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1. WO2007146126 - INSULIN COMPOSITION

Publication Number WO/2007/146126
Publication Date 21.12.2007
International Application No. PCT/US2007/013512
International Filing Date 08.06.2007
Chapter 2 Demand Filed 04.01.2008
IPC
A61K 38/28 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17from animals; from humans
22Hormones
28Insulins
A61K 9/107 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
10Dispersions; Emulsions
107Emulsions
CPC
A61K 38/28
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17from animals; from humans
22Hormones
28Insulins
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 47/08
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
A61K 47/12
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
12Carboxylic acids; Salts or anhydrides thereof
A61K 47/22
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
22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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
Applicants
  • CPEX PHARMACEUTICALS, INC. [US]/[US] (AllExceptUS)
  • GYURIK, Robert, J. [US]/[US] (UsOnly)
  • REPPUCCI, Carl [US]/[US] (UsOnly)
  • LI, Zhengmao [CN]/[US] (UsOnly)
Inventors
  • GYURIK, Robert, J.
  • REPPUCCI, Carl
  • LI, Zhengmao
Agents
  • DAVITZ, Michael, A.
Priority Data
60/811,91308.06.2006US
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) INSULIN COMPOSITION
(FR) COMPOSITION D'INSULINE
Abstract
(EN)
Compositions and methods are disclosed for treating a patient with insulin, wherein a composition in a form suitable for nasal delivery to a patient comprises a therapeutically effective amount of insulin, a permeation enhancer, a liquid carrier, and an acid present in said composition in an amount sufficient to provide an acidic pH, but not greater than a pH of 4.5, said acid being selected from the group consisting of: monovalent inorganic acid(s), sulfuric acid, and acetic acid. Preferably the composition is essentially-free of citrate(s) and essentially-free of phosphate(s). The composition being thus designed with the intent to provide a composition that is essentially-free of fibrilliform (or beta-sheet) insulin polymorphs. Also disclosed are pharmaceutical compositions for nasal administration to humans, or to warm-blooded animals, comprising: (A) a therapeutically effective amount of insulin; (B) a permeation enhancer; and (C) a liquid carrier; the compositions being further comprised of, or characterized by, any, or each, of: (D) a combination of non-ionic surfactants; wherein the combination of non-ionic surfactants comprises: (i) at least one fatty acid ester of a sugar or sugar alcohol and (ii) at least one pegylated fatty acid ester of a sugar or sugar alcohol; (E) an acidic pH, but no greater than a pH of 4.5; and (F) an osmolality of < 200 mOsmol/Kg H2O.
(FR)
L'invention concerne une composition et procédés servant à traiter un patient avec de l'insuline, ladite composition sous une forme convenant pour une administration nasale à un patient comprenant une quantité efficace du point de vue thérapeutique d'insuline, un agent augmentant la perméation, un véhicule liquide et un acide présent dans ladite composition en quantité suffisante pour fournir un pH acide, mais inférieure ou égale à 4,5, ledit acide étant sélectionné dans le groupe constitué d'acide(s) inorganique(s) monovalent(s), de l'acide sulfurique et de l'acide acétique. De préférence la composition est sensiblement exempte de citrate(s) et sensiblement exempte de phosphate(s). La composition est ainsi destinée à former une composition qui est sensiblement exempte de polymorphes en forme de fibrilles (ou en feuillets bêta) de l'insuline. L'invention concerne également des compositions pharmaceutiques destinées à une administration nasale à des humains ou à des animaux à sang chaud, comprenant : (A) une quantité efficace du point de vue thérapeutique d'insuline; (B) un agent augmentant la perméation; et (C) un véhicule liquide, les compositions comprenant en outre, ou étant en outre caractérisées par, l'un quelconque ou chacun de : (D) une association de tensioactifs non ioniques, ladite association de tensioactifs non ioniques comprenant (i) au moins un ester d'acide gras d'un sucre ou d'un alcool de sucre et (ii) au moins un ester d'acide gras pégylé d'un sucre ou d'un alcool de sucre; (E) un pH acide, mais inférieur ou égal à 4,5; et (F) une osmolalité < 200 mOsmol/kg de H2O.
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