Claims for Patent: 11,787,815

Summary for Patent: 11,787,815

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:	US18/174,736
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,787,815
Patent Claims:	1. An extended release pharmaceutical tablet comprising: (a) 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; (b) an acidic pH modifier; and (c) a release control polymer. 2. The tablet of claim 1, wherein the release control polymer is a hydrophilic polymer and wherein the acidic pH modifier is an organic acid. 3. The tablet of claim 2, wherein the organic acid is present in an amount from about 10 w/w % to about 35 w/w %. 4. The tablet of claim 3, wherein the organic acid is tartaric acid. 5. The tablet of claim 2, wherein the extended release formulation provides for the release 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 upon entry into a use environment at a rate substantially independent of the pH of the use environment, wherein the use environment has a pH range from about 1.2 to about 6.8. 6. The tablet of claim 5, wherein the organic acid is present in an amount from about 10 w/w % to about 35 w/w %. 7. The tablet of claim 6, wherein the organic acid is tartaric acid. 8. The tablet of claim 2, wherein the extended release solid dosage form, when added to a test medium comprising 900 mL of 50 mM pH 6.8 sodium phosphate buffer at 37° C.±0.5° C. in a standard USP rotating paddle apparatus when the paddles are rotated at 75 rpm±4%, dissolves from about 50% to about 90% 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 after about 8 hours. 9. The tablet of claim 8, wherein the organic acid is present in an amount from about 10 w/w % to about 35 w/w %. 10. The tablet of claim 9, wherein the organic acid is tartaric acid.