Fish oil transdermal patch

->>>> Click Here to Download <<<<<<<-

The method of claim 1 comprising the additional step of providing a reservoir means to said backing layer for holding said transdermal preparation. The method of claim 7 wherein said reservoir means is any one or combination of a member of the group consisting of a cavity, matrix material, adhesive layer and film.

The method of claim 1 wherein after step D, maintaining said transdermal preparation in contact with said skin for an effective period of time. A cannabis transdermal delivery structure comprising: a backing layer selected from the group consisting of a patch, strip, bandage or covering; said backing layer having a transdermal preparation comprising weight percent cannabis, weight percent carrier and weight percent skin permeation enhancer.

The structure of claim 11 wherein said transdermal preparation includes weight percent oil. The structure of claim 11 wherein said skin permeation enhancer has a HLB of about The structure of claim 11 wherein said backing layer includes a reservoir means for holding said transdermal preparation. The structure of claim 14 wherein said reservoir means is any one or combination of a member of the group consisting of a cavity, matrix material, adhesive layer and film.

The structure of claim 15 wherein said matrix material is selected from the group consisting of an open pore material, open weave fabric and a membrane. The transdermal structure of claim 14 wherein said reservoir means comprises a convex portion of said backing layer.

The structure of claim 11 wherein a secondary layer is attached to said backing layer, said secondary layer having an opening which forms a retention cavity with said backing layer for holding said transdermal preparation.

A structure for administering cannabis to skin, comprising: at least one layer of backing material suitable for attachment to said skin; and, a cannabis preparation on said backing material comprising weight percent cannabis, weight percent carrier and about weight percent permeation enhancer. The structure of claim 20 wherein said permeation enhancer has a HLB of The structure of claim 21 wherein said carrier includes about weight percent oil.

The structure of claim 22 wherein said oil is a member selected from the group consisting of mineral oil, vegetable oil, fish oil and animal oil. The structure of claim 20 wherein said backing material is any one or combination of a member selected from the group consisting of fabric, plastic, metal foil, rubber, resin film and membrane.

The structure of claim 20 wherein said backing material includes a reservoir means for retaining said cannabis preparation. The structure of claim 25 wherein said reservoir means comprises a member selected from the group consisting of cavity, matrix material, adhesive layer and film. The structure of claim 25 wherein said reservoir means includes a rate control means for regulating the flow of said cannabis preparation to said skin. More particularly, this invention concerns a system for delivering effective dosages of cannabis to one's bloodstream.

Several U. 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. 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. 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. As used herein, the term "oil" comprises any one or mixture of pharmaceutical grade light mineral oils, vegetable oils, fish and animal oils.

Examples of vegetable oils are sesame, corn cottonseed, almond, orange, lemon, eucalyptus, olive, peanut, safflower, cinnamon, clove and soybean oils. Other usable oils are cod liver and castor oils. The word "structure" means one or more layers of material suitable for attachment to one's skin, including strips or patches of fabric, plastic, metal foil, rubber, resin film, natural membranes and laminates of any one or combination of the above.

With reference to FIG. Since the cannabinoid structure may contain several active ingredients at variable concentrations, including THC and CBD, the listed parameters and specific materials may be varied to accomodate administration of specific ingredients or dosages. The backing layer 11 functions to protect the contents of the structure from environmental conditions, such as evaporation or abrasion. The backing layer 11 may have multiple linings, with the interior lining adjoining the reservoir means.

To protect the structure while in use, the inner surface of the backing layer should not interact with the cannabis ingredients.

Examples of materials having potential for comprising an effective backing layer include aluminized polyester and nonwoven polyester. Other examples are 3M Product Nos. With further reference to FIG. A rate controlling membrane 15 overlies the cavity for regulating dispersion of the cannabis chemicals.

The cavity comprises a round or oval-shaped convex area in the backing layer. It is sized to accommodate the selected volume of cannabis preparation The cannabis preparation comprises a liquid or gel carrier combined with the aforementioned oil and the cannabis component s. The amount of carrier can range from about weight percent of the overall preparation and the oil may be present in a range of weight percent of the preparation.

Other suitable carriers are natural rubber blends, viscoelastic semi-solids such as pressure sensitive adhesive materials, hydrogels, soft thermoplastic polymers such as ethylene vinyl acetate with high VA contents, elastomers such as polyisoprene elastomers and thermoplastic elastomers such as styrene-butadiene block copolymers.

Other effective gel or liquid carriers may include carbon tetrachloride, ethanolic solutions of resin and pyrahexyl mixed with THC, Tween 80 or petrol ether. In all cases, the carrier material should be inert to the cannabis chemicals and permit easy migration of the preparation to the patient's skin. The rate controlling means is located directly adjacent to the patient's skin. Its function is to control the flux of cannabis from the reservoir to the skin.

A preferred rate controlling means may comprise a polymer membrane having a predetermined permeability and thickness for allowing the release of effective amounts of cannabis continuously from several hours to several days. Once an appropriate polymer is chosen, the membrane may be formed by preparing a homogenous solution containing the polymer and an organic solvent. The solution is cast upon a glass plate or equivalent, where the solvent is evaporated from the solution.

The evaporation of the solvent results in a film which comprises the membrane, and the thickness of the membrane can be varied as required by the desired cannabis flux. Alternatively, the rate controlling membrane may be in film form. The cannabinoid patch may then be prepared by heat sealing the backing layer 11 around the perimeter of the membrane with the cavity in-between. Factors to consider in determining an appropriate polymer membrane include the polymer's resistance to deterioration from cannabis, and the polymer's permeability towards cannabis.

Previous transdermal applications have used dense nonporous materials such as commercial polyethylene Sclairfilm. Nonporous polymer materials offer the advantage of administering the drug over the greatest period of time.

