Chewable tablet and method of formulating
First Claim
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1. A process for preparing a chewable tablet comprising a micronized form or submicron form of an active ingredient, the method comprising the steps of combining the active ingredient with tablet excipients by geometric dilution to form a final mixture and applying direct compression to at least a portion of the final mixture to form at least one tablet.
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Abstract
Processes for preparing a chewable tablet comprising a micronized form of an active ingredient, the method comprising the steps of combining the active ingredient with tablet excipients by geometric dilution to form a final mixture and applying direct compression to at least a portion of the final mixture to form at least one tablet.
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Citations
38 Claims
- 1. A process for preparing a chewable tablet comprising a micronized form or submicron form of an active ingredient, the method comprising the steps of combining the active ingredient with tablet excipients by geometric dilution to form a final mixture and applying direct compression to at least a portion of the final mixture to form at least one tablet.
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6. A process for preparing a chewable tablet from a composition comprising an amount of at least one active ingredient in micronized form or submicron form and a plurality of tableting excipients, wherein the chewable tablet exhibits acceptable content uniformity of active ingredient, the process comprising:
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a) dividing a first tableting excipient into a plurality of portions; b) combining a percentage of the amount of the active ingredient with a first portion of the first tableting excipient in the absence of additional tableting excipients to form a primary premixture; c) combining one or more additional tableting excipients from the plurality of tableting excipients into one or more remaining portions of the first tableting excipient not containing the active ingredient to form one or more secondary premixtures; d) adding said one or more secondary premixtures to the primary premixture to form a main batch; and e) applying direct compression to at least a portion of the main batch to form at least one tablet. - View Dependent Claims (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, 32)
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- 33. A process for preparing a chewable tablet comprising an antihistamine in micronized form or submicron form and tableting excipients, the method comprising the steps of combining the loratadine with tableting excipients by geometric dilution to form a final mixture and applying direct compression on the final mixture to produce tablet shapes, wherein any two of said chewable tablets exhibits bioequivalence to one nonchewable tablet comprising an equal or similar amount of antihistamine.
- 36. A chewable tablet comprising an antihistamine in micronized form or submicron form and tableting excipients, wherein the chewable tablet exhibits acceptable organoleptic qualities, antihistamine content uniformity, rapid dissolution, a substantial absence of binding in the die cavities and a substantial absence of sticking to punch faces under compression.
Specification