DOCSLIB.ORG

(12) United States Patent (10) Patent No.: US 6,869,615 B2 Chen Et Al

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
(12) United States Patent (10) Patent No.: US 6,869,615 B2 Chen Et Al USOO68696.15B2 (12) United States Patent (10) Patent No.: US 6,869,615 B2 Chen et al. (45) Date of Patent: *Mar. 22, 2005 (54) PHARMACEUTICAL FORMULATIONS 3,385,886 A 5/1968 Nicholson et al. .......... 562/492 CONTAINING ANON-STEROIDAL ANTINFLAMMATORY DRUG AND A (List continued on next page.) PROTON PUMP INHIBITOR FOREIGN PATENT DOCUMENTS EP OOO5129 4/1979 ......... CO7D/403/12 (75) Inventors: Chih-Ming Chen, Davie, FL (US); EP O166287 6/1985 ......... CO7D/401/12 Unchalee Kositprapa, Davie, FL (US) EP O174726 7/1985 ......... CO7D/401/12 EP O295603 6/1988 ......... CO7D/401/12 (73) Assignee: Andrx Labs LLC, Davie, FL (US) EP OS19365 6/1992 ............ A61 K/9/20 GB 2163747 3/1986 ......... CO7D/235/28 (*) Notice: Subject to any disclaimer, the term of this WO 9427988 12/1994 ......... CO7D/401/12 patent is extended or adjusted under 35 WO 95O1977 1/1995 ......... CO7D/401/12 U.S.C. 154(b) by 0 days. WO 9725064 7/1997 .......... A61Kf45/06 This patent is Subject to a terminal dis OTHER PUBLICATIONS claimer. Hawkey, Chrisotpher J., et al., Omeprazole Compared with Misoprostol for Ulcers Associated with Nonsteriodal Anti (21) Appl. No.: 10/282,820 inflammatory Drugs, New England Journal of Medicine (Mar. 12, 1988), 338:727–734. (22) Filed: Oct. 28, 2002 Primary Examiner James M. Spear (65) Prior Publication Data (74) Attorney, Agent, or Firm-Davidson, Davidson & US 2003/0129235 A1 Jul. 10, 2003 Kappel, LLC (57) ABSTRACT Related U.S. Application Data An oral Solid dosage form includes a therapeutically effec (63) Continuation of application No. 09/659,222, filed on Sep. tive amount of an NSAID and a proton pump inhibitor in an 11, 2000, now Pat. No. 6,544,556. amount effective to inhibit or prevent gastrointestinal side (51) Int. Cl. ............................ A61K9/20: A61K 9/22; effects normally associated with the NSAID. Also disclosed A61K 9/26; A61 K9/28: A61 K9/54 is a method of treating a human patient in need of (52) U.S. Cl. ....................... 424/469; 424/451; 424/452; antiinflammatory, analgesic and/or antipyretic therapy, com 424/457; 424/458; 424/465; 424/468; 424/489; prising orally administering to the patient an oral pharma 424/470; 424/474; 424/490 ceutical dosage form which includes a therapeutically effec (58) Field of Search ................................. 424/489, 490, tive amount of an NSAID and an amount of a proton pump 424/469,451, 452, 457, 458, 464, 465, inhibitor effective to substantially inhibit gastrointestinal 470, 472, 468, 474, 484, 455, 456, 480, side effects of the NSAID. The invention is further related to 481,482, 493, 494, 495, 497, 496, 477 a method of prophylactically treating a human patient who is on a therapy known to have significant gastrointestinal (56) References Cited Side effects or is about to begin Such a therapy, via concur rent administration of an NSAID and a proton pump inhibi U.S. PATENT DOCUMENTS tor in a combination (single) oral dosage form. 3,161,654 A 12/1964 Shen .......................... 548/500 3.228,831 A 1/1966 Nicholson et al. .......... 