UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM INCORPORATING TASTE-MASKING COMPOSITIONS
First Claim
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1. A drug delivery composition comprising:
- (i) a flowable water-soluble film forming matrix;
(ii) a particulate bioeffecting agent uniformly stationed therein; and
(iii) a taste-masking agent coated or intimately associated with said particulate to provide taste-masking of the bioeffecting agent;
wherein the combined particulate and taste-masking agent have a particle size of 200 microns or less and said flowable water-soluble film forming matrix is capable of being dried without loss of uniformity in the stationing of said particulate bioeffecting agent therein.
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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.
144 Citations
34 Claims
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1. A drug delivery composition comprising:
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(i) a flowable water-soluble film forming matrix;
(ii) a particulate bioeffecting agent uniformly stationed therein; and
(iii) a taste-masking agent coated or intimately associated with said particulate to provide taste-masking of the bioeffecting agent;
wherein the combined particulate and taste-masking agent have a particle size of 200 microns or less and said flowable water-soluble film forming matrix is capable of being dried without loss of uniformity in the stationing of said particulate bioeffecting agent therein. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
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18. A thin film drug delivery composition comprising:
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(a) an edible water-soluble film forming matrix comprising at least one water-soluble polymer comprising polyethylene oxide alone or in combination with a hydrophilic cellulosic polymer; and
(b) a coated particulate active component uniformly stationed therein;
wherein the coating on the particulate active component is a taste-masking and/or controlled-release agent, and wherein the active component is uniformly distributed in the film composition. - View Dependent Claims (19, 20, 21, 22, 23, 24)
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25. A drug delivery vehicle comprising:
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a dry mucoadhering film having a thickness defined by opposed surfaces;
said film comprising;
(i) a water-soluble polymer;
(ii) a pharmaceutically active particle comprising a pharmaceutically active agent; and
a taste-masking agent;
wherein said particle having a particle size of less than about 200 microns and said taste-masking agent being present in amounts of about 15-80% by weight of the particle.
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26. A method of preparing a thin film drug delivery vehicle comprising:
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(a) providing a pharmaceutically active agent/taste-masking agent complex;
(b) combining the complex with a water-soluble polymer and a solvent to form a mixture with uniform distribution of said complex therein;
(c) casting said mixture onto a planar carrier surface to form a thin film on said carrier surface; and
(d) controllably drying said thin film to form a distribution variance of said complex having less than about 10% variance throughout any given area of said thin film. - View Dependent Claims (27, 28)
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29. A method of preparing a thin film drug delivery vehicle having a substantially uniform distribution of components comprising:
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(a) forming a masterbatch pre-mix of an edible water-soluble polymer component and water;
(b) feeding a predetermined amount of the premix to at least one mixer;
(c) adding to the at least one mixer a predetermined amount of a taste-masked active component comprising a particulate active component and a taste masking agent coating the particulate active component;
(d) mixing the premix and the taste-masked active component in the at least one mixer to form a uniform matrix;
(e) forming a wet film from the matrix;
(f) rapidly forming a visco-elastic film by applying hot air currents to the bottom side of the wet film with substantially no top air flow; and
(g) drying the visco-elastic film to form a self-supporting edible film. - View Dependent Claims (30, 31, 32, 33)
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34. A process for making a self-supporting, edible film having a substantially uniform distribution of components comprising:
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(a) forming a premix of an edible water-soluble polymer component containing polyethylene oxide and optionally one or more additional polymers;
(b) blending into the premix a taste-masked active component comprising a particulate active component coated with a taste masking agent, to form a uniform matrix;
(c) extruding a film from the matrix; and
(d) cooling the film to form a self-supporting edible film.
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Specification
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Current AssigneeAquestive Therapeutics, Inc.
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Original AssigneeMonosol Rx LLC (Kuraray Company Limited)
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InventorsYang, Robert, Myers, Garry, Fuisz, Richard, Fuisz, Joseph
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Granted Patent
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Time in Patent OfficeDays
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Field of Search
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US Class Current424/439
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CPC Class CodesA61K 31/138 Aryloxyalkylamines, e.g. pr...A61K 31/192 having aromatic groups, e.g...A61K 31/422 not condensed and containin...A61K 31/44 Non condensed pyridines; Hy...A61K 31/4422 1,4-Dihydropyridines, e.g. ...A61K 31/443 containing a five-membered ...A61K 31/4545 containing a six-membered r...A61K 31/519 ortho- or peri-condensed wi...A61K 31/549 having two or more nitrogen...A61K 31/567 substituted in position 17 ...A61K 31/635 having a heterocyclic ring,...A61K 31/704 attached to a condensed car...A61K 31/7048 having oxygen as a ring het...A61K 47/02 Inorganic compoundsA61K 47/10 Alcohols; Phenols; Salts th...A61K 47/22 Heterocyclic compounds, e.g...A61K 47/32 Macromolecular compounds ob...A61K 47/34 Macromolecular compounds ob...A61K 47/36 Polysaccharides; Derivative...A61K 47/38 Cellulose; Derivatives thereofView All
