Cyclosporine A is an established form of immunosuppressive treatment in organ transplantation involving kidney, liver, or heart. The absorption of cyclosporine during chronic administration of Sandimmune soft gelatin capsules and oral solution is known to be highly variable. It is recommended that patients taking the soft gelatin capsules or oral solution over a period of time be monitored at repeated intervals for cyclosporin A blood levels and subsequent dose adjustments be made in order to avoid either toxicity due to high levels or posible organ rejection due to low levels of cyclosporine A. Neoral is a new form of Sandimmune which utilizes a microemulsion technique that facilitates the absorption of cyclosporin A. In healthy normal volunteers, administration of Neoral soft gelatin capsules has demonstrated consistent and improved absorption characteristics resulting in a more predictable pharmacokinetic profile relative to Sandimmune soft gelatin capsules. It is hypothesized that this new microemulsion formulation of Sandimmune, because of its more consistent and improved absorption characteristics, will facilitate the management of transplant patients.

Project Start
1998-01-26
Project End
1998-11-30
Budget Start
1997-10-01
Budget End
1998-09-30
Support Year
38
Fiscal Year
1998
Total Cost
Indirect Cost
Name
University of Alabama Birmingham
Department
Type
DUNS #
004514360
City
Birmingham
State
AL
Country
United States
Zip Code
35294
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