514/568 26 Claims, 4 Drawing Sheets DECOFENAC Na ROMEPRAZOEDRABE 100 80 46OO 2O O 5 10 15 20 25 30 DISSOLUTIONTIME (min) O INITIAL O2 WEEKS US 6,869,615 B2 Page 2 U.S. PATENT DOCUMENTS 5,008,283 A 4/1991 Blackburn et al. .......... 514/.414 5,039,806 A 8/1991 Brandstram et al. ........ 546/271 g A 1/1971 A. al. ............... S. 5,045,321. A 9/1991 Makino et al. ............. 424/475 3. A s 2. R Ener s: 5,045,552. A 9/1991 Souda et al. ................ 514/338 3,766.263 A 10/1973 E. - - - - - 562.465 5,068,458. A 11/1991 Dales et al. ................ 568/634 3,843,681. A 10/1974 Demerson et al. .......... 548/432 5,204,118 A 4/1993 Goldman et al. 424/489 3.845.215 A 10/1974 Godfrey ........ ... 514/557 5,312.824. A 5/1994 Sohda et al. ................ 514/338 3904682 A 9/1975 Fried et all 562/466 5,417,980 A 5/1995 Goldman et al. ........... 424/464 4.00997 A 2/1977 Fried et al. - - - - - - - - - - - - - - - - - 560/56 5,510,382 A 4/1996 Stjernschantz et al. 514/530 2Y- - - 2 - - - - - - - - - - - - - - - - - - - - 5629,305 A 5/1997 Eek et al. ................... 514/199 4,045,563 A 8/1977 Berntsson et al. .......... 514/338 5,708.017Y/1 - 2 A 1/1998 Dave et al. ................. 514/393 4.255.431 A 3/1981 Junggren et al. ........... 514/338 2 - Y - 4,359,465. A 11/1982 Ruwart ....................... 514/314 5,798,120 A 8/1998 Tomohisa et al... 424/482 4472.409 A 9/1984 Senn-Bilfinger 514/338 5,817.338 A 10/1998 Bergstrand et al. ......... 424/468 2 - . 12 SCI . 5.877,192 A 3/1999 Lindberg et al............. 514/338 4,508.905 A 4/1985 Junggren et al. ........ 546/273.7 6,365,1842Y B1 * 4/2002 Depui et al. ... 424/469 4,628,098 A 12/1986 Nohara et al. ........... 546/273.7 2- Y-a-2 6544,556 B1 4/2003 Chen et al. ... 424/469 4,738.975 A 4/1988 Nohara et al. .... ... 514/338 6,613.354 B2 9/2003 Depui et all 424/458 4.786,505 A 11/1988 Lovgren et al. ............ 424/468 2Y------ CPUllel al. 4,853.230 A 8/1989 Lovgren et al. ............ 424/466 5,006,547 A 4/1991 Loose ........................ 514/.414 * cited by examiner U.S. Patent US 6,869,615 B2 (H)EWILNOILOTOSSIG U.S. Patent Mar. 22, 2005 Sheet 3 of 4 US 6,869,615 B2 ETTSCHWOHCETOZ\/?)dEWORJEENOWNE-HOTO|0 C od O S3 cC r N (eNOWN3O80%) OAOSSIONnOWW US 6,869,615 B2 1 2 PHARMACEUTICAL FORMULATIONS activity and inhibit hormone-induced uterine contractions CONTAINING ANON-STEROIDAL and certain types of cancer growth through inhibition of ANTINFLAMMATORY DRUG AND A prostaglandin G/HSynthase, also known as cyclooxygenase. PROTON PUMP INHIBITOR Inhibition of COX-1 causes a number of side effects includ ing inhibition of platelet aggregation associated with disor ders of coagulation, and gastrointestinal Side effects with the This application is a continuation of U.S. application Ser. possibility of ulcerations and of hemorrhage. It is believed No. 09/659,222, filed on Sep. 11, 2000 now U.S. Pat. No. that the gastrointestinal Side effects are due to a decrease in 6,544,556, the disclosure of which is hereby incorporated by the biosynthesis of prostaglandins which are cytoprotective reference in its entirety. of the gastric mucosa. FIELD OF THE INVENTION A high incidence of Side effects has historically been The present invention is related to the combination