Lansoprazole orally disintegrating tablets
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Accused Products
Abstract
The invention provides orally disintegrating tablets that readily disintegrates in the mouth, releasing enteric coated drug sub-tablets.
21 Citations
79 Claims
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1-40. -40. (canceled)
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41. An orally disintegrating tablet, comprising a plurality of enteric coated sub-tablets, mixed with one or more tablet excipients;
- wherein
the sub-tablets comprise, by weight of the tablet;
about 5% to about 20% inner core, substantially free of any alkaline stabilizing agent, and comprising one or more inert core excipients;
about 1% to about 15% acid sensitive drug in, on, or over the inner core;
about 0.5% to about 10% inert first coating layer, substantially free of the drug and any alkaline stabilizing agent, disposed over the inner core and the drug;
about 0.5% to about 10% alkaline stabilizing layer, comprising an alkaline stabilizing agent, disposed over the inner core and the acid sensitive drug; and
about 5% to about 40% outer coating, disposed over the alkaline stabilizing layer;
whereinthe orally disintegrating tablet is formulated to disintegrate when placed in a mouth. - View Dependent Claims (42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 75, 76, 77, 78, 79)
- wherein
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67. A method of preparing enteric coated sub-tablets, comprising:
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providing a plurality of inner cores, comprising an excipient and an acid sensitive drug in the core or in a layer over the core;
applying about 1% to about 20%, by weight of the sub-tablet, an inert first coating layer over the cores and drug;
applying about 1% to about 40%, by weight of the sub-tablet, an alkaline stabilizing layer, comprising an alkaline stabilizing agent, over the inert first coating layer; and
applying about 10% to about 75%, by weight of the sub-tablet, an outer coating over the alkaline stabilizing layer, forming enteric coated sub-tablets. - View Dependent Claims (68, 69, 70, 71, 72, 73)
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74. An enteric coated sub-tablet, comprising:
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an inner core, substantially free of any alkaline stabilizing agent, and comprising one or more inert core excipients;
about 5% to about 20%, by weight of the total coated core, acid sensitive drug in, on, or over the inner core;
about 1% to about 20%, by weight of the sub-tablet, an inert first coating layer, substantially free of the drug and any alkaline stabilizing agent, disposed over the inner core and the drug;
about 1% to about 40%, by weight of the sub-tablet, an alkaline stabilizing layer, comprising an alkaline stabilizing agent, disposed over the inner core and the acid sensitive drug; and
about 10% to about 75%, by weight of the sub-tablet, an outer coating disposed over the alkaline stabilizing layer.
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Specification