Claims for Patent: 12,397,120

Summary for Patent: 12,397,120

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:	US18/399,077
Patent Claims:	1. A method of administering a Gonadotropin Releasing Hormone (GnRH) agonist to a subject for the treatment of prostate cancer or central precocious puberty (CPP), the method comprising: (i) providing, in a pre-assembled configuration, a syringe-to-syringe mixing system containing the Gonadotropin Releasing Hormone (GnRH) agonist, wherein the syringe-to-syringe mixing system comprises: a first syringe and a second syringe, each of the first syringe and the second syringe having a respective outlet, wherein the first syringe contains a liquid formulation component and the second syringe contains the Gonadotropin Releasing Hormone (GnRH) agonist; and a valve assembly comprising a displaceable member, a guide member, and a displaceable seal, wherein the outlets of the first and second syringes are coupled to the valve assembly, wherein the displaceable seal comprises a flow port extending through the displaceable seal, wherein the displaceable member is coupled to the displaceable seal and slidable relative to the guide member between a first position and a second position, wherein in the first position of the displaceable member, the flow port of the displaceable seal is offset from the outlet of at least one of the first syringe or the second syringe, wherein in the second position of the displaceable member, the flow port of the displaceable seal is aligned with the outlets of both the first syringe and the second syringe, and wherein the valve assembly further comprises a selectively rotatable member, wherein the selectively rotatable member receives a portion of the first syringe, 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 to permit free rotation of the selectively rotatable member; and (ii) administering the GnRH agonist to the subject using the syringe-to-syringe mixing system by: (a) positioning the displaceable member in the second position to form a fluid flow path extending through the flow port of the displaceable seal and between the outlet of the first syringe and the outlet of the second syringe; (b) mixing, through the fluid flow path, the liquid formulation component with the GnRH agonist to form a reconstituted pharmaceutical composition; and (c) administering the reconstituted pharmaceutical composition containing the GnRH agonist to the subject via subcutaneous injection, wherein administering the reconstituted pharmaceutical composition via subcutaneous injection comprises: with the reconstituted pharmaceutical composition received within the second syringe, disconnecting the second syringe from the valve assembly; and subcutaneously delivering, using the second syringe, the reconstituted pharmaceutical composition to the subject. 2. The method of claim 1, wherein positioning the displaceable member in the second position comprises moving the displaceable member from the first position to the second position. 3. The method of claim 2, wherein the displaceable member comprises at least one resilient projection, wherein the guide member comprises at least one recess that receives a corresponding resilient projection of the at least one resilient projection when the displaceable member is in the second position, wherein the at least one resilient projection is displaced upon movement of the displaceable member from the first position to the second position, and wherein engagement between the guide member and the at least one resilient projection prevents or inhibits the displaceable member from returning to the first position when the at least one resilient projection is received within the at least one recess of the guide member. 4. The method of claim 1, wherein the mixing, through the fluid flow path, the liquid formulation with the GnRH agonist comprises cyclically mixing contents between the first and second syringes. 5. The method of claim 4, wherein the subject has prostate cancer. 6. The method of claim 5, wherein the reconstituted pharmaceutical composition comprises: about 7.5 mg of leuprolide acetate; 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 having at least one terminal carboxylic acid end group. 7. The method of claim 6, further comprising repeating the positioning, mixing, and administering steps once per month. 8. The method of claim 5, wherein the reconstituted pharmaceutical composition comprises: about 22.5 mg of leuprolide acetate; 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 having end groups that are hydroxyl-terminated. 9. The method of claim 8, further comprising repeating the positioning, mixing, and administering steps once every three months. 10. The method of claim 5, wherein the reconstituted pharmaceutical composition comprises: about 30 mg of leuprolide acetate; 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 having end groups that are hydroxyl-terminated. 11. The method of claim 10, further comprising repeating the positioning, mixing, and administering steps once every four months. 12. The method of claim 5, wherein the reconstituted pharmaceutical composition comprises: about 45 mg of leuprolide acetate; N-methyl-2-pyrrolidone; and an 85:15 poly(lactide-co-glycolide) (PLG) copolymer having a weight average molecular weight from about 20 kDa to about 26 kDa and having end groups that are hydroxyl-terminated. 