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Metered-dose and safety and compliance packaging for systemic anticancer therapy

A therapeutic agent and compliance technology, applied in the direction of anti-tumor drugs, organic active ingredients, and oral feeding equipment, etc., can solve the problems of complex compliance, toxicity and death of anti-tumor chemical agents, etc.

Inactive Publication Date: 2009-08-05
约翰·P·福德
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For example, the toxicity of antineoplastic chemicals can lead to death when patients repeatedly take the wrong dose they were prescribed
Compliance is further complicated by additional doses or supplements designed to mitigate the side effects of anticancer therapy

Method used

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  • Metered-dose and safety and compliance packaging for systemic anticancer therapy
  • Metered-dose and safety and compliance packaging for systemic anticancer therapy
  • Metered-dose and safety and compliance packaging for systemic anticancer therapy

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0191] Theoretical systemic exposure to uracil resulting from topical application of 1% (w / w) uracil ointment to hands and feet can be roughly estimated as follows.

[0192] Application of 0.1 g of 1% (w / w) uracil ointment 4 times daily to hands and feet represents a daily exposure of 4-8 mg uracil. Topical absorption of the agent through intact skin can be on the order of 1%, which results in systemic absorption of 40-8 g / day. This is in contrast to the daily exposure of uracil in UFT of approximately 1200 mg. Thus, mean systemic uracil exposure with uracil ointment averaged about 0.00005 times (0.005%) that of UFT.

[0193] However, on the surface of the skin, and just below the skin, the concentration of uracil should be about 10 mg / ml. A useful estimate of mean plasma 5-FU concentration is 0.5 pg / ml. Thus, topical administration of uracil ointment theoretically establishes a local concentration of uracil approximately 2000 times that of 5-FU at the skin, with a systemic...

Embodiment 2

[0195] A 48-year-old female patient presented with metastatic breast cancer. She has declined mastectomy and has previously failed on the following drugs: doxorubicin and cyclophosphamide, one week of paclitaxel, and one week of norvinblastine. Then Xeloda She was treated with 1% uracil ointment applied to the hands and feet. Using Xeloda The fifth cycle of treatment started with 1% uracil ointment.

[0196] Table 1 below summarizes the results in this patient.

[0197]

[0198] *ND: not described

[0199] The 1% uracil ointment makes Xeloda The dose can be escalated again, the Xeloda Anticancer activity at high doses. The 1% uracil ointment allows administration of high doses of It has improved anticancer efficacy (compare columns 5 and 6). The 1% uracil ointment did not have any visible toxicity.

Embodiment 3

[0201] Another patient, a 68-year-old Caucasian male diagnosed with metastatic colon cancer, was treated with and thalidomide for treatment. Hand-foot syndrome develops. Complete reversal of the symptoms occurred after treatment with topical 1% uracil ointment. The effect of treatment with thalidomide was not affected by the simultaneous use of 0.1 g 1% uracil ointment 4 times a day. There was no dose reduction or treatment delay of chemotherapy.

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Abstract

The invention provides a metered-dose package for coadministration of a first and a second component of a therapeutic agent. The metered-dose package includes a first plurality of fluidly noncommunicating chambers, each chamber sealably containing an individual dose of the first component, and a second plurality of chambers, each said chamber capable of reversibly receiving at least one dose of the second component. Also provided is a safety or compliance system.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of US Provisional Application 60 / 697,910, filed July 8, 2005, the disclosure of which is incorporated herein by reference in its entirety. Background technique [0003] Systemic administration of antineoplastic chemical agents has been a mainstay of cancer therapy for the past 50 years. However, despite the successful treatment of a large number of cancers, the systemic administration of these toxic agents is often accompanied by deleterious side effects that limit their clinical utility. For example, the antimetabolites fluorinated pyrimidines (fluoropyrimidines), e.g., 5-fluorouracil (5-FU) are still front-line treatments for a variety of cancers 40 years after their initial clinical use, but the Treatment can result in a variety of unwanted side effects. [0004] Oral administration of fluoropyrimidine antimetabolites, such as 5-FU, is considered unfavorable due to high activity i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/70
CPCA61K31/7072A61K31/513A61J7/04A61K9/0014A61K9/107A61K9/06A61K9/0056A61K9/0019A61K45/06A61P35/00A61P43/00A61K2300/00A61J7/0076
Inventor 约翰·P·福德
Owner 约翰·P·福德