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1. WO2021005478 - COMPRESSED MACITENTAN COMPOSITIONS, METHODS AND USES THEREOF

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Publication Number WO/2021/005478
Publication Date 14.01.2021
International Application No. PCT/IB2020/056304
International Filing Date 03.07.2020
IPC
A61K 9/16 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders
16Agglomerates; Granulates; Microbeadlets
A61K 9/20 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, lozenges or tablets
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
A61K 47/38 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
30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
38Cellulose; Derivatives thereof
A61K 31/506 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
33Heterocyclic compounds
395having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
495having six-membered rings with two nitrogen atoms as the only ring hetero atoms, e.g. piperazine
505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
506not condensed and containing further heterocyclic rings
A61P 9/12 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
9Drugs for disorders of the cardiovascular system
12Antihypertensives
Applicants
  • TECNIMEDE - SOCIEDADE TÉCNICO-MEDICINAL, SA [PT]/[PT]
Inventors
  • SILVA SERRA, João Pedro
  • FERREIRA PEREIRA, Ricardo José Camilo
Agents
  • PATENTREE
Priority Data
11563205.07.2019PT
19185065.008.07.2019EP
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) COMPRESSED MACITENTAN COMPOSITIONS, METHODS AND USES THEREOF
(FR) COMPOSITIONS DE MACITENTAN COMPRIMÉES, PROCÉDÉS ET UTILISATIONS DE CELLES-CI
Abstract
(EN)
The present disclosure also relates to compressed compositions comprising a therapeutically effective amount of macitentan, a sugar alcohol diluent and a surfactant. It also relates to the process of obtaining said compressed compositions, oral pharmaceutical compositions comprising them, and their use in the treatment of pulmonary arterial hypertension. The present disclosure also relates to solid oral pharmaceutical compositions comprising a therapeutically effective amount of macitentan that simultaneously display improved stability properties and adequate dissolution profiles represents an unmet need in the field of pharmaceutical macitentan formulation.
(FR)
La présente invention concerne des compositions comprimées comprenant une quantité thérapeutiquement efficace de macitentan, un diluant d'alcool de sucre et un tensioactif. L'invention concerne également le procédé d'obtention desdites compositions comprimées, des compositions pharmaceutiques orales les comprenant, et leur utilisation dans le traitement de l'hypertension artérielle pulmonaire. La présente invention concerne également des compositions pharmaceutiques orales solides comprenant une quantité thérapeutiquement efficace de macitentan qui présentent simultanément des propriétés de stabilité améliorées et des profils de dissolution adéquats qui représentent un besoin non satisfait dans le domaine de la formulation pharmaceutique de macitentan.
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