13. The method of claim 12, further comprising repeating the positioning, mixing, and administering steps once every six months. 14. The method of claim 4, wherein the subject is a pediatric patient 2 years of age or older having CPP. 15. The method of claim 14, wherein the reconstituted pharmaceutical composition comprises: about 45 mg of leuprolide acetate; and N-methyl-2-pyrrolidone; and an 85:15 poly(lactide-co-glycolide) (PLG) copolymer having a weight average molecular weight from about 20 kDa to about 26 kDa and having one distal end group that is hydroxyl-terminated and another distal end group that is either hydroxyl-terminated or ester-terminated. 16. The method of claim 15, further comprising repeating the positioning, mixing, and administering steps once every six months. 17. The method of claim 1, wherein the GnRH agonist comprises leuprolide or a pharmaceutically acceptable salt thereof. 18. The method of claim 1, wherein the selectively rotatable member comprises a threaded member that receives a portion of the first syringe. 19. The method of claim 1, wherein the selectively rotatable member comprises a Luer lock member. 20. The method of claim 1, wherein the at least one projection prevents or substantially prevents said selectively rotatable member from rotating when the displaceable member is in the first position. 21. The method of claim 1, wherein the first syringe cannot be detached from the valve assembly when the displaceable member is in the second position. 22. A method of administering a Gonadotropin Releasing Hormone (GnRH) agonist to a subject for the treatment of prostate cancer or central precocious puberty (CPP), the method comprising: (i) providing, in a pre-assembled configuration, a syringe-to-syringe mixing system containing the Gonadotropin Releasing Hormone (GnRH) agonist, wherein the syringe-to-syringe mixing system comprises: a first syringe and a second syringe, each of the first syringe and the second syringe having a respective outlet, wherein the first syringe contains a liquid formulation component and the second syringe contains the Gonadotropin Releasing Hormone (GnRH) agonist; and a valve assembly comprising a displaceable member, a guide member, and a displaceable seal, wherein the outlets of the first and second syringes are coupled to the valve assembly, wherein the displaceable seal comprises a flow port extending through the displaceable seal, wherein the displaceable member is coupled to the displaceable seal and slidable relative to the guide member between a first position and a second position, wherein in the first position of the displaceable member, the flow port of the displaceable seal is offset from the outlet of at least one of the first syringe or the second syringe, and wherein in the second position of the displaceable member, the flow port of the displaceable seal is aligned with the outlets of both the first syringe and the second syringe, wherein the displaceable member comprises at least one resilient projection, wherein the guide member comprises at least one recess that receives a corresponding resilient projection of the at least one resilient projection when the displaceable member is in the second position, wherein the at least one resilient projection is displaced upon movement of the displaceable member from the first position to the second position, and wherein engagement between the guide member and the at least one resilient projection prevents or inhibits the displaceable member from returning to the first position when the at least one resilient projection is received within the at least one recess of the guide member; and (ii) administering the GnRH agonist to the subject using the syringe-to-syringe mixing system by: (a) positioning the displaceable member in the second position to form a fluid flow path extending through the flow port of the displaceable seal and between the outlet of the first syringe and the outlet of the second syringe, wherein positioning the displaceable member in the second position comprises moving the displaceable member from the first position to the second position; (b) mixing, through the fluid flow path, the liquid formulation component with the GnRH agonist to form a reconstituted pharmaceutical composition; and (c) administering the reconstituted pharmaceutical composition containing the GnRH agonist to the subject via subcutaneous injection. 23. The method of claim 22, wherein the GnRH agonist comprises leuprolide or a pharmaceutically acceptable salt thereof. 24. The method of claim 23, wherein administering the reconstituted pharmaceutical composition via subcutaneous injection comprises: with the reconstituted pharmaceutical composition received within the second syringe, disconnecting the second syringe from the valve assembly; and subcutaneously delivering, using the second syringe, the reconstituted pharmaceutical composition to the subject. 25. The method of claim 24, wherein the subject has prostate cancer. 26. The method of claim 24, wherein the subject is a pediatric patient 2 years of age or older having CPP.