Claims for Patent: 10,603,305
✉ Email this page to a colleague
Summary for Patent: 10,603,305
Title: | Formulations comprising triptan compounds |
Abstract: | The invention provides a pharmaceutical composition for intranasal administration comprising a salt of sumatriptan or a physiologically acceptable solvate thereof, an alkyl glycoside or saccharide alkyl ester and optionally at least one pharmaceutically acceptable excipient, wherein the said composition provides T.sub.max value of less than 30 minutes upon said administration. Other aspects and embodiments are contemplated and described. The invention also provides a pharmaceutical composition for intranasal administration comprising a triptan, a pharmaceutically acceptable vehicle and a mucosal permeation enhancer, wherein upon said administration said composition provides a T.sub.max substantially equivalent to subcutaneous administration of said triptan. Other aspects and embodiments are contemplated and described. |
Inventor(s): | Gandhi; Rajesh (Sagar, IN), Manikonda; Sreekanth (Visakhapatnam, IN), Jana; Arun (Panna, IN), Kunte; Sameer Shrinivas (Mumbai, IN) |
Assignee: | Upsher-Smith Laboratories, LLC (Maple Grove, MN) |
Application Number: | 15/924,881 |
Patent Claims: |
1. A pharmaceutical composition for intranasal administration, comprising: an aqueous buffered solution comprising sumatriptan or a physiologically acceptable solvate thereof, citric
acid monohydrate; and a mucosal permeation enhancer consisting of an alkyl glycoside or saccharide ester selected from 1-O-n-Dodecyl-.beta.-D-Maltopyranoside, tridecyl maltoside, sucrose monododecanoate, sucrose monotridecanoate, and sucrose
monotetradecanoate; wherein said composition comprises 1 molar equivalent of sumatriptan and about 0.3 to 0.6 molar equivalent of citric acid monohydrate, and wherein said composition upon intranasal administration provides a T.sub.max substantially
equivalent to subcutaneous administration of said sumatriptan.
2. The composition as claimed in claim 1, wherein said composition provides T.sub.max value of less than about 30 minutes. 3. The composition as claimed in claim 1, wherein said alkyl glycoside or saccharide alkyl ester is present in a concentration of from about 0.05% to about 3.0%. 4. The composition as claimed in claim 1, wherein said composition provides T.sub.max value of less than about 15 minutes. 5. The composition as claimed in claim 1, wherein said composition upon nasal administration provides AUC.sub.0-2 ranging from about 22 to about 160 ngh/m-L. 6. The composition as claimed in claim 1, wherein said composition administered intranasally for treating human suffering from or susceptible to cephalic pain. 7. The composition as claimed in claim 6, wherein said composition administered intranasally for treating human suffering from or susceptible to migraine. 8. The composition as claimed in claim 6, wherein said composition administered intranasally for treating human suffering from or susceptible to cluster headache. 9. The composition as claimed in claim 1, wherein said composition comprises 2.5 mg to 25 mg of sumatriptan. 10. The composition as claimed in claim 1, wherein said composition is contained in a single dose nasal delivery device and administered into one nostril. 11. A method of treating a human suffering from or susceptible to migraine or cluster headache, comprising: intranasal administration of a composition comprising an aqueous buffered solution comprising sumatriptan or a physiologically acceptable solvate thereof, citric acid monohydrate; and a mucosal permeation enhancer consisting of an alkyl glycoside or saccharide ester selected from 1-O-n-Dodecyl-.beta.-D-Maltopyranoside, tridecyl maltoside, sucrose monododecanoate, sucrose monotridecanoate, and sucrose monotetradecanoate; wherein said composition comprises 1 molar equivalent of sumatriptan and about 0.3 to 0.6 molar equivalent of citric acid monohydrate, and said composition upon intranasal administration provides a T.sub.max substantially equivalent to subcutaneous administration of said sumatriptan. 12. The method as claimed in claim 11, wherein said composition provides T.sub.max value of less than about 30 minutes. 13. The method as claimed in claim 11, wherein said T.sub.max value of less than about 15 minutes. 14. The method as claimed in claim 11, wherein said alkyl glycoside or saccharide ester is present in a concentration of from about 0.05% to about 3.0%. 15. The method as claimed in claim 11, wherein said composition upon nasal administration provides AUC.sub.0-2 ranging from about 22 to about 160 ngh/mL. 16. A method of treating a human suffering from or susceptible to migraine or cluster headache, comprising: intranasal administration of a composition comprising an aqueous buffered solution comprising sumatriptan or a physiologically acceptable solvate thereof, citric acid monohydrate; and a mucosal permeation enhancer consisting of an alkyl glycoside or saccharide ester selected from 1-O-n-Dodecyl-.beta.-D-Maltopyranoside, tridecyl maltoside, sucrose monododecanoate, sucrose monotridecanoate, and sucrose monotetradecanoate; wherein said composition comprises 1 molar equivalent of sumatriptan and about 0.3 to 0.6 molar equivalent of citric acid monohydrate. 17. The method as claimed in claim 16, wherein said composition provides T.sub.max value of less than 30 minutes. 18. The method as claimed in claim 16, wherein said composition provides T.sub.max value of less than 15 minutes. 19. The method as claimed in claim 16, wherein said alkyl glycoside or saccharide ester is present in a concentration of from about 0.05% to about 3.0%. 20. The method as claimed in claim 16, wherein said alkyl glycoside or saccharide alkyl ester comprises 1-O-n-Dodecyl-.beta.-D-Maltopyranoside. 21. The method as claimed in claim 16, wherein said composition upon nasal administration provides AUC.sub.0-2 ranging from about 22 to about 160 ngh/mL. |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.