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1. WO2007035448 - HIGHLY CONCENTRATED POURABLE AQUEOUS SOLUTIONS OF POTASSIUM IBUPROFEN THEIR PREPARATION AND THEIR USES

Publication Number WO/2007/035448
Publication Date 29.03.2007
International Application No. PCT/US2006/035932
International Filing Date 15.09.2006
IPC
A61K 9/48 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
48Preparations in capsules, e.g. of gelatin, of chocolate
A61K 31/19 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
19Carboxylic acids, e.g. valproic acid
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
CPC
A61K 31/19
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic, hydroximic acids
19Carboxylic acids, e.g. valproic acid
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 9/4858
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
48Preparations in capsules, e.g. of gelatin, of chocolate
4841Filling excipients; Inactive ingredients
4858Organic compounds
Applicants
  • ALBEMARLE CORPORATION [US]/[US] (AllExceptUS)
  • HU, Patrick, C. [US]/[US] (UsOnly)
  • LAMBETH, Gregory, H. [US]/[US] (UsOnly)
  • MALCOLM, Arcelio, J. [US]/[US] (UsOnly)
Inventors
  • HU, Patrick, C.
  • LAMBETH, Gregory, H.
  • MALCOLM, Arcelio, J.
Agents
  • HOEFLING, Marcy, M.
Priority Data
60/719,01819.09.2005US
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) HIGHLY CONCENTRATED POURABLE AQUEOUS SOLUTIONS OF POTASSIUM IBUPROFEN THEIR PREPARATION AND THEIR USES
(FR) SOLUTIONS AQUEUSES VERSABLES FORTEMENT CONCENTRÉES D'IBUPROFÈNE DE POTASSIUM, LEUR PRÉPARATION ET LEURS UTILISATIONS
Abstract
(EN)
Concentrated pourable potassium ibuprofen liquid compositions, and preparation and uses thereof are described. They are composed of (i) at least 60 wt% of potassium ibuprofen in dissolved form; (ii) water; (iii) one or more polyethylene glycols, (iv) optionally up to 5 wt% of at least one C2-3 alkanol; and (v) optionally, ibuprofen in free acid form. The weight ratio of (ii):(iii) is at least 0.9:1. Compositions containing as much as 85.2 wt% of potassium ibuprofen in dissolved form have been successfully made. The highest level of potassium ibuprofen in dissolved form achieved in experiments reported in the presently-known prior art is but 24.2 wt%. The present compositions are suitable for use in the preparation of pharmaceutical products and various pharmaceutical dosage forms such as liquid-filled soft gelatin capsules, syrups, elixirs, suspensions; solid dosage forms such as tablets or caplets; and topically-applied products. such as lotions, creams or ointments.
(FR)
L’invention concerne des compositions liquides d'ibuprofène de potassium versables concentrées, et une préparation et des utilisations de celles-ci. Elles sont composées (i) d’au moins 60 % en poids d'ibuprofène de potassium sous forme dissoute ; (ii) d’eau ; (iii) d'un ou plusieurs glycols polyéthylèniques, (iv) en option jusqu'à 5 % en poids d'au moins un C2-3 alcanol ; et (v) en option, d'ibuprofène sous une forme d'acide libre. Le rapport pondéral de (ii):(iii) est d'au moins 0,9 :1. Des compositions contenant jusqu'à 85,2% en poids d'ibuprofène de potassium sous forme dissoute ont été produites avec succès. Le niveau le plus élevé d'ibuprofène de potassium sous forme dissoute obtenu dans des expériences signalées dans l'art antérieur actuellement connu n'est que de 24,2 % en poids. Les présentes compositions sont adéquates pour une utilisation dans la préparation de produits pharmaceutiques et diverses formes de dosages pharmaceutiques telles que des capsules de gélatine molles remplies de liquide, des sirops, des élixirs, des suspensions ; des formes de dosages solides telles que des cachets ou des comprimés ; et des produits appliqués de manière topique, tels que des lotions, des crèmes ou des pommades.
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