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WO2012021791A3 - Aqueous formulation with improved stability - Google Patents

Aqueous formulation with improved stability Download PDF

Info

Publication number
WO2012021791A3
WO2012021791A3 PCT/US2011/047563 US2011047563W WO2012021791A3 WO 2012021791 A3 WO2012021791 A3 WO 2012021791A3 US 2011047563 W US2011047563 W US 2011047563W WO 2012021791 A3 WO2012021791 A3 WO 2012021791A3
Authority
WO
WIPO (PCT)
Prior art keywords
aqueous formulation
improved stability
disulfide bond
polyalkylene oxide
acid
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.)
Ceased
Application number
PCT/US2011/047563
Other languages
French (fr)
Other versions
WO2012021791A2 (en
Inventor
Nagesh R. Palepu
Philip Christopher Buxton
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.)
Scidose LLC
Original Assignee
Scidose 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
Application filed by Scidose LLC filed Critical Scidose LLC
Publication of WO2012021791A2 publication Critical patent/WO2012021791A2/en
Publication of WO2012021791A3 publication Critical patent/WO2012021791A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
    • 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
    • A61K31/38—Heterocyclic compounds having sulfur as a ring hetero atom
    • A61K31/381—Heterocyclic compounds having sulfur as a ring hetero atom having five-membered rings
    • 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
    • A61K31/38—Heterocyclic compounds having sulfur as a ring hetero atom
    • A61K31/385—Heterocyclic compounds having sulfur as a ring hetero atom having two or more sulfur atoms in the same ring
    • 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
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

An aqueous formulation with improved storage stability of a biologically active agent is provided. The aqueous formulation includes compounds which can be an organic acid conjugated to a polyalkylene oxide, wherein the organic acid contains one or more cyclic disulfide bond or dithiols, which can form intramolecular cyclic disulfide bond. Preferred compounds included in the aqueous formulation include polyalkylene oxide conjugates of lipoic acid, dihydrolipoic acid, and other 1,3-dithiol or 1,3-disulfide containing organic acids. Additionally, preferred polyalkylene glycols are polyethylene glycol and polypropylene glycol.
PCT/US2011/047563 2010-08-13 2011-08-12 Aqueous formulation with improved stability Ceased WO2012021791A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US37359410P 2010-08-13 2010-08-13
US61/373,594 2010-08-13

Publications (2)

Publication Number Publication Date
WO2012021791A2 WO2012021791A2 (en) 2012-02-16
WO2012021791A3 true WO2012021791A3 (en) 2012-07-12

Family

ID=45568212

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2011/047563 Ceased WO2012021791A2 (en) 2010-08-13 2011-08-12 Aqueous formulation with improved stability

Country Status (1)

Country Link
WO (1) WO2012021791A2 (en)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104337761B (en) * 2013-08-07 2019-03-26 江苏豪森药业集团有限公司 Fulvestrant pharmaceutical composition
IL285928B2 (en) 2016-05-06 2025-06-01 Eagle Pharmaceuticals Inc Fulvestrant formulations and methods of using them
CN110407805A (en) * 2019-07-09 2019-11-05 江苏第二师范学院（江苏省教育科学研究院） Lipoic acid aldehyde derivative and preparation method thereof, application

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030207936A1 (en) * 2000-11-28 2003-11-06 Hongming Chen Pharmaceutical formulations comprising paclitaxel, derivatives, and pharmaceutically acceptable salts thereof
US6900338B1 (en) * 1998-11-25 2005-05-31 Yissum Research Development Company Of The Hebrew University Of Jerusalem Scavenger compounds
US20060135586A1 (en) * 2004-12-21 2006-06-22 Antoni Kozlowski Stabilized polymeric thiol reagents
WO2009086547A1 (en) * 2008-01-03 2009-07-09 Cedars-Sinai Medical Center Antioxidant nanosphere comprising [1,2]-dithiolane moieties

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6900338B1 (en) * 1998-11-25 2005-05-31 Yissum Research Development Company Of The Hebrew University Of Jerusalem Scavenger compounds
US20030207936A1 (en) * 2000-11-28 2003-11-06 Hongming Chen Pharmaceutical formulations comprising paclitaxel, derivatives, and pharmaceutically acceptable salts thereof
US20060135586A1 (en) * 2004-12-21 2006-06-22 Antoni Kozlowski Stabilized polymeric thiol reagents
WO2009086547A1 (en) * 2008-01-03 2009-07-09 Cedars-Sinai Medical Center Antioxidant nanosphere comprising [1,2]-dithiolane moieties

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
M. V. TRIVEDI ET AL.: "The role of thiols and disulfides on protein stability", CURRENT PROTEIN AND PEPTIDE SCIENCE, vol. 10, 2009, pages 614 - 625, XP055234745, DOI: doi:10.2174/138920309789630534 *

Also Published As

Publication number Publication date
WO2012021791A2 (en) 2012-02-16

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