IP Library › Granted Patent US 9,593,070
Granted Patent B2
US 9,593,070 · App. 14/205,721 · Granted Mar 14, 2017

Exo-S-mecamylamine formulation and use in treatment

Inventors: Douglas Shytle (Lutz, FL); Paul Sanberg (Spring Hill, FL); Mary Newman (Valrico, FL); Archie A. Silver (Tampa, FL)
Assignee: UNIVERSITY OF SOUTH FLORIDA
C07C211/38A61K31/13
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Quick Facts
Patent No.
US 9,593,070
App. No.
14/205,721
Granted
Mar 14, 2017
Kind
B2
Abstract

A pharmaceutical composition includes a therapeutically effective amount of exo-S-mecamylamine or a pharmaceutically acceptable salt thereof, substantially free of exo-R-mecamylamine in combination with a pharmaceutically acceptable carrier. Preferably the amount is about 0.5 mg to about 20 mg. Medical conditions are treated by administering a therapeutically effective amount of exo-S-mecamylamine or a pharmaceutically acceptable salt thereof, substantially free of its exo-R-mecamylamine, said amount being sufficient to ameliorate the medical condition. The medical conditions include but are not limited to substance addiction (involving nicotine, cocaine, alcohol, amphetamine, opiate, other psychostimulant and a combination thereof), aiding smoking cessation, treating weight gain associated with smoking cessation, hypertension, hypertensive crisis, Tourette's Syndrome and other tremors, cancer (such as small cell lung cancer), atherogenic profile, neuropsychiatric disorders (such as bipolar disorder, depression, an anxiety disorder, schizophrenia, a seizure disorder, Parkinson's disease and attention deficit hyperactivity disorder), chronic fatigue syndrome, Crohn's disease, autonomic dysreflexia, and spasmogenic intestinal disorders.

Claims (10)

1. An oral pharmaceutical composition comprising:

an effective amount of exo-S-mecamylamine or pharmaceutically acceptable salt thereof substantially free of exo-R-mecamylamine or a pharmaceutically acceptable salt thereof;

one or more pharmaceutically acceptable carriers; and

a pharmaceutical adjuvant,

wherein the oral pharmaceutical composition has a higher overall therapeutic index than the same amount of exo-R-mecamylamine substantially free of exo-S-mecamylamine.

2. The oral pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is a unit dosage form.

3. The oral pharmaceutical composition of claim 2 , wherein the unit dosage form is selected from the group consisting of a tablet, capsule, soft gelatin capsule, hard gelatin capsule, powder, lozenge, gum, emulsion, suspension, syrup, and solution.

4. The oral pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is formulated to provide rapid, sustained, or delayed release of the exo-S-mecamylamine or a pharmaceutically acceptable salt thereof.

5. The oral pharmaceutical composition of claim 1 , wherein the effective amount of exo-S-mecamylamine or pharmaceutically acceptable salt thereof is from about 0.001 mg/kg to about 6 mg/kg per day.

6. The oral pharmaceutical composition of claim 1 , wherein the effective amount of exo-S-mecamylamine or pharmaceutically acceptable salt thereof is from about 0.01 mg/kg to about 1.5 mg/kg per day.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 7, 2016
From: SHYTLE, DOUGLAS; SANBERG, PAUL; NEWMAN, MARY; SILVER, ARCHIE A.
To: UNIVERSITY OF SOUTH FLORIDA
Reel/Frame 039659/0867 →
Continuity (8)
Continuation 12886887 · Sep 21, 2010
Continuation 12651813 · Jan 4, 2010
Continuation 11278770 · Apr 5, 2006
Continuation 10441947 · May 19, 2003
Continuation 09882935 · Jun 15, 2001
Continuation In Part PCTUS9930153 · Dec 16, 1999
Provisional Application 60112534 · Dec 16, 1998
Related Publication 20140194525A1 · Jul 10, 2014