Methods and devices for providing prolonged drug therapy
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Abstract
Methods and devices for maintaining a desired therapeutic drug effect over a prolonged therapy period are provided. In particular, oral dosage forms that release drug within the gastrointestinal tract at an ascending release rate over an extended time period are provided. The dosage forms may additionally comprise an immediate-release dose of drug.
106 Citations
60 Claims
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1-17. -17. (Canceled)
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18. An osmotic dosage form comprising:
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a longitudinally compressed tablet core containing a plurality of layers wherein a drug is contained in at least one layer and at least one other layer comprises a suitable fluid-expandable polymer;
a semipermeable wall surrounding said longitudinally compressed tablet core to thereby form a compartment having an osmotic gradient to drive fluid from an external fluid environment contacting said semipermeable wall into said compartment; and
an orifice formed through said semipermeable wall and into said longitudinally compressed tablet core to permit drug to be released from within said compartment into said external fluid environment. - View Dependent Claims (19, 20, 21, 22, 24, 25, 31, 32, 33, 34)
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23. (Canceled)
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26-30. -30. (Canceled)
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35. A dosage form comprising:
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a first drug layer comprising 10 ng to 300 mg of a drug;
a second drug layer comprising 50 ng to 500 mg of a drug which second layer comprises more drug than the first layer;
a third layer comprising a composition that expands and displaces the first drug layer followed by the second drug layer from the dosage form;
a wall that surrounds the three layers, which wall is permeable to fluid and impermeable to drug; and
a passageway in the wall communicating with the first drug layer for delivering the first drug layer followed by the second drug layer from the dosage form wherein said components (a) through (d) are shaped and adapted to interact cooperatively such that drug is released from the dosage form at an ascending release rate for an extended time period. - View Dependent Claims (36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46)
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47. A dosage form comprising a capsule shaped tablet core comprising two layers, wherein:
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a first of said two layers comprises a portion of a drug, a second of said layers comprises a suitable fluid-expanding polymer and is adjacent said first layer, a semipermeable membrane surrounding the capsule shaped tablet 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 an orifice formed through the semipermeable membrane and into the capsule shaped tablet core at a location adjacent to the first layer to permit the drug to be released from within the compartment into the external fluid environment, and wherein the dosage form releases the drug at an ascending release rate for an extended time period. - View Dependent Claims (48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60)
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Specification