Oral drug dosage form comprising various release profiles
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 shell substrate having a top and a bottom that forms at least a first compartment and a second compartment, wherein the first compartment has a first top and a first bottom, wherein the second compartment has a second top and a second bottom, wherein the first top and the second top are positioned at the top of the shell substrate, wherein the first bottom and the second bottom are positioned at the bottom of the shell substrate;
b) a first substrate forming a first layer comprising a first drug embedded therein, a second substrate forming a second layer comprising a second drug embedded therein, wherein the second layer is stacked on top of the first layer, wherein the first layer and the second layer are both loaded into the first compartment, wherein the shell substrate leaves only the top surface of the second layer exposed at the first top of the first compartment; and
c) a third substrate forming a third layer comprising a third drug embedded therein, a fourth substrate forming a fourth layer comprising a fourth drug embedded therein, wherein the fourth layer is stacked on top of the third layer, wherein the third layer and the fourth layer are both loaded into the second compartment, wherein the shell substrate leaves only the top surface of the fourth layer exposed at the second top of the second compartment,
wherein upon exposure to gastrointestinal fluid the first drug is released according to a first drug release profile and the second drug is released according to a second drug release profile, wherein the first drug release profile is a first immediate-release (IR) profile, wherein the second drug release profile is a first extended-release (ER) profile,
wherein upon exposure to gastrointestinal fluid the third drug is released according to a third drug release profile and the fourth drug is released according to a fourth drug release profile, wherein i) the third drug release profile is a second IR profile and the fourth drug release profile is a second ER profile, or ii) the third drug release profile is a second ER profile and the fourth drug release profile is a second IR profile,
wherein the shell substrate has a slower dissolution rate than the first substrate, the second substrate, the third substrate, and the fourth substrate, and
wherein the second drug is released before the first drug.
2. The oral drug dosage form of claim 1 , wherein the first drug and the second drug are different.
3. The oral drug dosage form of claim 1 , wherein the first drug and the second drug are the same.
4. The oral drug dosage form of claim 3 , wherein the first drug and the second drug are both topiramate.
5. The oral drug dosage form of claim 1 , wherein the third drug and/or the fourth drug is different from the first drug and/or the second drug.
6. The oral drug dosage form of claim 1 , wherein the third drug and/or the fourth drug is the same as the first drug and/or the second drug.
7. The oral drug dosage form of claim 1 , wherein the third drug release profile and/or the fourth drug release profile is different from the first drug release profile and/or the second drug release profile.
8. The oral drug dosage form of claim 1 , wherein the third drug release profile or the fourth drug release profile is the same as the first drug release profile or the second drug release profile.
9. The oral drug dosage form of claim 1 , wherein the first substrate the second substrate, the third substrate, and the fourth substrate are erodible.
10. The oral drug dosage form of claim 1 , wherein the first layer and the second layer have different thicknesses.
11. The oral drug dosage form of claim 1 , wherein the first layer and the second layer have the same thickness.
12. The oral drug dosage form of claim 1 , wherein the shell substrate is non-erodible.
13. The oral drug dosage form of claim 1 , which is produced by three-dimensional (3D) printing.
14. The oral drug dosage form of claim 1 , wherein the second drug is released according to a zero-order release profile.
15. The oral drug dosage form of claim 1 , wherein the first layer and the second layer have the same top and bottom surface area.
16. The oral drug dosage form of claim 1 , wherein the third drug and the fourth drug are the same.
17. An oral drug dosage form comprising:
a) a shell substrate having a top and a bottom that forms at least a first compartment and a second compartment, wherein the first compartment has a first top and a first bottom, wherein the second compartment has a second top and a second bottom, wherein the first top and the second top are positioned at the top of the shell substrate, wherein the first bottom and the second bottom are positioned at the bottom of the shell substrate;
b) a first substrate forming a first layer comprising a first drug embedded therein, a second substrate forming a second layer comprising a second drug embedded therein, a third substrate forming a third layer comprising a third drug embedded therein, wherein the first layer is stacked on top of the second layer, and the second layer is stacked on top of the third layer, wherein the first layer, the second layer, and the third layer are all loaded into the first compartment, wherein the shell substrate leaves only the top surface of the first layer exposed at the first top of the first compartment; and
c) a fourth substrate forming a fourth layer comprising a fourth drug embedded therein, a fifth substrate forming a fifth layer comprising a fifth drug embedded therein, wherein the fourth layer is stacked on top of the fifth layer, wherein the fourth layer and the fifth layer are both loaded into the second compartment, wherein the shell substrate leaves only the top surface of the fourth layer exposed at the second top of the second compartment,
wherein upon exposure to gastrointestinal fluid the first drug is released according to a first drug release profile, the second drug is released according to a second drug release profile, and the third drug is released according to a third drug release profile, wherein the first drug release profile is a first IR profile, wherein the second drug release profile is a first ER profile, wherein the third drug release profile is a second IR profile,
wherein upon exposure to gastrointestinal fluid the fourth drug is released according to a fourth drug release profile and the fifth drug is released according to a fifth drug release profile, wherein i) the fourth drug release profile is a third IR profile and the fifth drug release profile is a second ER profile, or ii) the fourth drug release profile is a second ER profile and the fifth drug release profile is a third IR profile,
wherein the shell substrate has a slower dissolution rate than the first, the second, the third, the fourth, and the fifth substrates, and
wherein the first drug is released before the second drug, and the second drug is released before the third drug.
18. The oral drug dosage form of claim 17 , wherein the third drug release profile is different from the first drug release profile.
19. The oral drug dosage form of claim 17 , wherein the third drug release profile is the same as the first drug release profile.
20. The oral drug dosage form of claim 17 , wherein the first drug, the second drug, and the third drug are the same.