However, nonporous polymer materials are not necessarily optimally suited for a transdermal cannabinoid structure, since cannabis components have relatively large molecular sizes and exhibit unique chemical interactions such as binding with some materials.

The rate controlling means may also comprise porous materials which are fastened to the backing layer 11 with adhesives, sonic welding or heat sealing techniques. The cavity is then suspended between the backing layer and the porous material. Prior experimentation has shown that cannabis ingredients such as THC diffuse rapidly through certain porous materials such as rubber and plastic.

Furthermore, THC is insoluble with many solutions, including aqueous and ionically charged solutions. An application of an ionic aqueous solution to a porous material will hinder the diffusion rate of THC through the material and decrease flux of cannabis. Therefore, an appropriate combination of porous THC absorbing material, combined with a solution that is insoluble with THC, can form a suitable rate control means.

An example of such a rate controlling membrane includes mixing salt water with a porous rubber membrane that covers the cavity. The thickness of the porous rubber membrane, the concentration of the salt water, and the amount of available cannabis in the cavity are optimized experimentally to create a desired flux of THC to the patient's skin. For more information, ask your healthcare professional or pharmacist.

Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.

This is not all of the information you should read prior to using Xulane. Intended for US residents only. For more information, please review our Privacy Policy. This website is intended for residents of the United States who will have their prescription filled at a pharmacy in the United States.

Some medicines and grapefruit juice may increase your level of the hormone ethinyl estradiol if used together with Xulane.

Loading the player How well do you know your birth control facts? This site is intended for US healthcare professionals. The first scientific description of a vitamin D-deficiency, namely rickets, was provided in the 17th century by both Dr. Daniel Whistler 1 and Professor Francis Glisson 2 , but in , Sniadecki 3 was the first to recognize and report the association of rickets with a lack of sunlight exposure.

It had to wait for another 80 years before the work of Mellanby and McCollum led to the discovery of vitamin D in 4. Years have passed and still we are investigating the functions and benefits of VD.

There is confusion regarding the terminology of VD and its dosage. Ergocalciferol D2 is derived from sources such as fortified milk, herring, mackerel, tuna, salmon, sardines, eggs, fortified cereals and baked goods, while Vitamin D3, otherwise known as cholecalciferol, is a pro-hormone and essential nutrient produced in the skin with exposure to UV rays, animal products and fortified foods.

Vitamin D3 can be produced photochemically by the action of sunlight or ultraviolet light from the precursor sterol 7-dehydrocholesterol which is present in the epidermis of the skin. It can also be consumed in the form of fish oil, or eaten in foods such as eggs or fish. An analog of VD is produced synthetically. The deficiency of VD occurs due to inadequate exposure to the sun or due to its low content in the diet.

Extensive work of Sedrani et al. Al-Turki et al. Deficiency of vitamin D is noticed also in women who is prescribed the correct doses of vitamin D due to non compliance and also due to medication burden 11 - With the objective to assess the transdermal delivery of VD using aromatic oils and aloe vera gel as permeation enhancers, this prospective RCT was conducted.

After obtaining the approval from the research and ethical committee of University of Dammam and informed consent from 50 healthy unmarried, female students the study was commenced.

Participants picking up sealed envelope did randomization. Age, weight and height was taken, a detailed history, meticulous clinical examination was performed to rule out any diseases and as a standard hospital protocol complete blood picture, serum calcium, phosphorous, alkaline phosphatase, Parathormone and 25 Hydroxy Vitamin D3 25OHD.

A second blood sample was taken at the end of 3 months and the data was entered in the database and analyzed using a t -test to compare means between the two groups, for all the parameters tested before and after topical use of VD and AVG. The mean age was In the study group the average BMI was The average 25OHD in the study group pre-treatment was In the control group the pre-treatment 25OHD was In the control group there was no statistically change between the groups where as in the study group women who had lower level of 25OHD showed marked improvement in the levels of level of 25OHD.

Our study shows that our formulation of vitamin D3 can safely and effectively be delivered by dermal route reducing the incidence of non-compliance of oral route. Most common routes of administration of VD is either oral or recently invasive injectable route.

For any drug large proportions of oral prescriptions are never taken at all Recent estimates for noncompliance range from study to study with ranges of 62 to 84 percent using electronic monitoring 15 , 16 hence we believe that in the young and elderly oral route can be by passed by the use of transdermal route.

The use of skin to deliver oils and balms is known to mankind for many centuries, but physicians used creams and lotions to treat only skin diseases. Application of topical products to the skin can act locally or pass into the systemic circulation, or do both.

Since its first approval by the US FDA scopolamine for motion sickness in December 17 , many other were developed for transdermal and topical drug delivery 18 - Although the stratum corneum is an efficient barrier, some chemical substances are able to penetrate it and to reach the underlying tissues and blood vessels. These successful substances have to be lipophilic and VD is a fat-soluble which should be able to cross the skin barrier.

Efforts are up to investigate and modify the structure at the cellular level of the stratum corneum in maximizing the absorption. Morrow et al. The most ideal penetration enhancer discovered to date is undoubtedly water. Hydration of the stratum corneum has been shown to increase the penetration of both hydrophilic and hydrophobic drugs 25 , In this study we used a composition of aromatic oils and glycerine as permeation enhancer, which worked without complications.

At present VD supplementation is available in the oral and injection forms and both have their own limitations. The limitation of our study is that the numbers are smaller in both the groups keeping in regard to the deficiency of vitamin D.

We believe that we could have increased the number of patients. In conclusion the results of our study dictate us to state that topical route of vitamin D is possible, efficacious and safe. National Center for Biotechnology Information , U. Int J Biomed Sci.

Mir Sadat-Ali , Dalal A. Bubshait , Haifa A. Al-Turki , Dakheel A.