NZ713151A - 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
NZ713151A
NZ713151A NZ713151A NZ71315114A NZ713151A NZ 713151 A NZ713151 A NZ 713151A NZ 713151 A NZ713151 A NZ 713151A NZ 71315114 A NZ71315114 A NZ 71315114A NZ 713151 A NZ713151 A NZ 713151A
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New Zealand
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formulation
colchicine
hpmc
pharmaceutically acceptable
amount
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NZ713151A
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NZ713151B2 (en
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Susanne Riel
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Murray And Poole Enterprises Ltd
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Priority to NZ751885A priority Critical patent/NZ751885B2/en
Priority claimed from PCT/IB2014/001201 external-priority patent/WO2014170755A2/en
Publication of NZ713151A publication Critical patent/NZ713151A/en
Publication of NZ713151B2 publication Critical patent/NZ713151B2/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)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Pain & Pain Management (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biophysics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Rheumatology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Ophthalmology & Optometry (AREA)
  • Urology & Nephrology (AREA)
  • Biochemistry (AREA)
  • Hospice & Palliative Care (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Psychiatry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Pharmaceutical compositions of colchicine for once-a-day oral administration are provided. The formulations comprise a sustained-release component and an optional immediate- release component, the compositions of which can be selectively adjusted, respectively, to release the active ingredient along a pre-determined or desired release profile. The formulation comprises a release-retarding agent comprising HMPC and lactose monohydrate. Methods of treating or preventing cardiovascular disease and/or inflammatory disease in mammalian subjects comprising the administration of the novel formulations disclosed herein is also provided.

Description

(93%) and statins (95%) were randomly assigned colchicine 0.5 mg/day or no colchicine and followed for a median of 3 years (Nidorf et al., JACC, 2013, 61 (4), 404-410). This study showed that colchicine 0.5 mg/day administered in addition to statins and other standard secondary prevention therapies appeared effective for the prevention of cardiovascular events in patients with stable coronary disease.
For the treatment of gout, the recommended dose of colchcine (COLCRYS®) is 1.8 mg/day in one or multiple doses in one hour For adults with gout, treatment is initiated with a dose of 1.2 mg at the first sign of symptoms followed by 0.6 mg one hour later. (Physician's Desk Reference, 68th ed., (2014)).
COLCRYS® is an immediate release formulation. Adverse effects associated with the administration of COLCRYS® include, but are not limited to, nausea, vomiting, abdominal pain, diarrhea, hair loss, weakness, nerve irritation, severe anemia, low white blood counts, and low platelets (Physician's Desk Reference, 68th ed., (2014)).
The instant invention addresses these and other needs by providing a modified formulation of colchicine characterized by a sustained release of an active ingredient. This invention additionally provides an effective, once-daily dosage form of colchicine or salts thereof, which may improve patient compliance and also may reduce some of the side effects of colchicine compared to the current or higher daily doses of immediate release colchicine formulations.
BRIEF SUMARY OF THE INVENTION [0013a] In a first aspect there is provided a sustained release formulation of colchicine, comprising: (a) granules comprising 0.5 mg of colchicine or a pharmaceutically acceptable salt thereof, and a first hydroxypropyl methylcellulose (HPMC) in an amount of 0.5% to 1.5% (w/w) of the formulation; (b) a release retarding agent admixed with the colchicine granules in an amount of 10% to 30% w/w of the formulation, wherein the release retarding agent is equal parts (w/w) of a second HPMC and lactose monohydrate; and (c) at least one pharmaceutically acceptable excipient admixed with the granules; wherein the viscosity of the second HPMC is higher than the viscosity of the first HPMC, AH26(25575208_1):RTK wherein the formulation is in a form of a pill, a capsule, a caplet, a suppository, sublingual formulation, a pouch, a dermal patch, sprinkles, or in fixed combination with a surgically insertable medical device. [0013b] In a second aspect there is provided use of a sustained release formulation of colchicine according to the first aspect, for the manufacture of a medicament for preventing and/or treating a cardiovascular disease in a subject in need thereof. [0013c] In a third aspect there is provided use of a sustained release formulation of colchicine according to the first aspect, for the manufacture of a medicament for preventing and/or treating an inflammatory disease in a subject in need thereof. [0013d] In a fourth aspect there is provided a process of preparing a colchicine-sustained release formulation comprising: (A) forming a granulate by dissolving 0.5 mg of colchicine or a pharmaceutically acceptable salt thereof in an acceptable solvent; (B) adding a first hydroxypropyl methylcellulose (HPMC) of 6 mPa •s in an amount of 0.5% to 1.5% (w/w) of the formulation, a filling agent comprising lactose monohydrate in an amount of 10% to 80% (w/w) of the formulation, and pregelatinized starch to Step A, and forming a wet granulate; (C) drying the wet granulate of Step B; (D) blending the dried granulate from Step C with a retarding agent, wherein the release retarding agent is in an amount of 10% to 30% (w/w) of the formulation, and wherein the release retarding agent is equal parts of a second HPMC of 4000 mPa •s, and lactose monohydrate; and (E) compressing the final granulation from step D.
According to aspects of the invention illustrated herein, there is provided a sustained release formulation of colchicine as an active ingredient, the formulation comprising colchicine or a pharmaceutically acceptable salt thereof; a retarding agent; and at least one pharmaceutically acceptable excipient.
According to aspects of the invention illustrated herein, there is provided a method for treating and/or preventing a cardiovascular disease in a subject, comprising administering to the subject a therapeutically effective amount of a sustained release formulation of colchicine.
According to aspects of the invention illustrated herein, there is provided a method for treating and/or preventing an inflammatory disease in a subject, comprising administering AH26(25575208_1):RTK WE

