SG11201407688QA - Laquinimod formulations without alkalizing agent - Google Patents

Laquinimod formulations without alkalizing agent

Info

Publication number
SG11201407688QA
SG11201407688QA SG11201407688QA SG11201407688QA SG11201407688QA SG 11201407688Q A SG11201407688Q A SG 11201407688QA SG 11201407688Q A SG11201407688Q A SG 11201407688QA SG 11201407688Q A SG11201407688Q A SG 11201407688QA SG 11201407688Q A SG11201407688Q A SG 11201407688QA
Authority
SG
Singapore
Prior art keywords
international
pharmaceutical composition
subject
stable pharmaceutical
subject invention
Prior art date
Application number
SG11201407688QA
Inventor
Gadi Sarfati
Ioana Lovinger
Danit Licht
Muhammad Safadi
Original Assignee
Teva Pharma
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Teva Pharma filed Critical Teva Pharma
Publication of SG11201407688QA publication Critical patent/SG11201407688QA/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/47042-Quinolinones, e.g. carbostyril
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Neurosurgery (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Hospice & Palliative Care (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Psychiatry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 16 January 2014 (16.01.2014) WIPOIPCT (10) International Publication Number WO 2014/011750 A1 (51) International Patent Classification: A61K 31/47 ( 2006.01) (21) International Application Number: (22) International Filing Date: (25) Filing Language: (26) Publication Language: PCT/US2013/049894 10 July 2013 (10.07.2013) English English (30) Priority Data: 61/670,268 11 July 2012 (11.07.2012) (71) Applicant (for BB only): TEVA PHARMACEUTICAL INDUSTRIES LTD. [LL/IL]; 5 Basel Street, P.O. Box 3190, 49131 Petach Tikva (IL). (71) Applicant (for all designated States except BB, US): TEVA PHARMACEUTICALS USA, INC. [US/US]; 1090 Horsham Road, North Wales, PA 19454 (US). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. Ug (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). (72) Inventors; and (71) Applicants (for US only): SARFATII, Gadi [IL/IL] ; Kib­ butz Beit Guvrin (IL). LOVINGER, Ioana [IL/IL]; Rh. Tel Hai 98/3, 44245 Kfar Saba (IL). LICHT, Danit [IL/IL]; Rh. Keren Haysod 1, Givat Shmuel (IL). SAFADI, Muhammad [IL/IL]; c/o P.O. Box 50670, St. 5007 Apt. 5A, 16164 Nazareth (IL). (74) Agent: WHITE, John, P.; Cooper & Dunham LLP, 30 Rockefeller Plaza, New York, NY 10112 (US). Published: — with international search report (Art. 21(3)) — before the expiration of the time limit for amending the claims and to be republished in the event of receipt of amendments (Rule 48.2(h)) © i> © T? i-H o CJ o & (54) Title: LAQUINIMOD FORMULATIONS WITHOUT ALKALIZING AGENT (57) Abstract: The subject invention provides stable a pharmaceutical composition comprising therapeutically effective a amount of laquinimod, an amount of a filler, and an amount of a lubricant, wherein the stable pharmaceutical composition free of is an alkaliz - ing agent or an oxidation reducing agent. The subject invention also provides processes for making the stable pharmaceutical com - position and sealed packages comprising the stable pharmaceutical composition. The subject invention additionally provides method for treating a subject afflicted with form of multiple a sclerosis or for alleviating a symptom of multiple sclerosis in subject a afflic­ ted with a form of multiple sclerosis comprising administering to the subject a stable pharmaceutical composition as described herein. The subject invention further provides for use of a stable pharmaceutical composition as described herein for treating a sub - ject afflicted with form of multiple a sclerosis or for alleviating symptom a of multiple sclerosis in subject afflicted with form of a a multiple sclerosis.
SG11201407688QA 2012-07-11 2013-07-10 Laquinimod formulations without alkalizing agent SG11201407688QA (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201261670268P 2012-07-11 2012-07-11
PCT/US2013/049894 WO2014011750A1 (en) 2012-07-11 2013-07-10 Laquinimod formulations without alkalizing agent

Publications (1)

Publication Number Publication Date
SG11201407688QA true SG11201407688QA (en) 2014-12-30

Family

ID=49914501

Family Applications (2)

Application Number Title Priority Date Filing Date
SG11201407688QA SG11201407688QA (en) 2012-07-11 2013-07-10 Laquinimod formulations without alkalizing agent
SG10201700198VA SG10201700198VA (en) 2012-07-11 2013-07-10 Laquinimod formulations without alkalizing agent

