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Claims for Patent: 9,333,204

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Claims for Patent: 9,333,204

Title:Solid antiviral dosage forms
Abstract: The present disclosure relates to solid dosage forms comprising antiviral compounds and methods of using such dosage forms to treat antiviral infection.
Inventor(s): Miller; Jonathan M. (Lindenhurst, ID), Morris; John B. (Grayslake, IL), Sever; Nancy E. (Northbrook, IL), Schmitt; Eric A. (Libertyville, IL), Gao; Ping X. (Highland Park, IL), Shi; Yi (Libertyville, IL), Gao; Yi (Vernon Hills, IL), Liepold; Bernd (Dossenheim, DE), Moosmann; Anna (Winterbach, DE), Pauli; Mirko (Ludwigshafen, DE), Durak; Fatih (Ludwigshafen, DE), Kessler; Thomas (Schifferstadt, DE), Hoelig; Peter A. (Waechtersbach, DE), Rosenblatt; Karin (Mannheim, DE), Kostelac; Drazen (Mannheim, DE), Gokhale; Rajeev (Singapore, SG), Costello; Mark (Chicago, IL), Knable; Carl (Elmhurst, IL)
Assignee: AbbVie Inc. (North Chicago, IL)
Application Number:14/677,611
Patent Claims: 1. A solid dosage form comprising a first composition and a second composition, wherein: the first composition comprises 50 mg of ##STR00011## 8.33 mg of ##STR00012## 33.33 mg of ritonavir, 70-85% by weight of copovidone; and 5% to 10% by weight of a pharmaceutically acceptable surfactant or a combination of pharmaceutically acceptable surfactants, wherein all percentages are weight percentages relative to the total weight of the first composition, and wherein Compound 1, Compound 2 and ritonavir are formulated in amorphous solid dispersion; the second composition comprises 216.2 mg sodium monohydrate salt of ##STR00013## 20-40% copovidone, and 20-40% hypromellose, wherein all percentages are weight percentages relative to the total weight of the second composition; when dissolved in 900 mL of a dissolution medium using a standard USP dissolution Apparatus 2 (paddle) operating at 100 RPM at 37.degree. C., 50-60% Compound 1 in the solid dosage form is released within 1 hour, 50-60% Compound 2 in the solid dosage form is released within 1 hour, 50-60% ritonavir in the solid dosage form is released within 1 hour, and 0.5-2% Compound 4 in the solid dosage form is released within 1 hour, wherein the dissolution medium is 0.05 M sodium phosphate buffer (pH 6.8) with 15 mM cetyltrimethylammonium bromide (cTAB), and the total weight of the solid dosage form is 1200-1400 mg.

2. A method for treating hepatitis C virus (HCV) infection in a patient in need of such treatment, wherein the method comprises administering once daily to the patient at least one solid dosage form of claim 1.

3. A method for treating HCV infection in a patient in need of such treatment, wherein the method comprises administering once daily to the patient three solid dosage forms of claim 1.

4. A solid dosage form comprising a first composition and a second composition, wherein: the first composition comprises 50 mg of Compound 1, 8.33 mg of Compound 2, 33.33 mg of ritonavir, 70-85% by weight of copovidone; and 5% to 10% by weight of a pharmaceutically acceptable surfactant or a combination of pharmaceutically acceptable surfactants, wherein all percentages are weight percentages relative to the total weight of the first composition, and wherein Compound 1, Compound 2 and ritonavir are formulated in amorphous solid dispersion; the second composition comprises 216.2 mg sodium monohydrate salt of Compound 4, 20-40% copovidone, and 20-40% hypromellose, wherein all percentages are weight percentages relative to the total weight of the second composition; when dissolved in 900 mL of a dissolution medium using a standard USP dissolution Apparatus 2 (paddle) operating at 100 RPM at 37.degree. C., 95-100% Compound 1 in the solid dosage form is released within 4 hours, 95-100% Compound 2 in the solid dosage form is released within 4 hours, 95-100% ritonavir in the solid dosage form is released within 4 hours, and 10-15% Compound 4 in the solid dosage form is released within 4 hours, wherein the dissolution medium is 0.05 M sodium phosphate buffer (pH 6.8) with 15 mM cTAB, and the total weight of the solid dosage form is 1200-1400 mg.

5. A method for treating HCV infection in a patient in need of such treatment, wherein the method comprises administering once daily to the patient at least one solid dosage form of claim 4.

6. A method for treating HCV infection in a patient in need of such treatment, wherein the method comprises administering once daily to the patient three solid dosage forms of claim 4.

