Abstract: Oral film formulations comprising at least one hydrophobic active agent; and a polymeric matrix at least partly composed of hydrophobic or insoluble excipients, or a combination thereof, to facilitate a controlled or sustained dissolution. Wherein when the oral film formulation has an unfavorable environment for fast dissolution, it exhibits partial disintegration within 1 to 10 minutes and a sustained rate of dissolution as confirmed by a disintegration test conducted in a limited volume petri dish, and wherein the film undergoes disintegration into smaller and smaller pieces.

Abstract: Pharmaceutical compositions employing flavor entrapment to mitigate the unpleasant taste of active agents are described.

Abstract: An oral film dosage form includes a high viscosity polymer in an amount of from 1% to 5% by dry weight to reduce, modulate and/or control Cmax of an active agent. The high viscosity polymer has a viscosity of from 100 cps to 500 cps as determined at 2% concentration in water by weight at 25° C. using a Brookfield LVF viscometer with spindle no.

Abstract: An oral film dosage form includes a high viscosity polymer in an amount of from 1% to 5% by dry weight to reduce, modulate and/or control Cmax of an active agent. The high viscosity polymer has a viscosity of from 100 cps to 500 cps as determined at 2% concentration in water by weight at 25° C. using a Brookfield LVF viscometer with spindle no. 2 at 60 rpm.

Abstract: An oral film dosage form includes a high viscosity polymer in an amount of from 1% to 5% by dry weight to reduce, modulate and/or control Cmax of an active agent. The high viscosity polymer has a viscosity of from 100 cps to 500 cps as determined at 2% concentration in water by weight at 25° C. using a Brookfield LVF viscometer with spindle no.

Abstract: An oral film dosage form includes a high viscosity polymer in an amount of from 1% to 5% by dry weight to reduce, modulate and/or control Cmax of an active agent. The high viscosity polymer has a viscosity of from 100 cps to 500 cps as determined at 2% concentration in water by weight at 25° C. using a Brookfield LVF viscometer with spindle no. 2 at 60 rpm.

Abstract: Oral film dosage forms that provide improved solubilization and stabilization of an active ingredient in particle form include at least one primary crystallization inhibitor in an amount that inhibits growth and/or agglomeration of the active ingredient, a polyoxyethylated fatty acid glycerides in an amount that further enhances inhibition of crystallization, growth and agglomeration of the particles of the pharmaceutically active ingredient; and at least one plasticizer present in an amount that is effective to increase flexibility and elasticity of the film dosage form.

Abstract: Oral film dosage forms that provide improved solubilization and stabilization of an active ingredient in particle form include at least one primary crystallization inhibitor in an amount that inhibits growth and/or agglomeration of the active ingredient, a polyoxyethylated fatty acid glycerides in an amount that further enhances inhibition of crystallization, growth and agglomeration of the particles of the pharmaceutically active ingredient; and at least one plasticizer present in an amount that is effective to increase flexibility and elasticity of the film dosage form.

Abstract: An oral film dosage form includes a high viscosity polymer in an amount of from 1% to 5% by dry weight to reduce, modulate and/or control Cmax of an active agent. The high viscosity polymer has a viscosity of from 100 cps to 500 cps as determined at 2% concentration in water by weight at 25° C. using a Brookfield LVF viscometer with spindle no.

Abstract: Oral thin film dosage form of a stable dispersion of non-solubilized amorphous or partially amorphous active agent(s), having a mean particle size diameter D50 equal or less than 250 ?m, that remains uniformly distributed within a film matrix and contains at least one film forming polymer, and optional pharmaceutically-acceptable excipients, such as diluents, plasticizers, surfactants, sweeteners, and taste-masking agent(s), are prepared by a process including first providing the active agent in an amorphous particle form having a mean particle size diameter D50 equal or less than 250 ?m. Next, the active agent is suspended in a liquid film-forming formulation without dissolving the active agent. Therefore, the solvent is removed to form a film.

Abstract: An oral film dosage form for administration in the buccal cavity includes a film layer containing a safe and effective amount of an antihistamine and 3% to 12% (w/w) of a numbness mitigating agent.

Abstract: Oral thin film dosage form of a stable dispersion of non-solubilized amorphous or partially amorphous active agent(s), having a mean particle size diameter D50 equal or less than 250 ?m, that remains uniformly distributed within a film matrix and contains at least one film forming polymer, and optional pharmaceutically-acceptable excipients, such as diluents, plasticizers, surfactants, sweeteners, and taste-masking agent(s), are prepared by a process including first providing the active agent in an amorphous particle form having a mean particle size diameter D50 equal or less than 250 ?m. Next, the active agent is suspended in a liquid film-forming formulation without dissolving the active agent. Therefore, the solvent is removed to form a film.

Abstract: Oral thin film dosage form of a stable dispersion of non-solubilized amorphous or partially amorphous active agent(s), having a mean particle size diameter D50 equal or lower than 250 ?m, that remains uniformly distributed within a film matrix and contains at least one film former polymer, and optional pharmaceutically-acceptable excipients, such as diluents, plasticizers, surfactants, sweeteners, and taste-masking agent(s). The oral thin film dosage exhibits increased solubility or rate of dissolution and enhanced bioavailability compared to a crystalline form of the active agent(s). The oral dosage form also exhibits long term stability confirmed by no changes in the dissolution profile over time.