Dual lane coating
The present invention relates to methods and apparatuses for forming an active-containing film product, while significantly reducing the amount of wasted active material. The resulting product is an active-containing film product that meets the user's predetermined criteria of physical properties and is suitable for use.
1. A method of forming an active component-containing film product in a film forming apparatus, comprising the steps of:
a. providing a coating head configured to deposit a film forming matrix in a first lane and in a second lane onto a substrate, wherein said first lane and said second lane are offset from and substantially parallel to one another;
b. providing a first batch of a first film forming matrix comprising at least one polymer;
c. providing a second batch of a second film forming matrix comprising at least one polymer and an active component;
d. applying a layer of said first batch through said coating head in said first lane and drying said first applied layer to form a resulting surrogate film;
e. measuring said resulting surrogate film for at least one physical property;
f. optionally, adjusting at least one processing parameter and repeating steps (d) and (e) above to modify said at least one physical property; and thereafter
g. applying a layer of said second batch in said second lane and drying said second applied layer to form the active component-containing film product,
wherein said active component is selected from the group consisting of pharmaceuticals, pharmaceutically active agents, medicaments, drugs, neutraceuticals, cosmetic agents, biologic agents, bioeffecting substances, medicating active ingredients, medications, and combinations thereof; and wherein said surrogate film comprises less active component than said active component-containing film product or comprises no active component.
2. The method of claim 1 , wherein each of said lanes comprises two parallel dams forming the sides of said lane.
3. The method of claim 1 , wherein said coating head comprises at least three lanes.
4. The method of claim 1 , wherein said lanes each have width of about 20 to about 40 mm.
5. The method of claim 1 , wherein said first film forming matrix includes a polymer, a solvent, and no active.
6. The method of claim 1 , wherein said second film forming matrix includes a polymer, a solvent and an active.
7. The method of claim 1 , wherein said film forming apparatus comprises a coating roller, a movable substrate, and a drying apparatus.
8. The method of claim 7 , wherein step (d) comprises the step of moving said substrate through said drying apparatus.
9. The method of claim 1 , wherein said physical property includes at least one physical property selected from group consisting of film thickness, moisture content, coat weight, and combinations thereof.
10. The method of claim 1 , wherein said physical property includes visible defects.
11. The method of claim 1 , wherein said processing parameter comprises a parameter selected from the group consisting of roller gap size, substrate speed, drying temperature, and combinations thereof.
12. The method of claim 1 , wherein said second batch includes at least 30% active by weight based on the weight of the second batch.
13. The method of claim 1 , wherein said second batch is applied to said substrate at about 10 mg/cm 2 .
14. The method of claim 1 , further comprising the step of:
h. cutting said film product into a plurality of individual dosage units of the same size.
15. The method of claim 14 , wherein assays of said individual dosage units have a relative standard deviation not greater than 7.8%.