FORMULATIONS OF (+)-2-[1-(3-ETHOXY-4-METHOXY-PHENYL)-2-METHANESULFONYL-ETHYL]-4-ACETYLAMINOISOINDOLINE-1,3-DIONE
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.
1 . A pharmaceutical composition comprising compound A:
or a pharmaceutically acceptable salt thereof; a filler; a disintegrant; and a lubricant.
2 . The pharmaceutical composition of claim 1 , wherein the compound of formula (A) is present at an amount of about 5% to about 25 by weight of the total composition.
3 . The pharmaceutical composition of claim 1 , wherein the filler is lactose.
4 . The pharmaceutical composition of claim 3 , wherein the lactose is present at an amount of about 20% to 85% by weight of the total composition.
5 . The pharmaceutical composition of claim 3 , wherein the composition further comprises cellulose as a filler.
6 . The pharmaceutical composition of claim 5 , wherein the cellulose is present at an amount of about 10% to about 50% by weight of the total composition.
7 . The pharmaceutical composition of claim 1 , wherein the disintegrant is croscarmellose.
8 . The pharmaceutical composition of claim 7 , wherein the croscarmellose is present at an amount of about 2% to about 8% by weight of the total composition.
9 . The pharmaceutical composition of claim 1 , wherein the lubricant is magnesium stearate.
10 . The pharmaceutical composition of claim 9 , wherein the magnesium stearate is present at an amount of about 0.25% to about 5% of the total composition.
11 . The pharmaceutical composition of claim 1 , wherein the composition is coated with a coating formulation.
12 . The pharmaceutical composition of claim 1 , wherein the coating formulation comprises one or more excipients, wherein the excipient is a coating agent, a binder, a lubricant, a stabilizing agent, a plasticizer, an adhesive, a glidant, a diluent, or a combination thereof.
13 . The pharmaceutical composition of claim 12 , wherein the excipient is polyvinyl alcohol.
14 . The pharmaceutical composition of claim 13 , wherein the polyvinyl alcohol is present at an amount of about 35% to about 45% by weight of the total coating formulation.
15 . The pharmaceutical composition of claim 12 , wherein the excipient is polyethylene glycol.
16 . The pharmaceutical composition of claim 15 , wherein the polyethylene glycol is present at an amount of about 20% to about 25% by weight of the total coating formulation.
17 . The pharmaceutical composition of claim 12 , wherein the excipient is talc.
18 . The pharmaceutical composition of claim 17 , wherein the talc is present at an amount of about 10% to about 15% by weight of the total coating formulation.
19 . The pharmaceutical composition of claim 12 , wherein the excipients are one or more coloring agents.
20 . The pharmaceutical composition of claim 19 , wherein the coloring agents are present at an amount of about 25% to about 30% by weight of the total coating formulation.
21 . A tablet comprising:
(A) a core composition, wherein the core composition comprises:
or a pharmaceutically acceptable salt thereof, at an amount of about 10% by weight of the total core composition;
(ii) lactose at an amount of about 60% by weight of the total core composition;
(iii) microcrystalline cellulose at an amount of about 26.25% by weight of the total core composition;
(iv) croscarmellose at an amount of about 3% by weight of the total core composition; and
(v) magnesium stearate at an amount of about 0.75% by weight of the total core composition; and
(B) a coating formulation, wherein the coating formulation comprises:
(i) polyvinyl alcohol at an amount of about 40% by weight of the total coating formulation;
(ii) polyethylene glycol at an amount of about 20% by weight of the total coating formulation;
(iii) talc at an amount of about 15% by weight of the total coating formulation; and
(iv) a mixture of coloring agents at an amount of about 25% by weight of the total coating formulation.
22 . A method of treating, preventing or managing a disease or disorder comprising administering to a patient the pharmaceutical composition of claim 1 , wherein the disease or disorder is psoriasis, arthritis, dermatitis, acne, dermatomyositis, ulcerative colitis, Behcet's disease, Crohn's disease, sarcoidosis, uveitis, rosacea or lichen planus.
23 . The method of claim 22 , wherein the psoriasis is plaque-type psoriasis.
24 . The method of claim 22 , wherein the arthritis is psoriatic arthritis, rheumatoid arthritis, osteoarthritis or acute gouty arthritis.
25 . The method of claim 22 , wherein the dermatitis is atopic dermatitis or contact dermatitis.
26 . The method of claim 22 , wherein the sarcoidosis is chronic cutaneous sarcoidosis.
27 . A method of treating, preventing or managing a disease or disorder comprising administering to a patient the pharmaceutical composition of claim 21 , wherein the disease or disorder is psoriasis, arthritis, dermatitis, acne, dermatomyositis, ulcerative colitis, Behcet's disease, Crohn's disease, sarcoidosis, uveitis, rosacea or lichen planus.
28 . The method of claim 27 , wherein the psoriasis is plaque-type psoriasis.
29 . The method of claim 27 , wherein the arthritis is psoriatic arthritis, rheumatoid arthritis, osteoarthritis or acute gouty arthritis.
30 . The method of claim 27 , wherein the dermatitis is atopic dermatitis or contact dermatitis.
31 . The method of claim 27 , wherein the sarcoidosis is chronic cutaneous sarcoidosis.