3D printing methods for compartmented pharmaceutical dosage forms
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. A method for three-dimensional (3D) printing an oral drug dosage form comprising a water-insoluble substrate forming a compartment and a drug content contained within the compartment, wherein the drug content comprises a first erodible material admixed with an active pharmaceutical ingredient (API), and wherein the compartment is sealed by a plug comprising a second erodible material not admixed with the API, the method comprising:
(a) providing a homogenous melted mixture of the API and the first erodible material, a melted water-insoluble substrate, and a melted second erodible material to a 3D printer comprising a 3D printing nozzle;
(b) extruding the homogenous melted mixture through the 3D printing nozzle;
(c) depositing the extruded homogenous melted mixture on a planar surface;
(d) before, during, or after the extrusion of the homogenous melted mixture, separately extruding the melted water-insoluble substrate and the melted second erodible material through the 3D printing nozzle; and
(e) before, during, or after the deposition of the extruded homogenous melted mixture, separately depositing the extruded melted water-insoluble substrate and the extruded melted second erodible material on the planar surface,
thereby obtaining the 3D-printed oral drug dosage form.
2. The method of claim 1 , further comprising providing the API in a solid form and melting the API before step (a).
3. The method of claim 2 , wherein the API is in a powdered form.
4. The method of claim 2 , further comprising mixing the API with the first erodible material before step (a).
5. The method of claim 1 , wherein the first erodible material and the second erodible material are the same.
6. The method of claim 1 , wherein the first erodible material and the second erodible material are different.
7. The method of claim 1 , wherein the first erodible material comprises a water-soluble thermoplastic material, a plasticizer, or a combination thereof.
8. The method of claim 1 , wherein the second erodible material is selected from the group consisting of a water-soluble polymer, an erodible or dissolvable polymer, a wax, a saccharide, a plasticizer, and a combination thereof.
9. The method of claim 1 , wherein the water-insoluble substrate comprises a water-insoluble thermoplastic material.
10. The method of claim 1 , wherein the API is tofacitinib.
11. The method of claim 1 , further comprising providing a computer-aided 3D design of the oral drug dosage form for 3D printing.
12. The method of claim 1 , wherein the extruded melted water-insoluble substrate is deposited before the deposition of the extruded homogeneous melted mixture.
13. The method of claim 12 , wherein the extruded melted second erodible material is deposited after the deposition of the extruded homogenous melted mixture.
14. The method of claim 1 , wherein the extruded melted second erodible material is deposited after the deposition of the extruded homogenous melted mixture.