AU2011101745A4 - Transdermal patch - Google Patents

Abstract

2011101745 A transdermal patch containing one active ingredient, namely Zingiber officinale rhizome (commonly known as 'ginger'), for the treatment of an inflammatory condition, the transdermal patch includes: a) a sheet of an absorbent material, b) 0.5-8 g of Zingiber officinale rhizome, and c) a carrier agent of ethanol and water, wherein a mixture of the Zingiber officinale rhizome and carrier agent is applied to and absorbed into the absorbent sheet material such that the transdermal patch provides non-invasive treatment of the inflammatory condition, when the transdermal patch is placed on the skin of the recipient.

Description

- 1 Transdermal Patch Field of Invention The invention relates to a transdermal patch containing one active ingredient, namely an 5 extract of Zingiber officinale rhizome (Zingiber officinale rhizome commonly known as 'ginger'), for the treatment of inflammatory conditions, typically musculoskeletal tension, musculoskeletal pain, osteoarthritis, chronic flu-like symptoms of aching joints, tiredness, anxiety, chronic bronchial lung, and childbirth. 10 Background of Invention Joint pain is a debilitating condition that causes those who have it a lesser quality of life as any movement of or associated with the joint or joints is both painful and severely restricts what the sufferer can and cannot do. 15 The World Health Organisation declared the period from 2000 to 2010 the Bone and Joint Decade, with one of its primary aims the advancement of research and management of musculoskeletal disorders. Osteoarthritis is the most common of these disorders, with at least 80% of people over 65 years having radiographic evidence of osteoarthritis deterioration. Osteoarthritis is the most common cause of musculoskeletal pain and 20 disability in Western society and is cited as the reason for the majority of hip and knee joint replacements. There has been an ongoing need for more management options that use less invasive treatments. Chronic joint pain on mobilising and stiffness after inactivity are the primary concern for 25 people with osteoarthritis. Those with chronic joint pain tend to suffer anxiety, disturbed sleep, limitation in social and recreational activities and loss of overall quality of life. The prevalence of osteoarthritis in middle aged people causes a burden on society resulting in loss in work time and early retirement. The psychological impact of pain and disability 30 is significant, there is currently no known cure and slow, progressive joint deterioration in the hands, knees, hips and spine is common.

-2 Osteoarthritis is a complex disease and joint degeneration as observed by X-ray results in varying degrees of pain and immobility for people. Factors such as quality of life, coping mechanisms, psychosocial issues and personality type have an impact on who suffers the symptoms of this condition. 5 A variety of treatment options is generally required for people's individual needs; ideally the treatment manages both the osteoarthritis symptoms and the accompanying psychological issues. Research has shown people with osteoarthritis would prefer to manage their own condition, with an ambivalence regarding conventional medicines and 10 the use of surgical procedures considered a last resort. There is a need for a self-administered, non-toxic, natural therapy that relieves osteoarthritis symptoms, with none of the disadvantages of conventional medication or surgical procedures. There is a need for a treatment to control symptoms that is: easy to 15 administer, using minimal materials, comfortable to receive, with no known side effects. Ideally this treatment could be administered by a health practitioner and by the person experiencing the symptoms. People with osteoarthritis require a simple treatment that supports the management of chronic pain, relieves the anxiety and improves sleep and mobility. 