of a asSociated with chronic use of classic cyclooxygenase non-steroidal antiinflammatory drug (“NSAID") or one of inhibitors, all of which are about equipotent for COX-1 or its single enantiomers or salt of the NSAID, and a proton COX-2, or which are COX-1-selective. While renal toxicity pump inhibitor or one of its Single enantiomers, or an 15 occurs, it usually becomes evident in patients who already alkaline Salt of the proton pump inhibitor or one of its single exhibit renal insufficiency (D. Kleinknecht, Sem. Nephrol. enantiomers, in a Single oral pharmaceutical dosage form. 15: 228, 1995). By far, the most prevalent and morbid toxicity is gastrointestinal. Even with relatively nontoxic BACKGROUND drugs. Such as piroXicam, up to 4% of patients experience Although NSAIDs are often used for their gross bleeding and ulceration (M. J. S. Langman et al., antiinflammatory, analgesic, and/or antipyretic effects, it is Lancet 343: 1075, 1994). In the United States, it is estimated well known that NSAIDs have the potential to cause gas that some 2000 patients with rheumatoid arthritis and 20,000 trointestinal (GI) bleeding through a variety of mechanisms patients with Osteoarthritis die each year due to gastrointes related to their topical and systemic effects. The GI bleeding tinal side effects related to the use of COX inhibitors. In the may depend on the length of the treatment and on the 25 UK, about 30% of the annual 4000 peptic ulcer-related particular drug. This problem is important in cases where the deaths are attributable to COX inhibitors (Scrip 2162, p.17). therapy must be continued for a long period of time. For COX inhibitors cause gastrointestinal and renal toxicity due example, osteoarthritis and rheumatoid arthritis in the eld to the inhibition of Synthesis of homeostatic prostaglandins erly is often treated with long-term NSAID therapy, as responsible for epithelial mucus production and renal blood chronic treatment is needed to control pain and inflammation flow, respectively. and to improve quality of life. The Second form of cyclooxygenase, COX-2, is rapidly Additionally it is well known that because of their side and readily inducible by a number of agents including effects on the GI tract, NSAIDs are invariably administered mitogens, endotoxins, hormones, cytokines and growth fac after meals or, generally, when the Stomach is not empty. tors. It has been proposed that COX-2 is mainly responsible This pharmacological principle is confirmed by the recom 35 for the pathological effects of prostaglandins, which arise mendations found in the labeling of these medications. when rapid induction of COX-2 occurs in response to Such Patients who have an ulcer or who are susceptible to agents as inflammatory agents, hormones, growth factors, developing ulcers are commonly advised to avoid taking and cytokines. Selective inhibitors of COX-2 have anti NSAIDs for pain, inflammation, and/or fever. inflammatory, antipyretic and analgesic properties similar to Other measures which can be taken to decrease GI side 40 those of a conventional non-Steroidal anti-inflammatory affects associated with NSAID therapy is to coadminister an drug (NSAID), but COX-2 inhibitors have been touted as H2 blocker e.g.
