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AR126977A2 - DOSAGE FORM COMPOSITIONS COMPRISING A BRUTON'S TYROSINE KINASE INHIBITOR - Google Patents

DOSAGE FORM COMPOSITIONS COMPRISING A BRUTON'S TYROSINE KINASE INHIBITOR

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Publication number
AR126977A2
AR126977A2 ARP220102392A ARP220102392A AR126977A2 AR 126977 A2 AR126977 A2 AR 126977A2 AR P220102392 A ARP220102392 A AR P220102392A AR P220102392 A ARP220102392 A AR P220102392A AR 126977 A2 AR126977 A2 AR 126977A2
Authority
AR
Argentina
Prior art keywords
bruton
free base
crystalline salts
kinase inhibitor
kinase
Prior art date
Application number
ARP220102392A
Other languages
Spanish (es)
Inventor
Chen Kou Dawen Chiang Po Mao
Original Assignee
Hoffmann La Roche
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hoffmann La Roche filed Critical Hoffmann La Roche
Priority to ARP220102392A priority Critical patent/AR126977A2/en
Publication of AR126977A2 publication Critical patent/AR126977A2/en

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  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La invención se refiere, en general, a composiciones farmacéuticas en comprimido que comprenden ácido fumárico y el compuesto de base libre de (S)-2-(3’-(hidroximetil)-1-metil-5-((5-(2-metil-4-(oxetan-3-il)piperazin-1-il)piridin-2-il)amino)-6-oxo-1,6-dihidro-[3,4’-bipiridin]-2’-il)-7,7-dimetil-2,3,4,6,7,8-hexahidro-1H-ciclopenta[4,5]pirrolo[1,2-a]pirazin-1-ona que es un inhibidor de la tirosina cinasa de Bruton. La invención se refiere además a dispersiones sólidas amorfas que comprenden al menos un polímero y la base libre del compuesto inhibidor de la cinasa de Bruton. La invención se refiere además a sales cristalinas de mesilato, sales cristalinas de cloruro y sales cristalinas de sulfato de la base libre del compuesto inhibidor de la cinasa de Bruton. En algunos aspectos, las sales cristalinas son polimorfos individuales. Reivindicación 1: Una composición de dispersión sólida amorfa adecuada para el tratamiento de trastornos mediados por la actividad de la tirosina cinasa de Bruton, caracterizada porque comprende: (1) un componente polimérico, en donde el componente polimérico es copolímero de metacrilato, copolímero de amino metacrilato, polietilenglicol, acetato de polivinilo, o copolímero injertado de polivinilcaprolactama, o cualquier combinación de los mismos; y (2) de 20% en peso a 50% en peso de una base libre de estructura [1].The invention relates generally to pharmaceutical tablet compositions comprising fumaric acid and the free base compound of (S)-2-(3-(hydroxymethyl)-1-methyl-5-((5-(2 -methyl-4-(oxetan-3-yl)piperazin-1-yl)pyridin-2-yl)amino)-6-oxo-1,6-dihydro-[3,4-bipyridin]-2-yl )-7,7-dimethyl-2,3,4,6,7,8-hexahydro-1H-cyclopenta[4,5]pyrrolo[1,2-a]pyrazin-1-one which is a tyrosine inhibitor Bruton kinase. The invention further relates to amorphous solid dispersions comprising at least one polymer and the free base of the Bruton's kinase inhibitor compound. The invention further relates to mesylate crystalline salts, chloride crystalline salts and sulfate crystalline salts of the free base of the Bruton's kinase inhibitor compound. In some aspects, crystalline salts are individual polymorphs. Claim 1: An amorphous solid dispersion composition suitable for the treatment of disorders mediated by the activity of Bruton's tyrosine kinase, characterized in that it comprises: (1) a polymeric component, wherein the polymeric component is methacrylate copolymer, amino copolymer methacrylate, polyethylene glycol, polyvinyl acetate, or polyvinylcaprolactam graft copolymer, or any combination thereof; and (2) from 20% by weight to 50% by weight of a structure-free base [1].

ARP220102392A 2022-09-05 2022-09-05 DOSAGE FORM COMPOSITIONS COMPRISING A BRUTON'S TYROSINE KINASE INHIBITOR AR126977A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
ARP220102392A AR126977A2 (en) 2022-09-05 2022-09-05 DOSAGE FORM COMPOSITIONS COMPRISING A BRUTON'S TYROSINE KINASE INHIBITOR

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
ARP220102392A AR126977A2 (en) 2022-09-05 2022-09-05 DOSAGE FORM COMPOSITIONS COMPRISING A BRUTON'S TYROSINE KINASE INHIBITOR

Publications (1)

Publication Number Publication Date
AR126977A2 true AR126977A2 (en) 2023-12-06

Family

ID=89309898

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP220102392A AR126977A2 (en) 2022-09-05 2022-09-05 DOSAGE FORM COMPOSITIONS COMPRISING A BRUTON'S TYROSINE KINASE INHIBITOR

Country Status (1)

Country Link
AR (1) AR126977A2 (en)

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