IP Library Granted Patent US 9,662,301
Granted Patent B2
US 9,662,301 · App. 15/371,915 · Granted May 30, 2017

Production of unit dose constructs

Inventors: Matthew K. Musho (York, PA); John H. Lind (York, PA); Scott D. Barnhart (York, PA)
Assignee: ARX, LLC
A61K9/7007A61K9/006
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Quick Facts
Patent No.
US 9,662,301
App. No.
15/371,915
Granted
May 30, 2017
Kind
B2
Abstract

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.

Claims (17)

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; and

depositing the composition onto a foil substrate as a plurality of individual dosage units; and

removing at least a portion of the liquid carrier from the individual dosage units, wherein the foil substrate is a treated foil substrate having a modified surface energy on the side on which the composition is deposited.

2. The method of claim 1 , 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.

3. The method of claim 1 , wherein the step of removing liquid carrier includes drying the composition by the application of heat, vibration, ultrasound, or a combination thereof.

4. The method of claim 1 , 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 .

5. The method of claim 1 , further comprising, after the step of depositing, depositing a second composition to form multi-layered individual dosage units.

6. The method of claim 1 , wherein the step of depositing includes depositing the paste onto the foil substrate in a predetermined geometric shape having at least three sides.

7. The method of claim 6 , wherein the predetermined geometric shape includes a rounded corner.

8. The method of claim 1 , wherein the water soluble polymer comprises cellulose or a derivative thereof.

9. The method of claim 1 , wherein the active ingredient comprises a pharmaceutical drug.

10. The method of claim 1 , comprising depositing adjacent individual unit doses having different areas.

11. The method of claim 1 , wherein the individual dosage units are dissolvable films.

12. The method of claim 1 , wherein the individual dosage units are tablets or wafers.

13. The method of claim 1 , wherein the step of removing is carried out in an atmosphere having a lower oxygen content than air.

14. The method of claim 1 , wherein the step of removing is carried out in an atmosphere having less than 45% relative humidity.

Continuity (4)
Continuation 14161829 · Jan 23, 2014
Provisional Application 61755495 · Jan 23, 2013
Provisional Application 61755492 · Jan 23, 2013
Related Publication 20170087097A1 · Mar 30, 2017