Load more

Recommended publications
  • )&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
    [Show full text]
  • Pharmacology on Your Palms CLASSIFICATION of the DRUGS
    Pharmacology on your palms CLASSIFICATION OF THE DRUGS DRUGS FROM DRUGS AFFECTING THE ORGANS CHEMOTHERAPEUTIC DIFFERENT DRUGS AFFECTING THE NERVOUS SYSTEM AND TISSUES DRUGS PHARMACOLOGICAL GROUPS Drugs affecting peripheral Antitumor drugs Drugs affecting the cardiovascular Antimicrobial, antiviral, Drugs affecting the nervous system Antiallergic drugs system antiparasitic drugs central nervous system Drugs affecting the sensory Antidotes nerve endings Cardiac glycosides Antibiotics CNS DEPRESSANTS (AFFECTING THE Antihypertensive drugs Sulfonamides Analgesics (opioid, AFFERENT INNERVATION) Antianginal drugs Antituberculous drugs analgesics-antipyretics, Antiarrhythmic drugs Antihelminthic drugs NSAIDs) Local anaesthetics Antihyperlipidemic drugs Antifungal drugs Sedative and hypnotic Coating drugs Spasmolytics Antiviral drugs drugs Adsorbents Drugs affecting the excretory system Antimalarial drugs Tranquilizers Astringents Diuretics Antisyphilitic drugs Neuroleptics Expectorants Drugs affecting the hemopoietic system Antiseptics Anticonvulsants Irritant drugs Drugs affecting blood coagulation Disinfectants Antiparkinsonian drugs Drugs affecting peripheral Drugs affecting erythro- and leukopoiesis General anaesthetics neurotransmitter processes Drugs affecting the digestive system CNS STIMULANTS (AFFECTING THE Anorectic drugs Psychomotor stimulants EFFERENT PART OF THE Bitter stuffs. Drugs for replacement therapy Analeptics NERVOUS SYSTEM) Antiacid drugs Antidepressants Direct-acting-cholinomimetics Antiulcer drugs Nootropics (Cognitive
    [Show full text]
  • Marrakesh Agreement Establishing the World Trade Organization
    No. 31874 Multilateral Marrakesh Agreement establishing the World Trade Organ ization (with final act, annexes and protocol). Concluded at Marrakesh on 15 April 1994 Authentic texts: English, French and Spanish. Registered by the Director-General of the World Trade Organization, acting on behalf of the Parties, on 1 June 1995. Multilat ral Accord de Marrakech instituant l©Organisation mondiale du commerce (avec acte final, annexes et protocole). Conclu Marrakech le 15 avril 1994 Textes authentiques : anglais, français et espagnol. Enregistré par le Directeur général de l'Organisation mondiale du com merce, agissant au nom des Parties, le 1er juin 1995. Vol. 1867, 1-31874 4_________United Nations — Treaty Series • Nations Unies — Recueil des Traités 1995 Table of contents Table des matières Indice [Volume 1867] FINAL ACT EMBODYING THE RESULTS OF THE URUGUAY ROUND OF MULTILATERAL TRADE NEGOTIATIONS ACTE FINAL REPRENANT LES RESULTATS DES NEGOCIATIONS COMMERCIALES MULTILATERALES DU CYCLE D©URUGUAY ACTA FINAL EN QUE SE INCORPOR N LOS RESULTADOS DE LA RONDA URUGUAY DE NEGOCIACIONES COMERCIALES MULTILATERALES SIGNATURES - SIGNATURES - FIRMAS MINISTERIAL DECISIONS, DECLARATIONS AND UNDERSTANDING DECISIONS, DECLARATIONS ET MEMORANDUM D©ACCORD MINISTERIELS DECISIONES, DECLARACIONES Y ENTEND MIENTO MINISTERIALES MARRAKESH AGREEMENT ESTABLISHING THE WORLD TRADE ORGANIZATION ACCORD DE MARRAKECH INSTITUANT L©ORGANISATION MONDIALE DU COMMERCE ACUERDO DE MARRAKECH POR EL QUE SE ESTABLECE LA ORGANIZACI N MUND1AL DEL COMERCIO ANNEX 1 ANNEXE 1 ANEXO 1 ANNEX
    [Show full text]
  • (12) United States Patent (10) Patent No.: US 9,084,769 B2 Alex Et Al