Claims (30)

CLAIM :
1. A sustained release formulation of colchicine, comprising: (a) granules comprising 0.5 mg of colchicine or a pharmaceutically acceptable salt thereof, and a first hydroxypropyl methylcellulose (HPMC) in an amount of 0.5% to 1.5% (w/w) of the formulation; (b) a release retarding agent admixed with the colchicine granules in an amount of 10% to 30% w/w of the formulation, wherein the release retarding agent is equal parts (w/w) of a second HPMC and lactose monohydrate; and (c) at least one pharmaceutically acceptable excipient admixed with the granules; wherein the viscosity of the second HPMC is higher than the viscosity of the first HPMC, wherein the formulation is in a form of a pill, a capsule, a caplet, a suppository, sublingual formulation, a pouch, a dermal patch, sprinkles, or in fixed combination with a surgically insertable medical device.
2. The formulation of claim 1, wherein less than 70% of the colchicine is released in vitro within 2 hours at 37 °C.
3. The formulation of claims 1 or 2, wherein the formulation releases at least about 20% of the colchicine in vitro within the first 30 minutes.
4. The formulation of any one of claims 1-3, wherein the first HPMC has a viscosity of 6 mP a •s and the second HPMC has a viscosity of 4000 mP a •s.
5. The formulation of any one of claims 1 to 4, wherein the pharmaceutically acceptable excipient comprises one or more of a binder, a filling agent, a glidant, and a lubricant.
6. The formulation of any one of claims 1 to 5, wherein the pharmaceutically acceptable excipient comprises a binder, and wherein the binder comprises one or more of starches, gelatin, polyvinylpyrrolidone, cellulose derivatives, and polyvinyl alcohol.
7. The formulation of claim 6, wherein the cellulose derivative is HPMC or hydroxypropyl cellulose (HPC).
8. The formulation of claim 6, wherein the cellulose derivative forms a hydrophilic matrix. AH26(25575208_1):RTK
9. The formulation of any one of claims 1 to 8, wherein the pharmaceutically acceptable excipient comprises a filling agent , and wherein the filling agent comprises one or more of sucrose, lactose, trehalose, maltose, mannitol, sorbitol, croscarmellose sodium, crospovidone, alginic acid, sodium alginate, methacrylic acid divinyl benzene (DVB), cross-linked polyvinylpyrrolidone (PVP), microcrystalline cellulose, polacrilin potassium, sodium starch glycolate, starch, and pregelatinized starch.
10. The formulation of claim 9, wherein the total amount of filling agent in the formulation is between about 5.0 wt % and 90.0 wt % of the formulation.
11. The formulation of any one of claims 1 to 10, wherein the pharmaceutically acceptable excipient is a glidant, and wherein the glidant comprises one or more of colloidal silicon dioxide, magnesium trisilicate, powdered cellulose, talc, and tribasic calcium phosphate
12. The formulation of claim 11, wherein total amount of glidant in the formulation is between about 0.5 wt % to about 5 wt % of the formulation.
13. The formulation of any one of claims 1 to 12, wherein the pharmaceutically acceptable excipient is a lubricant, and wherein the lubricant comprises one or more of glyceryl behenate, stearic acid, hydrogenated vegetable oils, stearyl alcohol, leucine, polyethylene glycol, magnesium stearate, glyceryl monostearate, polyethylene glycol, ethylene oxide polymers, sodium lauryl sulfate, magnesium lauryl sulfate, sodium oleate, sodium stearyl fumarate, DL- leucine, and colloidal silica.
14. The formulation of claim 13, wherein the lubricant is included in an amount between about 0.5 wt % to about 5 wt % of the formulation.
15. The formulation of any one of claims 1 to 14, wherein the excipient is a starch, gelatin, polyvinylpyrrolidone (PVP), microcrystalline cellulose, hydroxypropyl cellulose (HPC), polyvinyl alcohol, or a mixture thereof.
16. The formulation of any one of claims 1 to 15, wherein the total amount of colchicine in the formulation is between about 0.25 wt % and about 0.75 wt % of the formulation.
17. The formulation of any one of claims 1 to 16, wherein the formulation comprises no immediate release component or layer. AH26(25575208_1):RTK
