Therapeutic formulation for reduced drug side effects
The present invention provides drug therapy formulations for reducing the side effects associated with a therapeutic. In some embodiments, the present invention provides a reduction in sleep- and diet-related side effects associated with a therapeutic.
1. A method of treating ADHD in a subject said method comprising administering to the subject having ADHD a once-daily dose of a pharmaceutical composition, wherein the pharmaceutical composition consists of:
a. a rapid release component consisting only of dexamphetamine, wherein the dexamphetamine has a mean diameter of up to 50 nm, and a cryoprotectant further wherein the rapid release component is prepared by a process comprising the steps of:
i) dispersing dexamphetamine in ethanol to generate a dispersed dexamphetamine;
ii) milling said dispersed dexamphetamine; and
iii) lyophilizing said dexamphetamine with said cryoprotectant to generate a powdered nanoparticulate dexamphetamine formulation consisting only of said dexamphetamine and said cryoprotectant; and
b. a delayed release component consisting only of guanfacine.
2. The method of claim 1 , wherein said dexamphetamine has a mean diameter of up to 25 nm.
3. The method of claim 1 , wherein the cryoprotectant is povidone.
4. The method of claim 1 , wherein the rapid release component and the delayed release component are not encapsulated within nanoparticles.
5. A method of treating ADHD in a subject said method comprising administering to the subject having ADHD a once-daily dose of a pharmaceutical composition, wherein the pharmaceutical composition consists of:
a. a rapid release component consisting only of dexamphetamine, wherein the dexamphetamine has a mean diameter of up to 50 nm;
b. a cryoprotectant; and
c. a delayed release component consisting only of guanfacine.
6. The method of claim 5 , wherein the dexamphetamine has a mean diameter of up to 25 nm.