20 Current osteoarthritis management strives to control symptoms of pain, maintain and improve the range of joint mobility, stabilise affected joints and limit impairment. These goals are typically achieved by using non-steroidal anti-inflammatory drugs (NSAIDs), analgesics and topical steroid injections. Invasive surgical procedures such as, arthroscopy, 25 arthroplasty and joint replacements are generally considered the final resort in management, with 80% of total joint replacements for people with osteoarthritis. Rheumatologists propose changes in diet and exercise. Diet is especially significant for the overweight or obese person with osteoarthritis and exercise programs helping to strengthen 30 surrounding muscle, improve joint stability and increase the range of movement of the osteoarthritis joint. Self management programs are encouraged by Rheumatologists, with education in understanding the condition and skills taught to self manage the symptoms and consequences. Self efficacy in arthritis rehabilitation is a psychological concept that -3 suggests one can exercise control over one's health habits and competency beliefs, with increased self confidence, self esteem and belief in one's ability to manage. It has been suggested by Rheumatologists that management is ideally individualised and 5 combines conventional with non-pharmacological and non-invasive strategies, such as the use of natural therapies. A national survey in 1997 found people with osteoarthritis in the USA choose to use more complementary alternative medicines (CAM) than for any other health condition. In 2004 a survey of 612 Americans with arthritis, the majority osteoarthritis, found the majority had or were using CAM for example, 10% meditation, 10 10% relaxation, 25% glucosamine and 17.9% chondroitin. It has been found by research that people with musculoskeletal tension and pain respond positively to heat and relaxation therapies. Heat therapies such as heat packs and spas and relaxation therapies such as hypnotic relaxation states and mindfulness meditation have 15 positive effects in managing symptoms of pain and discomfort in osteoarthritis. Known topical applications are found sometimes effective relieving localised joint pain. Voltaren gel was the first topical prescription approved by the USA FDA for osteoarthritis pain. Counter-irritants using substances such as; capsaicin, menthol, eucalyptus and 20 wintergreen oil are applied to the skin over the joint causing the skin to feel hot/cold, which distracts from the pain. The known methods for treatment of chronic joint pain, whilst being effective are not suitable to everyone and also have disadvantages, such as side effects. Conventional 25 medications are often rejected by people, either due to side-effects from long-term use or personal preference. For example, NSAIDs may cause gastro-intestinal disturbances and be a cardio-vascular risk and high doses of analgesics may cause damage to the liver and kidneys. People can be reluctant to have invasive procedures due to fear of the risks, their age and negative experiences of others. Diet and exercise are only important for some 30 individuals and only go part way towards solving the complex symptoms of osteoarthritis. Self-efficacy in osteoarthritis management is important, yet like diet and exercise it depends on the need, motivation and receptivity of the individual. CAM options are very popular yet are limited, not everyone benefits from for example, meditation, relaxation -4 and/or or glucosamine/chondroitin. Heat and relaxation therapies are often costly; difficult to access, time consuming, with often intensive and ongoing education required. These factors lead to compliance issues that compromise their application. Natural topical applications are considered an adjunct to medication rather than a complete answer to 5 managing symptoms of musculoskeletal pain and tension. External applications, such as medicated patches, aromatherapy massage, compresses and sponging, have been used by health practitioners for sometime to treat aliments, injuries and illness, however these are usually applied to the external part of the body at or adjacent 10 to where the ailment, injury or illness is located. The use of ginger to treat ailments, injury and illness is well known and had its origins in ancient oriental folk lore, having been used for thousands of years in oriental folk medicine. Today ginger is reportedly a routine treatment in homes and TCM clinics in the 15 Guangzhou province of China and ginger is part of the culture of the Cantonese people and as such is utilised in 'cold illnesses', such as certain types of arthritis and when there is stagnation of fluids in the body, as with bronchial asthma. Ginger is used therapeutically, both externally and internally for a wide range of health conditions such as circulatory, metabolic and excretory disturbances, and even child birth to relief bodily tension and 20 pain. Object of the Invention It is an object of the invention to provide a transdermal patch containing one active ingredient, namely an extract of Zingiber officinale rhizome (Zingiber officinale rhizome 