Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Reexamination Certificate
2000-09-05
2001-12-11
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Web, sheet or filament bases; compositions of bandages; or...
C424S443000, C424S447000, C424S448000
Reexamination Certificate
active
06328992
ABSTRACT:
FIELD OF THE INVENTION
This invention pertains to methods and products for the transdermal administration of cannabis. More particularly, this invention concerns a system for delivering effective dosages of cannabis to one's bloodstream.
BACKGROUND OF THE INVENTION
Methods and products for transdermally administering particular chemicals are known in the art. Several U.S. patents have issued for the transdermal application of chemicals, most recently for nicotine. This invention expands the concept of transdermal delivery to cannabis, since the unique social and chemical characteristics of cannabis lend it to such an application.
Several medicinal uses have been found for the active ingredients of cannabis, including the ingredients tetrahydrocannabinol (THC), cannabinol (CBN), cannabidiol (CBD) and cannabichromene (CBC). The medicinal uses of cannabis include (1) treatment of nausea and pain associated with cancer and chemotherapy; (2) nausea, pain and wasting associated with AIDS; (3) arthritis and rheumatism; (4) glaucoma; (5) migraines; (6)muscle spasticity associated with multiple sclerosis and paralysis; (7) alcohol and narcotics withdrawal; (8) stress and depression; (9) asthma; and (10) epileptic seizures. Despite the many proven or suspected benefits of cannabis, legal and social barriers prevent its widespread use. Currently, only Marinol, a synthetic form of THC is available by prescription to patients. One purpose of the present invention is to extend the widespread medicinal use of cannabis without triggering the legal or social barriers associated with prescription of the drug.
The chemical composition of cannabis and its active ingredients allow for its transdermal delivery. For instance, the primary active ingredient of cannabis is THC, which is effective in vivo at very low doses. Due to its high liphophilicity, THC exhibits strong tendency to bind to tissue and protein, making transdermal application difficult. Fatal misuse has also been a concern in previous transdermal applications, but cannabinoids are rarely fatal when overdosed. Furthermore, THC is rapidly metabolized in the body, such that concentration levels of the chemical in the bloodstream decreases rapidly if administered through traditional methods. In contrast, a transdermal application allows for small dosages of THC to be administered over an extended period of time, thereby allowing the concentration levels of the chemical to remain relatively steady in the bloodstream.
SUMMARY OF THE INVENTION
The present invention comprises a structure, such as a skin patch, bandage, covering or related assembly of materials, which can contain and administer an effective amount of cannabis or its chemical constituents during a predetermined period of time. One purpose of the structure is to allow for controlled delivery of the active chemicals, such that plasma levels of the chemicals may be controlled in a safe, convenient and effective manner for the patient.
This invention also comprises the method of treating a patient with a transdermal cannabis preparation. Most conveniently, this is accomplished by application of the transdermal structure described herein. Antecedent or conjunctive steps for increasing the permeability of the patient's skin may further comprise the method for transdermally applying cannabis.
The invention includes a reservoir means for retaining and dispersing the active ingredients of the cannabis. In one embodiment of the invention, the reservoir means includes a rate controlling means overlying a cavity formed in a backing layer containing the cannabis. The rate controlling means regulates flux, hereinafter defined as the diffusion flow rate of the cannabis to the skin.
The rate controlling means may comprise a nonporous polymer membrane for regulating the flux. Alternatively, the rate controlling means may comprise a porous material made of elements suitable for controlling the diffusion rate of cannabis. Examples of suitable porous materials include porous rubber or plastic layers soaked in an aqueous ionic solution.
The reservoir means may also comprise a polymer matrix material which suspends the cannabis and releases it in a controlled manner. The flux of the polymer matrix material may further be regulated by a rate controlling membrane.
REFERENCES:
patent: 6113940 (2000-09-01), Brooke et al.
Brooke Lawrence L.
Herrmann Cal C.
Yum Su Il
Hovet Kenneth J.
Howard S.
Page Thurman K.
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