Pharmaceutical compositions comprising 5HT receptor agonist and antiemetic particulates
First Claim
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1. A pharmaceutical composition comprising:
- a plurality of first particulates, wherein each first particulate comprises;
a 5HT1B/1D receptor agonist wherein;
(a) each first particulate has an average diameter of less than about 500 μ
m;
or (b) each first particulate comprises from about 55% to about 65% of the 5HT1B/1D receptor agonist (w/w); and
a plurality of second particulates, wherein each second particulate comprises;
(i) a core; and
(ii) a layer enclosing the core, wherein said layer comprises an antiemetic, andwherein the pharmaceutical composition is in a solid oral dosage form.
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Abstract
Pharmaceutical compositions and methods are provided to treat headache, headache-associated symptoms, photophobia, or adverse effects associated with the headache. Also provided herein are small smooth particulates comprising a 5HT1B/1D receptor agonist. Compositions for oral administration are described herein wherein the compositions comprise a combination of active agents, such as a 5HT1B/1D receptor agonist and one or more antiemetics.
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Citations
34 Claims
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1. A pharmaceutical composition comprising:
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a plurality of first particulates, wherein each first particulate comprises;
a 5HT1B/1D receptor agonist wherein;
(a) each first particulate has an average diameter of less than about 500 μ
m;
or (b) each first particulate comprises from about 55% to about 65% of the 5HT1B/1D receptor agonist (w/w); anda plurality of second particulates, wherein each second particulate comprises; (i) a core; and (ii) a layer enclosing the core, wherein said layer comprises an antiemetic, and wherein the pharmaceutical composition is in a solid oral dosage form. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 28, 29)
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15. A capsule comprising a pharmaceutical composition comprising:
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a plurality of first particulates, wherein each first particulate comprises;
a 5HT1B/1D receptor agonist wherein;
(a) each first particulate has an average diameter of less than about 500 μ
m;
or (b) each first particulate comprises from about 55% to about 65% of the 5HT1B/1D receptor agonist (w/w); anda plurality of second particulates, wherein each second particulate comprises; (i) a core; and (ii) a layer enclosing the core, wherein said layer comprises an antiemetic, and wherein the pharmaceutical composition is in a solid oral dosage form. - View Dependent Claims (16, 17, 18, 19, 20, 21, 22)
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23. A capsule comprising a pharmaceutical composition comprising:
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a plurality of first particulates, wherein each first particulate comprises; (i) about 100 mg to about 140 mg of sumatriptan succinate; and (ii) about 50 mg to about 150 mg of microcrystalline cellulose; and a plurality of second particulates, wherein each second particulate comprises; (i) about 10 mg to about 60 mg of promethazine hydrochloride; (ii) about 30 mg to about 150 mg of a sugar sphere; (iii) about 2.5 mg to about 15 mg of hydroxypropyl methylcellulose (HPMC); (iv) about 0.5 mg to about 10 mg of talc; (v) about 0.5 mg to about 10 mg of low-substituted hydroxypropyl cellulose (L-HPC); and (vi) about 5 mg to about 30 mg of a coating, wherein the promethazine hydrochloride, the HPMC, the talc, and the L-HPC are present in a layer enclosing the sugar sphere, and wherein the pharmaceutical composition is in a solid oral dosage form. - View Dependent Claims (24, 25)
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26. A method of treating a headache in a subject in need thereof, comprising administering to the subject a pharmaceutical composition comprising:
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a plurality of first particulates, wherein each first particulate comprises;
a 5HT1B/1D receptor agonist wherein;
(a) each first particulate has an average diameter of less than about 500 μ
m;
or (b) each first particulate comprises from about 55% to about 65% of the 5HT1B/1D receptor agonist (w/w); anda plurality of second particulates, wherein each second particulate comprises; (i) a core; and (ii) a layer enclosing the core, wherein said layer comprises an antiemetic. - View Dependent Claims (27, 30, 31, 32, 33, 34)
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Specification