HRP20210963T1 - Sustained-release formulations of colchicine and methods of using same - Google Patents

Sustained-release formulations of colchicine and methods of using same Download PDF

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Publication number
HRP20210963T1
HRP20210963T1 HRP20210963TT HRP20210963T HRP20210963T1 HR P20210963 T1 HRP20210963 T1 HR P20210963T1 HR P20210963T T HRP20210963T T HR P20210963TT HR P20210963 T HRP20210963 T HR P20210963T HR P20210963 T1 HRP20210963 T1 HR P20210963T1
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colchicine
formula
weight
optionally
group
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HRP20210963TT
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Croatian (hr)
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Susanne RIEL
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Murray & Poole Enterprises, Ltd.
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Priority claimed from EP14755124.6A external-priority patent/EP2986280B1/en
Application filed by Murray & Poole Enterprises, Ltd. filed Critical Murray & Poole Enterprises, Ltd.
Publication of HRP20210963T1 publication Critical patent/HRP20210963T1/en

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    • 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
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/06—Antigout agents, e.g. antihyperuricemic or uricosuric agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • 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
    • 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
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
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  • Urology & Nephrology (AREA)
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  • Hospice & Palliative Care (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Biochemistry (AREA)
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  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
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  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (9)

1. Formula za kontinuirano otpuštanje kolhicina kao aktivnog sastojka, gdje se formula sastoji od: (a) granula koje sadrže od 0.1 do 0.6 mg kolhicina ili njegove farmaceutski prihvatljive soli; (b) vezivnog sredstva, gdje je vezivno sredstvo hidroksipropil metilceluloza (HPMC) 6 mPa•s u količini od 1% do 30% (na težinu) formule; (c) usporavajući agens u količini od 5% do 40% (na težinu) formule, gdje je sredstvo za usporavanje raspršivač u kompleksnom spoju jednakih dijelova po težini HPMC-a sa stupnjem viskoznosti od 4000 mPa•s i monohidrata laktoze (Retalac®); te (d) najmanje jedna farmaceutski prihvatljiva pomoćna tvar izmiješana s granulama, dok je formula za kontinuirano otpuštanje u tableti.1. Formula for continuous release of colchicine as an active ingredient, where the formula consists of: (a) granules containing from 0.1 to 0.6 mg of colchicine or its pharmaceutically acceptable salt; (b) a binder, wherein the binder is hydroxypropyl methylcellulose (HPMC) 6 mPa·s in an amount of 1% to 30% (by weight) of the formula; (c) a retarding agent in an amount of 5% to 40% (by weight) of the formula, where the retarding agent is a dispersant in a complex combination of equal parts by weight of HPMC with a degree of viscosity of 4000 mPa•s and lactose monohydrate (Retalac®); you (d) at least one pharmaceutically acceptable excipient mixed with the granules, while the sustained release formula is in a tablet. 2. Formula iz patentnog zahtjeva 1, gdje je: farmaceutski prihvatljiva pomoćna tvar odabrana iz skupine koja se sastoji od punila, sredstva za klizanje i za podmazivanje, ili njihove kombinacije; gdje se punilo bira iz skupine koja se sastoji od saharoze, laktoze, m-čestičnog monohidrata laktoze, trehaloze, maltoze, manitola i sorbitola, natrijeve kroskarmeloze, krospovidona, alginske kiseline, natrij alginata, metakrilične kiseline divinil benzena (DVB), unakrsno vezanog polivinil pirolidona (PVP), mikrokristalne celuloze, kalijevog polakrilina, natrijevog škrobnog glikolata, škroba, pregelatiniziranog škroba i njihovih kombinacija, te gdje ukupna količina punila u formuli iznosi između otprilike 5.0 težine % i 90.0 težine % formule; gdje se sredstvo za klizanje bira iz skupine koja se sastoji od koloidnog silikon dioksida, magnezijevog trisilikata, celuloze u prahu, talka i trobaznog kalcijevog fosfata, opcionalno gdje ukupna količina sredstva za rastvaranje u tekućinu iznosi između otprilike0.5 % težine do otprilike 5 % težine formule; te gdje se sredstvo za