Modified release clopidogrel formulation
AssigneeCadila Healthcare Limited
InventorsPankaj Ramanbhai Patel, Sunilendu Bhushan Roy, Jay Shantilal Kothari
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Abstract
A once daily dosage form comprising Clopidogrel or a salt of Clopidogrel equivalent to 50 mg to 150 mg Clopidogrel is disclosed. Said dosage form provides at least one of the following in vivo plasma profile of Clopidogrel selected from: (a) Mean Tmax of about 3 or more hours. (b) Mean Cmax not above 1000 picogram/ml. (c) Mean AUC0-49h of more than 2500 picogram/ml/hr.
Claims9
A once daily dosage form comprising Clopidogrel or a salt of Clopidogrel equivalent to 50 mg to 150 mg Clopidogrel, said dosage form providing at least one of the following in vivo plasma profile of Clopidogrel selected from:
- (a) Mean Tmax of about 3 or more hours.
- (b) Mean Cmax not above 1000 picogram/ml.
- (c) Mean AUC0-49h of more than 2500 picogram/ml/hr.
A once daily dosage form comprising Clopidogrel or a salt of Clopidogrel equivalent to 50 mg to 150 mg Clopidogrel, said dosage form providing an in vivo plasma profile of Clopidogrel carboxy acid metabolite having Mean Cmax not above 1400 ng/ml.
Dependencies are inferred from the claim text.