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US 2014/0178480 A1Published application
Safety of psuedoephedrine drug products
AssigneePisgah Laboratories, Inc.
InventorsClifford Riley King, David W. Bristol, Michael L. English
Life of this patent
Estimating the term…
Abstract
Drug substances comprising a amine containing pharmaceutically active compound, and at least one of an alditol acetal and an aromatic organic acid as an addition salt or an additive.
Claims51
An oral dosage drug product comprising a pharmaceutically active compound and an alditol acetal wherein said oral dosage drug product is in a dose form selected from a solid and a solution.
A drug product comprising:
- a drug substance consisting of an organic acid addition salt of an active pharmaceutical wherein said active pharmaceutical is selected from the group consisting of pseudoephedrine and ephedrine and said organic acid addition salt is defined by Structure A
- wherein R1-R4 are independently selected from H, alkyl of 1-6 carbons, adjacent groups may be taken together to form a cyclic alkyl, cyclic alkyl-aryl, or cyclic aryl moiety;
- R5 is selected from H, or an alkali earth cation;
- R6 and R7 are independently selected from H, alkyl of 1-6 carbons, an alkali earth cation, and aryl of 6 to 12 carbons, in a number sufficient to complete the valence bonding of X, and
- wherein X is selected from nitrogen, oxygen or sulfur;
- and
- an additive selected from the group consisting of alditol acetal and an organic acid defined by Structure H:
- wherein R8-R11 are independently selected from H, alkyl or substituted alkyl of 1-6 carbons, adjacent groups may be taken together to form a cyclic alkyl, cyclic alkyl-aryl, or cyclic aryl moiety;
- R12 is selected from H, or an alkali earth cation;
- R13 and R14 are independently selected from H, alkyl of 1-6 carbons, an alkali earth cation, and aryl of 6 to 12 carbons, in a number sufficient to complete the valence bonding of X1;
- and
- wherein X1 is selected from nitrogen, oxygen or sulfur;
- and
- wherein said drug product is in a dose form selected from solid and liquid.
11 more elements
49-67. (canceled)
Dependencies are inferred from the claim text.