DK2750667T3 - Depotlipidprækoncentrat af farmakologisk aktivt stof og farmaceutisk sammensætning, der omfatter dette - Google Patents

Depotlipidprækoncentrat af farmakologisk aktivt stof og farmaceutisk sammensætning, der omfatter dette Download PDF

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DK2750667T3
DK2750667T3 DK12826818.2T DK12826818T DK2750667T3 DK 2750667 T3 DK2750667 T3 DK 2750667T3 DK 12826818 T DK12826818 T DK 12826818T DK 2750667 T3 DK2750667 T3 DK 2750667T3
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sorbitan
group
liquid crystal
fatty acid
pharmaceutical composition
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DK12826818.2T
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Jin Young Ko
Ji Yeon Kim
So Hyun Park
Sung Won An
Min Hyo Ki
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Chong Kun Dang Pharmaceutical Corp
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/18—Sulfonamides
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
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    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • 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
    • A61K47/26—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
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • 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
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
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    • A61K48/00—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
    • A61K48/0008—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy characterised by an aspect of the 'non-active' part of the composition delivered, e.g. wherein such 'non-active' part is not delivered simultaneously with the 'active' part of the composition
    • A61K48/0016—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy characterised by an aspect of the 'non-active' part of the composition delivered, e.g. wherein such 'non-active' part is not delivered simultaneously with the 'active' part of the composition wherein the nucleic acid is delivered as a 'naked' nucleic acid, i.e. not combined with an entity such as a cationic lipid

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  • Dermatology (AREA)
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  • Gastroenterology & Hepatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (14)

1. Depotlipidprækoncentrat, der omfatter: a) en sorbitan-umættet fedtsyreester med mindst to eller flere -OH (hydroxyl)-grupper på et polært hoved; b) et phospholipid; og c) et væskeformigt krystalhærdemiddel, der er fri for en ioniserbar gruppe, som har en hydrofob del på 15 til 40 carbonatomer med en triacylgruppe eller en carbonringstruktur, hvor lipidprækoncentratet er i en væskeformig tilstand i fravær af en vandig fluid og transformerer fra den væskeformige tilstand til en gellignende flydende krystal i nærvær af en vandig fluid.
2. Depotlipidprækoncentrat ifølge krav 1, hvor forbindelsen sorbitan-umættet fedtsyreester har strukturen med formel 1: hvor: R1 er OH; R2 er OH eller en alkylester på 4 til 30 carbonatomer med en eller flere umættede bindinger; og R3 er en alkylester på 4 til 30 carbonatomer med en eller flere umættede bindinger.
3. Depotlipidprækoncentrat ifølge krav 1, hvor forbindelsen sorbitan-umættet fedtsyreester er valgt fra gruppen, der består af sorbitanmonooleat, sorbitanmonolinoleat, sorbitanmonopalmitoleat, sorbitanmonomyristoleat, sorbitansesquioleat, sorbitansesquilinoleat, sorbitansesquipalmitoleat, sorbitansesquimyristoleat, sorbitandioleat, sorbitandilinoleat, sorbitandipalmitoleat, sorbitandimyristoleat og en blanding deraf.
4. Depotlipidprækoncentrat ifølge krav 1, hvor forbindelsen sorbitan-umættet fedtsyreester er valgt fra gruppen, der består af sorbitanmonooleat, sorbitanmonolinoleat, sorbitanmonopalmitoleat, sorbitanmonomyristoleat og en blanding deraf.
5. Depotlipidprækoncentrat ifølge krav 1, hvor phospholipidet indeholder en mættet eller umættet alkylestergruppe på 4 til 30 carbonatomer og er valgt fra gruppen, der består af phosphatidylcholin, phosphatidylethanolamin, phosphatidyIserin, phosphatidylglycerin, phosphatidylinositol, phosphatidsyre, sphingomyelin og en blanding deraf.
6. Depotlipidprækoncentrat ifølge krav 1, hvor det væskeformige krystalhærdemiddel er valgt fra gruppen, der består af triglycerid, retinylpalmitat, tocopherylacetat, cholesterol, benzylbenzoat og en blanding deraf.
7. Depotlipidprækoncentrat ifølge krav 1, hvor det væskeformige krystalhærdemiddel er valgt fra gruppen, der består af triglycerid, retinylpalmitat, tocopherylacetat, cholesterol og en blanding deraf.
8. Depotlipidprækoncentrat ifølge krav 1, hvor det væskeformige krystalhærdemiddel er tocopherylacetat.
9. Depotlipidprækoncentrat ifølge et hvilket som helst af kravene 1 til 8, hvor vægtforholdet mellem bestanddel a) og bestanddel b) er 10:1 til 1:10.
10. Depotlipidprækoncentrat ifølge et hvilket som helst af kravene 1 til 8, hvor vægtforholdet mellem summen af bestanddelene a) og b) og bestanddel c) er 100:1 til 1:1.
11. Farmaceutisk sammensætning, der omfatter d) en farmakologisk aktiv bestanddel valgt fra gruppen, der består af et protein, et peptid, en vaccine, et gen, et ikke-peptid- hormon, et syntetisk kemisk lægemiddel og en kombination deraf plus depotlipidprækoncentratet ifølge et hvilket som helst af kravene 1 til 8.
12. Farmaceutisk sammensætning ifølge krav 11, hvor vægtforholdet mellem bestanddel a) og bestanddel b) er 10:1 til 1:10.
13. Farmaceutisk sammensætning ifølge krav 11, hvor vægtforholdet mellem summen af bestanddelene a) og b) og bestanddel c) er 100:1 til 1:1.
14. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 8 og krav 11, som er i en formulering, hvilken formulering er valgt fra gruppen, der består af en injektion, en salve, en gel, en lotion, en kapsel, en tablet, en væske, en suspension, en spray, en inhalator, øjendråber, et klæbemiddel og et plaster.
DK12826818.2T 2011-08-30 2012-08-28 Depotlipidprækoncentrat af farmakologisk aktivt stof og farmaceutisk sammensætning, der omfatter dette DK2750667T3 (da)

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KR20110087160 2011-08-30
PCT/KR2012/006855 WO2013032207A1 (en) 2011-08-30 2012-08-28 Sustained-release lipid pre-concentrate of pharmacologically active substance and pharmaceutical composition comprising the same

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US (1) US9526787B2 (da)
EP (1) EP2750667B1 (da)
JP (1) JP5981997B2 (da)
KR (1) KR101494594B1 (da)
CN (1) CN103764127B (da)
AU (1) AU2012302422B2 (da)
BR (1) BR112014004967B1 (da)
CA (1) CA2845784C (da)
DK (1) DK2750667T3 (da)
ES (1) ES2661487T3 (da)
HU (1) HUE036150T2 (da)
LT (1) LT2750667T (da)
MX (1) MX351430B (da)
NO (1) NO2750667T3 (da)
PL (1) PL2750667T3 (da)
PT (1) PT2750667T (da)
RU (1) RU2632433C2 (da)
SI (1) SI2750667T1 (da)
TR (1) TR201802984T4 (da)
WO (1) WO2013032207A1 (da)

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US20140206616A1 (en) 2014-07-24
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US9526787B2 (en) 2016-12-27
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