Sustained release dosage forms of ziprasidone
AssigneePfizer Inc.
InventorsImran Ahmed, Leah Appel, Walter Babcock, Dwayne Friesen, Scott Herbig, David Lyon, Sheri Shamblin, Ravi Shanker, Daniel Smithey, Steven Sutton, Avinash Thombre, Kenneth Waterman
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Abstract
A sustained release solid oral dosage form for treatment of a psychotic disorder, for example schizophrenia, in a mammal is provided, which oral dosage form comprises ziprasidone in an amount effective in treating said psychotic disorder and a pharmaceutically acceptable carrier.
Claims50
A sustained release oral dosage form comprising a pharmaceutically effective amount of ziprasidone and a sustained release means for releasing at least a portion of said ziprasidone, wherein following administration to achieve steady state, said dosage form provides a steady state minimum blood ziprasidone concentration (Cmin) of at least 20 ng/ml, and a steady state maximum blood ziprasidone concentration (Cmax) of less than 330 ng/ml.
A sustained release oral dosage form comprising a pharmaceutically effective amount of ziprasidone, said dosage form releasing no greater than 90 wt % of said ziprasidone from said dosage form during the first 2 hours after administration to an in vitro use environment, wherein said dosage form comprises at least 30 mgA of ziprasidone, and said in vitro use environment is 900 mL of a dissolution medium of a simulated intestinal buffer solution.
A sustained release oral dosage form comprising a pharmaceutically effective amount of ziprasidone and a sustained release means for releasing at least a portion of said ziprasidone, wherein said at least a portion of said ziprasidone in said sustained release means is at least one of crystalline ziprasidone and ziprasidone combined with a cyclodextrin.
Dependencies are inferred from the claim text.