Compositions and Methods for Preparing Polymeric Films Loaded With Uniformly Distributed Drug Particles

A method for fabricating a film based pharmaceutical product comprising:

• providing dry active agent particles;
• micronizing the dry active agent particles and surface modifying the dry active agent particles with a dry coating agent via dry milling to obtain micronized active agent particles surface coated with the coating agent, the micronized active agent particles surface coated with the coating agent in dry powder form;
• mixing the micronized active agent particles surface coated with the coating agent in dry powder form with at least one film forming precursor to form a mixture;
• and
• drying and fabricating the mixture to form a film;
• wherein the dry active agent particles are simultaneously micronized and surface modified with the dry coating agent via a fluid energy mill;
• wherein the dry active agent particles include poorly water-soluble drug particles;
• wherein the micronized active agent particles surface coated with the coating agent are directly mixed with the at least one film forming precursor to form the mixture;
• wherein the dry coating agent is dry coated to the micronized active agent particles;
• and
• wherein the at least one film forming precursor is a polymer solution.

A method for fabricating a film based pharmaceutical product comprising:

• providing dry active agent particles;
• simultaneously micronizing the dry active agent particles and surface modifying the dry active agent particles with a dry coating agent via dry milling to obtain micronized active agent particles surface coated with the coating agent, the micronized active agent particles surface coated with the coating agent in dry powder form;
• mixing the micronized active agent particles surface coated with the coating agent in dry powder form with at least one film forming precursor to form a mixture;
• and
• drying and fabricating the mixture to form a film;
• wherein the dry active agent particles are simultaneously micronized and surface modified with the dry coating agent via a fluid energy mill;
• wherein the dry active agent particles include poorly water-soluble drug particles;
• wherein the micronized active agent particles surface coated with the coating agent are directly mixed with the at least one film forming precursor via a planetary mixer or an impeller mixer to form the mixture;
• wherein the dry coating agent is dry coated to the micronized active agent particles;
• wherein the at least one film forming precursor is a polymer solution;
• wherein the dry coating agent includes hydrophilic silica;
• wherein the mixture has a viscosity of from about 5,000 cP to about 18,500 cP;
• and
• wherein the micronized active agent particles include one or more particles having a particle size of about 4.2 μm.