JPWO2021142288A5 - Nalbuphine preparations administered to treat nalbuphine-treatable disorders - Google Patents

Claims (46)

A nalbuphine formulation comprising nalbuphine or a pharmaceutically acceptable salt or ester thereof, which is administered to a patient with liver impairment to treat a nalbuphine-treatable disorder,
Treating the nalbuphine treatable disorder comprises:
(a) determining a Child-Pugh score for the patient;
(b) administering to a patient with a Child-Pugh score of A a daily dose of nalbuphine or a pharmaceutically acceptable salt or ester thereof ranging from about 15 mg to about 360 mg;
(c) administering to a patient with a Child-Pugh score of B a daily dose of nalbuphine or a pharmaceutically acceptable salt thereof ranging from about 4 mg to about 120 mg;
(d) administering to a patient with a Child-Pugh score of C a daily dose of nalbuphine or a pharmaceutically acceptable salt thereof ranging from about 2 mg to about 45 mg;
The nalbuphine treatable disorder is a nalbuphine preparation selected from the group consisting of chronic cough, pruritus, pruritus associated with liver disease, prurigo nodularis, urinary tract pruritus, tardive dyskinesia, Huntington's disease, and levodopa-induced dyskinesia (LID). . 2. The nalbuphine formulation according to claim 1, wherein the patient has a Child-Pugh score of A. 3. The nalbuphine formulation of claim 2, wherein the daily dose is an equivalent amount of nalbuphine free base ranging from about 14 mg to about 324 mg. 3. The nalbuphine formulation of claim 2, wherein the equivalent of about 28 mg of nalbuphine free base is administered once a day. 3. The nalbuphine formulation of claim 2, wherein the equivalent of about 28 mg of nalbuphine free base is administered twice daily. 3. The nalbuphine formulation of claim 2, wherein the equivalent of about 54 mg of nalbuphine free base is administered once a day. 3. The nalbuphine formulation of claim 2, wherein the equivalent of about 54 mg of nalbuphine free base is administered twice daily. 3. The nalbuphine formulation of claim 2, wherein the equivalent of about 81 mg of nalbuphine free base is administered once a day. 3. The nalbuphine formulation of claim 2, wherein the equivalent of about 81 mg of nalbuphine free base is administered twice daily. 3. The nalbuphine formulation of claim 2, wherein the equivalent of about 108 mg of nalbuphine free base is administered once a day. 3. The nalbuphine formulation of claim 2, wherein the equivalent of about 108 mg of nalbuphine free base is administered twice daily. 3. The nalbuphine formulation of claim 2, wherein the equivalent of about 162 mg of nalbuphine free base is administered once daily. 3. The nalbuphine formulation of claim 2, wherein the equivalent of about 162 mg of nalbuphine free base is administered twice daily. 3. The nalbuphine formulation of claim 2, wherein the equivalent of about 324 mg of nalbuphine free base is administered once daily. 15. The nalbuphine formulation of any one of claims 1-14, wherein treating the nalbuphine-treatable disorder further comprises titrating the dose for about 7 to 30 days. 15. The nalbuphine formulation of any one of claims 1-14, wherein treating the nalbuphine-treatable disorder further comprises titrating the dose for about 7 to 14 days. 2. The nalbuphine formulation according to claim 1, wherein the patient has a Child-Pugh score of B. 2. The nalbuphine formulation according to claim 1, wherein the patient has a Child-Pugh score of C. 18. The nalbuphine formulation of claim 17, wherein the daily dose is an equivalent amount of nalbuphine free base ranging from about 3 mg to about 108 mg. 19. A nalbuphine formulation according to claim 17 or 18, wherein the equivalent of about 6 mg of nalbuphine free base is administered once a day. 19. A nalbuphine formulation according to claim 17 or 18, wherein the equivalent of about 6 mg of nalbuphine free base is administered twice a day. 19. A nalbuphine formulation according to claim 17 or 18, wherein the equivalent of about 9 mg of nalbuphine free base is administered once a day. 19. A nalbuphine formulation according to claim 17 or 18, wherein the equivalent of about 9 mg of nalbuphine free base is administered twice a day. 19. A nalbuphine formulation according to claim 17 or 18, wherein the equivalent of about 14 mg of nalbuphine free base is administered once a day. 19. A nalbuphine formulation according to claim 17 or 18, wherein the equivalent of about 14 mg of nalbuphine free base is administered twice a day. 19. A nalbuphine formulation according to claim 17 or 18, wherein the equivalent of about 18 mg of nalbuphine free base is administered once a day. 19. A nalbuphine formulation according to claim 17 or 18, wherein the equivalent of about 18 mg of nalbuphine free base is administered twice a day. 18. The nalbuphine formulation of claim 17, wherein the equivalent of about 28 mg of nalbuphine free base is administered once a day. 18. The nalbuphine formulation of claim 17, wherein the equivalent of about 28 mg of nalbuphine free base is administered twice daily. 18. The nalbuphine formulation of claim 17, wherein the equivalent of about 36 mg of nalbuphine free base is administered once a day. 18. The nalbuphine formulation of claim 17, wherein the equivalent of about 36 mg of nalbuphine free base is administered twice daily. 18. The nalbuphine formulation of claim 17, wherein the equivalent of about 54 mg of nalbuphine free base is administered once daily. 18. The nalbuphine formulation of claim 17, wherein the equivalent of about 54 mg of nalbuphine free base is administered twice daily. 19. The nalbuphine formulation of claim 18, wherein the daily dose is an equivalent amount of nalbuphine free base ranging from about 2 mg to about 41 mg. 19. The nalbuphine formulation of claim 18, wherein an equivalent amount of nalbuphine free base ranging from about 2 mg to about 7 mg is administered once daily. 19. The nalbuphine formulation of claim 18, wherein an equivalent amount of nalbuphine free base ranging from about 2 mg to about 7 mg is administered twice daily. 19. The nalbuphine formulation of claim 18, wherein an equivalent amount of nalbuphine free base ranging from about 9 mg to about 14 mg is administered once daily. 19. The nalbuphine formulation of claim 18, wherein an equivalent amount of nalbuphine free base ranging from about 9 mg to about 14 mg is administered twice daily. 19. The nalbuphine formulation of claim 18, wherein an equivalent amount of nalbuphine free base ranging from about 18 mg to about 27 mg is administered once daily. 19. The nalbuphine formulation of claim 18, wherein the equivalent of about 18 mg to about 27 mg of nalbuphine free base is administered twice daily. 19. The nalbuphine formulation of claim 18, wherein the equivalent of about 27 mg of nalbuphine free base is administered once daily. 19. The nalbuphine formulation of claim 18, wherein the equivalent of about 27 mg of nalbuphine free base is administered twice daily. 19. The nalbuphine formulation of any one of claims 17-18, wherein treating the nalbuphine-treatable disorder further comprises titrating the dose for about 7 to 30 days. 19. The nalbuphine formulation of any one of claims 17-18, wherein treating the nalbuphine-treatable disorder further comprises titrating the dose for about 7 to 14 days. 43. The nalbuphine formulation of claim 19 or any one of claims 28-42, wherein treating the nalbuphine-treatable disorder further comprises titrating the dose for about 7 to 30 days. 43. The nalbuphine formulation of claim 19 or any one of claims 28-42, wherein treating the nalbuphine-treatable disorder further comprises titrating the dose for about 7 to 14 days.