Claims for Patent: 11,541,043

Summary for Patent: 11,541,043

Title:	Low concentration delivery of an ergoline derivative for treatment of a headache
Abstract:	Provided are ergoline derivative containing medicaments disposed within a preassembled, prefilled, single-use delivery device, methods for administering a medicament using a preassembled, prefilled, single-use delivery device, and systems or kits that contain one or more preassembled, prefilled, single-use devices and user instructions, such as for treatment of a migraine or other headache.
Inventor(s):	Ralph Solarski, Robert Edward Malone
Assignee:	Relevale Inc
Application Number:	US17/841,042
Patent Claims:	1. A parenteral pharmaceutical composition comprising dihydroergotamine or a pharmaceutically acceptable salt thereof at a concentration of about 1 mg/mL and one or more pH maintaining or pH adjusting agents, wherein pH of the composition is between about 3 to about 5, the composition being contained in a preassembled, prefilled, single-use delivery device that is capable of delivering a dose of between about 0.5 to about 3 mg of the dihydroergotamine or the pharmaceutically acceptable salt thereof to a patient and is not user adjustable with respect to dosage or dosing rate. 2. The composition of claim 1, wherein the one or more pH maintaining or pH adjusting agents includes a buffer. 3. The composition of claim 2, wherein pH of the composition is maintained between 3.4 and 4.9. 4. The composition of claim 1, wherein pH of the composition is maintained between 3.4 and 4.9. 5. The composition of claim 1, wherein the dihydroergotamine or the pharmaceutically acceptable salt thereof is dihydroergotamine mesylate. 6. The composition of claim 5, wherein the dose is about 1 mg of dihydroergotamine mesylate. 7. The composition of claim 6, wherein the single-use delivery device is an autoinjector that includes a tension spring, and a rate of dosing depends on the degree of tension in the tension spring. 8. The composition of claim 7, wherein the tension spring has a predetermined amount of tension so as to provide a desired dosing rate. 9. The composition of claim 8, wherein the predetermined amount of tension is preloaded. 10. The composition of claim 6, wherein the single-use delivery device is an autoinjector that includes a dosing mechanism comprising an injection spring having a degree of compression applied thereto, and a rate of dosing that depends on the degree of compression applied to the injection spring. 11. The composition of claim 10, wherein the degree of compression of the injection spring is predetermined so as to provide a predetermined dosing rate and is not user adjustable. 12. The composition of claim 1, wherein the one or more pH maintaining or pH adjusting agents prevent any sudden change in pH of the composition. 13. The composition of claim 1, wherein the single-use delivery device further comprises a trigger mechanism for actuating an actuating lever maintained under pressure in an armed position. 14. The composition of claim 1, wherein the composition is contained in the single-use delivery device by a plunger. 15. The composition of claim 1, wherein the composition is contained in the single-use delivery device by a plunger until activated by a trigger. 16. The composition of claim 15 wherein the single-use delivery device further comprises a pawl member that releasably interfaces with a retainer in an armed position until the pawl member is released from the retainer by the trigger to activate the plunger. 17. The composition of claim 15, wherein the trigger activates a piston rod depressing the plunger and delivering the dose through an injection needle. 18. The composition of claim 1, wherein the single-use delivery device further comprises a moveable safety shield that is moveable about an injection needle to protect against inadvertent contact with the injection needle. 19. The composition of claim 1, wherein the single-use delivery device further comprises a piston rod retained in an armed position keeping a tension spring under compression, the piston rod being in contact with a plunger, and when a trigger is actuated, the piston rod is released from its retainer and urged forward by the tension spring. 20. The composition of claim 1, wherein the single-use delivery device further comprises a suction cup facilitating removal of a safety cap.