Formulations of 2-(4-chlorophenyl)-N-((2-(2,6- dioxopiperidin-3-yl)-1-oxoisoindolin-5-yl)methyl)-2,2-difluoroacetamide

1. A vial comprising a lyophilized formulation, wherein the lyophilized formulation comprises: 2-(4-chlorophenyl)-N-((2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolin-5-yl)methyl)-2,2-difluoroacetamide, or a stereoisomer or mixture of stereoisomers, pharmaceutically acceptable salt, tautomer, prodrug, solvate, hydrate, co-crystal, clathrate, or polymorph thereof (Compound 1), a buffer and a bulking agent.

2. The vial of claim 1 , wherein the lyophilized formulation comprises about 0.1% to about 2% Compound 1 based on the total weight of the lyophilized formulation.

3. The vial of claim 1 , wherein the lyophilized formulation comprises from about 0.1% to about 1% Compound 1 based on the total weight of the lyophilized formulation.

4. The vial of claim 1 , wherein the lyophilized formulation comprises about 0.36% Compound 1 based on the total weight of the lyophilized formulation.

5. The vial of claim 1 , wherein the lyophilized formulation comprises a citrate buffer.

6. The vial of claim 5 , wherein the lyophilized formulation comprises about 5% to about 25% citrate buffer based on total weight of the lyophilized formulation.

7. The vial of claim 5 , wherein citrate buffer comprises anhydrous citric acid and anhydrous sodium citrate.

8. The vial of claim 7 , wherein the citrate buffer comprises about 2% to about 10% anhydrous citric acid based on total weight of the lyophilized formulation.

9. The vial of claim 7 , wherein the citrate buffer comprises about 5% to about 8% anhydrous citric acid based on total weight of the lyophilized formulation.

10. The vial of claim 7 , wherein the citrate buffer comprises about 6% to about 8% anhydrous citric acid based on total weight of the lyophilized formulation.

11. The vial of claim 7 , wherein the citrate buffer comprises about 6.41% anhydrous citric acid based on total weight of the lyophilized formulation.

12. The vial of claim 7 , wherein the citrate buffer comprises about 2% to about 15% anhydrous sodium citrate based on total weight of the lyophilized formulation.

13. The vial of claim 7 , wherein the citrate buffer comprises about 4% to about 10% anhydrous sodium citrate based on total weight of the lyophilized formulation.

14. The vial of claim 7 , wherein the citrate buffer comprises about 6.37% anhydrous sodium citrate based on total weight of the lyophilized formulation.

15. The vial of claim 1 , wherein the bulking agent is selected from the group consisting of mannitol, sulfobutylether-β-cyclodextrin, β-cyclodextrin, hydroxypropyl β-cyclodextrin and methylated β-cyclodextrin.

16. The vial of claim 1 , wherein the bulking agent is hydroxypropyl β-cyclodextrin.

17. The vial of claim 7 , wherein the lyophilized formulation comprises about 70% to about 95% bulking agent based on total weight of the lyophilized formulation.

18. The vial of claim 7 , wherein the lyophilized formulation comprises about 70% to about 95% bulking agent based on total weight of the lyophilized formulation.

19. The vial of claim 16 , wherein the lyophilized formulation comprises about 80% to about 90% hydroxypropyl β-cyclodextrin based on total weight of the lyophilized formulation.

20. The vial of claim 16 , wherein the lyophilized formulation comprises about 86.86% hydroxypropyl β-cyclodextrin based on total weight of the lyophilized formulation.

21. The vial of claim 1 , wherein the lyophilized formulation comprises about 0.1% to about 1% Compound 1, about 6% to about 8% anhydrous citric acid, about 4% to about 10% anhydrous sodium citrate and about 70% to about 95% bulking agent, all based on total weight of the lyophilized formulation.

22. The vial of claim 1 , wherein the lyophilized formulation comprises about 0.36% Compound 1, about 6.41% anhydrous citric acid, about 6.37% anhydrous sodium citrate and about 86.86% bulking agent, all based on total weight of the lyophilized formulation.

23. The vial of claim 1 , wherein the vial is a 20 cc vial.