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NZ789295B2 - Pharmaceutical compositions comprising epa and a cardiovascular agent and methods of using the same - Google Patents
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NZ789295B2 - Pharmaceutical compositions comprising epa and a cardiovascular agent and methods of using the same - Google Patents

Pharmaceutical compositions comprising epa and a cardiovascular agent and methods of using the same Download PDF

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Publication number
NZ789295B2
NZ789295B2 NZ789295A NZ78929510A NZ789295B2 NZ 789295 B2 NZ789295 B2 NZ 789295B2 NZ 789295 A NZ789295 A NZ 789295A NZ 78929510 A NZ78929510 A NZ 78929510A NZ 789295 B2 NZ789295 B2 NZ 789295B2
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NZ
New Zealand
Prior art keywords
pharmaceutical composition
epa
ethyl
dha
weight
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Application number
NZ789295A
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NZ789295A (en
Inventor
Mehar Manku
Jonathan Rowe
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Declare The First & True Inventor S Of The Invention Disclosed In The Complete Specification Filed With The Present Application Are As Listed If You Do Not Make This Declaration You Will Have To Submit A Declaration Of Inventorship In The Future Before Your Application Can Be Accepted We
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Amarin Pharmaceuticals Ireland Limited
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Publication date
Application filed by Amarin Pharmaceuticals Ireland Limited filed Critical Amarin Pharmaceuticals Ireland Limited
Priority to NZ807894A priority Critical patent/NZ807894B2/en
Priority claimed from NZ771180A external-priority patent/NZ771180A/en
Publication of NZ789295A publication Critical patent/NZ789295A/en
Publication of NZ789295B2 publication Critical patent/NZ789295B2/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • 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
    • A61K31/13—Amines
    • A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/222—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin with compounds having aromatic groups, e.g. dipivefrine, ibopamine
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/23—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin of acids having a carboxyl group bound to a chain of seven or more carbon atoms
    • A61K31/232—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin of acids having a carboxyl group bound to a chain of seven or more carbon atoms having three or more double bonds, e.g. etretinate
    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
    • A—HUMAN NECESSITIES
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    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/366—Lactones having six-membered rings, e.g. delta-lactones
    • A—HUMAN NECESSITIES
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    • 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
    • A61K31/397—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having four-membered rings, e.g. azetidine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
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    • 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
    • A61K31/403—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 condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/405—Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
    • 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
    • A61K31/435—Heterocyclic 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
    • A61K31/47—Quinolines; Isoquinolines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • 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
    • A61K31/74—Synthetic polymeric materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
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    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/10—Dispersions; Emulsions
    • A61K9/127—Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant
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    • A—HUMAN NECESSITIES
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    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A—HUMAN NECESSITIES
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    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
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    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs 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
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    • A61P9/12—Antihypertensives

Abstract

Disclosed is a pharmaceutical composition comprising EPA and a cardiovascular agent, wherein the composition contains not more than 10% DHA by weight, if any, and methods using the composition.

Claims (14)

WE CLAIM:
1. A pharmaceutical composition comprising eicosapentaenoic acid (EPA) or ethyl-EPA, docosahexaenoic acid (DHA) or ethyl-DHA, and one or more surfactants, wherein the one or more surfactants comprises Polysorbate 80 and a poloxamer.
2. The pharmaceutical composition of claim 1, further comprising one or more additional fatty acids selected from the group consisting of linolenic acid (LA), arachidonic acid (AA), alpha-linolenic acid (ALA), stearadonic acid (STA), eicosatrienoic acid (ETA), docosapentaenoic acid (DPA), or combinations thereof.
3. The pharmaceutical composition of claim 1 or claim 2, comprising a mixture of EPA or ethyl-EPA and DHA or ethyl-DHA, in a ratio of EPA or ethyl-EPA to DHA or ethyl-DHA from greater than about 2:1 to about 19:1, wherein the ethyl-EPA and DHA or ethyl-DHA in combination comprise more than about 50% by weight of total fatty acids present in the pharmaceutical composition.
4. The pharmaceutical composition of any one of claims 1 to 3, comprising a mixture of EPA or ethyl-EPA and DHA or ethyl-DHA, wherein EPA or ethyl-EPA comprises about 50% by weight of total fatty acids present in the pharmaceutical composition and the DHA or ethyl-DHA comprises about 20% by weight of total fatty acids present in the pharmaceutical composition.
5. The pharmaceutical composition of any one of claims 1 to 4, wherein the one or more surfactants further comprises a polypropylene glycol or a hypromellose.
6. The pharmaceutical composition of any one of claims 1 to 5, wherein the Polysorbate 80 is present in an amount from about 0.25% to about 15% by weight of the pharmaceutical composition.
7. The pharmaceutical composition of any one of claims 1 to 6, further comprising one or more antioxidants.
8. The pharmaceutical composition of claim 7, wherein the one or more antioxidants is a tocopherol.
9. The pharmaceutical composition of claim 8, wherein the tocopherol comprises from about 0.0001% to about 5% of the total weight of the pharmaceutical composition.
10. A pharmaceutical composition comprising (a) a mixture of ethyl-EPA and ethyl- DHA in a ratio of about 2:1 to about 3.5:1, (b) Polysorbate 80 in an amount from about 0.25% to about 15% by weight of the pharmaceutical composition, (c) polyoxypropylene block copolymer in an amount from about 0.25% to about 15% by weight of the pharmaceutical composition, and (d) one or more antioxidants.
11. The pharmaceutical composition of claim 10, wherein the one or more antioxidant is a tocopherol.
12. The pharmaceutical composition of claim 11, wherein the tocopherol comprises from about 0.0001% to about 5% of the total weight of the pharmaceutical composition.
13. The pharmaceutical composition of any one of claims 1 to 12, wherein the composition is present in a capsule.
14. A pharmaceutical composition as claimed in any one of claims 1 to 13, substantially as herein described with reference to any example thereof. 'g -i Ki I! vc Lipid Hydroperoxides (pM) Lipid Hydroperoxides {\M) ut it -tx CO K3 O) a o a o a o X X X X a |i' o i o ^ o o x x X J J?ii, =•> o y!, ! •n •n era qa XI *! " ft- X »•* pisiil V ^ ' ' u, n 6 i KJ > - I | l« Hi VC •r. H S Lipid Hydroperoxides (pM) vC Lipid Hydroperoxides (pM) IV* PJ 00 K1 Ol o o o o o o 4- o o o o o o o B O § ai S i i i o o o o | i if B. n A' '' •n •ti '% K> oc" aa 1 S! § m ! !*< •U i I Cft Q> JU rt + 0; > 2 c n o m o £. + 0) nn cu §5.^1
NZ789295A 2010-04-29 Pharmaceutical compositions comprising epa and a cardiovascular agent and methods of using the same NZ789295B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
NZ807894A NZ807894B2 (en) 2010-04-29 Pharmaceutical compositions comprising epa and a cardiovascular agent and methods of using the same

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US17375909P 2009-04-29 2009-04-29
NZ771180A NZ771180A (en) 2009-04-29 2010-04-29 Pharmaceutical compositions comprising epa and a cardiovascular agent and methods of using the same

Publications (2)

Publication Number Publication Date
NZ789295A NZ789295A (en) 2024-02-23
NZ789295B2 true NZ789295B2 (en) 2024-05-24

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