25 commonly known as 'ginger'), for the treatment of inflammatory conditions, typically osteoarthritis that ameliorates some of the disadvantages and limitations of the known art or at least provide the public with a useful choice. Definitions 30 The following are definitions of certain terms used in the description herein. inflammatory condition: a bodies response resulting from injury or destruction of tissues, typically musculoskeletal tension, musculoskeletal pain, osteoarthritis, -5 chronic flu-like symptoms of aching joints, tiredness, anxiety, chronic bronchial lung, and childbirth tension and pain. mid-back: includes the area of the back at the base of the lungs, over the 5 kidneys or on the lumbar region. recipient: any person having an inflammatory condition. health practitioners: any person able to provide health or medical assistance, 10 advice or therapy such as a doctor, nurse, care giver, homeopath. Summary of Invention In a first aspect the invention resides an improved transdermal patch containing one active ingredient, namely Zingiber officinale rhizome (commonly known as 'ginger'), for the 15 treatment of an inflammatory condition, the transdermal patch includes: a) a sheet of an absorbent material, b) 0.5-8g of Zingiber officinale rhizome, and c) a carrier agent of ethanol and water, wherein a mixture of the Zingiber officinale rhizome and carrier agent is applied to and 20 absorbed into the absorbent sheet material such that the transdermal patch provides non invasive treatment of the inflammatory condition, when the transdermal patch is placed on the skin of the recipient. Preferably, the transdennal patch is adapted to be placed on the skin in the mid back area 25 of the recipient. Preferably, the transdermal patch is adapted to be placed on the skin in the area of specific joints or muscles of the recipient. 30 Preferably, the transdermal patch is adapted to be placed on the skin in the area on and/or adjacent the kidney region of the recipient. Zingiber -6 Preferably, the Zingiber officinale rhizome is dry Zingiber officinale rhizome. Preferably, the absorbent sheet material is rectangular in shape. 5 Preferably, the absorbent sheet material is dimensioned 20cm x 15cm Preferably, the absorbent sheet material has a plurality of fold lines to allow the transdermal patch to be folded. 10 Preferably, the fold lines extend longitudinally and transversely on the absorbent sheet material. Preferably, the absorbent sheet material is able to be folded to a size that is 3.75cm by 5cm. 15 Preferably, the mixture is moist. Preferably, the mixture is either in a liquid, paste or gel fonn prior to being applied to the absorbent material. 20 Preferably, the transdermal patch is able to be folded such it is able to fit and sealed within a package. Preferably the package is dimensioned 8cm x 6cm x 0.5cm. 25 Preferably, the package is made from an aluminium foil laminate. Preferably, the laminate package is 0.025mm thick and is impermeable to light, oxygen and water. 30 Preferably, the laminate package is finished on its inside surface with a polymer or resin material.

-7 Preferably, the absorbent sheet material is a non-woven substrate manufactured from a natural material or naturally derived material or a synthetic material or a mixture thereof Preferably, the natural material is selected from the group consisting of the cotton, flax, 5 linen, paper or cellulose families. Preferably the naturally derived material is selected from the group consisting of viscose rayon or solvent spun rayon. 10 Preferably, the synthetic material is selected from the group consisting of the polyamide, polyester, polyolefin, polyurethane or polyacrylate families. Preferably, the absorbent sheet material consists of a laminate having at least two layers, one being an inner layer of absorbent material and the other being an outer layer, wherein 15 the inner layer is adapted, when in use to be applied and contact the skin of the recipient. Preferably, the outer layer is a non-occlusive film selected from the group consisting of polypropylene, polyurethane and polyethylene. 20 Preferably, the inner layer has along its side edges a releasable adhesive tape such that the patch is able to be adhered to the skin of the recipient. Preferably, the absorbent sheet material consists of absorbent material, which is adapted when in use to be applied in contact with the skin of the recipient. 25 In a second aspect the invention resides an improved package containing a transdermal patch, the package including: a) a salable pouch, b) a transdermal patch described in the first aspect. 