Claims for Patent: 11,931,559

Summary for Patent: 11,931,559

Title:	Systems and methods for mixing syringe valve assemblies
Abstract:	A syringe mixing system is provided for housing and mixing contents between at least two syringes. In some embodiments, a syringe coupler is provided that receives first and second syringes and includes a valve member that is convertible between a closed position and an open position. Retention systems for preventing or inhibiting removal of at least one syringe after use are also provided.
Inventor(s):	James Sherman, Casey Dean, Carl Hart, John Bingham, Hossam Aboudagher
Assignee:	Tolmar International Ltd
Application Number:	US18/233,193
Patent Claims:	1. A method for mixing a pharmaceutic composition, comprising: providing a syringe mixing system, the system comprising a valve assembly with a displaceable member comprising a user-interface and a guide member, wherein the displaceable member is slidable relative to the guide member, and wherein the user-interface is operable to receive a force from a user and transmit the force to a displaceable seal; a selectively rotatable member operable to receive a syringe; wherein the valve assembly composes a first position wherein a fluid flow through the assembly is fully occluded, and a second position in which fluid is allowed to flow; wherein the displaceable member comprises at least one projection in communication with the selectively rotatable member when the displaceable member is in the first position, and wherein the at least one projection is spaced apart from the selectively rotatable member when the displaceable member is in the second position and the selectively rotatable member is freely rotatable when the displaceable member is in the second position; coupling a first syringe and a second syringe to the valve assembly, wherein the first syringe and the second syringe each comprise a syringe barrel with a hollow body defining an internal chamber, wherein the syringe barrel has a proximal end and a distal dispensing end with an outlet, and a plunger slidably disposed within the hollow body for applying pressure to a syringe content housed within the internal chamber; displacing the displaceable member relative to the guide member in a direction substantially perpendicular to a longitudinal axis of at least one of the first syringe and the second; and cyclically mixing contents between the first syringe and the second syringe to prepare the contents for delivery to a patient. 2. The method of claim 1, wherein the pharmaceutical composition comprises about 7.5 mg of leuprolide acetate as the active pharmaceutical ingredient and N-methyl-2-pyrrolidone and a 50:50 poly(lactic acid-co-glycolic acid) (PLGA) copolymer having a weight average molecular weight from about 31 kDa to about 45 kDa and at least one terminal carboxylic acid end group as the liquid formulation component. 3. The method of claim 1, wherein the pharmaceutical composition comprises about 22.5 mg of leuprolide acetate as the active pharmaceutical ingredient and N-methyl-2-pyrrolidone, and a 75:25 poly(lactide-co-glycolide) (PLG) copolymer having a weight average molecular weight from about 17 kDa to about 21 kDa and end groups that are hydroxyl-terminated as the liquid formulation component. 4. The method of claim 1, wherein the pharmaceutical composition comprises about 30 mg of leuprolide acetate as the active pharmaceutical ingredient and N-methyl-2-pyrrolidone, and a 75:25 poly(lactide-co-glycolide) (PLG) copolymer having a weight average molecular weight from about 17 kDa to about 21 kDa and one distal end group that is hydroxyl-terminated and the other distal end group that is either hydroxyl-terminated or ester-terminated as the liquid formulation component. 5. The method of claim 1, wherein the pharmaceutical composition comprises about 45 mg of leuprolide acetate as the active pharmaceutical ingredient and N-methyl-2-pyrrolidone, and a 85:15 poly(lactide-co-glycolide) (PLG) copolymer having a weight average molecular weight from about 20 kDa to about 26 kDa and one distal end group that is hydroxyl-terminated and the other distal end group that is either hydroxyl-terminated or ester-terminated as the liquid formulation component. 6. A method for mixing a pharmaceutic composition, comprising: providing a syringe mixing system, the system comprising a valve assembly with a displaceable member comprising a user-interface and a guide member, wherein the displaceable member is slidable relative to the guide member, and wherein the user-interface is operable to receive a force from a user and transmit the force to a displaceable seal; wherein the displaceable member comprises at least one resilient projection and the guide member comprises at least one recess for receiving the at least one resilient projection; and wherein the at least one resilient projection is operable to be displaced upon movement of the displaceable member from a first position and wherein the at least one resilient projection prevents or inhibits the displaceable member from being returned to the first position when it is provided in the at least one recess of the guide member; coupling a first syringe and a second syringe to the valve assembly, wherein the first syringe and the second syringe each comprise a syringe barrel with a hollow body defining an internal chamber, wherein the syringe barrel has a proximal end and a distal dispensing end with an outlet, and a plunger slidably disposed within the hollow body for applying pressure to a syringe content housed within the internal chamber; displacing the displaceable member relative to the guide member in a direction substantially perpendicular to a longitudinal axis of at least one of the first syringe and the second; and cyclically mixing contents between the first syringe and the second syringe to prepare the contents for delivery to a patient. 