Thin film with non-self-aggregating uniform heterogeneity and drug delivery systems made therefrom
View Patent ↗The invention relates to the film products and methods of their preparation that demonstrate a non-self-aggregating uniform heterogeneity. Desirably the films disintegrate in water and may be formed by a controlled drying process, or other process that maintains the required uniformity of the film.
1. A process for forming a self-supporting, edible film having a substantially uniform distribution of components comprising at least one anti-emetic compound, said film being dissolvable or disintegrable, comprising the steps of:
(a) providing a wet matrix having a uniform distribution of edible components, said components comprising a water-soluble polymer component, an active component comprising at least one anti-emetic compound in the form of particles and water to form an edible matrix with a compositionally uniform distribution of said components;
(b) deaerating said matrix by mixing to prevent cavitation of the matrix in a manner which pulls air into the matrix;
(c) forming a wet film from said deaerated wet matrix by coating or casting the film;
(d) drying said film within about 10 minutes or fewer,
wherein said drying step further comprises:
(i) rapidly forming a visco-elastic film having said anti-emetic particles uniformly distributed throughout within about the first 4.0 minutes by applying hot air currents at temperatures of about 60° C. to about 100° C. to said film to prevent flow migration and intermolecular forces from creating aggregates or conglomerates of said anti-emetic particles thereby maintaining the compositional uniform distribution of components; and
(ii) further drying said visco-elastic film to form a self-supporting edible film having anti-emetic particles uniformly distributed throughout; and
(e) dividing said self-supporting film into dosage forms of substantially equal dimensions, wherein each of said dosage forms is compositionally equal, and wherein said dosage forms are each dissolvable or disintegrable in liquid.
2. The process of claim 1 , wherein each of said dosage forms has substantially the same mass.
3. The process of claim 1 , wherein each of said dosage forms has substantially the same thickness.
4. A process for forming a self-supporting, edible film having a substantially uniform distribution of components comprising at least one anti-emetic compound, said film being dissolvable or disintegrable, comprising the steps of:
(a) providing a wet matrix having a uniform distribution of edible components, said components comprising a water-soluble polymer component, an active component comprising at least one anti-emetic compound in the form of particles and water to form an edible matrix with a compositionally uniform distribution of said components;
(b) deaerating said matrix by mixing to prevent cavitation of the matrix, thereby reducing formation of air bubbles;
(c) forming a wet film from said deaerated wet matrix by coating or casting the film, said film having a top surface, a bottom surface and a depth between said top and bottom surfaces; and
(d) drying said film within about 10 minutes or fewer,
wherein said drying step further comprises:
(i) rapidly forming a visco-elastic film having said anti-emetic particles uniformly distributed throughout within about the first 4.0 minutes by applying hot air currents at temperatures of about 60° C. to about 100° C. to said film to prevent flow migration and intermolecular forces from creating aggregates or conglomerates of said anti-emetic particles thereby maintaining the compositional uniform distribution of components; and
(ii) further drying said visco-elastic film to form a self-supporting edible film having anti-emetic particles uniformly distributed throughout, said dried film having a uniform distribution of said polymer and said solvent components, a uniform weight and a uniform thickness, and wherein said dried film is dissolvable or disintegrable in liquid.
5. The process of claim 1 , wherein said at least one anti-emetic compound is granisetron.
6. The process of claim 1 , wherein said at least one anti-emetic compound is nabilone.
7. The process of claim 4 , wherein said at least one anti-emetic compound is granisetron.
8. The process of claim 4 , wherein said at least one anti-emetic compound is nabilone.