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1. WO2022140181 - METHODS OF ADMINISTERING INTRAVENOUS BACLOFEN

Publication Number WO/2022/140181
Publication Date 30.06.2022
International Application No. PCT/US2021/064055
International Filing Date 17.12.2021
IPC
A61K 31/197 2006.1
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
195having an amino group
197the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid (GABA), beta-alanine, epsilon-aminocaproic acid, pantothenic acid
A61K 45/06 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
45Medicinal preparations containing active ingredients not provided for in groups A61K31/-A61K41/132
06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
A61K 9/00 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
CPC
A61K 31/197
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
195having an amino group
197the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
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
A61P 43/00
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
43Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Applicants
  • ALLAYSIS, LLC [US]/[US]
  • REGENTS OF THE UNIVERSITY OF MINNESOTA [US]/[US]
  • DIAZ, Gilberto [US]/[US]
Inventors
  • DIAZ, Gilberto
  • TATA, Prasad
  • ALHADEFF, Dan, Simon
  • GOMEZ, Adolfo, L.
  • SCHROGIE, John
  • KRIEL, Robert, L.
  • KRACH, Linda
  • CLOYD, James, C.
  • COLES, Lisa
  • SCHMITZ, Natalie
Agents
  • SHAPIRO-BARR, Tania
  • ANDRUS, Alex
  • KRUEGER, Katherine, A.D.
  • VIKSNINS, Ann, S.
  • MALEN, Peter, L.
  • MICKELSON, John, W.
  • NIU, Lin
  • PADYS, Danny, J.
  • HARRIS, Robert, J.
Priority Data
63/130,50324.12.2020US
Publication Language English (en)
Filing Language English (EN)
Designated States
Title
(EN) METHODS OF ADMINISTERING INTRAVENOUS BACLOFEN
(FR) PROCÉDÉS D'ADMINISTRATION DE BACLOFÈNE INTRAVEINEUX
Abstract
(EN) Methods tor the intravenous (IV) administration of a therapeutically effective amount of baclofen at a dosing regimen winch mimics the oral pharmacokinetic profile of baclofen are disclosed. The disclosed methods meet bioequivalence criteria for both systemic exposure (AUC) and maximum plasma concentration (Cmax) compared to oral administration.
(FR) L'invention concerne des procédés pour l'administration intraveineuse (IV) d'une quantité thérapeutiquement efficace de baclofène selon un régime posologiqu qui imite le profil pharmacocinétique oral du baclofène. Les procédés de l'invention répondent à des critères de bioéquivalence à la fois pour une exposition systémique (AUC) et pour une concentration plasmatique maximale (Cmax) par comparaison avec une administration orale.
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