Method and system for forming a dosage form within a packaging
A method and system of forming a pharmaceutical dosage form within a portion of a blister packaging. The method includes the steps of providing a blister packaging for the dosage form with depressions. A predetermined amount of a drug-containing powder material comprising drug-containing particles is deposited into a substantially uniform powder layer within the depressions. A binding liquid is then deposited in a pattern on the powder layer within the depressions, to bind the particles of the powder layer and form an incremental wetted layer. Excess solvent in the binding material can be removed to form an incremental bound layer. These steps are repeated in sequence at least one or more times to form the pharmaceutical dosage form within the blister packaging.
1. A method of forming a dosage form within a portion of a packaging for the dosage form, comprising the steps of:
1) providing a portion of a packaging for the dosage form, the portion of the packaging comprising at least one depression, the depression comprising a sidewall,
2) depositing a predetermined first amount of a powder material comprising particles into a substantially uniform first powder layer within the at least one depression, wherein the sidewall has a depression depth, and the substantially uniform first powder layer has a thickness of at least 5%, and up to 50%, of the depression depth,
3) depositing a binding liquid in a pattern on the first powder layer within the at least one depression, to bind at least a portion of the particles of the first powder layer to form an incremental first wetted powder layer,
4) depositing a predetermined second amount of a powder material comprising particles into a substantially uniform second powder layer within the at least one depression and onto the first wetted powder layer, wherein the substantially uniform second powder layer has a thickness of at least 5%, and up to 50%, of the depression depth,
5) depositing a binding liquid in a pattern on the second powder layer within the at least one depression, to bind at least a portion of the particles of the second powder layer to form an incremental second wetted powder layer, and
6) optionally repeating steps 4) and 5) in sequence at least one or more times, thereby forming the dosage form within the portion of the packaging for the dosage form.
2. The method according to claim 1 , wherein the at least one depression has a fixed shape and volume.
3. The method according to claim 1 , wherein the packaging comprises a sheet including a plurality of the depressions formed into the sheet, and where the sidewall in the depression extends from the sheet to a closed end.
4. The method according to claim 1 , wherein step 4) is repeated at least three times.
5. The method according to claim 1 , wherein the powder material comprises particles of a binder material, and the binding liquid binds the particles of the binder material.
6. The method according to claim 1 , further including a step, preceding step 2), of depositing an amount of a binding liquid on at least the closed end of the depression.
7. The method according to claim 1 , wherein the at least one depression includes an inner surface that includes a release agent.
8. The method according to claim 1 , wherein the binding liquid comprises a volatile solvent.
9. The method according to claim 8 , further including a step of evaporatively removing, after step 3), a portion of the volatile solvent from the incremental first wetted powder layer, to form an incremental first bound powder laver.
10. The method according to claim 8 , further including a step of evaporatively removing, after step 5), a portion of the volatile solvent from the incremental second wetted powder layer.
11. The method according to claim 1 , wherein the pattern of the deposited binding liquid includes a peripheral pattern of binding liquid, applied to the powder layer at the inner surface of the depression.
12. The method according to claim 1 , further including a step of applying a lidding layer over the dosage form and the at least one depression to form a sealed packaging for the dosage form.
13. The method according to claim 1 , wherein the binding liquid is deposited by inkjet printing to form the dosage form.
14. The method according to claim 1 , wherein the step 2) of depositing the predetermined amount of the powder material comprising particles into the substantially uniform powder layer within the at least one depression, comprises:
1) depositing a predetermined amount of a powder material comprising particles into the at least one depression, and
2) forming the deposited, predetermined amount of the powder material into a substantially uniform powder layer within the at least one depression.
15. The method according to claim 1 , wherein the step of forming includes tamping a last deposited, predetermined amount of the powder material into a last formed powder layer having an upper surface.
16. A package comprising a film material having one or more depressions therein, the one or more depressions containing a shaped, bound-powder dosage form, formed within the one or more depressions according to the method of claim 1 , and a peelable or removable covering sheet adhered to the film material, so as to enclose the bound-powder article within the one or more depressions.
17. The package according to claim 16 , wherein a peripheral portion of the bound-powder article that confronts the inner surface of the one or more depressions includes an additional amount of a binding liquid.
18. The package according to claim 16 , wherein the bound-powder article comprises a 3D printed, rapidly-dispersible dosage form.
19. The package according to claim 16 , wherein the bound-powder article is formed within the one or more depressions by binding a powder deposited within the one or more depressions with a binding liquid.
20. The package according to claim 16 , wherein the bound-powder article contains an active pharmaceutical ingredient (API).