METHOD FOR TREATING INTESTINAL DISEASES PRESENTING AT LEAST ONE INFLAMMATORY COMPONENT

1 . A method for treating an intestinal disease presenting at least one inflammatory component and/or maintaining remission of an intestinal disease presenting at least one inflammatory component in a patient, previously or simultaneously administered a first composition comprising at least a compound for treating said disease comprising administering to said patient, said second composition comprising:

(1) a tablet core comprising:

a) budesonide in an amount effective for treating or maintaining remission of an intestinal disease presenting at least one inflammatory component,

b) at least one lipophilic excipient;

c) at least one amphiphilic excipient; and

d) at least one hydrophilic excipient; and

(2) a coating on said tablet core, said coating comprising a gastro-resistant film.

2 . The method according to claim 1 , wherein the first composition is administered to the patient previously to the second composition.

3 . The method according to claim 1 , wherein the first composition is administered to the patient simultaneously with the second composition.

4 . The method according to claim 1 , wherein the intestinal disease presenting at least one inflammatory component is inflammatory bowel disease, such as ulceratve colitis, Crohn's disease or active mild to moderate ulcerative colitis.

5 . The method according to claim 1 , wherein the intestinal disease presenting at least one inflammatory component is acute diverticulitis and the maintenance is the maintenance of the acute phase of a diverticular disease.

6 . The method according to claim 1 , wherein the second composition comprises 1 mg to 18 mg budesonide in a single dose or a divided dose, such as 3 mg budesonide, 4.5 mg budesonide, 6 mg budesonide, 9 mg budesonide, 12 mg budesonide, 15 mg budesonide or 18 mg budesonide.

7 . The method according to claim 1 , wherein the second composition comprises 1 mg to 12 mg budesonide, such as 3 mg budesonide, 4.5 mg budesonide, 6 mg budesonide, 9 mg budesonide.

8 . The method according to claim 6 , wherein the second composition comprises 6 mg budesonide or 9 mg budesonide.

9 . The method according to claim 1 , wherein said at least a compound comprised in the first composition is selected from systemic corticosteroids and non-systemic corticosteroids.

10 . The method according to claim 9 , wherein said at least a compound comprised in the first composition is budesonide.

11 . The method according to claim 10 , wherein the first composition comprises 1 mg to 18 mg budesonide, such as 1 mg to 12 mg budesonide or 6 mg budesonide or 9 mg budesonide.

12 . The method according to claim 9 , wherein said at least a compound comprised in the first composition is 5-aminosalicylic acid (5-ASA).

13 . The method according to claim 12 , wherein the first composition comprises 2400 mg 5-aminosalicylic acid (5-ASA) or at least 2400 mg 5-aminosalicylic acid (5-ASA).

14 . The method according to claim 1 , wherein said at least a compound comprised in the first composition is selected from systemic antibiotics, topical antibiotics, sulphonamides, antinfective chemotherapeutics, antinfective compounds and motility-controlling drugs.

15 . The method according to claim 1 , wherein said at least a compound comprised in the first composition is selected from absorbable antibiotics, unabsorbable antibiobiotics, betalactamic antibiotics and chinolones.

16 . The method according to claim 1 , wherein said at least a compound comprised in the first composition is selected from ampicillin, amoxicillin, ciprofloxacin, fidaxomicin, erythromycin, paromomycine, trimethoprim-sulphamethoxazole, metronidazole, vancomycin, Bismuth salts, Bismuth derivatives, rifaximine, rifamycin SV, chloramphenicol, streptomycin, bacitracin and neomycin.

17 . The method according to claim 16 , wherein said at least a compound comprised in the first composition is rifamycin SV.

18 . The method according to claim 17 , wherein the first composition comprises 400 mg to 2000 mg rifamycin SV, such as 800 mg rifamycin SV or 1200 mg rifamycin SV or 1800 mg rifamycin SV.

19 . The method according to claim 18 , wherein the first composition comprises 400 mg to 2000 mg rifamycin SV and the second composition comprises 6 mg to 18 mg budesonide, such as 800 mg rifamycin SV and 6 mg budesonide, or 800 mg rifamycin SV and 9 mg budesonide, or 1200 mg rifamycin SV and 6 mg budesonide, or 1200 mg rifamycin SV and 9 mg budesonide, or 1800 mg rifamycin SV and 6 mg budesonide, or 1800 mg rifamycin SV and 9 mg budesonide.

20 . The method according to claim 16 , wherein said at least a compound comprised in the first composition is ciprofloxacin.

21 . The method according to claim 20 , wherein the first composition comprises 500 mg to 1500 mg ciprofloxacin.

22 . The method according to claim 21 , wherein the first composition comprises 500 mg to 1500 mg ciprofloxacin and the second composition comprises 6 mg to 18 mg budesonide, such as 500 mg ciprofloxacin and 6 mg budesonide, or 500 mg ciprofloxacin and 9 mg budesonide, or 750 mg ciprofloxacin and 6 mg budesonide, or 750 mg ciprofloxacin and 9 mg budesonide, or 1000 mg ciprofloxacin and 6 mg budesonide, or 1000 mg ciprofloxacin and 9 mg budesonide.

23 . The method according to claim 1 , wherein the second composition is administered for at least 4 weeks or for at least 8 weeks or for at least 12 months.

24 . The method according to claim 1 , wherein the patient is in need of maintaining remission of an intestinal disease presenting at least one inflammatory component.

25 . The method according to claim 1 , wherein

said at least one lipophilic excipient is stearic acid,

said at least one amphiphilic excipient is lecithin,

said at least one hydrophilic excipient is hydroxypropylcellulose, and

said gastro-resistant film comprises at least one methacrylic acid polymer or copolymer.

26 . The method according to claim 1 , wherein

(1) the tablet core comprises:

a) 3 mg, or 4.5 mg or 6 mg, or 9 mg or 12 mg or 15 mg or 18 mg budesonide,

b) stearic acid,

c) lecithin; and

d) hydroxypropylcellulose; and wherein

(2) the gastro-resistant film comprises at least one methacrylic acid polymer or copolymer.

27 . The method according to claim 25 , wherein said tablet core further comprises microcrystalline cellulose, lactose, silicon dioxide, and magnesium stearate.

28 . The method according to claim 1 , wherein the tablet core is a multi-matrix tablet core, wherein each lipophilic excipient is a lipophilic matrix-forming excipient, wherein each amphiphilic excipient is an amphiphilic matrix-forming excipient and wherein each hydrophilic excipient is a hydrophilic matrix-forming excipient.

29 . The method of claim 1 , wherein said first composition comprises 5-aminosalicylic acid, said second composition being in the form of a single tablet comprising 9 mg of budesonide.

30 . The method according to claim 29 , wherein the patient is treated with the first composition previously to the second composition.

31 . The method according to claim 29 , wherein said patient has a UCDAI score of greater than or equal to 4 prior to said second composition being administered to said patient.

32 . The method according to claim 29 , wherein said patient is experiencing an ulcerative colitis flare prior to said second composition being administered to said patient.

33 . The method according to claim 29 , wherein the second composition is administered for up to 8 weeks.

34 . A method for maintaining remission of ulcerative colitis in a patient, comprising administering a composition in the form of a single tablet comprising 6 mg of budesonide

35 . The method of claim 34 , wherein said tablet is administered for up to 12 months or for up to six months.