Methods and dosage forms for controlled delivery of paliperidone and risperidone
First Claim
1. A method for treating a condition responsive to paliperidone or risperidone comprising orally administering a dosage form containing an active agent selected from the group consisting of paliperidone, risperidone and pharmaceutically acceptable addition salts thereof wherein the dosage form releases the the active agent at a substantially ascending release rate for a prolonged period of time.
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Accused Products
Abstract
Dosage forms and methods for providing a substantially ascending rate of release of paliperidone or risperidone are provided. The sustained release dosage forms provide therapeutically effective average steady-state plasma paliperidone or risperidone concentrations when administered once per day. This once-a-day dosing regimen results in only one peak plasma paliperidone or risperidone concentration occurrence in each 24 hour period. In addition, the peak plasma paliperidone or risperidone concentration occurs at a later time following dose administration and exhibits a lesser magnitude than the peak plasma paliperidone or risperidone concentration that occurs following administration of paliperidone or risperidone in an immediate-release dosage form.
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Citations
51 Claims
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1. A method for treating a condition responsive to paliperidone or risperidone comprising orally administering a dosage form containing an active agent selected from the group consisting of paliperidone, risperidone and pharmaceutically acceptable addition salts thereof wherein the dosage form releases the the active agent at a substantially ascending release rate for a prolonged period of time.
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2. A method for administering an active agent to a subject comprising:
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administering a dosage from to the subject wherein the dosage form comprises;
(a) a core comprising a plurality of layers wherein a drug composition contains an active agent in at least one layer and at least one other layer comprises a suitable fluid-expandable polymer;
(b) a semipermeable membrane surrounding the core to form a compartment having an osmotic gradient to drive fluid from an external fluid environment contacting the semipermeable membrane into the compartment; and
(c) an orifice formed through the semipermeable membrane and into the core to permit the active agent to be released from within the compartment into the external fluid environment;
wherein the dosage form releases the active agent at a substantially ascending release rate for a prolonged period of time. - View Dependent Claims (3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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- 22. A method for delivering an active agent, the method comprising orally administering to a subject a capsule shaped tablet dosage form containing an active agent selected from the group consisting of paliperidone, risperidone and pharmaceutically acceptable addition salt thereof wherein the dosage form releases the active agent from the dosage form at a substantially ascending release rate for a prolonged period of time.
- 34. A capsule shaped tablet dosage form comprising a drug layer composition having an active agent wherein the dosage form, following oral administration to a subject, releases the active agent from the dosage form at a substantially ascending release rate for a prolonged period of time.
Specification