MAGNESIUM-CONTAINING OXYTOCIN FORMULATIONS AND METHODS OF USE
Disclosed are methods and compositions for the treatment of autism spectrum disorder, related disorders and symptoms of such disorders, comprising co-administration of an oxytocin peptide and magnesium ions. Co-administration of an oxytocin peptide and magnesium ions results in a synergistic or enhanced effect on reducing social and communication deficits in a patient suffering from an autism spectrum disorder.
1 .- 46 . (canceled)
47 . A method of treating social and communication deficits associated with a disorder selected from the group consisting of social anxiety, obsessive-compulsive disorder, social communication disorder, attention deficit hyperactivity disorder, Prader-Willi syndrome, Timothy syndrome, Fragile-X syndrome, Rett syndrome and Williams syndrome, comprising administering to a subject in need thereof an oxytocin peptide and a magnesium salt, formulated in an aqueous solution, wherein the concentration of the oxytocin peptide in the aqueous solution is between about 5 IU/mL and about 8000 IU/mL and wherein the magnesium salt is in an amount capable of providing between about 50 mM and about 1200 mM of magnesium ions in the aqueous solution.
48 . The method according to claim 47 , wherein the aqueous solution is formulated for craniofacial mucosal administration.
49 . The method according to claim 48 , wherein the craniofacial mucosal administration is intranasal administration.
50 . The method according to claim 47 , wherein the oxytocin peptide is human oxytocin comprising the sequence of amino acids set forth in SEQ ID NO: 1.
51 . The method according to claim 47 , wherein the disorder is social anxiety.
52 . The method according to claim 47 , wherein the disorder is Prader-Willi syndrome.
53 . The method according to claim 47 , wherein the magnesium salt is magnesium chloride.
54 . The method according to claim 53 , wherein the magnesium chloride is magnesium chloride hexahydrate.
55 . The method according to claim 54 , wherein the magnesium chloride hexahydrate is in an amount capable of providing between about 200 mM and about 1200 mM of magnesium ions in the aqueous solution.
56 . The method according to claim 47 , wherein the concentration of the oxytocin peptide in the aqueous solution is between about 50 IU/mL and about 1000 IU/mL.
57 . The method according to claim 47 , wherein the aqueous solution is administered in a volume between about 50 μL and about 1000 μL.
58 . The method according to claim 47 , wherein the aqueous formulation is contained in a device for intranasal administration.
59 . The method according to claim 58 , wherein the device is a nasal pump apparatus.
60 . The method according to claim 59 , wherein the nasal pump apparatus comprises a reservoir bottle attached to a pump actuator.
61 . The method according to claim 60 , wherein the pump actuator is metered to deliver a specified volume of about 50 μL.
62 . The method according to claim 60 , wherein the pump actuator is metered to deliver a specified volume of about 100 μL.
63 . The method according to claim 59 , wherein the nasal pump apparatus comprises a reservoir bottle attached to an aerosolizer.
64 . The method according to claim 59 , wherein the nasal pump apparatus comprises one or more of the following:
(i) a filter for preventing back flow;
(ii) a metal-free fluid path; and
(iii) a plastic material stable to gamma-radiation.