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1. WO2000043034 - MONODISPERSE HEXAMERIC ACYLATED INSULIN ANALOG FORMULATIONS

Publication Number WO/2000/043034
Publication Date 27.07.2000
International Application No. PCT/US2000/001627
International Filing Date 26.01.2000
Chapter 2 Demand Filed 23.08.2000
IPC
A61K 47/02 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
02Inorganic compounds
A61K 47/10 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
08containing oxygen
10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols ; Poloxamers; PEG/POE alkyl ethers
A61K 47/26 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
CPC
A61K 47/02
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
02Inorganic compounds
A61K 47/10
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
08containing oxygen, ; e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
A61K 47/26
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
A61K 9/0019
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
0012Galenical forms characterised by the site of application
0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
Applicants
  • ELI LILLY AND COMPANY [US/US]; Lilly Corporate Center Indianapolis, IN 46285, US (AllExceptUS)
  • NG, Kingman [CN/US]; US (UsOnly)
  • LI, Shun [US/US]; US (UsOnly)
  • WATTS, Eric, Alan [US/US]; US (UsOnly)
Inventors
  • NG, Kingman; US
  • LI, Shun; US
  • WATTS, Eric, Alan; US
Agents
  • BENT, Stephen, A. ; Foley & Lardner Suite 500 3000 K Street, N.W. Washington, DC 20007-5109, US
Priority Data
60/117,29126.01.1999US
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) MONODISPERSE HEXAMERIC ACYLATED INSULIN ANALOG FORMULATIONS
(FR) FORMULATIONS D'ANALOGUES D'INSULINE ACYLES HEXAMERES MONODISPERSES
Abstract
(EN)
The present invention provides formulations and methods for preparing formulations containing an aqueous solution at a pH of greater than about 7.9. The aqueous solution includes an isotonicity agent, a phenolic derivative, zinc ions, and an acylated human insulin analog. More particularly, the invention relates to formulations having a pH of greater than about 7.9 that include a monoacylated human insulin analog such as an acylated des(B30) human insulin analog or an analog that comprises a native or modified human insulin A chain optionally modified at position A21, and a modified native human insulin B chain optionally modified at position B3 and modified at position B28, or at both positions B28 and B29, and that contains a lysine residue at either position B28 or B29 acylated with a fatty acid residue. The invention also provides a method for treating a patient suffering from hyperglycemia using the pharmaceutical formulations of the invention.
(FR)
L'invention a trait à des formulations et à des procédés de préparation de formulations qui contiennent une solution aqueuse présentant un pH supérieur à environ 7,9. La solution aqueuse comporte un agent d'isotonicité, un dérivé phénolique, des ions zinc, et un analogue d'insuline humaine acylé. Plus particulièrement, l'invention a trait à des formulations présentant un pH supérieur à environ 7,9 qui contiennent un analogue d'insuline humaine monoacylé, tel qu'un analogue d'insuline humaine des(B30) acylé ou un analogue comportant une chaîne A d'insuline humaine modifiée ou native éventuellement modifiée en position A21, et une chaîne B d'insuline humaine native modifiée éventuellement modifiée en position B3, et modifiée en position B28, ou aux deux positions B28 et B29, et qui contient un résidu de lysine en position B28 ou B29 acylé à l'aide d'un résidu d'acide gras. L'invention concerne également une méthode de traitement d'un patient atteint d'hyperglycémie à l'aide des formulations pharmaceutiques de l'invention.
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