Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
DC CAFCFirst Claim
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1. A drug delivery composition comprising:
- (i) a 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
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 coated or intimately associated with said particulate to provide taste-masking of the active;
wherein the combined particulate and taste-masking agent have a particle size of 200 microns or less and said flowable water-soluble or water swellable film-forming matrix is capable of being dried without loss of substantial uniformity in the stationing of said particulate active therein; and
wherein the uniformity subsequent to casting and drying of the matrix is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said at least one active.
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Accused Products
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.
204 Citations
76 Claims
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1. A drug delivery composition comprising:
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(i) a 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
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 coated or intimately associated with said particulate to provide taste-masking of the active; wherein the combined particulate and taste-masking agent have a particle size of 200 microns or less and said flowable water-soluble or water swellable film-forming matrix is capable of being dried without loss of substantial uniformity in the stationing of said particulate active therein; and wherein the uniformity subsequent to casting and drying of the matrix is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said at least one active. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 21, 22, 23, 24, 25, 75, 76)
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16. A thin film drug delivery composition comprising:
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(a) a cast film comprising an edible water-soluble or water swellable film-forming matrix comprising at least one water-soluble or water swellable polymer comprising polyethylene oxide alone or in combination with a hydrophilic cellulosic polymer; 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; and (b) a coated particulate active component substantially uniformly stationed in the matrix; wherein the coating on the particulate active component is a taste-masking agent, and wherein the active component is substantially uniformly distributed in the film composition; and wherein the uniformity subsequent to casting and drying of the matrix is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said at least one active. - View Dependent Claims (17, 18, 19, 20, 26, 27)
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28. A drug delivery composition comprising:
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(i) a 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
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 coated or intimately associated with said particulate to provide taste-masking of the active; wherein the combined particulate and taste-masking agent have a particle size of 200 microns or less and said flowable water-soluble or water swellable film-forming matrix is capable of being dried without loss of substantial uniformity in the stationing of said particulate active therein; wherein the uniformity subsequent to casting and drying of the matrix is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said at least one active; and wherein the coated particulate active has a shape selected from the group consisting of spherically shaped particles, ellipsoidally shaped particles, irregularly shaped particles, and combinations thereof. - View Dependent Claims (29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47)
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48. A thin film drug delivery composition comprising:
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(a) a cast film comprising an edible water-soluble or water swellable film-forming matrix comprising at least one water-soluble or water swellable polymer comprising polyethylene oxide alone or in combination with a hydrophilic cellulosic polymer; 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; and (b) a coated particulate active component substantially uniformly stationed in the matrix; wherein the coating on the particulate active component is a taste-masking agent, and wherein the active component is substantially uniformly distributed in the film composition; wherein the uniformity subsequent to casting and drying of the matrix is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said at least one active; and wherein the at least one water-soluble polymer comprises about 20% to about 100% by weight polyethylene oxide. - View Dependent Claims (49, 50, 51, 52, 53, 54)
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55. A thin film drug delivery composition comprising:
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(a) a cast film comprising an edible water-soluble or water swellable film-forming matrix comprising at least one water-soluble or water swellable polymer comprising polyethylene oxide alone or in combination with a hydrophilic cellulosic polymer; 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; and (b) a coated particulate active component substantially uniformly stationed in the matrix; wherein the coating on the particulate active component is a taste-masking agent, and wherein the active component is substantially uniformly distributed in the film composition; wherein the uniformity subsequent to casting and drying of the matrix is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said at least one active; and wherein the at least one water-soluble polymer comprises a hydrophilic cellulosic polymer in a ratio of up to about 4;
1 with polyethylene oxide. - View Dependent Claims (56, 57, 58, 59, 60, 61)
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62. A drug delivery composition comprising:
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(i) a 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
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 dried without loss of substantial uniformity in the stationing of said particulate active therein; and wherein the uniformity subsequent to casting and drying of the matrix is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said at least one active. - View Dependent Claims (63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74)
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Specification