Therapeutic formulation for reduced drug side effects

10463,633

13/093662

April 25, 2011

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.

Desai, Subhash (Wilmette, IL, US)

KemPharm, Inc. (Celebration, FL, US)

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.

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