7. The method of claim 6, wherein the pharmaceutical composition comprises about 7.5 mg of leuprolide acetate as the active pharmaceutical ingredient and N-methyl-2-pyrrolidone and a 50:50 poly(lactic acid-co-glycolic acid) (PLGA) copolymer having a weight average molecular weight from about 31 kDa to about 45 kDa and at least one terminal carboxylic acid end group as the liquid formulation component. 8. The method of claim 6, wherein the pharmaceutical composition comprises about 22.5 mg of leuprolide acetate as the active pharmaceutical ingredient and N-methyl-2-pyrrolidone, and a 75:25 poly(lactide-co-glycolide) (PLG) copolymer having a weight average molecular weight from about 17 kDa to about 21 kDa and end groups that are hydroxyl-terminated as the liquid formulation component. 9. The method of claim 6, wherein the pharmaceutical composition comprises about 30 mg of leuprolide acetate as the active pharmaceutical ingredient and N-methyl-2-pyrrolidone, and a 75:25 poly(lactide-co-glycolide) (PLG) copolymer having a weight average molecular weight from about 17 kDa to about 21 kDa and one distal end group that is hydroxyl-terminated and the other distal end group that is either hydroxyl-terminated or ester-terminated as the liquid formulation component. 10. The method of claim 6, wherein the pharmaceutical composition comprises about 45 mg of leuprolide acetate as the active pharmaceutical ingredient and N-methyl-2-pyrrolidone, and a 85:15 poly(lactide-co-glycolide) (PLG) copolymer having a weight average molecular weight from about 20 kDa to about 26 kDa and one distal end group that is hydroxyl-terminated and the other distal end group that is either hydroxyl-terminated or ester-terminated as the liquid formulation component. 11. A syringe coupler that is operable to receive a first syringe barrel and a second syringe barrel associated with a syringe mixing system, the syringe coupler comprising: a displaceable member operable to be selectively contacted by a user to convert the syringe coupler from a first position to a second position; a seal with a flow port that is moveable with the displaceable member; a first syringe receiving-member and a second syringe-receiving member, wherein at least one of the first syringe-receiving member and the second syringe-receiving member comprises a threaded member; wherein the displaceable member comprises a projection in selective communication with the threaded member to enable the threaded member to be freely rotatable when the displaceable member is provided in the second position; wherein the threaded member is substantially prevented from rotating relative to the syringe coupler when the displaceable member is provided in the first position; and wherein the threaded member is freely rotatable when the displaceable member is provided in the second position. 12. The syringe coupler of claim 11, wherein the first position comprises a closed position in which fluid flow through the coupler is occluded and wherein the second position comprises an open position in which fluid flow through the coupler is enabled. 13. The syringe coupler of claim 11, wherein the threaded member further comprises a contact surface operable to be engaged by a portion of the syringe coupler when the syringe coupler is provided in the first position. 14. The syringe coupler of claim 11, wherein the threaded member comprises a flow port, and wherein the flow port of the seal and the flow port of the threaded member are offset relative to one another in the first position. 15. The syringe coupler of claim 11, wherein the threaded member comprises a flow port, and wherein the flow port of the seal and the flow port of the threaded member are aligned in the second position. 16. The syringe coupler of claim 11, wherein the syringe coupler comprises at least one resilient member to secure the syringe coupler in the second position and substantially prevent the syringe coupler from returning to the first position. 17. The syringe coupler of claim 11, wherein the first syringe receiving-member and the second syringe-receiving member each comprise Luer lock members that are operable to receive a distal end of a syringe. 18. The syringe coupler of claim 11, further comprising a first syringe and a second syringe secured to the syringe coupler, wherein at least one of the first syringe and the second syringe comprises leuprolide or a pharmaceutically acceptable salt thereof. 19. The syringe coupler of claim 11, wherein the displaceable member further comprises at least one resilient projection.