Claims for Patent: 10,016,393

Summary for Patent: 10,016,393

Title:	Stabilized pharmaceutical dosage forms comprising atrasentan
Abstract:	The present disclosure relates to: (a) methods of using stabilized pharmaceutical dosage forms comprising atrasentan, or a pharmaceutically acceptable salt thereof, and, optionally, another therapeutic agent to treat type 2 diabetes, microalbuminuria or macroalbuminuria; and (b) methods for the preparation of such pharmaceutical dosage forms.
Inventor(s):	Ye Huang, Andrew K. Koski, Katherine E. Peterson
Assignee:	AbbVie Inc
Application Number:	US15/154,710
Patent Claims:	1. A stable solid pharmaceutical dosage form comprising: from about 0.4 mg to about 0.85 mg atrasentan free base, or an equivalent amount of a pharmaceutically acceptable salt thereof; and L-cysteine, or a pharmaceutically acceptable salt thereof, wherein the mole ratio of L-cysteine, or a pharmaceutically acceptable salt thereof, to atrasentan free base, or a pharmaceutically acceptable salt thereof, is from about 2:1 to about 1:2. 2. The dosage form of claim 1, comprising about 0.75 mg atrasentan free base, or an equivalent amount of a pharmaceutically acceptable salt thereof. 3. The dosage form of claim 1, wherein the mole ratio of L-cysteine, or a pharmaceutically acceptable salt thereof, to atrasentan free base, or a pharmaceutically acceptable salt thereof, is about 1:1. 4. The dosage form of claim 1, further comprising from about 1 wt. % to about 5 wt. % of a binder selected from the group consisting of hydroxypropyl methylcellulose, hydroxypropyl ethylcellulose, and hydroxypropyl cellulose. 5. The dosage form of claim 4, wherein the polymeric binder is hydroxypropyl methylcellulose. 6. The dosage form of claim 4, further comprising: from about 1 wt. % to about 6 wt. % of a disintegrant selected from cross-linked polyvinyl pyrrolidone, sodium starch glycolate and sodium croscarmellose; and from about 85 wt. % to about 99 wt. % of a diluent selected from lactose, mannitol, isomalt, microcrystalline cellulose, dicalcium phosphate, and combinations thereof. 7. The dosage form of claim 6, wherein the disintegrant is crospovidone and the diluent is lactose. 8. The dosage form of claim 6, further comprising: from about 0.1 wt. % to about 0.8 wt. % of a glidant; and from about 0.5 wt. % to about 2 wt. % of a lubricant. 9. The dosage form of claim 8, wherein the glidant is silicon dioxide and the lubricant is glyceryl behenate. 10. The dosage form of claim 1, further comprising: from about 1 wt. % to about 5 wt. % hydroxypropyl methylcellulose; from about 1 wt. % to about 6 wt. % crospovidone; from about 85 wt. % to about 99 wt. % lactose; from about 0.1 wt. % to about 0.8 wt. % silicon dioxide; and from about 0.5 wt. % to about 2 wt. % glyceryl behenate. 11. The dosage form of claim 10 wherein the dosage form is a tablet core, wherein said tablet core further comprises a film coating disposed thereon.