Crystalline salts of a plasma kallikrein inhibitor
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.
1. A method of treating hereditary angioedema, comprising administering to a subject in need a pharmaceutical composition comprising a bis(hydrochloride) crystalline salt of Compound I,
and a pharmaceutically acceptable carrier;
wherein the pharmaceutical composition is an oral dosage form; and the oral dosage form contains about 75 mg to about 250 mg of the bis(hydrochloride) crystalline salt of Compound I.
2. The method of claim 1 , wherein the oral dosage form contains about 75 mg to about 175 mg of the bis(hydrochloride) crystalline salt of Compound I.
3. The method of claim 1 , wherein the oral dosage form contains about 100 mg to about 250 mg of the bis(hydrochloride) crystalline salt of Compound I.
4. The method of claim 1 , wherein the oral dosage form contains about 100 mg to about 200 mg of the bis(hydrochloride) crystalline salt of Compound I.
5. The method of claim 1 , wherein the oral dosage form contains about 100 mg to about 175 mg of the bis(hydrochloride) crystalline salt of Compound I.
6. The method of claim 1 , wherein the oral dosage form contains about 125 mg to about 250 mg of the bis(hydrochloride) crystalline salt of Compound I.
7. The method of claim 1 , wherein the oral dosage form contains about 125 mg to about 200 mg of the bis(hydrochloride) crystalline salt of Compound I.
8. The method of claim 1 , wherein the oral dosage form contains about 125 mg to about 175 mg of the bis(hydrochloride) crystalline salt of Compound I.
9. The method of claim 1 , wherein the oral dosage form contains about 100 mg of the bis(hydrochloride) crystalline salt of Compound I.
10. The method of claim 1 , wherein the oral dosage form contains about 125 mg of the bis(hydrochloride) crystalline salt of Compound I.
11. The method of claim 1 , wherein the oral dosage form contains about 150 mg of the bis(hydrochloride) crystalline salt of Compound I.
12. The method of claim 1 , wherein the oral dosage form contains about 175 mg of the bis(hydrochloride) crystalline salt of Compound I.
13. The method of claim 1 , wherein the oral dosage form contains about 200 mg of the bis(hydrochloride) crystalline salt of Compound I.
14. The method of claim 1 , wherein the oral dosage form is a capsule, an ingestible tablet, a buccal tablet, a troche, an elixir, a suspension, a syrup, a powder, or a wafer.
15. The method of claim 14 , wherein the oral dosage form is a capsule.
16. The method of claim 1 , wherein the hereditary angioedema is type I hereditary angioedema, type II hereditary angioedema, or type III hereditary angioedema.