COMPOSITIONS FOR REDUCTION OF SIDE EFFECTS
The present invention provides drug therapy formulations. In some embodiments, the present invention provides combinations of pharmaceutical agents (e.g., stimulant and non-stimulant), pharmaceutical formulations (e.g., nanoparticualte, non-nanoparticualte, etc.), and release profiles (e.g., immediate release, delayed release, sustained release, etc.) to provide therapeutic benefit with reduced side effects.
1 - 88 . (canceled)
89 . A method of treating a subject with ADHD, the method comprising:
administering to the subject a once daily dose of a pharmaceutical composition comprising:
a) nanoparticulate formulated stimulant for rapid release and rapid onset of therapeutic action; and
b) a non-stimulant;
wherein the pharmaceutical composition is formulated for sequential release of the stimulant followed by the non-stimulant.
90 . The method of claim 89 , wherein said stimulant is an amphetamine.
91 . The method of claim 89 , wherein said stimulant is a methylphenidate.
92 . The method of claim 89 , wherein said stimulant or non-stimulant is provided as a prodrug.
93 . The method of claim 92 , wherein said stimulant is lisdexamfetamine.
94 . The method of claim 89 , wherein said non-stimulant is guanfacine.
95 . The method of claim 89 , wherein the pharmaceutical composition is formulated for sequential release of the stimulant between 0.15 hours or less and 2 hours and non-stimulant between 3 and 12 hours.
96 . The method of claim 89 , wherein the non-stimulant is coated for enteric release.
97 . The method of claim 89 , wherein the pharmaceutical composition comprises 10 mg or less of said stimulant.
98 . The method of claim 89 , wherein said pharmaceutical composition is formulated to provide a peak blood concentration of said stimulant in less than 15 minutes after administration.
99 . The method of claim 89 , wherein said pharmaceutical composition further comprises an agent to deter abuse of said pharmaceutical composition.
100 . The method of claim 89 , wherein the subject is a human child under the age of 18.
101 . The method of claim 89 , wherein the subject is a human adult.
102 . The method of claim 89 , wherein said administration produces three release peaks in the plasma of said subject.
103 . The method of claim 102 , wherein said three release peaks are two stimulant peaks and one non-stimulant peak.
104 . The method of claim 90 , wherein said nanoparticulate formulated amphetamine is prepared by a method comprising milling said amphetamine in ethanol to produce a dry powder nanoparticulate amphetamine.
105 . A pharmaceutical composition comprising:
a) nanoparticulate formulated amphetamine formulated for rapid release and rapid onset of therapeutic action; and
b) guanfacine formulated for sequential release after said amphetamine.
106 . The composition of claim 105 , wherein said guanfacine is coated for enteric release.
107 . The composition of claim 105 , wherein the pharmaceutical composition is formulated for sequential release of the amphetamine between 0.15 hours or less and 2 hours and guanfacine between 3 and 12 hours.
108 . The composition of claim 105 , wherein the pharmaceutical composition comprises 10 mg or less of said amphetamine.