18. The formulation of any one of claims 1 to 17, wherein the formulation is formulated for once daily administration.
19. The formulation of any one of claims 1 to 18, wherein the formulation further comprises a statin.
20. The formulation of claim 19, wherein the statin is admixed with the formulation.
21. The formulation of claim 19 or claim 20, wherein the statin is one or more of atorvastatin, rosuvastatin, simvastatin, and pravastatin, or a salt thereof.
22. Use of a sustained release formulation of colchicine according to any one of claims 1-21, for the manufacture of a medicament for preventing and/or treating a cardiovascular disease in a subject in need thereof.
23. The use of claim 22, wherein the cardiovascular disease is acute pericarditis, recurrent pericarditis, post-pericardiotomy syndrome (PPS), or cardiovascular events in subjects with stable coronary disease.
24. The use of claim 22 or claim 23, wherein the composition further comprises a conventional therapy for long-term prevention of an acute cardiovascular event in subjects with established stable coronary disease.
25. The use of claim 24, wherein the acute cardiovascular event is acute coronary syndrome, out-of-hospital cardiac arrest, or noncardioembolic ischemic stroke.
26. Use of a sustained release formulation of colchicine according to any one of claims 1 to 21, for the manufacture of a medicament for preventing and/or treating an inflammatory disease in a subject in need thereof.
27. The use of claim 26, wherein the inflammatory disease is gout, familial Mediterranean fever, Behcet´s disease, age-related macular degeneration, or Alzheimer´s disease.
28. A process of preparing a colchicine-sustained release formulation comprising: (A) forming a granulate by dissolving 0.5 mg of colchicine or a pharmaceutically acceptable salt thereof in an acceptable solvent; (B) adding a first hydroxypropyl methylcellulose (HPMC) of 6 mPa •s in an amount of AH26(25575208_1):RTK 0.5% to 1.5% (w/w) of the formulation, a filling agent comprising lactose monohydrate in an amount of 10% to 80% (w/w) of the formulation, and pregelatinized starch to Step A, and forming a wet granulate; (C) drying the wet granulate of Step B; (D) blending the dried granulate from Step C with a retarding agent, wherein the release retarding agent is in an amount of 10% to 30% (w/w) of the formulation, and wherein the release retarding agent is equal parts of a second HPMC of 4000 mPa •s, and lactose monohydrate; and (E) compressing the final granulation from step D.
29. The process of claim 28, further comprising adding talc as a glidant in Step D, and adding stearic acid as a lubricant in Step D.
30. The process of claims 28 or 29, wherein the amount of each component in the colchicine- sustained release formulation is as follows: Ingredient mg / Tablet Tablet Colchicine 0.500 0.5 Lactose monohydrate 59.00 59.0 Pregelatinized Starch 7.50 7.5 HPMC 6 mPa •s 1.000 1.0 Purified water q.s. q.s. lactose monohydrate 10.0 - 30.00 10.0 - and 30.0 HPMC 4000 mPa •s, (
NZ713151A 2013-04-16 2014-04-16 Sustained-release formulations of colchicine and methods of using same NZ713151B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
NZ751885A NZ751885B2 (en) 2013-04-16 2014-04-16 Sustained-release formulations of colchicine and methods of using same

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201361812514P 2013-04-16 2013-04-16
US61/812,514 2013-04-16
EPEP13194505.7 2013-11-26
EP13194505 2013-11-26
PCT/IB2014/001201 WO2014170755A2 (en) 2013-04-16 2014-04-16 Sustained-release formulations of colchicine and methods of using same

Publications (2)

Publication Number Publication Date
NZ713151A true NZ713151A (en) 2021-01-29
NZ713151B2 NZ713151B2 (en) 2021-04-30

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JP6887043B2 (en) 2021-06-16
HRP20210963T1 (en) 2021-09-17
JP2020125335A (en) 2020-08-20
ES2870718T3 (en) 2021-10-27
IL242001B (en) 2021-07-29
HUE054663T2 (en) 2021-09-28
LT2986280T (en) 2021-06-25
DK2986280T3 (en) 2021-06-14
JP2019065032A (en) 2019-04-25
JP6697539B2 (en) 2020-05-20
NZ751885A (en) 2021-01-29

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