CELECOXIB AND AMLODIPINE FORMULATION AND METHOD OF MAKING THE SAME
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Accused Products
Abstract
Provided herein is a celecoxib and amlodipine composition and method of making the same. The composition contains granules containing celecoxib. The amlodipine is incorporated into the composition as an extragranulate.
2 Citations
25 Claims
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1-10. -10. (canceled)
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11. A pharmaceutical composition comprising:
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(i) a dry granulate comprising celecoxib or a pharmaceutically acceptable salt, wherein the dry granulate has a loss on drying (LOD) % of about 2.5% or less, wherein said dry granulate does not include amlodipine; and (ii) an extragranulate comprising amlodipine or a pharmaceutically acceptable salt thereof; and
optionally(iii) one or more excipients selected from the group consisting of a diluent, a disintegrant, a surfactant, a binder, a glidant, a lubricant, and combinations thereof. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
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25. A pharmaceutical composition comprising:
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a dry granulate comprising celecoxib or a pharmaceutically acceptable salt thereof and a diluent, a disintegrant, a binder, and a surfactant, wherein the dry granulate has a loss on drying (LOD) % of about 2.5% or less, wherein said dry granulate does not include amlodipine; and an extragranulate comprising either amlodipine or amlodipine besylate, and a diluent, a disintegrant, a glidant, and a lubricant.
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Specification