podmazivanje bira iz skupine koja se sastoji od gliceril behanata, stearinske kiseline, hidrogeniziranih biljnih ulja, stearinskog alkohola, leucina, polietilen glikola, magnezijevog stearata, gliceril monostearata, polietilen glikola, polimera etilen oksida, natrijevog lauril sulfata, magnezijevog lauril sulfata, natrijevog oleata, natrijevog stearil fumarata, DL-leucina i koloidnog silikata, opcionalno gdje se sredstvo za podmazivanje uključuje u količini između otprilike0.5 težine% do otprilike5 % težine formule.2. Formula from patent claim 1, where: a pharmaceutically acceptable excipient selected from the group consisting of fillers, glidants and lubricants, or combinations thereof; where the filler is selected from the group consisting of sucrose, lactose, m-particle lactose monohydrate, trehalose, maltose, mannitol and sorbitol, croscarmellose sodium, crospovidone, alginic acid, sodium alginate, divinyl benzene methacrylic acid (DVB), cross-linked polyvinyl pyrrolidone (PVP), microcrystalline cellulose, potassium polyacrylic acid, sodium starch glycolate, starch, pregelatinized starch, and combinations thereof, and wherein the total amount of fillers in the formula is between about 5.0 wt% and 90.0 wt% of the formula; wherein the glidant is selected from the group consisting of colloidal silicon dioxide, magnesium trisilicate, powdered cellulose, talc, and tribasic calcium phosphate, optionally wherein the total amount of the liquid solubilizing agent is between about 0.5% by weight to about 5% by weight formulas; you wherein the lubricant is selected from the group consisting of glyceryl behanate, stearic acid, hydrogenated vegetable oils, stearic alcohol, leucine, polyethylene glycol, magnesium stearate, glyceryl monostearate, polyethylene glycol, ethylene oxide polymer, sodium lauryl sulfate, magnesium lauryl sulfate , sodium oleate, sodium stearyl fumarate, DL-leucine and colloidal silicate, optionally wherein the lubricant is included in an amount between about 0.5% by weight to about 5% by weight of the formula. 3. Formula tvrdnje 1 ili tvrdnje 2, gdje je kompresijska jačina tablete između otprilike 30N i otprilike 130N.3. The formula of claim 1 or claim 2, wherein the compressive strength of the tablet is between about 30N and about 130N. 4. Formula prema bilo kojem od zahtjeva 1-3, za uporabu u prevenciji i/ili liječenju kardiovaskularnih bolesti, opcionalno gdje se kardiovaskularna bolest bira iz skupine koja se sastoji od akutne perikardije, ponavljajuće perikardije, post-perikardijskog sindroma (PPS) i kardiovaskularnih događaja kod pacijenata sa stabilnom koronarnom bolešću.4. A formulation according to any one of claims 1-3, for use in the prevention and/or treatment of cardiovascular disease, optionally wherein the cardiovascular disease is selected from the group consisting of acute pericardia, recurrent pericardia, post-pericardial syndrome (PPS) and cardiovascular events in patients with stable coronary disease. 5. Formula za uporabu sukladno zahtjevu 4, gdje je formula za uporabu u kombinaciji s konvencionalnom terapijom za dugoročnu prevenciju akutnog kardiovaskularnog događaja kod pacijenata s ustanovljenom stabilnom koronarnom bolešću, opcionalno gdje je rečeni akutni kardiovaskularni događaj akutni koronarni sindrom, od bolničkog zastoja srca ili nekardioembolijskog ishemijskog udara, te opcionalno gdje konvencionalna terapija uključuje primjenu statina spojivog s kolhicinom, gdje se statin spojiv s kolhicinom primjenuje u fiksnoj ili nefiksnoj kombinaciji s kolhicinom, opcionalno gdje se statin spojiv s kolhicinom bira iz skupine koja se sastoji od atorvastatina, rosuvastatina, simvastatina i pravastatina, derivata njegovih soli.5. Formula for use according to claim 4, where the formula for use in combination with conventional therapy for the long-term prevention of an acute cardiovascular event in patients with established stable coronary disease, optionally where said acute cardiovascular event is acute coronary syndrome, from hospital cardiac arrest or non-cardioembolic ischemic stroke, and optionally where the conventional therapy includes the administration of a statin compatible with colchicine, where the statin compatible with colchicine is used in a fixed or non-fixed combination with colchicine, optionally where the statin compatible with colchicine is selected from the group consisting of atorvastatin, rosuvastatin, simvastatin and pravastatin, derivatives thereof salts. 