    US009084769B2 (12) United States Patent (10) Patent No.: US 9,084,769 B2 Alex et al. (45) Date of Patent: Jul. 21, 2015 (54) COMPOSITIONS COMPRISING NON (2013.01); A61K31/192 (2013.01); A61 K STEROIDAL ANTI-INFLAMMLATORY DRUGS 31/415 (2013.01); A61 K3I/7016 (2013.01) AND METHODS FOR USE THEREOF (58) Field of Classification Search CPC A61K 2300/00; A61K 31/7016; A61K 33/30 (71) Applicants:Phillip Alex, Abingdon, MD (US); Ben USPC .................................. 424/641, 451, 474, 490 Johns, Scotch Plains, NJ (US) See application file for complete search history. (72) Inventors: Phillip Alex, Abingdon, MD (US); Ben (56) References Cited Johns, Scotch Plains, NJ (US) |U.S. PATENT DOCUMENTS (*) Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 2010/0150861 A1* 6/2010 Geibel et al. ................. 424/85.2 U.S.C. 154(b) by 0 days. OTHER PUBLICATIONS (21) Appl. No.: 13/705,552 Watanabe et al. Prebiotic Properties of Epilactose. Aug. 5, 2008. J. Dairy Sci. pp. 4518-4526.” (22) Filed: Dec. 5, 2012 Lanza et al. NSAID-induced gastric ulceration is dose related by weight: an endoscopic study with flurbiprofen. May 1993. Am J (65) Prior Publication Data Gastroenterol. Abstract.” |US 2013/0142869 A1 Jun. 6, 2013 * cited by examiner Primary Examiner – Frederick Krass Related U.S. Application Data Assistant Examiner – Tracy Liu (60) Provisional application No. 61/566,765, filed on Dec. (74) Attorney, Agent, or Firm – Christina Chamberlin 5, 2011. (57) ABSTRACT (51) Int. Cl. The invention provides analgesic, antipyretic and anti-in A6 IK 3.1/7016 (2006.01) flammatory compositions containing epilactose in combina A6 IK 33/30 (2006.01) tion with non-steroidal anti-inflammatory drugs and pharma A6 IK 31/167 (2006.01) ceutically acceptable zinc compounds.
    [Show full text]
  • Vr Meds Ex01 3B 0825S Coding Manual Supplement Page 1
    vr_meds_ex01_3b_0825s Coding Manual Supplement MEDNAME OTHER_CODE ATC_CODE SYSTEM THER_GP PHRM_GP CHEM_GP SODIUM FLUORIDE A12CD01 A01AA01 A A01 A01A A01AA SODIUM MONOFLUOROPHOSPHATE A12CD02 A01AA02 A A01 A01A A01AA HYDROGEN PEROXIDE D08AX01 A01AB02 A A01 A01A A01AB HYDROGEN PEROXIDE S02AA06 A01AB02 A A01 A01A A01AB CHLORHEXIDINE B05CA02 A01AB03 A A01 A01A A01AB CHLORHEXIDINE D08AC02 A01AB03 A A01 A01A A01AB CHLORHEXIDINE D09AA12 A01AB03 A A01 A01A A01AB CHLORHEXIDINE R02AA05 A01AB03 A A01 A01A A01AB CHLORHEXIDINE S01AX09 A01AB03 A A01 A01A A01AB CHLORHEXIDINE S02AA09 A01AB03 A A01 A01A A01AB CHLORHEXIDINE S03AA04 A01AB03 A A01 A01A A01AB AMPHOTERICIN B A07AA07 A01AB04 A A01 A01A A01AB AMPHOTERICIN B G01AA03 A01AB04 A A01 A01A A01AB AMPHOTERICIN B J02AA01 A01AB04 A A01 A01A A01AB POLYNOXYLIN D01AE05 A01AB05 A A01 A01A A01AB OXYQUINOLINE D08AH03 A01AB07 A A01 A01A A01AB OXYQUINOLINE G01AC30 A01AB07 A A01 A01A A01AB OXYQUINOLINE R02AA14 A01AB07 A A01 A01A A01AB NEOMYCIN A07AA01 A01AB08 A A01 A01A A01AB NEOMYCIN B05CA09 A01AB08 A A01 A01A A01AB NEOMYCIN D06AX04 A01AB08 A A01 A01A A01AB NEOMYCIN J01GB05 A01AB08 A A01 A01A A01AB NEOMYCIN R02AB01 A01AB08 A A01 A01A A01AB NEOMYCIN S01AA03 A01AB08 A A01 A01A A01AB NEOMYCIN S02AA07 A01AB08 A A01 A01A A01AB NEOMYCIN S03AA01 A01AB08 A A01 A01A A01AB MICONAZOLE A07AC01 A01AB09 A A01 A01A A01AB MICONAZOLE D01AC02 A01AB09 A A01 A01A A01AB MICONAZOLE G01AF04 A01AB09 A A01 A01A A01AB MICONAZOLE J02AB01 A01AB09 A A01 A01A A01AB MICONAZOLE S02AA13 A01AB09 A A01 A01A A01AB NATAMYCIN A07AA03 A01AB10 A A01
    [Show full text]
  • Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Notices DIX to the HTSUS—Continued
    20558 Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Notices DEPARMENT OF THE TREASURY Services, U.S. Customs Service, 1301 TABLE 1.ÐPHARMACEUTICAL APPEN- Constitution Avenue NW, Washington, DIX TO THE HTSUSÐContinued Customs Service D.C. 20229 at (202) 927±1060. CAS No. Pharmaceutical [T.D. 95±33] Dated: April 14, 1995. 52±78±8 ..................... NORETHANDROLONE. A. W. Tennant, 52±86±8 ..................... HALOPERIDOL. Pharmaceutical Tables 1 and 3 of the Director, Office of Laboratories and Scientific 52±88±0 ..................... ATROPINE METHONITRATE. HTSUS 52±90±4 ..................... CYSTEINE. Services. 53±03±2 ..................... PREDNISONE. 53±06±5 ..................... CORTISONE. AGENCY: Customs Service, Department TABLE 1.ÐPHARMACEUTICAL 53±10±1 ..................... HYDROXYDIONE SODIUM SUCCI- of the Treasury. NATE. APPENDIX TO THE HTSUS 53±16±7 ..................... ESTRONE. ACTION: Listing of the products found in 53±18±9 ..................... BIETASERPINE. Table 1 and Table 3 of the CAS No. Pharmaceutical 53±19±0 ..................... MITOTANE. 53±31±6 ..................... MEDIBAZINE. Pharmaceutical Appendix to the N/A ............................. ACTAGARDIN. 53±33±8 ..................... PARAMETHASONE. Harmonized Tariff Schedule of the N/A ............................. ARDACIN. 53±34±9 ..................... FLUPREDNISOLONE. N/A ............................. BICIROMAB. 53±39±4 ..................... OXANDROLONE. United States of America in Chemical N/A ............................. CELUCLORAL. 53±43±0
    [Show full text]
  • United States Patent (19) 11 Patent Number: 5,955,097 Tapolsky Et Al
    USOO595.5097A United States Patent (19) 11 Patent Number: 5,955,097 Tapolsky et al. (45) Date of Patent: Sep. 21, 1999 54 PHARMACEUTICAL PREPARATION 4,894,232 1/1990 Reul et al. .............................. 424/439 APPLICABLE TO MUCOSAL SURFACES 4,900,554 2/1990 Yanagibashi et al. 424/448 AND BODY TISSUES 4,906.463 3/1990 Cleary et al. ....... ... 424/78 4.915,948 4/1990 Gallopo et al. ......................... 424/435 5,059,189 10/1991 Cilento et al. .......................... 604/307 Inventors: Gilles H. Tapolsky; David W. 5,081,157 1/1992 Pomerantz ... 514/781 Osborne, both of The Woodlands, Tex. 5,081,158 1/1992 Pomerantz 514/781 5,137,729 8/1992 Kuroya et al.. Assignee: Virotex Corporation, Ft. Collins, Colo. 5,166,233 11/1992 Takamasa et al. 5,192,802 3/1993 Rencher .................................. 514/535 Appl. No.: 08/733,454 5,298.258 3/1994 Akemi et al.. 5,314.915 5/1994 Rencher .................................. 514/535 Filed: Oct. 18, 1996 5,462,749 10/1995 Rencher ... ... 424/484 Int. Cl." ............................. A61F 13/00; A61K 9/14 5,540,930 7/1996 Guy et al. ............................... 424/434 U.S. Cl. ............................................. 424/434; 424/486 FOREIGN PATENT DOCUMENTS Field of Search ...................................... 424/434, 486 56-100714 8/1981 Japan. References Cited Primary Examiner Bernard Lipman ASSistant Examiner N. Sarofim U.S. PATENT DOCUMENTS Attorney, Agent, or Firm Morrison & Foerster LLP 3.257.276 6/1966 Broh-Kahn et al.. 57 ABSTRACT 3,640,741 2/1972 Etes ......................................... 106/170 3.996,934 12/1976 Zaffaroni. The present invention relates to a non water-Soluble phar 4,226,848 10/1980 Nagai et al.
