Drug granule coatings that impart smear resistance during mechanical compression
First Claim
1. A drug formulation comprising granules having a substrate and a coating, said granule substrate comprising a solubilizing agent or a low solubility therapeutic drug, or both, and said granule coating comprising a hydrophilic polymer.
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Abstract
A drug formulation is disclosed comprising granules having a substrate and a coating, said granule substrate comprising a solubilizing surfactant or a low solubility therapeutic drug, or both, and said granule coating comprising a hydrophilic polymer. Also disclosed is a drug formulation consisting of a tablet core made by mechanical compression, wherein said tablet core comprises granules having a substrate and a coating, said granule substrate comprising a solubilizing surfactant or a low solubility therapeutic drug, or both, and said granule coating comprising a hydrophilic polymer. Also disclosed is a dosage form for oral administration of topiramate, comprising a tablet core and an osmotic delivery system. Methods for controlling topiramate release patterns by altering the composition of the topiramate dosage form are also disclosed.
95 Citations
34 Claims
- 1. A drug formulation comprising granules having a substrate and a coating, said granule substrate comprising a solubilizing agent or a low solubility therapeutic drug, or both, and said granule coating comprising a hydrophilic polymer.
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22. A dosage form comprising
(a) a core comprising a first drug composition, a second drug composition and a push layer comprising an osmopolymer; - wherein each of the first and second drug compositions comprise granules having a substrate and a coating, said granule substrate comprising a solubilizing agent and a low solubility therapeutic drug, and said granule coating comprising a hydrophilic polymer.
(b) a semi-permeable wall surrounding the core; and
(c) an exit orifice through the semi-permeable wall for releasing the drug compositions from the dosage form over a prolonged period of time. - View Dependent Claims (23, 24, 25)
- wherein each of the first and second drug compositions comprise granules having a substrate and a coating, said granule substrate comprising a solubilizing agent and a low solubility therapeutic drug, and said granule coating comprising a hydrophilic polymer.
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26. A dosage form comprising
(a) a core comprising a drug composition, wherein the drug composition comprise granules having a substrate and a coating, said granule substrate comprising a low solubility therapeutic drug and optionally a solubilizing agent, and said granule coating comprising one or more layers, wherein each granule coating layer comprises an independently selected hydrophilic polymer; -
(b) a semi-permeable wall surrounding the core; and
(c) an exit orifice through the semi-permeable wall for releasing the drug compositions from the dosage form over a prolonged period of time. - View Dependent Claims (27, 28, 29, 30, 31, 32, 33, 34)
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Specification