Claims for Patent: 12,545,645

Summary for Patent: 12,545,645

Title:	Crystalline salts of a plasma kallikrein inhibitor
Abstract:	Disclosed are crystalline salts of Compound I, methods of preparing them, and related pharmaceutical preparations thereof. Also disclosed are methods of treatment using the crystalline salts of the invention.
Inventor(s):	Yahya El-Kattan, Yarlagadda S. Babu
Assignee:	Biocryst Pharmaceuticals Inc
Application Number:	US19/312,645
Patent Claims:	1. A crystalline salt of compound I, wherein the crystalline salt is a bis(hydrochloride) salt complexed with water in a molar ratio of less than 1:2.5 of the crystalline salt to water. 2. The crystalline salt of claim 1, wherein the molar ratio is 1:1 of the crystalline salt to water. 3. The crystalline salt of claim 1, wherein the molar ratio is 1:2 of the crystalline salt to water. 4. The crystalline salt of claim 1, wherein the molar ratio is 1:2.5 of the crystalline salt to water. 5. The crystalline salt of claim 1, wherein the crystalline salt has an XRPD pattern substantially similar to that shown in FIG. 1 . 6. The crystalline salt of claim 2, wherein the crystalline salt has an XRPD pattern substantially similar to that shown in FIG. 1 . 7. The crystalline salt of claim 3, wherein the crystalline salt has an XRPD pattern substantially similar to that shown in FIG. 1 . 8. The crystalline salt of claim 4, wherein the crystalline salt has an XRPD pattern substantially similar to that shown in FIG. 1 . 9. A pharmaceutical composition comprising a crystalline salt of compound I, and one or more pharmaceutically acceptable carriers, wherein said composition is for oral administration, and wherein the crystalline salt that is formulated with the one or more pharmaceutically acceptable carriers is a bis(hydrochloride) salt complexed with water in a molar ratio of less than 1:2.5 of the crystalline salt to water. 10. The pharmaceutical composition of claim 9, wherein the molar ratio is 1:1 of the crystalline salt to water. 11. The pharmaceutical composition of claim 9, wherein the molar ratio is 1:2, of the crystalline salt to water. 12. The pharmaceutical composition of claim 9, wherein the molar ratio is 1:2.5 of the crystalline salt to water. 13. The pharmaceutical composition of claim 9, wherein said composition contains a therapeutically effective amount of said crystalline salt for prophylaxis to prevent attacks of hereditary angioedema. 14. The pharmaceutical composition of claim 10, wherein said composition contains a therapeutically effective amount of said crystalline salt for prophylaxis to prevent attacks of hereditary angioedema. 15. The pharmaceutical composition of claim 11, wherein said composition contains a therapeutically effective amount of said crystalline salt for prophylaxis to prevent attacks of hereditary angioedema. 16. The pharmaceutical composition of claim 12, wherein said composition contains a therapeutically effective amount of said crystalline salt for prophylaxis to prevent attacks of hereditary angioedema. 17. The pharmaceutical composition of claim 13, wherein said composition is an oral dosage form comprising about 125 to about 175 mg of the crystalline salt. 18. The pharmaceutical composition of claim 14, wherein said composition is an oral dosage form comprising about 125 to about 175 mg of the crystalline salt. 19. The pharmaceutical composition of claim 15, wherein said composition is an oral dosage form comprising about 125 to about 175 mg of the crystalline salt. 20. The pharmaceutical composition of claim 16, wherein said composition is an oral dosage form comprising about 125 to about 175 mg of the crystalline salt. 21. The pharmaceutical composition of claim 17, wherein the hereditary angioedema is type I hereditary angioedema or type II hereditary angioedema. 22. The pharmaceutical composition of claim 18, wherein the hereditary angioedema is type I hereditary angioedema or type II hereditary angioedema. 23. The pharmaceutical composition of claim 19, wherein the hereditary angioedema is type I hereditary angioedema or type II hereditary angioedema. 24. The pharmaceutical composition of claim 20, wherein the hereditary angioedema is type I hereditary angioedema or type II hereditary angioedema. 25. The pharmaceutical composition of claim 9, wherein the crystalline salt that is formulated with the one or more pharmaceutically acceptable carriers has an XRPD pattern substantially similar to that shown in FIG. 1 . 26. The pharmaceutical composition of claim 10, wherein the crystalline salt that is formulated with the one or more pharmaceutically acceptable carriers has an XRPD pattern substantially similar to that shown in FIG. 1 . 27. The pharmaceutical composition of claim 11, wherein the crystalline salt that is formulated with the one or more pharmaceutically acceptable carriers has an XRPD pattern substantially similar to that shown in FIG. 1 . 28. The pharmaceutical composition of claim 12, wherein the crystalline salt that is formulated with the one or more pharmaceutically acceptable carriers has an XRPD pattern substantially similar to that shown in FIG. 1 .