IP Library › Patent Application 13791816
Patent Application
App. No. 13/791,816

DELAYED-RELEASE GLUCOCORTICOID TREATMENT OF RHEUMATOID ARTHRITIS BY IMPROVING SIGNS AND SYMPTOMS, SHOWING MAJOR OR COMPLETE CLINICAL RESPONSE AND BY PREVENTING FROM JOINT DAMAGE

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Quick Facts
Patent No.
US None
App. No.
13/791,816
Abstract

The present invention refers to the treatment of a patient suffering from rheumatoid arthritis by showing a reduction in signs and symptoms, a major or complete clinical response (remission) or even prevention of structural damages to the joints by administering a delayed-release dosage form of a glucocorticoid to a subject in need thereof.

Claims (12)

1 .- 47 . (canceled)

48 . A method of administering a glucocorticosteroid active substance selected from prednisone, prednisolone, and methylprednisolone to a patient in need thereof comprising

administering to the patient an oral dosage form comprising a defined core and a compression coating surrounding the core,

wherein the patient has been instructed to administer the oral dosage form together with or not later than 3 hours after consuming a high fat meal, and

wherein release of the glucocorticosteroid active substance from the oral dosage form is pH-independent and occurs between about 2 to about 6 hours after the oral dosage form has been immersed in an aqueous medium.

49 . The method of claim 48 , wherein the dosage form comprises 10 mg prednisone.

50 . The method of claim 48 , wherein the dosage form comprises 5 mg prednisone.

51 . The method of claim 48 , wherein the dosage form comprises 1 mg prednisone.

52 . The method of claim 48 , wherein the delayed-release dosage form has an in vivo lag time (tlag) of from about 2 hours to about 6 hours after administration.

53 . The method of claim 48 , wherein the delayed-release dosage form has an in vivo lag time (tlag) of from about 3 hours to about 5 hours after administration.

54 . The method of claim 48 , wherein the delayed-release dosage form does not have an enteric coating.

55 . The method of claim 48 , wherein the delayed-release dosage form comprises a non-soluble/non-swellable coating and a core comprising the active agent and a disintegrant and/or a swelling agent.