomepromazine embonate, levomepro refers to a compound or compounds that are effective in mazine maleate, loratadine, maprotiline hydrochloride, treating pain (analgesic) and are also effective at reducing maprotiline mesilate, maprotiline resinate, meclozine hydro fever (antipyretic). chloride, mecysteine hydrochloride, medifoxamine fuma US 2014/0094438 A1 Apr. 3, 2014 rate, mefenidramium metilsulfate, mepyramine maleate, those skilled in the art from this detailed description. The meduitazine, methaqualone, methdilazine hydrochloride, invention will be further illustrated by the following non metixene hydrochloride, mizolastine, moxisylyte hydrochlo limiting examples. ride, niaprazine, orphenadrine hydrochloride, oxaflumazine disuccinate, oxatomide, oxolamine benzilate, oxolamine cit WORKING EXAMPLES rate, oXomemazine, oXomemazine hydrochloride, parathiaz ine teoclate, perimetazine, pheniramine maleate, phenoxy 0022. The products listed below exemplify certain of the benzamine hydrochloride, phenyltoloxamine, products in accordance with the claimed invention. In the phenyltoloxamine citrate, pimethixene, pipotiazine, piprete products listed below, only the primary active ingredients, col dihydrochloride, pizotifene malate, prednazoline, profe i.e., analgesic/antipyretic, analgesic adjunct or antihistamine namine hydrochloride, promethazine, promethazine hydro is listed. It would be apparent to one of ordinary skill in the art chloride, promethazine embonate, promethazine that the listed product formulations could contain inertingre polyvinylbenzene-metacrylate, propiomazine, terfenadine, dients such as buffers, fillers and other inactive ingredients. thenalidine tartrate, thenyldiamine hydrochloride, thiazina mium metilsulfate, thonzylamine hydrochloride, tripelen Product 1 namine hydrochloride, triprolidine hydrochloride, and tyma (0023 Choline Salicylate 870 mg Zoline hydrochloride, and combinations thereof. (0024 Caffeine 65 mg 0014. In another embodiment, the compositions of the present invention may comprise one or more of about 1 mg to Product 2 1500 mg of an analgesic/antipyretic, 1 mg
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    2-Bromopyridine Safety Data Sheet According to the federal final rule of hazard communication revised on 2012 (HazCom 2012) Date of Compilation : July 03 ’ 2019 Date of Revision : February 09 ’ 2021 Revision due date : January 2024 Revision Number : 01 Version Name : 0034Gj Ghs01 Div.3 sds 2-Bromopyridine Supersedes date : July 03 ’ 2019 Supersedes version : 0034Gj Ghs00 Div.3 sds 2-Bromopyridine Jubilant Ingrevia Limited Page 1 of 9 2-Bromopyridine Safety Data Sheet According to the federal final rule of hazard communication revised on 2012 (HazCom 2012) SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING 1.1. Product identifier PRODUCT NAME : 2-Bromopyridine CAS RN : 109-04-6 EC# : 203-641-6 SYNONYMS : 2-Pyridyl bromide, Pyridine, 2-bromo-, beta-Bromopyridine, o-Bromopyridine SYSTEMATIC NAME : 2-Bromopyridine, -Pyridine, 2-bromo- MOLECULAR FORMULA : C5H4BrN STRUCTURAL FORMULA N Br 1.2. Relevant identified uses of the substance or mixture and uses advised against 1.2.1. Relevant identified uses 2-Bromopyridine is used as an intermediate in the pharmaceutical industry for the manufacture of Atazanavir (an antiretroviral drug), Carbinoxamine, Chloropyramine, triprolidine (antihistamine drugs), Disopyramide Phosphate (an antiarrythmic drug), Mefloquine (antimalarial drug), Pipradrol (mild CNS stimulant) etc. Uses advised against: None 1.3. Details of the supplier of the safety data sheet Jubilant Ingrevia Limited REGISTERED & FACTORY OFFICE: Jubilant Ingrevia Limited Bhartiagram, Gajraula , District: Amroha, Uttar Pradesh-244223, India PHONE NO: +91-5924-252353 to 252360 Contact Department-Safety: Ext. 7424 , FAX NO : +91-5924-252352 HEAD OFFICE: Jubilant Ingrevia Limited, Plot 1-A, Sector 16-A,Institutional Area, Noida, Uttar Pradesh, 201301 - India T +91-120-4361000 - F +91-120-4234881 / 84 / 85 / 87 / 95 / 96 [email protected] -www.jubilantingrevia.com 1.4.
  • )&F1y3x PHARMACEUTICAL APPENDIX to THE

    )&F1y3x PHARMACEUTICAL APPENDIX to THE

    )&f1y3X PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE )&f1y3X PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 3 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. Product CAS No. Product CAS No. ABAMECTIN 65195-55-3 ACTODIGIN 36983-69-4 ABANOQUIL 90402-40-7 ADAFENOXATE 82168-26-1 ABCIXIMAB 143653-53-6 ADAMEXINE 54785-02-3 ABECARNIL 111841-85-1 ADAPALENE 106685-40-9 ABITESARTAN 137882-98-5 ADAPROLOL 101479-70-3 ABLUKAST 96566-25-5 ADATANSERIN 127266-56-2 ABUNIDAZOLE 91017-58-2 ADEFOVIR 106941-25-7 ACADESINE 2627-69-2 ADELMIDROL 1675-66-7 ACAMPROSATE 77337-76-9 ADEMETIONINE 17176-17-9 ACAPRAZINE 55485-20-6 ADENOSINE PHOSPHATE 61-19-8 ACARBOSE 56180-94-0 ADIBENDAN 100510-33-6 ACEBROCHOL 514-50-1 ADICILLIN 525-94-0 ACEBURIC ACID 26976-72-7 ADIMOLOL 78459-19-5 ACEBUTOLOL 37517-30-9 ADINAZOLAM 37115-32-5 ACECAINIDE 32795-44-1 ADIPHENINE 64-95-9 ACECARBROMAL 77-66-7 ADIPIODONE 606-17-7 ACECLIDINE 827-61-2 ADITEREN 56066-19-4 ACECLOFENAC 89796-99-6 ADITOPRIM 56066-63-8 ACEDAPSONE 77-46-3 ADOSOPINE 88124-26-9 ACEDIASULFONE SODIUM 127-60-6 ADOZELESIN 110314-48-2 ACEDOBEN 556-08-1 ADRAFINIL 63547-13-7 ACEFLURANOL 80595-73-9 ADRENALONE