Pharmaceutical preparations for the targeted treatment of crohn's disease and ulcerative colitis
AssigneeNovatis AG
InventorUlrich Posanski
Life of this patent
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Abstract
The invention relates to a pharmaceutical preparation, which contains an immunosuppressive active agent in dissolved form in a starch capsule, or hard or soft gelatin capsule which has been coated with one or several polymer films. The invention further relates to a process for the production of the pharmaceutical preparation.
Claims23
A pharmaceutical preparation comprising
- 1) a pharmaceutically acceptable solvent in which cyclosporin A is soluble,
- 2) cyclosporin A dissolved in the pharmaceutically acceptable solvent, forming a solution of the cyclosporin A in the pharmaceutically acceptable solvent,
- 3) a starch capsule or a hard or soft gelatin capsule which encapsulates the solution of the cyclosporin A;
- and
- 4) optionally, a medicament excipient selected from the group consisting of a surface-active agent and an agent which affects viscosity,
- wherein said capsule has been coated with at least one polymer composition containing at least one pore-forming agent in an amount effective to increase the diffusion rate through the polymer coating.
A method of treating Crohn's disease, ulcerative colitis, or inflammatory occurrences associated therewith, wherein the method comprises:
- orally administering a pharmaceutical preparation comprising
- 1) a pharmaceutically acceptable solvent in which cyclosporin A is soluble,
- 2) cyclosporin A in an amount effective for treating Crohn's disease, ulcerative colitis, or inflammatory occurrences associated therewith, wherein the cyclosporin A is dissolved in the pharmaceutically acceptable solvent, forming a solution of the cyclosporin A in the pharmaceutically acceptable solvent,
- 3) a starch capsule or a hard or soft gelatin capsule which encapsulates the solution of the cyclosporin A;
- and
- 4) optionally, a medicament excipient selected from the group consisting of a surface-active agent and an agent which affects viscosity,
- wherein said capsule has been coated with at least one polymer composition containing at least one pore-forming agent in an amount effective to increase the diffusion rate through the polymer coating.
A process for the production of a pharmaceutical preparation comprising a starch capsule or a hard or soft gelatin capsule, and cyclosporin A in dissolved form, wherein the process comprises:
- 1) dissolving the cyclosporin A in a solvent which is suitable for encapsulation into starch or gelatin capsules, or in a mixture of several solvents and other excipients,
- 2) filling the solution into starch capsules, or hard or soft gelatin capsules in a measured dose,
- 3) sealing the capsules, and
- 4) coating the capsules with a solution or dispersion of a polymer or polymer mixture and drying the capsules, wherein the coating procedure may be repeated one or more times and the polymer solution or dispersion contains at least one pore-forming agent in an amount effective to increase the diffusion rate through the polymer coating.
Dependencies are inferred from the claim text.