UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM INCORPORATING TASTE-MASKING COMPOSITIONS
The present invention relates to rapid dissolve thin film drug delivery compositions for the oral administration of active components. The active components are provided as taste-masked or controlled-release coated particles uniformly distributed throughout the film composition. The compositions may be formed by wet casting methods, where the film is cast and controllably dried, or alternatively by an extrusion method.
1 . An oral film for delivery of an active in individual unit doses comprising:
(i) a continuously cast and dried film produced on a manufacturing coating line, from which substantially equally sized individual dosage units containing a desired amount of active are cut, said continuously cast film comprising a flowable water-soluble or water swellable film-forming matrix comprising one or more substantially water soluble or water swellable polymers; and at least one particulate active substantially uniformly distributed in the film-forming matrix;
wherein said matrix has a viscosity sufficient to aid in substantially maintaining non-self-aggregating uniformity of the particulate active in the matrix; and
(ii) a taste-masking agent coated onto or intimately associated with the particulate active to provide taste-masking of the active;
wherein the combined particulate active and taste-masking agent have a particle size of 200 microns or less and the flowable water-soluble or water swellable film-forming matrix, as continuously cast on the manufacturing coating line, is capable of being dried without loss of substantial uniformity in the distribution of the particulate active therein; and
wherein said uniformity subsequent to continuously casting and drying of the film is measured by the cut substantially equally sized individual unit doses which do not vary by more than 10% of a desired amount of the at least one active.