Family Applications After (1)

Application Number Title Priority Date Filing Date
SG10201700198VA SG10201700198VA (en) 2012-07-11 2013-07-10 Laquinimod formulations without alkalizing agent

Country Status (19)

Country Link
US (1) US20140018386A1 (en)
EP (1) EP2872141A4 (en)
JP (1) JP2015527321A (en)
KR (1) KR20150036553A (en)
CN (1) CN104470519A (en)
AR (1) AR091706A1 (en)
AU (1) AU2013290274A1 (en)
BR (1) BR112015000321A2 (en)
CA (1) CA2873230A1 (en)
EA (1) EA201590193A1 (en)
HK (1) HK1209054A1 (en)
IL (1) IL236229A0 (en)
MX (1) MX2015000398A (en)
NZ (1) NZ630241A (en)
SG (2) SG11201407688QA (en)
TW (1) TW201408299A (en)
UA (1) UA115555C2 (en)
WO (1) WO2014011750A1 (en)
ZA (1) ZA201500287B (en)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL2234485T3 (en) 2007-12-20 2014-06-30 Teva Pharma Stable laquinimod preparations
AU2013214909A1 (en) 2012-02-03 2014-09-18 Teva Pharmaceutical Industries Ltd. Use of laquinimod for treating Crohn's disease patients who failed first-line anti-TNFa therapy
TW201400117A (en) 2012-06-05 2014-01-01 Teva Pharma Treatment of ocular inflammatory disease using laquinimod
TW201410244A (en) 2012-08-13 2014-03-16 Teva Pharma Laquinimod for treatment of GABA mediated disorders
JP2015535287A (en) 2012-11-07 2015-12-10 テバ ファーマシューティカル インダストリーズ リミティド Laquinimod amine salt
WO2014153145A2 (en) 2013-03-14 2014-09-25 Teva Pharmaceutical Industries Ltd. Crystals of laquinimod sodium and improved process for the manufacture thereof
JP2017514824A (en) 2014-04-29 2017-06-08 テバ ファーマシューティカル インダストリーズ リミティド Laquinimod for the treatment of relapsing-remitting multiple sclerosis (RRMS) patients with high disability
CN107823150A (en) * 2017-10-25 2018-03-23 北京素维生物科技有限公司 It is a kind of can rapid dispersion tablet and preparation method thereof
CN107823168A (en) * 2017-10-25 2018-03-23 北京素维生物科技有限公司 A kind of rapidly-soluble tablet and preparation method thereof

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0001621D0 (en) * 2000-01-26 2000-03-15 Astrazeneca Ab Pharmaceutical compositions
SE0400235D0 (en) * 2004-02-06 2004-02-06 Active Biotech Ab New composition containing quinoline compounds
CN101291911B (en) * 2005-10-19 2014-08-13 泰华制药工业有限公司 Crystals of laquinimod sodium, and process for the manufacture thereof
WO2007146248A2 (en) * 2006-06-12 2007-12-21 Teva Pharmaceutical Industries, Ltd. Stable laquinimod preparations
PL2234485T3 (en) * 2007-12-20 2014-06-30 Teva Pharma Stable laquinimod preparations
EP2376456A2 (en) * 2008-12-17 2011-10-19 Actavis Group Ptc Ehf Highly pure laquinimod or a pharmaceutically acceptable salt thereof
CA2843432A1 (en) * 2011-07-28 2013-01-31 Teva Pharmaceutical Industries Ltd. Treatment of multiple sclerosis with combination of laquinimod and interferon-beta

Also Published As

Publication number Publication date
IL236229A0 (en) 2015-01-29
SG10201700198VA (en) 2017-02-27
US20140018386A1 (en) 2014-01-16
TW201408299A (en) 2014-03-01
EP2872141A4 (en) 2016-01-13
KR20150036553A (en) 2015-04-07
BR112015000321A2 (en) 2017-06-27
UA115555C2 (en) 2017-11-27
ZA201500287B (en) 2016-10-26
AR091706A1 (en) 2015-02-25
CN104470519A (en) 2015-03-25
MX2015000398A (en) 2015-04-10
HK1209054A1 (en) 2016-03-24
JP2015527321A (en) 2015-09-17
WO2014011750A8 (en) 2014-12-04
WO2014011750A1 (en) 2014-01-16
CA2873230A1 (en) 2014-01-16
EA201590193A1 (en) 2015-04-30
EP2872141A1 (en) 2015-05-20
NZ630241A (en) 2017-09-29
AU2013290274A1 (en) 2014-11-27

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