6. Formula prema bilo kojem od zahtjeva 1-3, za uporabu kod prevencije i/ili liječenja upalne bolesti, opcionalno gdje se upalna bolest bira iz skupine koja se sastoji od gihta, porodične mediteranske groznice, Behčetove bolesti, starosno vezane degeneracije makule i Alzheimerove bolesti.6. A formulation according to any one of claims 1-3, for use in the prevention and/or treatment of an inflammatory disease, optionally wherein the inflammatory disease is selected from the group consisting of gout, familial Mediterranean fever, Behçet's disease, age-related macular degeneration and Alzheimer's diseases. 7. Formula za uporabu sukladno zahtjevu 6, gdje ukupna dnevna doza kolhicina koja se primjenjuje na subjekta ne iznosi više od otprilike 0,75 mg.7. The formulation for use according to claim 6, wherein the total daily dose of colchicine administered to the subject is no more than about 0.75 mg. 8. Proces priprave tablete s kontinuiranim otpuštanjem kolhicina koji se sastoji od: (A) formiranja otopine rastapanjem kolhicina u vodi, gdje se kolhicin daje u količini tako da se rezultantna tableta sastoji od 0,25 do 0,75 % (na težinu) kolhicina; (B) dodavanje vezivnog sredstva i punila u otopinu Koraka A, te formiranje vlažnog granulata, gdje je vezivno sredstvo hidroksipropil metilceluloza (HPMC) 6 mPa•s i dodaje se u količini tako da se rezultantna tableta sastoji od 1% do 30% (na težinu) vezivnog sredstva; (C) sušenje vezivnog sredstva iz Koraka B; (D) miješanje sušenog granulata iz Koraka C sa sredstvom za usporavanje, punilom, sredstvom za klizanje i za podmazivanje, gdje je sredstvo za usporavanje raspršivač u kompleksnom spoju jednakih dijelova po težini HPMC- sa stupnjem viskoznosti od 4000 mPa•s i monohidrata laktoze (Retalac®) i dodaje se u količini tako da se rezultantna tableta sastoji od 5 do 40 % (na težinu) sredstva za usporavanje; te (E) komprimiranje završnog granulata iz Koraka D u tabletu.8. The process of preparing a tablet with continuous release of colchicine, which consists of: (A) forming a solution by dissolving colchicine in water, wherein the colchicine is provided in an amount such that the resultant tablet comprises 0.25 to 0.75% (by weight) of colchicine; (B) adding a binder and filler to the solution of Step A, and forming a wet granulate, where the binder is hydroxypropyl methylcellulose (HPMC) 6 mPa•s and is added in an amount such that the resulting tablet consists of 1% to 30% (by weight ) binding agent; (C) drying the binder from Step B; (D) mixing the dried granulate from Step C with a retarding agent, filler, sliding and lubricating agent, where the retarding agent is a dispersant in a complex combination of equal parts by weight of HPMC- with a viscosity grade of 4000 mPa•s and lactose monohydrate (Retalac ®) and added in an amount such that the resulting tablet consists of 5 to 40% (by weight) retarder; you (E) compressing the final granulate from Step D into a tablet. 9. Proces iz zahtjeva 8, gdje: je u Koraku B punilo koje se rabi monohidrat laktoze i pregelatinizirani škrob; a u Koraku D punilo koje se rabi je monohidrat laktoze, sredstvo za klizanje je talk, a sredstvo za podmazivanje je stearinska kiselina; i/ili posebni sastojci i količine koji se rabe su: [image] 9. The process of claim 8, where: in Step B, the filler used is lactose monohydrate and pregelatinized starch; and in Step D, the filler used is lactose monohydrate, the gliding agent is talc, and the lubricating agent is stearic acid; and/or special ingredients and quantities used are: [image]
HRP20210963TT 2013-04-16 2021-06-16 Sustained-release formulations of colchicine and methods of using same HRP20210963T1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201361812514P 2013-04-16 2013-04-16
EP13194505 2013-11-26
EP14755124.6A EP2986280B1 (en) 2013-04-16 2014-04-16 Sustained-release formulations of colchicine and methods of using same
PCT/IB2014/001201 WO2014170755A2 (en) 2013-04-16 2014-04-16 Sustained-release formulations of colchicine and methods of using same

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HRP20210963T1 true HRP20210963T1 (en) 2021-09-17

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JP (2) JP6697539B2 (en)
DK (1) DK2986280T3 (en)
ES (1) ES2870718T3 (en)
HR (1) HRP20210963T1 (en)
HU (1) HUE054663T2 (en)
IL (1) IL242001B (en)
LT (1) LT2986280T (en)

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ES2870718T3 (en) 2021-10-27
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JP2019065032A (en) 2019-04-25
NZ751885A (en) 2021-01-29
JP6887043B2 (en) 2021-06-16
DK2986280T3 (en) 2021-06-14
LT2986280T (en) 2021-06-25
IL242001B (en) 2021-07-29
NZ713151A (en) 2021-01-29

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