Abuse deterrent and anti-dose dumping pharmaceutical salts useful for the treatment of attention deficit/hyperactivity disorder
AssigneePisgah Laboratories, Inc.
InventorsClifford Riley King, Stephen G. D'Ambrosio, David W. Bristol
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Abstract
A pharmaceutical composition comprising a drug substance consisting essentially of a pharmaceutically acceptable organic acid addition salt of an amine containing pharmaceutically active compound wherein the amine containing pharmaceutical active compound is selected from the group consisting of racemic or single isomer ritalinic acid or phenethylamine derivatives and the drug substance has a physical form selected from amorphous and polymorphic.
Claims18
A drug system comprising:
- a first drug product comprising a first drug substance consisting essentially of a first amine containing pharmaceutically active compound with an immediate release profile of said first amine containing pharmaceutically active compound from said first drug substance at gastrointestinal pH to reach a therapeutic level;
- and
- a second drug product comprising a second drug substance wherein said second drug substance has a slower release profile of racemic or single isomer ritalinic acid or phenethylamine from said second drug substance at gastrointestinal pH suitable for maintaining said therapeutic level wherein said second drug substance consist of A-B-C wherein said A-B-C is defined:
- A is said second amine containing pharmaceutically active compound selected from said racemic or single isomer of ritalinic acid, methylphenidate or phenethylamine;
- B is a bidentate linking group defined by the formula:
- wherein Y1 and Y2 are independently selected from oxygen;
- R10 and R11 are absent;
- G1 and G2 independently represent ionically bound groups A and C
- R12 and R13 are independently selected from hydrogen, alkyl or 1-6 carbons, alkylacyl of 1-8 carbons or arylacyl of 7-15 carbons;
- R14 will replace one of R15, R16, R17 or R18 and one of R19, R20, R21 or R22 and is an alkyl or branched alkyl of 1-10 carbons, aryl, arylalkyl of 7-15 carbons and wherein R14 may include at least one optically active carbon;
- and
- R15, R16, R17, R18, R19, R20, R21 and R22, are independently selected from hydrogen, alkyl of 1-6 carbons, and wherein adjacent groups may be taken together to form a cyclic alkyl or cyclic aryl moiety;
- and
- C is an amine which is other than ritalinic acid, phenethylamine, or methylphenidate.
The drug system of claim wherein said dissolution modifying amine is defined by the formula:
- wherein:
- R30 and R31 are independently selected from an alkyl of 1-5 carbons;
- R32 and R33 are independently selected from hydrogen and R30—(O—CH2CH2)x(OCH2CHR31)y—;
- and
- x and y are integers independently selected to have a ratio of from 1:20 to 20:1 and said dissolution modifying amine has a molecular weight of at least 200 to no more than 3000.
Dependencies are inferred from the claim text.