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Last Updated: March 28, 2024

Claims for Patent: 7,348,025


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Summary for Patent: 7,348,025
Title:Small particle liposome aerosols for delivery of anticancer drugs
Abstract: Provided herein is a method of treating primary lung cancer or metastatic cancer to the lung in an individual by delivering at least once to the respiratory tract of the individual via inhalation a nebulized liposomal aerosol comprising a dilauroylphosphatidylcholine liposome containing camptothecin or a derivative thereof in an amount sufficient to deliver a pharmacologically effective dose of the camptothecin or its derivative to treat the cancer. Also provided is a nebulized liposomal aerosol comprising the DLPC containing the camptothecin or its derivative and a method of making the liposome-drug comprising the aerosol.
Inventor(s): Knight; J. Vernon (Houston, TX), Koshkina; Nadezhda (Houston, TX), Gilbert; Brian (Houston, TX), Verschraegen; Claire F. (Albuquerque, NM)
Assignee: Research Development Foundation (Carson City, NV)
Application Number:10/663,573
Patent Claims:1. A method for treating a primary lung cancer or a metastatic cancer to the lung in an individual comprising the step of: delivering at least once to the respiratory tract of the individual via inhalation a nebulized liposomal aerosol comprising a dilauroylphosphatidylcholine liposome containing camptothecin or a derivative thereof in an amount sufficient to deliver a pharmacologically effective dose of said camptothecin or derivative thereof to treat said cancer, wherein said dose of camptothecin or derivative thereof delivered via inhalation is about 0.26 mg/m.sup.2/day to about 1.04 mg/m.sup.2/ day.

2. The method of claim 1, wherein said nebulized liposomal aerosol is delivered via an inhalation regimen comprising twice a day for 5 consecutive days within a week for one or more consecutive weeks.

3. The method of claim 2, wherein a period of consecutive weeks is the first 8 weeks out of a 10 week period.

4. The method of claim 3, wherein the inhalation regimen is repeated after week 10.

5. The method of claim 2, wherein said nebulized liposomal aerosol is inhaled for 60 minutes during each period of inhalation in the regimen.

6. The method of claim 1, wherein concentration of said camptothecin or derivative thereof in said dilauroylphosphatidylcholine liposome comprising said liposomal aerosol does not exceed 1.0 mg/ml.

7. The method of claim 6, wherein the concentration of said camptothecin or derivative thereof in said dilauroylphosphatidylcholine liposome comprising the liposomal aerosol is about 0.4 mg/ml.

8. The method of claim 1, wherein a ratio of camptothecin or derivative thereof to dilauroylphosphatidylcholine in said liposome comprising the liposomal aerosol is about 1:10 to about 1:50 wt:wt.

9. The method of claim 1, wherein said camptothecin derivative is 9-nitro-camptothecin, 9-amino-camptothecin or 10,11-methylenedioxy-camptothecin.

10. The method of claim 1, wherein said metastatic cancer is a sarcoma, a melanoma, lung cancer endometrial cancer, cervical cancer, pancreatic cancer, thyroid cancer or trophoblastic cancer.

11. The method of claim 1, wherein said liposomal aerosol is produced by the following steps: dissolving said camptothecin or derivative thereof in a volume of DMSO to produce dissolved camptothecin or derivative thereof; dissolving dilauroylphosphatidylcholine in an appropriate solvent to produce a dissolved dilauroylphosphatidylcholine; combining said dissolved camptothecin or derivative thereof and said dissolved dilauroylphosphatidylcholine to produce a solution, said solution having a DMSO concentration not exceeding about 5% of the total volume of said solution wherein a weight ratio of said camptothecin or derivative thereof to said dilauroylphosphatidylcholine in said solution is in a range of about 1:10 wt:wt to about 1:50 wt:wt of said solution; evaporating said solvents from said solution to produce a powder; and redissolving said powder in sterile water to produce a suspension, wherein a concentration of said camptothecin or derivative thereof in said sterile water does not exceed said 1.0 mg/ml.

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