Osmotic dosage form
The present invention is directed to a modified release dosage form for delivering at least one pharmaceutically active ingredient. The dosage form has a first immediate release core for an active ingredient and an osmotic core or osmotic chamber containing at least one pharmaceutically active ingredient that can be the same or a different active ingredient contained in the first immediate release core. A shell having one or more portions surrounds the first immediate release core and osmotic core/chamber. The osmotic chamber includes a barrier layer that is substantially impermeable to the pharmaceutically active ingredient contained therein.
1 . A dosage form comprising a first immediate release core containing at least one pharmaceutically active ingredient, an osmotic core containing at least one pharmaceutically active ingredient that is the same or different from the pharmaceutically active ingredient provided in the first core, and a unitary shell that conforms and coats at least a substantial portion of both the first immediate release core and the osmotic core, wherein the shell material is substantially impermeable to the pharmaceutically active ingredient in the osmotic core.
2 . A dosage form according to claim 1 wherein at least one passageway is provided through the shell to the immediate release core with sufficient size for immediate release of the active contained therein and at least one passageway is provided through the unitary shell to the osmotic chamber.
3 . A dosage form according to claim 2 , wherein the passageways are provided with a fill material that is compositionally different from the shell.
4 . A dosage form according to claim 1 , wherein the first immediate release core is a multi-layer tablet.
5 . A dosage form according to claim 1 , wherein the pore volume of the shell as applied is less than 0.2 cc/g for pores having a diameter between about 0.5 to about 5 microns.
6 . A dosage form comprising a first immediate release core containing at least one pharmaceutically active ingredient, an osmotic core containing at least one pharmaceutically active ingredient that is the same or different from the pharmaceutically active ingredient provided in the first immediate release core, and a shell having distinct, compositionally different portions and that conforms and coats at least a substantial portion of both the first immediate release core and the osmotic core, wherein the shell has a major portion consisting essentially of material that is substantially impermeable to the pharmaceutically active ingredient in the osmotic chamber and a second portion of the shell in contact with the immediate release core that consists essentially of immediate release material.
6 . A dosage form according to claim 6 wherein at least one passageway is provided through the shell to the osmotic chamber.
7 . A dosage form according to claim 6 , wherein the first immediate release core comprises a compressed solid tablet.
8 . A dosage form according to claim 6 , wherein the first immediate release core is a multi-layer tablet.
9 . A dosage form according to claim 6 , wherein all portions of the shell are substantially free of pores having a diameter of 0.5 to 5.0 microns.
10 . A dosage form according to claim 6 , wherein the pore volume of all portions of the shell as applied is less than 0.2 cc/g for pores having a diameter between about 0.5 to about 5 microns.
11 . A dosage form comprising a first immediate release core containing at least one pharmaceutically active ingredient, an osmotic core containing at least one pharmaceutically active ingredient that is the same or different from the pharmaceutically active ingredient provided in the first immediate release core, and a unitary shell that conforms and coats at least a substantial portion of the first immediate release core and the osmotic core, wherein a portion of the shell provided over the immediate release core is sufficiently thin that it ruptures upon swelling of the immediate release core to release the active contained therein.
12 . A dosage form according to claim 11 wherein at least one passageway is provided through the shell to the osmotic chamber.
13 . A dosage form according to claim 1 1 , wherein the first immediate release core comprises a compressed solid tablet.
14 . A dosage form according to claim 11 , wherein the shell is substantially free of pores having a diameter of 0.5 to 5.0 microns.
15 . A dosage form according to claim 1 1 , wherein the pore volume of the shell as applied is less than 0.2 cc/g for pores having a diameter between about 0.5 to about 5 microns.
16 . A dosage form comprising a first immediate release core containing a pharmaceutically active ingredient, an osmotic chamber containing one pharmaceutically active ingredient that is the same or different from the pharmaceutically active ingredient provided in the first core, and a shell that consists essentially of an immediate release material and coats at least a substantial portion of the first immediate release core and the osmotic chamber, wherein the osmotic chamber comprises a barrier layer that is substantially impermeable to the active ingredient contained therein.
17 . A dosage form according to claim 16 wherein a passageway is provided through the barrier layer.
18 . A dosage form according to claim 16 , wherein the first immediate release core comprises a compressed solid tablet.
19 . A dosage form according to claim 16 , wherein the shell as applied is substantially free of pores having a diameter of 0.5 to 5.0 microns.
20 . A dosage form according to claim 16 , wherein the pore volume of shell as applied is less than 0.2 cc/g for pores having a diameter between about 0.5 to about 5 microns.
21 . A dosage form comprising a first core containing a pharmaceutically active ingredient, an osmotic chamber containing one pharmaceutically active ingredient that is the same or different from the pharmaceutically active ingredient provided in the first core, and a shell having distinct, compositionally different portions that coat a substantial portion of the first core and osmotic chamber, wherein the first shell portion that is in contact with the first core provides an immediate release of the pharmaceutically active ingredient in the first core and the second shell portion in contact with the osmotic chamber produces a modified release profile.
22 . A dosage form according to claim 21 , wherein the first immediate release core comprises a compressed solid tablet.
23 . A dosage form according to claim 21 , wherein the first immediate release core is a multi-layer tablet.
24 . A dosage form according to claim 21 , wherein all portions of the shell are substantially free of pores having a diameter of 0.5 to 5.0 microns.
25 . A dosage form according to claim 21 , wherein the pore volume of all portions of the shell as applied are less than 0.2 cc/g for pores having a diameter between about 0.5 to about 5 microns.
26 . A method for preparing a dosage form comprising:
a) providing a first immediate release core containing at least one pharmaceutically active ingredient and an osmotic core or an osmotic chamber containing at least one pharmaceutically active ingredient that is the same or different from the pharmaceutically active ingredient provided in the first core to shell-forming module,
b) providing a shell that conforms and coats at least a substantial portion of both the first immediate release core and the osmotic core or osmotic chamber.
27 . A method for preparing a dosage form comprising:
a) providing a first immediate release core containing at least one pharmaceutically active ingredient and an osmotic core or an osmotic chamber containing at least one pharmaceutically active ingredient that is the same or different from the pharmaceutically active ingredient provided in the first core to a shell-forming module,
b) providing a shell having distinct portions and that conforms and coats at least a substantial portion of both the first immediate release core and the osmotic core or osmotic chamber.