US Patent:
20030049272, Mar 13, 2003
Inventors:
Yatindra Joshi - Princeton NJ, US
Russell Somma - Sparta NJ, US
International Classification:
A61K038/00
A61K031/137
A61K031/401
A61K031/366
A61K035/78
A61K031/195
A61K033/38
A61K031/19
US Classification:
424/195180, 514/002000, 514/649000, 424/725100, 424/760000, 424/619000, 424/722000, 514/162000, 514/557000, 514/569000, 514/423000, 514/643000, 514/567000, 514/575000, 514/460000
Abstract:
A pharmaceutical composition which reduces or eliminates the drug abuse potential of central nervous system stimulant comprising: (a) a central nervous system stimulant selected from the group consisting of methylphenidate, amphetamine, methamphetamine, and combinations thereof; and (b) a mucous membrane irritant selected from the group consisting of organic and inorganic acid, salt, ketone, nitrite, sulfide, bisulfate, persulfate, glycerophosphate, hypophosphate, borate, titanate, amino acid, peptide, and combinations thereof, wherein the mucous membrane irritant produces irritation when contacted with the skin or mucous membrane. The present invention is based on the discovery that a central nervous system stimulant, such as methylphenidate, in combination with a mucous membrane irritant, such as citric acid, reduces or eliminates potential drug abuse by producing “irritation” when contacted with the dermis layer of skin or mucous membrane, and thus, prevents nasal absorption and/or injectability of the drug.