System and method for fabrication of uniform polymer films containing nano and micro particles via continuous drying process

A method for fabricating a pharmaceutical product comprising:

• providing a film forming precursor composition that includes one or more superdisintegrants;
• providing active agent nano-particles;
• mixing the aqueous film forming precursor composition and the one or more superdisintegrants with the active agent nano-particles to form a mixture, the mixture formed prior to formation of a stripfilm fabricated from the mixture, the mixture having a viscosity of from about 4,000 cP to about 25,000 cP, wherein due to the high swelling capacity of the one or more superdisintegrants, their addition to the aqueous film forming precursor composition raises the viscosity of the mixture;
• and
• drying and fabricating the mixture to form the stripfilm fabricated from the mixture;
• wherein the mixture is dried at about 0° C. to about 80° C. and at about 20% relative humidity to about 90% relative humidity for about 10 minutes to about 90 minutes to form the stripfilm;
• wherein the film forming precursor composition includes one or more water-soluble polymers, or one or more water-insoluble polymers;
• wherein the active agent nano-particles include one or more pharmaceutical active agent nano-particles;
• and
• wherein the stripfilm has an active agent nano-particle loading of from about 0.01 weight % to about 50 weight %.

A method for fabricating a pharmaceutical product comprising:

• providing a film forming precursor composition and active agent particles;
• mixing the aqueous film forming precursor composition with the active agent particles to form a mixture, the mixture formed prior to formation of a stripfilm fabricated from the mixture, the mixture having a viscosity of at least 6,000 cP;
• re-dispersing the fabricated stripfilm in a medium to form a re-dispersion;
• and
• drying and casting the mixture to form the stripfilm fabricated from the mixture;
• wherein the mixture is dried at about 0° C. to about 80° C. and at about 30% relative humidity to about 70% relative humidity for about 15 minutes to about 45 minutes to form the stripfilm;
• wherein the film forming precursor composition includes one or more water-soluble polymers, or one or more water-insoluble polymers;
• wherein the active agent particles include one or more active agent micro-particles, or one or more active agent nano-particles;
• wherein the active agent particles include one or more BCS Class II or IV poorly water-soluble drug particles;
• wherein the mixture is a suspension of the aqueous film forming precursor composition and the active agent particles;
• wherein the drying step includes convective drying in laminar flow conditions to form the stripfilm;
• wherein the stripfilm has an active agent particle loading of from about 0.50 weight % to about 30 weight %;
• wherein the stripfilm is formed by casting the mixture onto a substrate;
• wherein the stripfilm has an active agent particle loading uniformity throughout an interior of the stripfilm, the active agent particle loading uniformity varying in uniformity of active agent loading by less than 6% relative standard deviation over average active agent particle mass per unit area of the stripfilm;
• and
• wherein the fabricated stripfilm has a water content of from about 5 weight % to about 8 weight %.

A method for fabricating a pharmaceutical product, comprising:

• providing an aqueous film forming precursor composition;
• providing active agent particles;
• mixing the aqueous film forming precursor composition with the active agent particles to form a mixture, the mixture formed prior to formation of a stripfilm fabricated from the mixture, the mixture of the aqueous film forming precursor composition and the active agent particles having a viscosity of from about 100 cP to about 25,000 cP;
• re-dispersing the fabricated stripfilm in a medium to form a re-dispersion;
• and
• drying and fabricating the mixture to form the stripfilm fabricated from the mixture;
• wherein the mixture is dried at about 0° C. to about 80° C. for about 10 minutes to about 90 minutes to form the stripfilm.

A method for fabricating a pharmaceutical product, comprising:

• providing a film forming precursor composition that includes one or more superdisintegrants;
• providing active agent particles;
• mixing the aqueous film forming precursor composition and the one or more superdisintegrants with the active agent particles to form a mixture, the mixture formed prior to formation of a stripfilm fabricated from the mixture, the mixture having a viscosity of from about 4,000 cP to about 25,000 cP, wherein due to the high swelling capacity of the one or more superdisintegrants, their addition to the aqueous film forming precursor composition raises the viscosity of the mixture;
• re-dispersing the fabricated stripfilm in a medium to form a re-dispersion;
• and
• drying and fabricating the mixture to form the stripfilm fabricated from the mixture;
• wherein the mixture is dried at about 0° C. to about 80° C. and at about 20% relative humidity to about 90% relative humidity for about 10 minutes to about 90 minutes to form the stripfilm;
• wherein the film forming precursor composition includes one or more water-soluble polymers, or one or more water-insoluble polymers;
• wherein the active agent particles include one or more pharmaceutical active agent particles;
• and
• wherein the stripfilm has an active agent particle loading of from about 0.01 weight % to about 50 weight %.