Multiparticulate modified release composition
DC CAFCFirst Claim
1. A multiparticulate modified release composition containing at least one active ingredient and having a first component comprising a first population of active ingredient-containing particles and at least one subsequent component, each subsequent component comprising a subsequent population of active ingredient-containing particles, the active ingredient contained in the first and subsequent components being the same or different;
- wherein the at least one subsequent population of active ingredient containing particles further comprises a modified release coating or, alternatively or additionally, a modified release matrix material, such that the composition following oral delivery to a subject delivers the active ingredient or active ingredients in a pulsatile manner.
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Abstract
The invention relates to a multiparticulate modified release composition that in operation delivers an active ingredient in a pulsed or bimodal manner. The multiparticulate modified release composition comprises an immediate release component and a modified release component; the immediate release component comprising a first population of active ingredient containing particles and the modified release component compnsimg a second population of active ingredient containing particles coated with a controlled release coating; wherein the combination of the immediate release and modified release components in operation deliver the active ingredient in a pulsed or a bimodal manner. The invention also relates to a solid oral dosage form containing such a multiparticulate modified release composition. The plasma profile achieved by the multiparticulate modified release composition is advantageous in reducing patient tolerance to the active ingredient and in increasing patient compliance by reducing dosage frequency.
517 Citations
37 Claims
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1. A multiparticulate modified release composition containing at least one active ingredient and having a first component comprising a first population of active ingredient-containing particles and at least one subsequent component, each subsequent component comprising a subsequent population of active ingredient-containing particles, the active ingredient contained in the first and subsequent components being the same or different;
- wherein the at least one subsequent population of active ingredient containing particles further comprises a modified release coating or, alternatively or additionally, a modified release matrix material, such that the composition following oral delivery to a subject delivers the active ingredient or active ingredients in a pulsatile manner.
- 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, 30, 31, 32, 33, 34, 35, 36)
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27. A method, wherein a multiparticulate modified release composition comprising:
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a. a first population of active ingredient containing particles and b. at least one subsequent population of active ingredient containing particles, wherein the subsequent population of active ingredient containing particles further comprises a coating selected from the group consisting of a modified release coating and a modified release matrix material, and wherein oral administration of the composition to a subject in need of the active ingredient releases the active ingredient in a pulsatile manner. - View Dependent Claims (28, 29, 37)
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Specification