Rapidly dissolving robust dosage form
DCFirst Claim
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1. A hard, compresed, rapidly dissolvable dosage form adapted for direct oral dosing comprising:
- an active ingredient and a matrix including a non-direct compression filter and a lubricant, said dosage form being adapted to rapidly dissolve in the mouth of a patient and thereby liberate said active ingredient, and having a friability of about 2% or less when tested according to the U.S.P., said dosage form having a hardness of at least about 15 Newtons.
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Abstract
The invention is directed to a hard tablet that can be stored, packaged and processed in bulk. Yet the tablet dissolves rapidly in the mouth of the patient with a minimum of grit. The tablet is created from an active ingredient mixed into a matrix of a non-direct compression filler and a relatively high lubricant content.
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40 Claims
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1. A hard, compresed, rapidly dissolvable dosage form adapted for direct oral dosing comprising:
- an active ingredient and a matrix including a non-direct compression filter and a lubricant, said dosage form being adapted to rapidly dissolve in the mouth of a patient and thereby liberate said active ingredient, and having a friability of about 2% or less when tested according to the U.S.P., said dosage form having a hardness of at least about 15 Newtons.
- View Dependent Claims (2, 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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3. An openable and recloseable package containing a plurality of hard, compressed, rapidly dissolving tablets adapted for direct oral dosing comprising:
- particles including an active ingredient and a protective material, said particles being provided in an amount of between about 0.01 and about 75% by weight based on the weight of said tablets; and
a tablet matrix including a non-direct compression filler and a hydrophobic lubricant;
said tablet matrix comprising at least about 60% rapidly water soluble ingredients based on the total weight of the matrix material;
said tablet having a hardness of between about 15 and about 50 Newtons, a friability of less than 2% when measured by U.S.P. and being adapted to both dissolve spontaneously in the mouth of a patient in less than about 60 seconds and thereby liberate said particles.
- particles including an active ingredient and a protective material, said particles being provided in an amount of between about 0.01 and about 75% by weight based on the weight of said tablets; and
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32. A hard, compressed, rapidly dissolving tablet adapted for direct oral dosing comprising:
- particles including an active ingredient and a protective material, said particles being provided in an amount of between about 0.01 and about 75% by weight based on the weight of the tablet; and
a matrix including a non-direct compression filler, a wicking agent, and a hydrophobic lubricant;
said tablet matrix comprising at least about 60% rapidly water soluble ingredients based on the total weight of the matrix material;
said tablet having a hardness of between about 15 and about 50 Newtons, a friability of less than 2% when measured by U.S.P. and being adapted to dissolve spontaneously in the mouth of a patient in less than about 60 seconds and thereby liberate said particles and be capable of being stored in bulk. - View Dependent Claims (33, 34, 35, 36)
- particles including an active ingredient and a protective material, said particles being provided in an amount of between about 0.01 and about 75% by weight based on the weight of the tablet; and
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37. A method of making a packaged, orally disintegrable dosage form, comprising the steps of:
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(a) forming a mixture including an active ingredient and a matrix including a non-direct compression filler and a lubricant; (b) compressing said mixture to form a plurality of hard, compressed, rapidly disintegrable dosage forms having said active ingredient distributed in said orally dissolvable matrix, said dosage forms being adapted for direct oral dosing, said dosage forms having a hardness of at least about 15 Newtons and being adapted to dissolve spontaneously in the mouth of a patient in less than about 60 seconds and thereby liberate said active ingredient; and (c) storing said tablets in bulk prior to packaging said tablets. - View Dependent Claims (38, 39, 40)
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Specification