Claims for Patent: 11,780,847

Summary for Patent: 11,780,847

Title:	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1- carboxamide and solid state forms thereof
Abstract:	The present disclosure relates to processes for preparing (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide, solid state forms thereof, and corresponding pharmaceutical compositions, methods of treatment (including treatment of rheumatoid arthritis), kits, methods of synthesis, and products-by-process.
Inventor(s):	Jayanthy Jayanth, Mohamed-Eslam F. Mohamed, Ahmed A. Othman, Patrick J. Marroum, Peter T. Mayer, Ben Klünder
Assignee:	AbbVie Inc
Application Number:	US18/174,738
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,780,847
Patent Claims:	1. An oral extended-release tablet comprising: 15 mg of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and at least one pharmaceutically acceptable excipient, wherein: a single administration of the tablet to healthy adult subjects results in a mean AUCinf from about 220 ng hours/mL to about 450 ng hours/mL of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide; and a single administration of the tablet to healthy adult subjects results in a mean Cmax from about 25 ng/mL to about 40 ng/mL of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxide. 2. The tablet of claim 1, wherein the administration under fasting conditions results in a mean AUCinf from about 220 ng hours/mL to about 320 ng hours/mL. 3. The tablet of claim 1, wherein the administration under fed conditions results in a mean AUCinf from about 240 ng hours/mL to about 450 ng hours/mL. 4. The tablet of claim 1, wherein the difference in the mean AUCinf under fed conditions versus fasting conditions is about 30% or less. 5. The tablet of claim 1, wherein the difference in the mean Cmax under fed conditions versus fasting conditions is about 30% or less. 6. The tablet of claim 1, wherein the difference in the mean Cmax under fed conditions versus fasting conditions is about 30% or less. 7. The tablet of claim 1, wherein the administration results in a median Tmax from about 2.0 to about 4.0 hours of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide. 8. The tablet of claim 7, wherein the administration under fasting conditions results in a median Tmax of about 3.0 hours.