Orally disintegrating tablets of atomoxetine
First Claim
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1. A multiparticulate pharmaceutical composition comprising:
- (a) a plurality of timed, pulsatile-release (TPR) beads, wherein the TPR beads comprise drug-containing particles comprising atomoxetine or a pharmaceutically acceptable salt thereof,wherein said drug-containing particles are coated with a TPR membrane comprising a blend of a water-insoluble polymer and an enteric polymer.
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Abstract
A coated multi-particulate pharmaceutical dosage form such as an orally disintegrating tablet (ODT) presentation for delivering atomoxetine or a pharmaceutically acceptable salt thereof, a selective norepinephrine reuptake inhibitor indicated for the treatment of ADHD, into the body to maintain a therapeutically effective amount of atomoxetine in the plasm. The dosage form may comprise one or more populations of coated atomoxetine-containing particles (beads, pellets, granules etc.) providing a pre-designed rapid release profile after a predesigned lag-time of about 0 to 6 hours following oral administration.
237 Citations
29 Claims
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1. A multiparticulate pharmaceutical composition comprising:
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(a) a plurality of timed, pulsatile-release (TPR) beads, wherein the TPR beads comprise drug-containing particles comprising atomoxetine or a pharmaceutically acceptable salt thereof, wherein said drug-containing particles are coated with a TPR membrane comprising a blend of a water-insoluble polymer and an enteric polymer. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 24, 25, 26, 27)
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19. A method for the preparation of multi-particulate pharmaceutical dosage form comprising the steps of:
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(a) preparing rapidly-dispersing microgranules by granulating a powder mixture comprising a sugar alcohol or a saccharide or a combination thereof having an average particle diameter of not more than about 30 μ
m and a disintegrant,(b) preparing TPR beads by applying to drug-containing particles comprising atomoxetine or a pharmaceutically acceptable salt thereof, a TPR coating comprising a combination of a water-insoluble polymer and an enteric polymer, thereby providing an in-vitro lag-time of about 1 to 6 hours, (c) optionally, preparing taste-masked beads by coating drug-containing particles with a water-insoluble polymer, thereby providing taste-masking properties, (d) blending rapidly dispersing microgranules from step (a), TPR beads from step (b) and optionally taste-masked beads from step (c), and (e) compressing the blend from step (d) to form an orally disintegrating tablet. - View Dependent Claims (20, 21, 22, 23, 28, 29)
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Specification