Oral drug dosage forms having desired drug release profiles and uses thereof
The present disclosure provides a stable solid pharmaceutical dosage form for oral administration. The dosage form includes a substrate that forms at least one compartment and a drug content loaded into the compartment. The dosage form is so designed that the active pharmaceutical ingredient of the drug content is released in a controlled manner.
1. An oral drug dosage form comprising:
a) a column core having a top surface and a bottom surface,
wherein the column core comprises at least two vertical segments in direct contact with each other, each comprising a different drug embedded in a substrate; and
b) a shell wrapping around the column core,
wherein the shell is in direct contact with the at least two segments and leaves the top, bottom, or both surfaces exposed,
wherein the shell has a slower dissolution rate than the substrate in the column core, and
wherein upon exposure to gastrointestinal fluid the shell blocks the interface between the segments and the gastrointestinal fluid, and the drugs in the at least two vertical segments are simultaneously released through the exposed surface.
2. The oral drug dosage form of claim 1 , wherein the shell is water insoluble.
3. The oral drug dosage form of claim 1 , wherein the substrate in each of the at least two vertical segments are the same.
4. The oral drug dosage form of claim 1 , wherein the substrate in each of the at least two vertical segments are different from each other.
5. The oral drug dosage form of claim 4 , wherein the drugs in the at least two different vertical segments are released at different rates.
6. The oral drug dosage form of claim 1 , wherein the column core comprises at least three vertical segments.
7. The oral drug dosage form of claim 6 , wherein the at least three vertical segments are pie-shaped.
8. The oral drug dosage form of claim 1 , wherein only the top surface of the column core is exposed.
9. The oral drug dosage form of claim 1 , wherein both the top surface and bottom surface of the column core are exposed.
10. The oral drug dosage form of claim 1 , wherein the drugs in the at least two different vertical segments are released according to a zero-order release profile.
11. The oral drug dosage form of claim 1 , wherein the drug in the at least two different vertical segments are released according to a first-order release profile.
12. The oral drug dosage form of claim 1 , wherein the drug in one of the at least two different vertical segments is released according to a zero-order release profile, and wherein the drug in another one of the at least two different vertical segments are released according to a first-order release profile.
13. The oral dosage form of claim 1 , wherein the substrate is made of a thermoplastic material.
14. An oral drug dosage form comprising:
a) a column core comprising a drug having a top surface and a bottom surface,
wherein the column core comprises at least two vertical segments in direct contact with each other, each comprising the drug embedded in a different substrate; and
b) a shell wrapping around the column core,
wherein the shell is in direct contact with the at least two segments and leaves the top, bottom, or both surfaces exposed,
wherein the shell has a slower dissolution rate than the substrate in the column core;
wherein upon exposure to gastrointestinal fluid the shell blocks the interface between the segments and the gastrointestinal fluid and the drugs in the at least two vertical segments are simultaneously released through the exposed surface, and
wherein the drugs in the at least two different vertical segments are released at different rates.
15. The oral drug dosage form of claim 14 , wherein the shell is water insoluble.
16. The oral drug dosage form of claim 14 , wherein the column core comprises at least three vertical segments.
17. The oral drug dosage form of claim 16 , wherein the at least three vertical segments are pie-shaped.
18. The oral drug dosage form of claim 14 , wherein only the top surface of the column core is exposed.
19. The oral drug dosage form of claim 14 , wherein both the top surface and bottom surface of the column core are exposed.
20. The oral dosage form of claim 14 , wherein the substrate is made of a thermoplastic material.