30 -8 In a third aspect the invention resides an improved method in making a transdermal patch containing one active ingredient, namely Zingiber officinale rhizome (commonly known as 'ginger'), for the treatment of an inflammatory condition, the method includes: a) preparing a tincture by adding Zingiber officinale rhizome to a carrier agent of 5 ethanol and water, b) saturating a sheet of absorbent material with the tincture such that 0.5-8g of Zingiber officinale rhizome is deposited on the absorbent material, c) folding the saturated sheet material to a smaller size, and d) placing and sealing the folded transdennal patch in a package. 10 Preferably, the mixture contains at least 25% alcohol. Preferably, the carrier agent contains between 25% to 90% alcohol. 15 Preferably, the tincture is in the form of a liquid, paste or gel. Preferably, the Zingiber officinale rhizome is extracted from a dried Zingiber officinale root. 20 Preferably, the Zingiber officinale rhizome is in powder form prior to addition to the carrier agent. Preferably, the zingiber officinale rhizome is fresh and the carrier agent is a supercritical fluid extraction (SFE) of carbon dioxide (CO 2 ). 25 Preferably, the tincture is prepared using cold percolation, where the percolate is made from mixing the powdered Zingiber officinale rhizome with the carrier agent and then draining the excess liquid to fonn a useable percolate. 30 In a fourth aspect the invention resides in a method of application of a transdermal patch as mentioned in the first or second aspects, the method includes: a) preheating the transdermal patch, b) applying the heated transdermal patch to the skin of the recipient, -9 c) removing the transdermal patch after 10 to 30 minutes, d) repeating steps a) to c) daily for seven consecutive days, and e) repeating thereafter as needed to manage the inflammatory condition. 5 Preferably, the inflammatory condition is an arthritic condition. Preferably, the arthritic condition is osteoarthritis. Preferably, the transdermal patch is heated up to 400C. 10 Preferably, the transdermal patch is heated, whilst still within the sealed package by placing the package in hot water for a period of time. Preferably, the transdermal patch is heated for a few minutes prior to application to a 15 recipient. Preferably, the transdermal patch is held in situ on the recipient by a pre-warmed cloth and towel that wraps around the entire torso of the recipient. 20 Preferably, the transdermal patch is held in situ on the recipient by an adhesive. Preferably, the adhesive is a plaster tape. In a fifth aspect the invention resides in a kit of parts for the treatment of an inflammatory 25 condition, the kit of parts includes: a) a package; a transdermal patch as described in the first aspect. Any other aspects herein described. 30 Brief Description The invention will now be described by way of example only, by reference to the accompanying drawings: - 10 Figure 1 is a plan view of a transdenral patch in accordance with a preferred embodiment of the invention. Figure 2 is a plan view of a folded transdermal patch in accordance with a preferred 5 embodiment of the invention. Figure 3 is a cut-away view showing a package containing a transdennal patch in accordance with a preferred embodiment of the invention. 10 Figure 4 shows a transdermal patch as applied to a recipient in accordance with a preferred embodiment of the invention. Description of Drawings The following description will describe the invention in relation to preferred embodiments 15 of the invention, namely a transdermal patch containing one active ingredient, namely an extract of Zingiber officinale rhizome (Zingiber officinale rhizome commonly known as 'ginger'), for the treatment of inflammatory conditions, typically osteoarthritis. The invention is in no way limited to these preferred embodiments as they are purely to exemplify the invention only and that possible variations and modifications would be 20 readily apparent without departing from the scope of the invention. This invention pertains to the use of Zingiber officinale rhizome (Zingiber officinale rhizome commonly known as 'ginger'). Traditional Chinese medicine and anthroposophic medicine and nursing consider the relationship between the characteristics of a therapeutic 25 plant substance (such as ginger) in an external application and that of a potential recipient is significant c.f. to internal application. Zingiber officinale (ginger) is in the Zingiberacae