Pharmaceutical compositions comprising prasugrel and cyclodextrin derivatives and methods of making and using the same
AssigneeCyDex Pharmaceuticals, Inc.
InventorsGerold L. Mosher, Stephen G. Machatha, Daniel J. Cushing
Life of this patent
Estimating the term…
Abstract
The present invention is directed to pharmaceutical compositions comprising prasugrel and a cyclodextrin derivative, and methods of making and using the same.
Claims38
A method of administering prasugrel and its pharmaceutically acceptable salts to a subject suffering from an acute coronary syndrome, comprising:
- identifying a subject suffering from an acute coronary syndrome;
- administering to the subject a loading dose of a pharmaceutical composition comprising:
- prasugrel, and
- a cyclodextrin derivative of formula I:
- wherein:
- n is 4, 5 or 6, and
- R1, R2, R3, R4, R5, R6, R7, R8 and R9 are independently selected from:
- —OH, a straight-chain or branched —O—(C1-C8-(alkylene))-SO3− group, an optionally substituted straight-chain, branched, or cyclic —O—(C1-C10) group, an optionally substituted straight-chain, branched, or cyclic —S—(C1-C10) group, and a saccharide, and
- wherein the cyclodextrin derivative is present in a concentration of at least 100:1 by weight relative to the prasugrel;
- and
- subsequently administering to the subject a maintenance dose of said pharmaceutical composition, wherein the maintenance dose comprises a lower amount of prasugrel than the loading dose.
A method for inhibiting platelet activation in a patient for which oral administration of prasugrel is contra-indicated, comprising parenterally administering to the patient a therapeutically effective amount of a pharmaceutical composition comprising:
- prasugrel, and
- a cyclodextrin derivative of formula I:
- wherein:
- n is 4, 5 or 6, and
- R1, R2, R3, R4, R5, R6, R7, R8 and R9 are independently selected from:
- —OH, a straight-chain or branched —O—(C1-C8-(alkylene))-SO3− group, an optionally substituted straight-chain, branched, or cyclic —O—(C1-C10) group, an optionally substituted straight-chain, branched, or cyclic —S—(C1-C10) group, and a saccharide, and
- wherein the cyclodextrin derivative is present in a concentration of at least 100:1 by weight relative to the prasugrel.
A method of inhibiting platelet activation in a patient in need thereof, comprising, prior to the patient undergoing an invasive procedure, administering to the patient a therapeutically effective amount of prasugrel in a pharmaceutical composition comprising:
- prasugrel, and
- a cyclodextrin derivative of formula I:
- wherein:
- n is 4, 5 or 6, and
- R1, R2, R3, R4, R5, R6, R7, R8 and R9 are independently selected from:
- —OH, a straight-chain or branched —O—(C1-C8-(alkylene))-SO3− group, an optionally substituted straight-chain, branched, or cyclic —O—(C1-C10) group, an optionally substituted straight-chain, branched, or cyclic —S—(C1-C10) group, and a saccharide, and
- wherein the cyclodextrin derivative is present in a concentration of at least 100:1 by weight relative to the prasugrel.
A method of preparing a prasugrel composition for parenteral administration, comprising reconstituting a solid prasugrel composition with a pharmaceutically acceptable diluent, wherein the prasugrel composition comprises:
- prasugrel or its pharmaceutically acceptable salt, and
- a cyclodextrin derivative of formula I:
- wherein:
- n is 4, 5 or 6, and
- R1, R2, R3, R4, R5, R6, R7, R8 and R9 are independently selected from:
- —OH, a straight-chain or branched —O—(C1-C8-(alkylene))-SO3− group, an optionally substituted straight-chain, branched, or cyclic —O—(C1-C10) group, an optionally substituted straight-chain, branched, or cyclic —S—(C1-C10) group, and a saccharide, and
- wherein the cyclodextrin derivative is present in a concentration of at least 100:1 by weight relative to the prasugrel.
Dependencies are inferred from the claim text.