PHARMACEUTICAL COMPOSITIONS OF 3-(6-(1-(2,2-DIFLUOROBENZO[D][1,3]DIOXOL-5-YL) CYCLOPROPANECARBOXAMIDO)-3-METHYLPYRIDIN-2-YL) BENZOIC ACID AND ADMINISTRATION THEREOF
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Accused Products
Abstract
A pharmaceutical composition comprising Compound 1, (3-(6-(1-(2,2-difluorobenzo [d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid), and at least one excipient selected from: a filler, a diluent, a disintegrant, a surfactant, a binder, a glidant and a lubricant, the composition being suitable for oral administration to a patient in need thereof to treat a CFTR mediated disease such as Cystic Fibrosis. Methods for treating a patient in need thereof include administering an oral pharmaceutical formulation of Compound 1 to the patient.
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Citations
79 Claims
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1-55. -55. (canceled)
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56. A tablet for oral administration comprising:
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a. 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid (Compound
1) Form I wherein the Compound 1 Form I is present in an amount ranging from 25 mg to 250 mg;b. a filler; c. a disintegrant; d. a surfactant; e. a lubricant; and f. a binder which is polyvinylpyrrolidone. - View Dependent Claims (60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79)
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57. A tablet for oral administration comprising:
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a. Compound 1 Form I wherein the Compound 1 Form I is present in an amount ranging from 25 mg to 250 mg; b. a filler; c. a disintegrant which is croscarmellose sodium and is present in an amount of about 6 wt % to about 10 wt % by weight of the tablet; d. a surfactant; e. a lubricant; and f. a binder.
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58. A tablet for oral administration comprising:
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a. Compound 1 Form I wherein the Compound 1 Form I is present in an amount ranging from 25 mg to 250 mg; b. a filler; c. a disintegrant; d. a surfactant which is sodium lauryl sulfate and is present in an amount of 0.3 wt % to 2 wt % by weight of the tablet; e. a lubricant; and f. a binder.
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59. A tablet for oral administration comprising:
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a. Compound 1 Form I wherein the Compound 1 Form I is present in an amount ranging from 25 mg to 250 mg; b. a filler; c. a disintegrant; d. a surfactant; e. a lubricant; and f. a binder; wherein Compound 1 Form I is present in an amount of 30 wt % to 70 wt % by weight of the tablet.
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Specification