Pharmaceutical compositions
Methods and compositions are provided which comprise effective amounts of analgesic to treat a subject, including reducing or eliminating an adverse effect associated with the analgesic.
1. A solid pharmaceutical oral dosage form comprising only two active agents:
a controlled-release matrix comprising, an effective amount of a first active agent that is a triptan to treat a headache, wherein the triptan is provided as: from about 25 mg to about 100 mg of sumatriptan, or a pharmaceutically acceptable salt of sumatriptan; and
an immediate-release matrix comprising, an effective amount of a second active agent that is an antiemetic to treat triptan induced nausea or vomiting, wherein the antiemetic is provided as: from about 12.5 mg to about 50 mg of promethazine, or a pharmaceutically acceptable salt of promethazine,
wherein about 90% to about 100% of the first active agent is released by about 60 minutes in a dissolution test as measured by USP Apparatus 2 (Paddle Apparatus), and about 90% to about 100% of the second active agent is released by about 40 minutes in a dissolution test as measured by USP Apparatus 2 (Paddle Apparatus).
2. The solid pharmaceutical oral dosage form of claim 1 , wherein the controlled-release matrix comprises microcrystalline cellulose, polyvinylpyrrolidone, croscarmellose sodium, and magnesium stearate.
3. The solid pharmaceutical oral dosage form of claim 1 , wherein the solid pharmaceutical oral dosage form is multiparticulates.
4. The solid pharmaceutical oral dosage form of claim 3 , wherein the multiparticulates comprise:
controlled-release particulates comprising the triptan, and
immediate-release particulates comprising the antiemetic.
5. The solid pharmaceutical oral dosage form of claim 1 , wherein the immediate-release matrix comprises microcrystalline cellulose and croscarmellose sodium.
6. The solid pharmaceutical oral dosage form of any one of claim 1 , 3 or 4 , wherein about 25 mg of the promethazine is provided.
7. The solid pharmaceutical oral dosage form of any one of claim 1 , 3 or 4 , wherein the triptan is the pharmaceutically acceptable salt of sumatriptan that is sumatriptan succinate.
8. The solid pharmaceutical oral dosage form of any one of claim 1 , 3 or 4 , wherein the antiemetic is the pharmaceutically acceptable salt of promethazine that is promethazine hydrochloride.
9. The solid pharmaceutical oral dosage form of claim 3 or 4 , wherein the multiparticulates are beads, spheres, or pellets.
10. The solid pharmaceutical oral dosage form of claim 3 or 4 , wherein the multiparticulates are enteric-coated.
11. The solid pharmaceutical oral dosage form of claim 3 or 4 , wherein the multiparticulates are contained within a capsule.
12. The solid pharmaceutical oral dosage form of claim 11 , wherein the capsule is a soft gelatin capsule or a hard gelatin capsule.
13. The solid pharmaceutical oral dosage form of claim 11 , wherein the capsule comprises an inner dosage component and an outer dosage component, the outer dosage component being in the form of an envelope over the inner dosage component.
14. The solid pharmaceutical oral dosage form of claim 13 , wherein the inner dosage and outer dosage components are separated by an enteric layer.
15. The solid pharmaceutical oral dosage form of claim 11 , wherein the capsule has micro drilled holes.
16. A method of treating a headache in a subject, comprising administering to the subject the solid pharmaceutical oral dosage form of any one of claim 1 , 3 or 4 .
17. The method of claim 16 , wherein the headache is a migraine headache, a cluster headache, a hemicrania continua headache, a chronic headache, a tension headache, a chronic tension headache, or any combination thereof.
18. The method of claim 16 , wherein the solid pharmaceutical oral dosage form alleviates nausea or vomiting.
19. The solid pharmaceutical oral dosage form of claim 8 , wherein about 25 mg of the promethazine hydrochloride is provided.
20. The multiparticulates of claim 3 or 4 , wherein the triptan is the pharmaceutical acceptable salt of sumatriptan that is sumatriptan succinate; and the antiemetic is the pharmaceutical acceptable salt of promethazine that is promethazine hydrochloride.
21. A method of treating pain in a subject, comprising administering to the subject the solid pharmaceutical oral dosage form of any one of claim 1 , 3 or 4 .
22. A method of treating photophobia in a subject, comprising administering to the subject the solid pharmaceutical oral dosage form of any one of claim 1 , 3 or 4 .
23. The method of claim 22 , wherein the photophobia is associated with a migraine headache.
24. The solid pharmaceutical oral dosage form of claim 1 , further comprising a coating material.
25. The solid pharmaceutical oral dosage form of claim 1 , further comprising polyvinyl alcohol.
26. The solid pharmaceutical oral dosage form of claim 1 , further comprising hydroxypropyl methylcellulose.
27. The solid pharmaceutical oral dosage form of claim 26 , wherein the hydroxypropyl methylcellulose is hydroxypropyl methylcellulose 2910.
28. The solid pharmaceutical oral dosage form of claim 1 , wherein the triptan is provided as from about 25 mg to about 100 mg of sumatriptan.
29. The method of claim 16 , wherein the headache is a migraine headache with or without aura.
30. The method of claim 16 , wherein the headache is acute.