Back to results
US 2017/0290777 A1Published application
Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
AssigneeMonosol Rx, LLC
InventorsRobert K. Yang, Richard C. Fuisz, Garry L. Myers, Joseph M. Fuisz
Life of this patent
Estimating the term…
Abstract
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.
Claims30
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.
5 more elements
An oral film for delivery of an active in individual unit doses comprising:
- (i) a continuously cast and dried film produced on a manufacturing line, from which substantially equally sized individual dosage units are cut, 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;
- wherein said matrix has a viscosity sufficient to aid in substantially maintaining non-self-aggregating uniformity of the particulate active in the matrix;
- (ii) the particulate active being substantially uniformly distributed in the matrix;
- and
- (iii) a taste-masking agent selected from the group consisting of flavors, sweeteners, flavor enhancers, and combinations thereof to provide taste-masking of the particulate active;
- wherein the particulate active has 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 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.
6 more elements
A drug delivery composition comprising:
- (i) a continuously cast and dried film produced on a manufacturing line comprising a flowable water-soluble or water swellable film-forming matrix comprising one or more substantially water soluble or water swellable polymers;
- and a desired amount of at least one active;
- wherein said matrix has a viscosity sufficient to aid in substantially maintaining non-self-aggregating uniformity of the active in the matrix;
- (ii) a particulate active substantially uniformly stationed in the matrix;
- and
- (iii) a taste-masking agent selected from the group consisting of flavors, sweeteners, flavor enhancers, and combinations thereof to provide taste-masking of the active;
- wherein the particulate active has a particle size of 200 microns or less and said flowable water-soluble or water swellable film-forming matrix is capable of being continuously cast and dried on the manufacturing line without loss of substantial uniformity in the stationing of said particulate active therein;
- and
- wherein said uniformity subsequent to continuously casting and drying of the matrix is measured by substantially equally sized individual unit doses cut from the cast and dried film which do not vary by more than 10% of said desired amount of said at least one active
6 more elements
Dependencies are inferred from the claim text.