    [Show full text]
  • PHARMACEUTICAL APPENDIX to the HARMONIZED TARIFF SCHEDULE Harmonized Tariff Schedule of the United States (2008) (Rev
    Harmonized Tariff Schedule of the United States (2008) (Rev. 2) Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE Harmonized Tariff Schedule of the United States (2008) (Rev. 2) 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 ACIDUM GADOCOLETICUM 280776-87-6 ABAFUNGIN 129639-79-8 ACIDUM LIDADRONICUM 63132-38-7 ABAMECTIN 65195-55-3 ACIDUM SALCAPROZICUM 183990-46-7 ABANOQUIL 90402-40-7 ACIDUM SALCLOBUZICUM 387825-03-8 ABAPERIDONUM 183849-43-6 ACIFRAN 72420-38-3 ABARELIX 183552-38-7 ACIPIMOX 51037-30-0 ABATACEPTUM 332348-12-6 ACITAZANOLAST 114607-46-4 ABCIXIMAB 143653-53-6 ACITEMATE 101197-99-3 ABECARNIL 111841-85-1 ACITRETIN 55079-83-9 ABETIMUSUM 167362-48-3 ACIVICIN 42228-92-2 ABIRATERONE 154229-19-3 ACLANTATE 39633-62-0 ABITESARTAN 137882-98-5 ACLARUBICIN 57576-44-0 ABLUKAST 96566-25-5 ACLATONIUM NAPADISILATE 55077-30-0 ABRINEURINUM 178535-93-8 ACODAZOLE 79152-85-5 ABUNIDAZOLE 91017-58-2 ACOLBIFENUM 182167-02-8 ACADESINE 2627-69-2 ACONIAZIDE 13410-86-1 ACAMPROSATE
    [Show full text]
  • Malaysian Statistics on Medicines 2007
    MALAYSIAN STATISTICS ON MEDICINES 2007 Edited by: Faridah AMY, Sivasampu S, Lian LM, Hazimah H, Kok LC, Chinniah RJ With contributions from Lian LM, Tang RY, Hafizh AA, Hazimah H, Gan HH, Kok LC, Leow AY, Lim JY, Thoo S, Hoo LP, Faridah AMY, Lim TO, Sivasampu S, Nour Hanah O, Fatimah AR, Nadia Fareeda MG, Goh A, Rosaida MS, Menon J, Radzi H, Yung CL, Michelle Tan HP, Yip KF, Chinniah RJ, Khutrun Nada Z, Masni M, Sri Wahyu T, Jalaludin MY, Leow NCW, Norafidah I, G R Letchuman R, Fuziah MZ, Mastura I, Sukumar R, Yong SL, Lim YX, Yap PK, Lim YS, Sujatha S, Goh AS, Chang KM, Wong SP, Omar I, Alan Fong YY, David Quek KL, Feisul IM, Long MS, Christopher Ong WM, Ghazali Ahmad, Abdul Rashid Abdul Rahman, Hooi LS, Khoo EM, Sunita Bavanandan, Nur Salima Shamsudin, Puteri Juanita Zamri, Sim KH, Wan Azman WA, Abdul Kahar AG, Faridah Y, Sahimi M, Haarathi C, Nirmala J, Azura MA, Asmah J, Rohna R, Choon SE, Roshidah B, Hasnah Z, Wong CW, Noorsidah MY, Sim HY, J Ravindran, Nik Nasri, Ghazali I, Wan Abu Bakar, Tham SW, J Ravichandran, Zaridah S, W Zahanim WY, Intan SS, Tan AL, Malek R, Sothilingam S, Syarihan S, Foo LK, Low KS, Janet YH Hong, Tan ATB, Lim PC, Loh YF, Nor Azizah, Sim BLH, Mohd Daud CY, Sameerah SAR, Muhd Nazri, Cheng JT, Lai J, Rahela AK, Lim GCC, Azura D, Rosminah MD, Kamarun MK, Nor Saleha IT, Tajunisah ME, Wong HS, Rosnawati Yahya, Manjulaa DS, Norrehan Abdullah, H Hussein, H Hussain, Salbiah MS, Muhaini O, Low YL, Beh PK, Cardosa MS, Choy YC, Lim RBL, Lee AW, Choo YM, Sapiah S, Fatimah SA, Norsima NS, Jenny TCN, Hanip R, Siti Nor
    [Show full text]
  • 2 12/ 35 74Al