7. A solid dosage form comprising a first composition and a second composition, wherein: the first composition comprises 50 mg of Compound 1, 8.33 mg of Compound 2, 33.33 mg of ritonavir, 70-85% by weight of copovidone; and 5% to 10% by weight of a pharmaceutically acceptable surfactant or a combination of pharmaceutically acceptable surfactants, wherein all percentages are weight percentages relative to the total weight of the first composition, and wherein Compound 1, Compound 2 and ritonavir are formulated in amorphous solid dispersion; the second composition comprises 216.2 mg sodium monohydrate salt of Compound 4, 20-40% copovidone, and 20-40% hypromellose, wherein all percentages are weight percentages relative to the total weight of the second composition; when dissolved in 900 mL of a dissolution medium using a standard USP dissolution Apparatus 2 (paddle) operating at 100 RPM at 37.degree. C., 95-100% Compound 1 in the solid dosage form is released within 6 hours, 95-100% Compound 2 in the solid dosage form is released within 6 hours, 95-100% ritonavir in the solid dosage form is released within 6 hours, and 15-20% Compound 4 in the solid dosage form is released within 6 hours, wherein the dissolution medium is 0.05 M sodium phosphate buffer (pH 6.8) with 15 mM cTAB, and the total weight of the solid dosage form is 1200-1400 mg.

8. A method for treating HCV infection in a patient in need of such treatment, wherein the method comprises administering once daily to the patient at least one solid dosage form of claim 7.

9. A method for treating HCV infection in a patient in need of such treatment, wherein the method comprises administering once daily to the patient three solid dosage forms of claim 7.

10. A solid dosage form comprising a first composition and a second composition, wherein: the first composition comprises 50 mg of Compound 1, 8.33 mg of Compound 2, 33.33 mg of ritonavir, 70-85% by weight of copovidone; and 5% to 10% by weight of a pharmaceutically acceptable surfactant or a combination of pharmaceutically acceptable surfactants, wherein all percentages are weight percentages relative to the total weight of the first composition, and wherein Compound 1, Compound 2 and ritonavir are formulated in amorphous solid dispersion; the second composition comprises 216.2 mg sodium monohydrate salt of Compound 4, 20-40% copovidone, and 20-40% hypromellose, wherein all percentages are weight percentages relative to the total weight of the second composition; when dissolved in 900 mL of a dissolution medium using a standard USP dissolution Apparatus 2 (paddle) operating at 100 RPM at 37.degree. C., 100% Compound 1 in the solid dosage form is released within 8 hours, 100% Compound 2 in the solid dosage form is released within 8 hours, 100% ritonavir in the solid dosage form is released within 8 hours, 20-30% Compound 4 in the solid dosage form is released within 8 hours, 30-40% Compound 4 in the solid dosage form is released within 12 hours, and 40-60% Compound 4 in the solid dosage form is released within 16 hours, wherein the dissolution medium is 0.05 M sodium phosphate buffer (pH 6.8) with 15 mM cTAB, and the total weight of the solid dosage form is 1200-1400 mg.

11. A method for treating HCV infection in a patient in need of such treatment, wherein the method comprises administering once daily to the patient at least one solid dosage form of claim 10.

12. A method for treating HCV infection in a patient in need of such treatment, wherein the method comprises administering once daily to the patient three solid dosage forms of claim 10.

13. A solid dosage form comprising a first composition and a second composition, wherein: the first composition comprises 50 mg of Compound 1, 8.33 mg of Compound 2, 33.33 mg of ritonavir, 70-85% by weight of copovidone; and 5% to 10% by weight of a pharmaceutically acceptable surfactant or a combination of pharmaceutically acceptable surfactants, wherein all percentages are weight percentages relative to the total weight of the first composition, and wherein Compound 1, Compound 2 and ritonavir are formulated in amorphous solid dispersion; the second composition comprises 216.2 mg sodium monohydrate salt of Compound 4, 20-40% copovidone, and 20-40% hypromellose, wherein all percentages are weight percentages relative to the total weight of the second composition; when dissolved in 900 mL of a dissolution medium using a standard USP dissolution Apparatus 2 (paddle) operating at 100 RPM at 37.degree. C., 100% Compound 1 in the solid dosage form is released within 8 hours, 100% Compound 2 in the solid dosage form is released within 8 hours, 100% ritonavir in the solid dosage form is released within 8 hours, 20-30% Compound 4 in the solid dosage form is released within 8 hours, 30-40% Compound 4 in the solid dosage form is released within 12 hours, 40-60% Compound 4 in the solid dosage form is released within 16 hours, and 60-80% Compound 4 in the solid dosage form is released within 24 hours, wherein the dissolution medium is 0.05 M sodium phosphate buffer (pH 6.8) with 15 mM cTAB, and the total weight of the solid dosage form is 1200-1400 mg.

14. A method for treating HCV infection in a patient in need of such treatment, wherein the method comprises administering once daily to the patient at least one solid dosage form of claim 13.

15. A method for treating HCV infection in a patient in need of such treatment, wherein the method comprises administering once daily to the patient three solid dosage forms of claim 13.
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