Methods and compositions for oral pharmaceutical therapy

摘要

It now has been found that oral administration of pharmaceutical agents, including N-methylol transfer agents such as Taurolidine may be used to provide efficacious blood plasma concentration of the agents for treatment of diseases by providing release of the active agent into the duodenum or jejunum of a patient and/or at a pH of about 5.4 to about 6.5. Embodiments of the invention therefore provide oral dosage forms, compositions and methods for administration of pharmaceutical agents to the duodenum or jejunum of a patient, and/or which release at a pH of about 5.4 to about 6.5.

主权项

1. A method of achieving a blood, serum, or plasma level in a subject of at least about 4 μg/mL of an N-methylol transfer agent comprising taurolidine, taurultam, a derivative of taurolidine or taurultam, or a combination thereof, comprising administering to said subject a capsule comprising the N-methylol transfer agent and a pharmaceutically acceptable targeted release carrier, said targeted release carrier providing an efficacious blood, serum or plasma level of said N-methylol transfer agent in said subject, after oral administration of said capsule, to treat a disease in said subject, wherein, after said oral administration, said carrier
(a) carries said agent substantially intact through said subject's stomach and releases said agent into said subject's duodenum or jejunum, wherein said agent enters the subject's bloodstream through said duodenum or jejunum, (b) releases said agent at a pH of about 5.4 to about 6.5, wherein said agent enters the subject's bloodstream, or (c) both.