CA2789798C - Oral formulations and lipophilic salts of methylnaltrexone - Google Patents

Oral formulations and lipophilic salts of methylnaltrexone Download PDF

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Publication number
CA2789798C
CA2789798C CA2789798A CA2789798A CA2789798C CA 2789798 C CA2789798 C CA 2789798C CA 2789798 A CA2789798 A CA 2789798A CA 2789798 A CA2789798 A CA 2789798A CA 2789798 C CA2789798 C CA 2789798C
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CA
Canada
Prior art keywords
pharmaceutical composition
methylnaltrexone
certain embodiments
composition
dodecyl sulfate
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
CA2789798A
Other languages
English (en)
French (fr)
Other versions
CA2789798A1 (en
Inventor
Syed M. Shah
Christopher Richard Diorio
Eric C. Ehrnsperger
Xu Meng
Kadum A. Al Shareffi
Jonathan Marc Cohen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Wyeth LLC
Original Assignee
Wyeth LLC
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
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Application filed by Wyeth LLC filed Critical Wyeth LLC
Publication of CA2789798A1 publication Critical patent/CA2789798A1/en
Application granted granted Critical
Publication of CA2789798C publication Critical patent/CA2789798C/en
Active legal-status Critical Current
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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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/2022—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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • 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
    • 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
    • A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
    • 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
    • A61P1/10—Laxatives
    • 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
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • 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
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D489/00—Heterocyclic compounds containing 4aH-8, 9 c- Iminoethano-phenanthro [4, 5-b, c, d] furan ring systems, e.g. derivatives of [4, 5-epoxy]-morphinan of the formula:
    • C07D489/06—Heterocyclic compounds containing 4aH-8, 9 c- Iminoethano-phenanthro [4, 5-b, c, d] furan ring systems, e.g. derivatives of [4, 5-epoxy]-morphinan of the formula: with a hetero atom directly attached in position 14
    • C07D489/08—Oxygen atom

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Emergency Medicine (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Inorganic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Pain & Pain Management (AREA)
  • Otolaryngology (AREA)
  • Hospice & Palliative Care (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
CA2789798A 2010-03-11 2011-03-10 Oral formulations and lipophilic salts of methylnaltrexone Active CA2789798C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US31301810P 2010-03-11 2010-03-11
US61/313,018 2010-03-11
PCT/US2011/027913 WO2011112816A1 (en) 2010-03-11 2011-03-10 Oral formulations and lipophilic salts of methylnaltrexone

Publications (2)

Publication Number Publication Date
CA2789798A1 CA2789798A1 (en) 2011-09-15
CA2789798C true CA2789798C (en) 2020-09-22

Family

ID=44148539

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2789798A Active CA2789798C (en) 2010-03-11 2011-03-10 Oral formulations and lipophilic salts of methylnaltrexone

Country Status (32)

Country Link
US (8) US8524276B2 (enExample)
EP (2) EP3178472B1 (enExample)
JP (4) JP6143409B2 (enExample)
KR (2) KR101982482B1 (enExample)
CN (2) CN102918039B (enExample)
AR (1) AR080491A1 (enExample)
AU (1) AU2011224275B2 (enExample)
BR (1) BR112012022873B1 (enExample)
CA (1) CA2789798C (enExample)
CL (1) CL2012002192A1 (enExample)
CO (1) CO6630134A2 (enExample)
CR (1) CR20120476A (enExample)
EA (1) EA029096B1 (enExample)
EC (1) ECSP12012208A (enExample)
ES (1) ES2623926T3 (enExample)
GE (1) GEP201606550B (enExample)
GT (1) GT201200247A (enExample)
HU (1) HUE033133T2 (enExample)
IL (1) IL221452A (enExample)
MA (1) MA34146B1 (enExample)
MX (2) MX368805B (enExample)
MY (1) MY160727A (enExample)
NZ (3) NZ601595A (enExample)
PE (1) PE20130063A1 (enExample)
PH (1) PH12012501622A1 (enExample)
PL (2) PL2371357T3 (enExample)
SG (3) SG10201501821RA (enExample)
TN (1) TN2012000392A1 (enExample)
TW (2) TWI605814B (enExample)
UA (2) UA123856C2 (enExample)
WO (1) WO2011112816A1 (enExample)
ZA (1) ZA201808498B (enExample)

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AU2020268767B8 (en) * 2019-05-07 2025-08-07 Bausch Health Ireland Limited Liquid oral dosage formulations of methylnaltrexone
WO2020245214A1 (en) 2019-06-03 2020-12-10 Bausch Health Ireland Limited Use of methylnaltrexone and rifaximin for treatment of increased gut permeability or associated disorders
CA3177250A1 (en) 2020-05-02 2021-11-11 Bausch Health Ireland Limited Methods of reducing mortality risk in subjects suffering from an underlying disease or condition by administration of methylnaltrexone
WO2023031955A1 (en) * 2021-08-28 2023-03-09 Redasani Vijayendrakumar Virendrakumar Ji Oral pharmaceutical compositions of methylnaltrexone and salt thereof

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Also Published As

Publication number Publication date
US20120070495A1 (en) 2012-03-22
TWI589293B (zh) 2017-07-01
US20190117645A1 (en) 2019-04-25
HK1245673A1 (zh) 2018-08-31
TWI605814B (zh) 2017-11-21
TW201622724A (zh) 2016-07-01
JP2011190259A (ja) 2011-09-29
US20130330407A1 (en) 2013-12-12
CN107308125A (zh) 2017-11-03
US20190117646A1 (en) 2019-04-25
PL2371357T3 (pl) 2017-09-29
CN102918039B (zh) 2017-06-09
UA123856C2 (uk) 2021-06-16
MX2012009125A (es) 2012-09-07
CN102918039A (zh) 2013-02-06
EP3178472B1 (en) 2021-10-27
KR20130010900A (ko) 2013-01-29
JP6647368B2 (ja) 2020-02-14
JP6429955B2 (ja) 2018-11-28
PE20130063A1 (es) 2013-02-11
EA201270741A1 (ru) 2013-02-28
ES2623926T3 (es) 2017-07-12
UA111717C2 (uk) 2016-06-10
US10376505B2 (en) 2019-08-13
WO2011112816A1 (en) 2011-09-15
US20160206612A1 (en) 2016-07-21
JP2016029054A (ja) 2016-03-03
NZ601595A (en) 2015-01-30
CN107308125B (zh) 2021-07-16
KR20180118260A (ko) 2018-10-30
PL3178472T3 (pl) 2022-02-14
MA34146B1 (fr) 2013-04-03
BR112012022873B1 (pt) 2021-09-14
NZ703564A (en) 2016-08-26
JP2017206553A (ja) 2017-11-24
US20140249171A1 (en) 2014-09-04
JP2019034958A (ja) 2019-03-07
US9314461B2 (en) 2016-04-19
BR112012022873A2 (pt) 2016-08-30
US10307417B2 (en) 2019-06-04
MX368805B (es) 2019-10-17
NZ702826A (en) 2016-08-26
KR101913102B1 (ko) 2018-10-31
MY160727A (en) 2017-03-15
EP2371357B1 (en) 2017-02-01
JP6143409B2 (ja) 2017-06-07
EA029096B1 (ru) 2018-02-28
CO6630134A2 (es) 2013-03-01
AU2011224275B2 (en) 2015-10-01
CA2789798A1 (en) 2011-09-15
AR080491A1 (es) 2012-04-11
CR20120476A (es) 2012-11-30
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