WO2006050315A3 - Aliphatic amine polymer salts for tableting - Google Patents

Aliphatic amine polymer salts for tableting Download PDF

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Publication number
WO2006050315A3
WO2006050315A3 PCT/US2005/039366 US2005039366W WO2006050315A3 WO 2006050315 A3 WO2006050315 A3 WO 2006050315A3 US 2005039366 W US2005039366 W US 2005039366W WO 2006050315 A3 WO2006050315 A3 WO 2006050315A3
Authority
WO
WIPO (PCT)
Prior art keywords
aliphatic amine
amine polymer
tablets
tableting
polymer salts
Prior art date
Application number
PCT/US2005/039366
Other languages
French (fr)
Other versions
WO2006050315A2 (en
Inventor
Hitesh Bhagat
Jeffery Marc Goldberg
Abizer Harianawala
Louis Brenner
Original Assignee
Genzyme Corp
Hitesh Bhagat
Jeffery Marc Goldberg
Abizer Harianawala
Louis Brenner
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=36120243&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2006050315(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to AU2005302243A priority Critical patent/AU2005302243B2/en
Priority to ES05814880.0T priority patent/ES2621553T3/en
Priority to EP16199305.0A priority patent/EP3167878B1/en
Priority to DK05814880.0T priority patent/DK1807057T3/en
Priority to JP2007539273A priority patent/JP5307398B2/en
Priority to CA2586023A priority patent/CA2586023C/en
Priority to EP05814880.0A priority patent/EP1807057B1/en
Priority to MX2007004939A priority patent/MX2007004939A/en
Priority to BRPI0517916A priority patent/BRPI0517916B8/en
Priority to CN2005800361808A priority patent/CN101043878B/en
Application filed by Genzyme Corp, Hitesh Bhagat, Jeffery Marc Goldberg, Abizer Harianawala, Louis Brenner filed Critical Genzyme Corp
Priority to LTEP05814880.0T priority patent/LT1807057T/en
Publication of WO2006050315A2 publication Critical patent/WO2006050315A2/en
Publication of WO2006050315A3 publication Critical patent/WO2006050315A3/en
Priority to HK08103313.6A priority patent/HK1113543A1/en
Priority to HRP20170505TT priority patent/HRP20170505T1/en
Priority to CY20171100424T priority patent/CY1119155T1/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
    • A61K9/20—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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • 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
    • A61K31/785—Polymers containing nitrogen
    • 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
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • 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
    • A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
    • 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
    • A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
    • A61P3/14—Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Obesity (AREA)
  • Endocrinology (AREA)
  • Rheumatology (AREA)
  • Urology & Nephrology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Macromolecular Compounds Obtained By Forming Nitrogen-Containing Linkages In General (AREA)

Abstract

The tablets, compositions and methods of the present invention, comprising a carbonate salt of an aliphatic amine polymer and s monovalent anion can prevent or ameliorate acidosis, in particular acidosis in patients with renal disease. The tablets and compositions of the present invention maintain a disintegration time of no greater than 30 minutes at 37°C and at pH of at least 1 for a period of at least ten weeks at 60 °C. Furthermore, the tablets are stable for extended periods of time without the need for specialized storage conditions.
PCT/US2005/039366 2004-11-01 2005-11-01 Aliphatic amine polymer salts for tableting WO2006050315A2 (en)

Priority Applications (14)

Application Number Priority Date Filing Date Title
LTEP05814880.0T LT1807057T (en) 2004-11-01 2005-11-01 Aliphatic amine polymer salts for tableting
CN2005800361808A CN101043878B (en) 2004-11-01 2005-11-01 Aliphatic amine polymer salts for tableting
BRPI0517916A BRPI0517916B8 (en) 2004-11-01 2005-11-01 tablet comprising sevelamer carbonate and sodium chloride, and use of a tablet
DK05814880.0T DK1807057T3 (en) 2004-11-01 2005-11-01 ALIFATIC AMINE POLYMER SALTS FOR TABLET PREPARATION
ES05814880.0T ES2621553T3 (en) 2004-11-01 2005-11-01 Aliphatic amine polymer salts for tablet formation
CA2586023A CA2586023C (en) 2004-11-01 2005-11-01 Aliphatic amine polymer salts for tableting
EP05814880.0A EP1807057B1 (en) 2004-11-01 2005-11-01 Aliphatic amine polymer salts for tableting
AU2005302243A AU2005302243B2 (en) 2004-11-01 2005-11-01 Aliphatic amine polymer salts for tableting
EP16199305.0A EP3167878B1 (en) 2004-11-01 2005-11-01 Aliphatic amine polymer salts for tableting
JP2007539273A JP5307398B2 (en) 2004-11-01 2005-11-01 Aliphatic amine polymer salt for tablet manufacture
MX2007004939A MX2007004939A (en) 2004-11-01 2005-11-01 Aliphatic amine polymer salts for tableting.
HK08103313.6A HK1113543A1 (en) 2004-11-01 2008-03-25 Aliphatic amine polymer salts for tableting
HRP20170505TT HRP20170505T1 (en) 2004-11-01 2017-03-28 Aliphatic amine polymer salts for tableting
CY20171100424T CY1119155T1 (en) 2004-11-01 2017-04-10 POLYMERIC SOLUBLE AMINES SALTS FOR TABLET

