Production of unit dose constructs
Dissolvable unit dose constructs and their method of manufacture are disclosed in which the unit dose constructs are formed of a composition including a polymer matrix that includes a water soluble polymer, active ingredient, and a liquid carrier. The composition is deposited directly, such as by stenciling, to form individual unit doses without the need to cut and convert long, continuous rolls of film.
1. A method of forming a dissolvable unit dose construct comprising:
providing a muco-adhesive composition comprising a polymer matrix, the polymer matrix comprising a water soluble polymer, the composition further comprising an active ingredient and a liquid carrier, the composition in the form of a thixotropic paste;
stenciling the paste onto a substrate to deposit the composition as a plurality of individual dosage units; and
removing at least a portion of the liquid carrier from the individual dosage units.
2. The method of claim 1 , wherein the step of stenciling deposits the paste onto a substrate in a predetermined geometric shape having at least three sides.
3. The method of claim 2 , wherein the predetermined geometric shape includes a rounded corner.
4. The method of claim 1 , wherein the substrate is a foil substrate.
5. The method of claim 4 , wherein the foil substrate is a treated foil substrate having a modified surface energy on a surface facing the deposited composition.
6. The method of claim 5 , wherein a first area of the treated foil substrate has a modified surface energy on the surface facing the deposited composition that is lower than a surface energy of a second area of the surface of the treated foil substrate facing the deposited composition.
7. The method of claim 1 , wherein the water soluble polymer comprises cellulose or a derivative thereof.
8. The method of claim 1 , wherein the active ingredient comprises a pharmaceutical drug.
9. The method of claim 1 , wherein the muco-adhesive composition is provided as a paste having a viscosity in the range of 20,000 cps to 500,000 cps at a shear rate in the range of 0.05 s −1 to 10 s −1 .
10. The method of claim 1 , wherein the step of removing comprises removing at least a portion of the liquid carrier by vacuum drying.
11. The method of claim 10 , wherein the step of removing further comprises, contemporaneously with vacuum drying, removing at least a portion of the liquid carrier by heating, cooling, ultrasonic, vibration or a combination thereof.
12. The method of claim 1 , further comprising depositing a second composition, after the step of stenciling, to form multi-layered individual dosage units.
13. The method of claim 1 , comprising depositing adjacent individual unit doses having different areas.
14. The method of claim 1 , wherein the individual dosage units are dissolvable films.
15. The method of claim 1 , wherein the individual dosage units are tablets or wafers.
16. The method of claim 1 , wherein the step of removing is carried out in an atmosphere having a lower oxygen content than air.
17. The method of claim 1 , wherein the step of removing is carried out in an atmosphere having less than 45% relative humidity.
18. A method of forming a dissolvable unit dose construct comprising:
providing a muco-adhesive composition comprising a polymer matrix, the polymer matrix comprising a water soluble polymer, the composition further comprising an active ingredient and a liquid carrier;
depositing the composition onto a foil substrate as a plurality of individual dosage units; and vacuum drying the individual dosage units to remove at least a portion of the liquid carrier wherein a second vacuum is applied to an opposite side of the foil on which the composition is deposited, the second vacuum applied contemporaneously with the step of vacuum drying.
19. A method of forming a dissolvable unit dose construct comprising:
providing a muco-adhesive composition comprising a polymer matrix, the polymer matrix comprising a water soluble polymer, the composition further comprising an active ingredient and a liquid carrier;
depositing the composition onto a foil substrate as a plurality of individual dosage units; and
vacuum drying the individual dosage units to remove at least a portion of the liquid carrier wherein the foil substrate is a treated foil substrate having a modified surface energy on the side on which the composition is deposited.
20. The method of claim 19 , wherein a first area of the treated foil substrate has a modified surface energy on the side on which the composition is deposited that is lower than a surface energy of a second area on the side of the treated foil substrate on which the composition is deposited.
21. A method of forming a dissolvable unit dose construct comprising:
providing a muco-adhesive composition comprising a polymer matrix, the polymer matrix comprising a water soluble polymer, the composition further comprising an active ingredient and a liquid carrier;
depositing the composition onto a foil substrate as a plurality of individual dosage units; and
vacuum drying the individual dosage units to remove at least a portion of the liquid carrier wherein the step of depositing comprises stenciling.
22. The method of claim 21 , wherein the composition is provided as a thixotropic paste having a viscosity in the range of 20,000 cps to 500,000 cps at a shear rate in the range of 0.05 s −1 to 10 s −1 .
23. The method of claim 17 , further comprising, after the step of depositing, depositing a second composition to form multi-layered individual dosage units.
24. The method of claim 21 , further comprising drying the composition by the application of heat, vibration, ultrasound, or a combination thereof contemporaneously with the step of vacuum drying.