WO2012032414A3 - Compositions comprising a fatty acid oil mixture, a surfactant, and a statin - Google Patents

Compositions comprising a fatty acid oil mixture, a surfactant, and a statin Download PDF

Info

Publication number
WO2012032414A3
WO2012032414A3 PCT/IB2011/002727 IB2011002727W WO2012032414A3 WO 2012032414 A3 WO2012032414 A3 WO 2012032414A3 IB 2011002727 W IB2011002727 W IB 2011002727W WO 2012032414 A3 WO2012032414 A3 WO 2012032414A3
Authority
WO
WIPO (PCT)
Prior art keywords
statin
surfactant
fatty acid
oil mixture
acid oil
Prior art date
Application number
PCT/IB2011/002727
Other languages
French (fr)
Other versions
WO2012032414A2 (en
Inventor
Svein Olaf Hustvedt
Preben Houlberg Olesen
Gunnar Berge
Jo Erik Johnsrud Klaveness
Original Assignee
Pronova Biopharma Norge As
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 Pronova Biopharma Norge As filed Critical Pronova Biopharma Norge As
Publication of WO2012032414A2 publication Critical patent/WO2012032414A2/en
Publication of WO2012032414A3 publication Critical patent/WO2012032414A3/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
    • A61K31/202—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having three or more double bonds, e.g. linolenic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Diabetes (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Cardiology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Dispersion Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

Preconcentrates comprising a fatty acid oil mixture, at least one surfactant, and at least one statin or pharmaceutically acceptable salt, hydrate, solvate, or complex thereof, and uses thereof are disclosed. The preconcentrates may be capable of forming a self-nanoemulsifying drug delivery system (SNEDDS), a self- microemulsifying drug delivery system (SMEDDS), or self-emulsifying drug delivery systems (SEDDS) in an aqueous solution.
PCT/IB2011/002727 2010-09-08 2011-09-08 Compositions comprising a fatty acid oil mixture, a surfactant, and a statin WO2012032414A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US38107010P 2010-09-08 2010-09-08
US61/381,070 2010-09-08

Publications (2)

Publication Number Publication Date
WO2012032414A2 WO2012032414A2 (en) 2012-03-15
WO2012032414A3 true WO2012032414A3 (en) 2012-05-03

Family

ID=45811014

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2011/002727 WO2012032414A2 (en) 2010-09-08 2011-09-08 Compositions comprising a fatty acid oil mixture, a surfactant, and a statin

Country Status (2)

Country Link
AR (1) AR082930A1 (en)
WO (1) WO2012032414A2 (en)

