SYSTEM FOR DELIVERING NEBULIZED CYCLOSPORINE AND METHODS OF TREATMENT
First Claim
1. An apparatus for administration of aerosolized cyclosporine, comprising,a pressurized delivery device coupled to an exhalation filter or trap, wherein the exhalation filter or trap is capable of maintaining an efficiency of greater than 90% during usage with a liquid formulation comprising cyclosporine for aerosolization by the device.
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Abstract
Systems comprising a pressurized delivery device and a formulation of cyclosporine coupled to an exhalation filter or trap that is capable of preventing cyclosporine from escaping into the local environment are provided. An apparatus for use in the system comprises either an exhalation filter and a pressurized delivery device, wherein the exhalation filter is capable of providing high filter efficiency and maintaining low filter resistance after usage with the formulation, or a trap which provides a means for expired gas to be released into a solvent chamber containing a solvent with a high affinity for cyclosporine. These systems may be used to treat patients with pulmonary disorders, organ transplant patients such as lung transplant patients, and other immune-related disorders.
9 Citations
28 Claims
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1. An apparatus for administration of aerosolized cyclosporine, comprising,
a pressurized delivery device coupled to an exhalation filter or trap, wherein the exhalation filter or trap is capable of maintaining an efficiency of greater than 90% during usage with a liquid formulation comprising cyclosporine for aerosolization by the device.
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28. A method for selecting an exhalation filter for use in a system comprising a nebulizer coupled to the exhalation filter, wherein the nebulizer contains a liquid formulation comprising cyclosporine, comprising:
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turning on a compressor and a respirator pump in a breathing apparatus to nebulize the solution, wherein the apparatus comprises a test exhalation filter, the compressor, the respirator pump, an inhalation filter, a trap filter, and a nebulizer containing said liquid cyclosporine formulation wherein the components of the apparatus are coupled to each other to form the breathing apparatus capable of simulating breathing; turning off the compressor and the respirator pump after the nebulizer runs dry; measuring the test filter efficiency by testing the trap filter to measure the quantity of cyclosporine that passed through the test filter; measuring the filter resistance of the test filter, wherein a filter efficiency of greater than 90%, and an increase in filter resistance between the test filter before the turning on step and after the turning off step of less than 0.1 cmH2O0.5·
min/L, are indicative of an appropriate exhalation filter to be used with said solution.
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Specification