ORALLY DISINTEGRATING DOSAGE FORMS
First Claim
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1. An orally disintegrating dosage form comprising:
- a plurality of lipid coated active substrates, and a silicified excipient.
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Abstract
The present invention is directed to orally disintegrating dosage forms comprising lipid coated substrates and silicified excipients. The use of silicified excipients in the orally disintegrating dosage form along with lipid coating of active agents, allows for improvements in the ability to prepare these dosage forms. Further, the dosage form can prevent unpleasant taste or aftertaste and provide better chemical and mechanical stability of the coated active substrate. This present invention also provides the possibility of harder more durable tablets, along with targeted immediate or modified release profiles for the active agent.
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Citations
65 Claims
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1. An orally disintegrating dosage form comprising:
a plurality of lipid coated active substrates, and a silicified excipient. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31)
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32. A method of preparing an orally disintegrating dosage form, comprising:
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a) blending a plurality of lipid coated active agent substrates with excipients that include a silicified excipient;
b) optionally adding additional excipients;
c)tableting the pre-mix to form an orally disintegrating dosage form. - View Dependent Claims (33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63)
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64. An orally disintegrating dosage form, comprising
a plurality of substrates comprising an active agent microencapsulated with hydrogenated vegetable oil or an animal fat, a particulate agglomerate of a co-processed microcrystalline cellulose and from about 0.1% to about 20% silicon dioxide, by weight of the microcrystalline cellulose, the microcrystalline cellulose and silicon dioxide being in intimate association with each other, and the silicon dioxide portion of the agglomerate being derived from a silicon dioxide having a particle size from about 1 nanometer (nm) to about 100 microns (.mu.m), based on average primary particle size, the plurality of substrates and particulate agglomerate of coprocessed microcrystalline cellulose being directly compressed into a solid dosage form containing a therapeutically effective amount of the active agent and an effective amount of said coprocessed microcrystalline cellulose such that the dosage form disintegrates in the oral cavity of a human leaving swallowable residuals within two minutes, without ingestion of water.
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65. An orally disintegrating dosage form, comprising
a compressed mixture of (1) a plurality of substrates comprising an active agent microencapsulated with hydrogenated vegetable oil or an animal fat and (2) a particulate agglomerate of coprocessed microcrystalline cellulose and from about 0.1% to about 20% silicon dioxide, by weight of the microcrystalline cellulose, the microcrystalline cellulose and silicon dioxide being in intimate association with each other, and the silicon dioxide portion of the agglomerate being derived from a silicon dioxide having a particle size from about 1 nanometer (nm) to about 100 microns (.mu.m), based on average primary particle size, the mixture of substrates and coprocessed microcrystalline cellulose being capable of being sieved through a USSS 40-mesh screen with no observable clogging on the screen.
Specification