IP Library › Patent Application 19536004
Patent Application
App. No. 19/536,004

FORMULATIONS OF (+)-2-[1-(3-ETHOXY-4- METHOXY-PHENYL)-2-METHANESULFONYL-ETHYL]-4-ACETYLAMINOISOINDOLINE-1,3-DIONE

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Quick Facts
Patent No.
US None
App. No.
19/536,004
Abstract

Pharmaceutical compositions and single unit dosage forms of (+)-2-[1-(3-ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethyl]-4-acetylaminoisoindoline-1,3-dione, or a pharmaceutically acceptable stereoisomer, prodrug, salt, solvate, hydrate, or clathrate thereof, are provided herein. Also provided are methods of treating, managing, or preventing various diseases or disorders.

Claims (19)

1 .- 26 . (canceled)

27 . A method of treating a disease or disorder selected from the group consisting of psoriasis, arthritis, dermatitis, acne, dermatomyositis, ulcerative colitis, Behcet's disease, Crohn's disease, sarcoidosis, uveitis, rosacea, and lichen planus, comprising administering to a patient in need thereof a pharmaceutical composition in the form of an oral tablet, the pharmaceutical composition comprising:

a) a core composition, wherein the core composition comprises Compound A:

or a pharmaceutically acceptable salt thereof, a filler, a disintegrant, and a lubricant, wherein the filler comprises i) lactose monohydrate in an amount of 50% to 65% by weight of the total core composition and ii) cellulose in an amount of 15% to 40% by weight of the total core composition, and

b) a coating formulation comprising polyvinyl alcohol.

28 . The method of claim 27 , wherein the disease is psoriasis.

29 . The method of claim 28 , wherein the psoriasis is plaque-type psoriasis.

30 . The method of claim 27 , wherein the disease is arthritis.

31 . The method of claim 30 , wherein the arthritis is psoriatic arthritis, rheumatoid arthritis, osteoarthritis, or acute gouty arthritis.

32 . The method of claim 31 , wherein the arthritis is psoriatic arthritis.

33 . The method of claim 27 , wherein the disease is Behcet's disease.

34 . The method of claim 27 , wherein Compound A is present in an amount of 5% to 25% by weight of the total core composition.

35 . The method of claim 27 , wherein the disintegrant is croscarmellose.

36 . The method of claim 35 , wherein the croscarmellose is present at an amount of 2% to 8% by weight of the total core composition.

37 . The method of claim 27 , wherein the lubricant is magnesium stearate.

38 . The method of claim 37 , wherein the magnesium stearate is present at an amount of 0.25% to 5% of the total core composition.

39 . The method of claim 27 , wherein the coating formulation comprises one or more of a coating agent, a binder, a lubricant, a stabilizing agent, a plasticizer, an adhesive, a glidant, a diluent, or a combination thereof.

40 . The method of claim 39 , wherein the coating formulation further comprises polyethylene glycol.

41 . The method of claim 27 , wherein the core composition comprises Compound A in an amount of 5% to 25% by weight of the total core composition, lactose in an amount of 50% to 65% by weight of the total core composition, microcrystalline cellulose in an amount of 15% to 40% by weight of the total core composition, croscarmellose in an amount of 2% to 8% by weight of the total core composition, and magnesium stearate in an amount of 0.25% to 5% by weight of the total core composition.