Novel formulations of a bruton's tyrosine kinase inhibitor
US-2016038496-A1 · Feb 11, 2016 · US
US12268666B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-12268666-B2 |
| Application number | US-202418440563-A |
| Country | US |
| Kind code | B2 |
| Filing date | Feb 13, 2024 |
| Priority date | Jul 31, 2018 |
| Publication date | Apr 8, 2025 |
| Grant date | Apr 8, 2025 |
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A spray-dried dispersions and pharmaceutical composition of (S)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoropropan-2-yl)-1H-pyrazole-4-carboxamide, pharmaceutically acceptable salts thereof, or a combination thereof and the use of the spray-dried dispersion and pharmaceutical composition in the treatment of cancer and autoimmune and inflammatory diseases are disclosed. Also provided are crystalline forms of (S)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoropropan-2-yl)-1H-pyrazole-4-carboxamide also useful in the treatment of cancer and autoimmune and inflammatory diseases.
Opening claim text (preview).
What is claimed is: 1. A spray-dried dispersion comprising a compound of Formula I: or a pharmaceutically acceptable salt thereof and one or more polymers selected from the group consisting of an HPMCAS polymer, an HPMC polymer, a vinylpyrrolidone-vinyl acetate copolymer, and a polyvinylpyrrolidone (PVP) polymer. 2. The spray-dried dispersion according to claim 1 , comprising the compound of Formula I. 3. The spray-dried dispersion according to claim 2 , wherein the compound of Formula I is present in amorphous form. 4. The spray-dried dispersion according to claim 3 , comprising the compound of Formula I and an HPMCAS polymer. 5. The spray-dried dispersion according to claim 4 , wherein the ratio of the compound of Formula I to the HPMCAS polymer is about 1:4 to about 4:1. 6. The spray-dried dispersion according to claim 4 , wherein the ratio of the compound of Formula I to the HPMCAS polymer is about 1:1. 7. The spray-dried dispersion according to claim 6 , wherein the HPMCAS polymer is one or more of HPMCAS-MG, HPMCAS-LF, HPMCAS-LG, HPMCAS-MF, HPMCAS-HF, or HPMCAS-HG. 8. The spray-dried dispersion according to claim 7 , wherein the HPMCAS polymer is HPMCAS-MG.
against CD20 · CPC title
Crystalline forms, e.g. polymorphs · CPC title
having a heterocyclic ring, e.g. sulfadiazine · CPC title
Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin · CPC title
Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose · CPC title
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