    (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 22 March 2012 (22.03.2012) 2 12/ 35 74 Al (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 9/16 (2006.01) A61K 9/51 (2006.01) kind of national protection available): AE, AG, AL, AM, A61K 9/14 (2006.01) 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, PCT/EP201 1/065959 HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, (22) International Filing Date: KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, 14 September 201 1 (14.09.201 1) ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PE, PG, PH, PL, PT, QA, RO, RS, RU, (25) Filing Language: English RW, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, (26) Publication Language: English TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: 61/382,653 14 September 2010 (14.09.2010) US (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (71) Applicant (for all designated States except US): GM, KE, LR, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, NANOLOGICA AB [SE/SE]; P.O Box 8182, S-104 20 ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, Stockholm (SE).
    [Show full text]
  • (12) United States Patent (10) Patent No.: US 9,452,180 B2 Tei Et Al
    USOO945218OB2 (12) United States Patent (10) Patent No.: US 9,452,180 B2 Tei et al. (45) Date of Patent: Sep. 27, 2016 (54) NSAIDS-INDUCED GASTROINTESTINAL (52) U.S. Cl. MUCOSAL DISORDERALLEVATOR AND CPC ......... A6 IK3I/7016 (2013.01); A61K 31/192 MANUFACTURING METHOD THEREOF (2013.01); A61K 31/196 (2013.01); A61 K 31/405 (2013.01); A61K 3.1/5415 (2013.01); (71) Applicant: Next21 K.K., Tokyo (JP) A6 IK3I/616 (2013.01); A61K 45/06 (2013.01); A61K 47/26 (2013.01); C07H 3/04 (72) Inventors: Yuichi Tei, Tokyo (JP); Nobuo Sasaki, (2013.01) Tokyo (JP); Shigeki Suzuki, Tokyo (JP) (58) Field of Classification Search None (73) Assignee: Next21 K.K., Bunkyo-Ku, Tokyo (JP) See application file for complete search history. (*) Notice: Subject to any disclaimer, the term of this (56) References Cited patent is extended or adjusted under 35 U.S.C. 154(b) by 77 days. U.S. PATENT DOCUMENTS (21) Appl. No.: 14/295,154 2005/0003000 A1*ck 1/2005 Einig ..................... A612.3 (22) Filed: Jun. 3, 2014 OTHER PUBLICATIONS O O Zhang et al., The effects of cryoprotectants on the freeze-drying of (65) Prior Publication Data ibuprofen-loaded solid lipid microparticles (SLM) European Jour US 2014/0323429 A1 Oct. 30, 2014 nal of Pharmaceutics and Biopharmaceutics (2008) vol. 69 pp. 750-759.* Related U.S. Application Data * cited by examiner (62) Division of application No. 13/132,613, filed as application No. PCT/JP2009/006603 on Dec. 3, 2009, Primary Examiner — Eric Olson now abandoned. (74) Attorney, Agent, or Firm — Osha Liang LLP (30) Foreign Application Priority Data (57) ABSTRACT A method of manufacturing a medical drug of alleviating Dec.
    [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]