Families Citing this family (33)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2424356B1 (en) 2009-04-29 2017-08-23 Amarin Pharmaceuticals Ireland Limited Stable pharmaceutical composition and methods of using same
RU2624506C2 (en) 2009-04-29 2017-07-04 АМАРИН КОРПОРЕЙШН ПиЭлСи Pharmaceutical compositions containing epa and cardiovascular agents and their application methods
EP3698781A1 (en) 2009-06-15 2020-08-26 Amarin Pharmaceuticals Ireland Limited Compositions comprising eicosapentaenoic acid for treating myocardial infarction in a subject on concomitant statin therapy
RU2012116079A (en) 2009-09-23 2013-10-27 АМАРИН КОРПОРЕЙШН ПиЭлСи PHARMACEUTICAL COMPOSITION, INCLUDING OMEGA-3 FATTY ACID AND HYDROXY DERIVATED STATIN AND WAYS OF ITS APPLICATION
NZ744990A (en) 2010-11-29 2019-10-25 Amarin Pharmaceuticals Ie Ltd Low eructation composition and methods for treating and/or preventing cardiovascular disease in a subject with fish allergy/hypersensitivity
US11712429B2 (en) 2010-11-29 2023-08-01 Amarin Pharmaceuticals Ireland Limited Low eructation composition and methods for treating and/or preventing cardiovascular disease in a subject with fish allergy/hypersensitivity
US11291643B2 (en) 2011-11-07 2022-04-05 Amarin Pharmaceuticals Ireland Limited Methods of treating hypertriglyceridemia
JP6307442B2 (en) 2012-01-06 2018-04-04 アマリン ファーマシューティカルス アイルランド リミテッド Compositions and methods for reducing the level of high sensitivity (HS-CRP) in a subject
EP3072510B1 (en) 2012-03-30 2019-05-08 Micelle BioPharma, Inc. Omega-3 fatty acid ester compositions
US10898458B2 (en) 2012-03-30 2021-01-26 Micelle Biopharma, Inc. Self-micellizing fatty acids and fatty acid ester compositions and their use in the treatment of disease states
US9480651B2 (en) 2012-03-30 2016-11-01 Sancilio & Company, Inc. Omega-3 fatty acid ester compositions unitary pharmaceutical dosage forms
US20160228397A1 (en) 2012-03-30 2016-08-11 Sancilio & Company, Inc. Omega-3 fatty acid ester compositions
PT3363433T (en) 2012-06-29 2021-02-15 Amarin Pharmaceuticals Ie Ltd Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
WO2014074552A2 (en) 2012-11-06 2014-05-15 Amarin Pharmaceuticals Ireland Limited Compositions and methods for lowering triglycerides without raising ldl-c levels in a subject on concomitant statin therapy
US20140187633A1 (en) 2012-12-31 2014-07-03 Amarin Pharmaceuticals Ireland Limited Methods of treating or preventing nonalcoholic steatohepatitis and/or primary biliary cirrhosis
US9452151B2 (en) 2013-02-06 2016-09-27 Amarin Pharmaceuticals Ireland Limited Methods of reducing apolipoprotein C-III
US9624492B2 (en) 2013-02-13 2017-04-18 Amarin Pharmaceuticals Ireland Limited Compositions comprising eicosapentaenoic acid and mipomersen and methods of use thereof
US20140271841A1 (en) 2013-03-15 2014-09-18 Amarin Pharmaceuticals Ireland Limited Pharmaceutical composition comprising eicosapentaenoic acid and derivatives thereof and a statin
US10966968B2 (en) 2013-06-06 2021-04-06 Amarin Pharmaceuticals Ireland Limited Co-administration of rosiglitazone and eicosapentaenoic acid or a derivative thereof
US20150065572A1 (en) 2013-09-04 2015-03-05 Amarin Pharmaceuticals Ireland Limited Methods of treating or preventing prostate cancer
US9585859B2 (en) 2013-10-10 2017-03-07 Amarin Pharmaceuticals Ireland Limited Compositions and methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy
MX2016004487A (en) 2013-10-30 2016-11-10 Banner Life Sciences Llc Enteric soft capsules comprising polyunsaturated fatty acids.
TR201403323A2 (en) 2014-03-21 2015-10-21 Ege Ueniversitesi Bilim Teknoloji Uygulama Ve Arastirma Merkezi Ebiltem Self-micro/nanoemulsifying drug carrying system for oral use of rosuvastatin
WO2015185240A1 (en) * 2014-06-04 2015-12-10 Sigma-Tau Industrire Farmaceutiche Riunite S.P.A. Compositions containing simvastatin in omega-3 polyunsaturated fatty acids
US10561631B2 (en) 2014-06-11 2020-02-18 Amarin Pharmaceuticals Ireland Limited Methods of reducing RLP-C
WO2015195662A1 (en) 2014-06-16 2015-12-23 Amarin Pharmaceuticals Ireland Limited Methods of reducing or preventing oxidation of small dense ldl or membrane polyunsaturated fatty acids
US9895333B2 (en) 2014-06-26 2018-02-20 Patheon Softgels Inc. Enhanced bioavailability of polyunsaturated fatty acids
MA40846A (en) * 2014-10-10 2017-09-05 Sancilio & Company Inc COMPOSITIONS OF FATTY ACIDS AND SELF-MICELLIZING FATTY ACID ESTERS, AS WELL AS THEIR USE IN THE TREATMENT OF DISEASE CONDITIONS
EP3248599B1 (en) * 2015-01-21 2022-07-06 Mochida Pharmaceutical Co., Ltd. Omega-3 fatty acid self-emulsifying composition
AU2016402338A1 (en) * 2016-04-14 2018-11-08 Michael LUCEY Combinational compositions and methods of use thereof
WO2018213663A1 (en) 2017-05-19 2018-11-22 Amarin Pharmaceuticals Ireland Limited Compositions and methods for lowering triglycerides in a subject having reduced kidney function
US11058661B2 (en) 2018-03-02 2021-07-13 Amarin Pharmaceuticals Ireland Limited Compositions and methods for lowering triglycerides in a subject on concomitant statin therapy and having hsCRP levels of at least about 2 mg/L
SG11202102872QA (en) 2018-09-24 2021-04-29 Amarin Pharmaceuticals Ie Ltd Methods of reducing the risk of cardiovascular events in a subject

Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5502077A (en) * 1988-08-11 1996-03-26 Norsk Hydro A.S. Fatty acid composition
WO1999029316A1 (en) * 1997-12-10 1999-06-17 Severson, Mary, L. Pharmaceutical compositions containing an omega-3 fatty acid oil
WO1999056727A2 (en) * 1998-05-07 1999-11-11 Elan Corporation, Plc Solvent/cosolvent free microemulsion and emulsion preconcentrate drug delivery systems
EP1157692A1 (en) * 2000-05-22 2001-11-28 Quatex N.V. Composition of fatty acids containing at least 80% by weight of EPA and DHA or their derivatives and its pharmaceutical use
US20060034815A1 (en) * 2004-08-06 2006-02-16 Hector Guzman Novel statin pharmaceutical compositions and related methods of treatment
WO2006085144A2 (en) * 2004-10-15 2006-08-17 Photonz Corporation Limited Compositions containing high omega-3 and low saturated fatty acid levels
US20060211763A1 (en) * 2005-03-08 2006-09-21 Abdel Fawzy Treatment with Statin and Omega-3 Fatty Acids and a Combination Product Thereof
US20070141138A1 (en) * 2005-12-20 2007-06-21 Cenestra Llc Omega 3 fatty acid formulations
US20080085911A1 (en) * 2006-10-10 2008-04-10 Reliant Pharmaceuticals, Inc. Statin and omega-3 fatty acids for reduction of apo-b levels
WO2010103404A1 (en) * 2009-03-09 2010-09-16 Pronova Biopharma Norge As Compositions comprising a fatty acid oil mixture and a surfactant, and methods and uses thereof
WO2011048493A1 (en) * 2009-10-23 2011-04-28 Pronova Biopharma Norge As Coated capsules and tablets of a fatty acid oil mixture