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US62400104P 2004-11-01 2004-11-01
US60/624,001 2004-11-01
US62875204P 2004-11-17 2004-11-17
US60/628,752 2004-11-17

Publications (2)

Publication Number Publication Date
WO2006050315A2 WO2006050315A2 (en) 2006-05-11
WO2006050315A3 true WO2006050315A3 (en) 2006-06-29

Family

ID=36120243

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2005/039366 WO2006050315A2 (en) 2004-11-01 2005-11-01 Aliphatic amine polymer salts for tableting

Country Status (18)

Country Link
US (4) US7985418B2 (en)
EP (2) EP1807057B1 (en)
JP (2) JP5307398B2 (en)
CN (2) CN102824322A (en)
AU (1) AU2005302243B2 (en)
BR (1) BRPI0517916B8 (en)
CA (2) CA2586023C (en)
CY (1) CY1119155T1 (en)
DK (1) DK1807057T3 (en)
ES (2) ES2621553T3 (en)
HK (1) HK1113543A1 (en)
HR (1) HRP20170505T1 (en)
HU (1) HUE033638T2 (en)
LT (1) LT1807057T (en)
MX (1) MX2007004939A (en)
PL (1) PL1807057T3 (en)
PT (1) PT1807057T (en)
WO (1) WO2006050315A2 (en)

Cited By (2)

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Publication number Priority date Publication date Assignee Title
US9579343B2 (en) 1999-10-19 2017-02-28 Genzyme Corporation Direct compression polymer tablet core
US9585911B2 (en) 2005-09-15 2017-03-07 Genzyme Corporation Sachet formulation for amine polymers

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US7985418B2 (en) 2004-11-01 2011-07-26 Genzyme Corporation Aliphatic amine polymer salts for tableting
EP1830832A1 (en) * 2004-12-30 2007-09-12 Genzyme Corporation Zinc-containing treatments for hyperphosphatemia
EP1951266A2 (en) 2005-09-02 2008-08-06 Genzyme Corporation Method for removing phosphate and polymer used therefore
CA2626734A1 (en) * 2005-11-08 2007-05-18 Genzyme Corporation Magnesium-containing polymers for the treatment of hyperphosphatemia
JP2009542653A (en) * 2006-07-05 2009-12-03 ジェンザイム コーポレーション Iron (II) containing therapeutic agent for hyperphosphatemia
US7964182B2 (en) * 2006-09-01 2011-06-21 USV, Ltd Pharmaceutical compositions comprising phosphate-binding polymer
JP2010504975A (en) 2006-09-29 2010-02-18 ゲンズイメ コーポレーション Amide dendrimer composition
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US20100316589A1 (en) * 2007-12-14 2010-12-16 Hitesh Bhagat Coated Pharmaceutical Compositions
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WO2010041274A2 (en) * 2008-10-07 2010-04-15 Shasun Chemicals And Drugs Limited Process for the preparation of carbonate salts of cross-linked amine polymers
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US20100330175A1 (en) * 2009-06-24 2010-12-30 Jobdevairakkam Christopher N Cross-linked polyallylamine tablet core
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CN102895204B (en) * 2012-11-08 2014-12-31 南京生命能科技开发有限公司 Sevelamer carbonate crude drug for preparing tablets, preparation method and application thereof
CA2912911C (en) 2013-06-05 2023-10-03 Tricida, Inc. Proton-binding polymers for oral administration
CN103393610B (en) * 2013-07-05 2014-12-24 常州方圆制药有限公司 Preparation for quickly disintegrating fatty amine polymer salt
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CN109715142B (en) * 2016-06-14 2021-10-12 苏州韬略生物科技有限公司 Sevelamer carbonate for tableting
CN107157947A (en) * 2017-05-04 2017-09-15 方达医药技术（苏州）有限公司 A kind of 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate piece and preparation method thereof
CN107397734B (en) * 2017-08-24 2020-06-30 正大制药（青岛）有限公司 Stable sevelamer carbonate tablet and preparation method thereof
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