Compositions for drug administration
View Patent ↗The present invention provides compositions and methods and for increasing the bioavailability of therapeutic agents in a subject, as well as compositions and methods for providing migraine pain relief. The compositions include at least one alkyl glycoside and at least one therapeutic agent, such as a 5-HT receptor agonist, wherein the alkylglycoside has an alkyl chain length from about 10 to about 16 carbon atoms.
1. A method of providing a 5-HT agonist to a subject comprising intranasally administering to the subject a composition, the composition comprising:
i) a 5-HT receptor agonist, wherein the 5-HT agonist is sumatriptan, naratriptan, rizatriptan, eletriptan, frovatriptan, almotriptan, zolmitriptan, salt thereof, or combination thereof; and
ii) an alkylsaccharide, wherein the alkylsaccharide has an alkyl chain including between 10 to 16 carbons, and wherein the Tmax is 20 minutes or less.
2. The method of claim 1 , wherein the alkylsaccharide is undecyl-beta-D- maltoside, dodecyl-beta-D-maltoside, tridecyl-beta-D-maltoside, tetradecyl-beta-D-maltoside, sucrose mono-dodecanoate, or combination thereof.
3. The method of claim 1 , further comprising ethylenediaminetetraacetic acid (EDTA) or a salt thereof.
4. The method of claim 1 , wherein the 5-HT receptor agonist is sumatriptan in an amount of about 20 mg, and further wherein the composition provides an AUC0-1hr of about 10 ng*hr/mL or more and an AUC0-4hr of about 40 ng*hr/mL.
5. The method of claim 1 , wherein the composition has a pH of about 7.0 or less.
6. A method of providing rapid onset of migraine pain relief in a subject comprising intranasally administering to the subject a composition, the
composition comprising:
a) a therapeutically effective amount of a 5-HT receptor agonist, wherein the 5-HT agonist is sumatriptan, naratriptan, rizatriptan, eletriptan, frovatriptan, almotriptan, zolmitriptan, salt thereof, or combination thereof; and
b) an alkylsaccharide, wherein the alkylsaccharide has an alkyl chain including between 10 to 16 carbons, and
wherein the composition exhibits a Tmax of 20 minutes or less in the subject, thereby providing rapid onset of migraine pain relief.
7. The method of claim 6 , wherein the alkylsaccharide is undecyl-beta-D- maltoside, dodecyl-beta-D-maltoside, tridecyl-beta-D-maltoside, tetradecyl-beta-D-maltoside, sucrose mono-dodecanoate, or combination thereof.
8. The method of claim 6 , further comprising ethylenediaminetetraacetic acid (EDTA) or a salt thereof.
9. The method of claim 6 , wherein the composition has a pH of about 7.0 or less.
10. A method of providing a reduced incidence of migraine pain recurrence in a subject comprising intranasally administering to the subject a
composition, the composition comprising:
a) a therapeutically effective amount of a 5-HT receptor agonist, wherein the 5-HT agonist is sumatriptan, naratriptan, rizatriptan, eletriptan, frovatriptan, almotriptan, zolmitriptan, salt thereof, or combination thereof; and
b) an alkylsaccharide, wherein the alkylsaccharide has an alkyl chain including between 10 to 16 carbons, and
wherein the composition provides a Tmax of 20 minutes or less, thereby providing a reduced incidence of migraine pain recurrence in the subject.
11. The method of claim 10 , wherein the alkylsaccharide is undecyl-beta-D- maltoside, dodecyl-beta-D-maltoside, tfidecyl-beta-D-maltoside, tetradecyl-beta-D-maltoside, sucrose mono-dodecanoate, or combination thereof.
12. The method of claim 10 , further comprising ethylenediaminetetraacetic acid (EDTA) or a salt thereof.
13. The method of claim 10 , wherein the composition has a pH of about 7.0 or less.