Patent Citations (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5502077A (en) * 1988-08-11 1996-03-26 Norsk Hydro A.S. Fatty acid composition
WO1999029316A1 (en) * 1997-12-10 1999-06-17 Severson, Mary, L. Pharmaceutical compositions containing an omega-3 fatty acid oil
WO1999056727A2 (en) * 1998-05-07 1999-11-11 Elan Corporation, Plc Solvent/cosolvent free microemulsion and emulsion preconcentrate drug delivery systems
EP1157692A1 (en) * 2000-05-22 2001-11-28 Quatex N.V. Composition of fatty acids containing at least 80% by weight of EPA and DHA or their derivatives and its pharmaceutical use
US20060034815A1 (en) * 2004-08-06 2006-02-16 Hector Guzman Novel statin pharmaceutical compositions and related methods of treatment
WO2006085144A2 (en) * 2004-10-15 2006-08-17 Photonz Corporation Limited Compositions containing high omega-3 and low saturated fatty acid levels
US20060211763A1 (en) * 2005-03-08 2006-09-21 Abdel Fawzy Treatment with Statin and Omega-3 Fatty Acids and a Combination Product Thereof
US20070141138A1 (en) * 2005-12-20 2007-06-21 Cenestra Llc Omega 3 fatty acid formulations
US20080085911A1 (en) * 2006-10-10 2008-04-10 Reliant Pharmaceuticals, Inc. Statin and omega-3 fatty acids for reduction of apo-b levels
WO2010103404A1 (en) * 2009-03-09 2010-09-16 Pronova Biopharma Norge As Compositions comprising a fatty acid oil mixture and a surfactant, and methods and uses thereof
WO2010103402A1 (en) * 2009-03-09 2010-09-16 Pronova Biopharma Norge As Compositions comprising a fatty acid oil mixture comprising epa and dha in free acid form and a surfactant, and methods and uses thereof
WO2010119319A1 (en) * 2009-03-09 2010-10-21 Pronova Biopharma Norge As Compositions comprising a fatty acid oil mixture and a free fatty acid, and methods and uses thereof
WO2011048493A1 (en) * 2009-10-23 2011-04-28 Pronova Biopharma Norge As Coated capsules and tablets of a fatty acid oil mixture

Also Published As

Publication number Publication date
WO2012032414A2 (en) 2012-03-15
AR082930A1 (en) 2013-01-16

Similar Documents

Publication Publication Date Title
WO2012032414A3 (en) Compositions comprising a fatty acid oil mixture, a surfactant, and a statin
WO2012032415A3 (en) Compositions comprising a fatty acid oil mixture comprising epa and dha in free acid form, a surfactant, and a statin
WO2012032417A3 (en) Compositions comprising a fatty acid oil mixture, a free fatty acid, and a statin
IL180597A0 (en) Pharmaceutical multilayer tablet for controlled release of active ingredients with highly ph-dependent solubility
WO2012021715A3 (en) Stable formulations of linaclotide
PH12019500030A1 (en) Compositions comprising a fatty acid oil mixture and a surfactant, and methods and uses thereof
IN2014MN02213A (en)
DE602007013611D1 (en)
TW200744665A (en) Vitamin E succinate stabilized pharmaceutical compositions, methods for the preparation and the use thereof
WO2011012816A3 (en) Pharmaceutical formulation
WO2011041729A3 (en) Compounds as lysophosphatidic acid receptor antagonists
WO2011017350A3 (en) Compounds as lysophosphatidic acid receptor antagonists
WO2011080148A3 (en) An aqueous intravenous nanosuspension with reduced adverse effects
NZ631345A (en) Pharmaceutical compositions having improved storage stability
WO2011149854A3 (en) Stable formulations of fatty acids
WO2009081174A3 (en) Anti - retroviral combination
WO2010070449A3 (en) Highly pure laquinimod or a pharmaceutically acceptable salt thereof
AU2012280198A8 (en) Darunavir combination formulations
WO2011019326A3 (en) Solubility and stability enchancing pharmaceutical formulation
WO2009060952A1 (en) Novel preparation
WO2008001201A3 (en) Pharmaceutical compositions of clopidogrel
MX2012001691A (en) Orally disintegrating compositions of linaclotide.
JO3587B1 (en) Oral dosage forms of bendamustine
WO2010148314A3 (en) Preparation of esomeprazole and its pharmaceutically acceptable salts
WO2012054093A3 (en) Acyl piperidine inhibitors of soluble epoxide hydrolase

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 11823129

Country of ref document: EP

Kind code of ref document: A2

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 11823129

Country of ref document: EP

Kind code of ref document: A2