阅读说明：本技术 用于治疗呈现至少一种炎性组分的肠道疾病的方法 (Method for treating intestinal diseases presenting at least one inflammatory component ) 是由 卢吉·摩洛 杰拉尔德·托马斯·普洛尔 温德尔·维伦加 迈克尔·芳菁·黄 爱默生·大卫·巴拉德 于 2013-02-13 设计创作，主要内容包括：本申请涉及用于治疗呈现至少一种炎性组分的肠道疾病的方法。本公开内容涉及使用布地奈德MMX组合物治疗呈现至少一种炎性组分的肠道疾病诸如炎性肠病或憩室病和/或维持呈现至少一种炎性组分的肠道疾病诸如炎性肠病(IBD)或憩室病的缓解的方法。(The present application relates to methods for treating intestinal disorders presenting at least one inflammatory component. The present disclosure relates to methods of treating and/or maintaining remission of intestinal diseases presenting at least one inflammatory component, such as Inflammatory Bowel Disease (IBD) or diverticular disease, using budesonide MMX compositions.)

1. A medicament for treating a patient suffering from ulcerative colitis, said patient having previously been administered 5-aminosalicylic acid (5-ASA) and having a UCDAI score greater than or equal to 4, said medicament comprising a combination of a first composition comprising 5-aminosalicylic acid and a second composition in the form of a single tablet, said single tablet comprising:

(1) a tablet core comprising:

a)9mg budesonide;

b) at least one lipophilic excipient;

c) at least one amphiphilic excipient; and

d) at least one hydrophilic excipient; and

(2) a coating on the core, the coating comprising a gastro-resistant membrane.

2. The medicament of claim 1, wherein the second composition is administered for up to 8 weeks.

3. The medicament of claim 1 or claim 2, wherein the patient has the UCDAI score of less than or equal to 1 after the treatment.

4. The medicament of any one of claims 1-3, wherein the patient has experienced a recurrence of ulcerative colitis prior to administration of the second composition to the patient.

5. The medicament of any one of claims 1-4, wherein the first composition and the second composition are administered to the patient simultaneously.

6. Use of a combination of a first composition and a second composition in the manufacture of a medicament for the treatment of ulcerative colitis in a patient, wherein when the medicament is used the first composition and the second composition are used simultaneously, separately or sequentially, the first composition comprising 5-aminosalicylic acid and the second composition being in the form of a single tablet comprising:

(1) a tablet core comprising:

a)9mg budesonide;

b) at least one lipophilic excipient;

c) at least one amphiphilic excipient; and

d) at least one hydrophilic excipient; and

(2) a coating on the core, the coating comprising a gastric resistant film;

wherein the patient is treated with the first composition prior to the second composition; and wherein the patient has a UCDAI score greater than or equal to 4 prior to administration of the second composition to the patient.

7. The use of claim 6, wherein the patient experienced a relapse of ulcerative colitis prior to administration of the second composition to the patient.

8. The use according to any one of claims 6 to 7, wherein the second composition is administered for up to 8 weeks when the medicament is used.

9. The use according to any one of claims 6 to 8, wherein the patient has the UCDAI score of less than or equal to 1 following the treatment.

10. Use of a combination of a first composition and a second composition in the manufacture of a medicament for treating ulcerative colitis in a patient, wherein when the medicament is used, the first composition comprises 5-aminosalicylic acid and the second composition is in the form of a single tablet comprising:

(1) a tablet core comprising:

a)9mg budesonide;

b) at least one lipophilic excipient;

c) at least one amphiphilic excipient; and

d) at least one hydrophilic excipient; and

(2) a coating on the core, the coating comprising a gastric resistant film;

wherein the second composition is administered to the patient once daily for up to 8 weeks or a portion thereof; wherein after the treatment, the ulcerative colitis in the patient is in remission; and wherein the patient has a UCDAI score greater than or equal to 4 prior to administration of the second composition to the patient.

11. The use of claim 10, wherein the second composition is administered to the patient for 8 weeks.

12. The use of claim 10, wherein the patient has the UCDAI score of less than or equal to 1 after the treatment.

13. The use of claim 10, wherein the patient experienced a relapse of ulcerative colitis prior to administration of the second composition to the patient.

14. The use of claim 10, wherein the first composition and the second composition are administered to the patient simultaneously.

15. Use of a combination of a first composition and a second composition in the manufacture of a medicament for treating ulcerative colitis in a patient who has previously been administered a composition comprising 5-aminosalicylic acid, wherein when the medicament is used, the first composition comprises 5-aminosalicylic acid and the second composition is in the form of a single tablet comprising:

(1) a tablet core comprising:

a)9mg budesonide;

b) at least one lipophilic excipient;

c) at least one amphiphilic excipient; and

d) at least one hydrophilic excipient; and

(2) a coating on the core, the coating comprising a gastric resistant film;

wherein the second composition is administered to the patient once daily for up to 8 weeks or a portion thereof; wherein after the treatment, the ulcerative colitis in the patient is in remission; and wherein the patient has a UCDAI score greater than or equal to 4 prior to administration of the second composition to the patient.

16. The use of claim 15, wherein the second composition is administered to the patient for 8 weeks.

17. The use of claim 15, wherein the patient has the UCDAI score of less than or equal to 1 after the treatment.

18. The use of claim 15, wherein the patient experienced a relapse of ulcerative colitis prior to administration of the second composition to the patient.

19. The use of claim 15, wherein the first composition and the second composition are administered to the patient simultaneously.

Examples

The embodiments described below may be modified using methods known to those skilled in the art to prepare dosage forms, such as tablets, each of which contains from about 1mg to about 20mg of budesonide, such as about 1mg to about 12mg of budesonide, about 1mg to about 18mg of budesonide, about 15mg of budesonide, about 12mg of budesonide, about 9mg of budesonide, about 6mg of budesonide, about 4.5mg of budesonide, or about 3mg of budesonide.

Unless otherwise indicated, the dissolution test described herein was performed by introducing individual tablets into a container containing from 500ml to 1000ml of a buffer solution set to pH 7.2 such that the pH conditions of the large intestine would be reproduced. To simulate human conditions, the test was carried out at a temperature of 37 ℃. + -. 2 ℃ and samples were taken at a predetermined time period of lysis of the medium to determine the percentage of active ingredient dissolved over time.