family that has 1300 species, with 80-90 comprising the Zingiber species. Zingiber officinale is the only medicinal ginger in this 30 species. Zingiber officinale is a tropical, cultivated monocotyledon plant that prefers the humid, sheltered conditions of the tropics. Historically Zingiber officinale distribution is found under the forest canopy in Southern Asia, Indonesia and Malaysia. The Zingiber officinale rhizome is harvested for medicinal purposes in the plant's winter period. This - 11 rhizome is very pungent and rich with aromatic oils, fats and starches. The pungent principle in the gingerols and shogaols is responsible for ginger's pharmacological activity. Zingiber officinale rhizome comprises: 4-7.5% oleoresin in the form of gingerols and their related dehydrated products known as shogaols, 1-3.5% of volatile oils in the form of 5 sesquiterpenes such as: bisabolene, zingi-benene, camphene and acurcumene, 6-10% lipids such as: triglycerides, phosphatidic acid, lecithins and free fatty acids, 9-10% proteins and 40-60% carbohydrates in the form of silicate starches. Zingiber officinale rhizome is both edible and used in internal and external therapeutic treatments. 10 Internal use of ginger Zingiber officinale (ginger) is claimed to have both anti-inflammatory and anti-emetic properties. Zingiber officinale is claimed to be carminative, anti-emetic, spasmolytic, anti inflammatory and a peripheral circulatory stimulant. 15 Zingiber officinale active constituents, gingerols and shogaols are claimed to diminish production of enzymes, cyclooxygenase -1 and -2 and 5-lipooxygenase that produce the pro-inflammatory prostoglandins and leukotrienes, when breaking down fatty acids. Additionally, Zingiber officinale extract inhibits 5-lipoxygenase, which is an additional quality that is proposed to give Zingiber officinale a better therapeutic profile and fewer 20 side effects than nonsteroidal anti-inflammatory drugs. Animal studies have found Zingiber officinale extract has a significant role as an anti arthritic agent by acting as an anti-thrombotic and anti-inflammatory. It has been found that that highly purified and standardised oral Zingiber officinale extract has a statistically 25 significant effect on reducing symptoms of knee pain and stiffness in patients with osteoarthritis. Trials that compared oral Zingiber officinale extract with an anti inflammatory drug found Zingiber officinale's effect on reducing symptoms of hip and knee osteoarthritis was significant. However, there are possible side effects of taking Zingiber officinale or Zingiber officinale extracts internally. A common concern is that 30 high doses of oral Zingiber officinale potentially cause gastrointestinal complaints External use of ginger - 12 Zingiber officinale is claimed to be effective, when applied externally. For example, Zingiber officinale oil that is specially prepared to include the gingerols and shagaols relieves post-operative nausea and vomiting for 80% of high risk patients, when applied externally naso cutaneously. Gingerol-enriched dry extract has been evaluated for its 5 topical anti-inflammatory activity and its permeation of human epidermis. Gingerols and shogaols have been reported to permeate human epidermis, suggesting potential transdennal drug delivery as an anti inflammatory agent. Because external application of Zingiber officinale avoids the digestive processes it has been used for centuries to treat pain and discomfort of the joints in China. Traditional Chinese Medicine clinics at 10 Guangdong and Foshan Hospitals in Guangzhou, China, use the external application of Zingiber officinale as a routine treatment in a compress, as moxibustion (a slow burning herbal stick) or in combination with other 'hot herbs' that is generally applied externally at or adhacent the area affected. Zingiber officinale rhizome slices are more often placed on meridian points, either with moxibustion or in combination with other herbs, for conditions 15 such as bronchial asthma, indigestion, diarrhoea, arthritis and poor circulation. In European hospitals specialising in complementary healthcare, Zingiber officinale is used as an external compress, to bring warmth to the organs, especially the liver and kidneys. After some experimentation the external Zingiber officinale compress has been found to bring a sense of awakening and increased interest in life, especially when applied to the kidneys. 20 Zingiber officinale compresses are applied to the skin of the mid-back, preferably in kidney region and used in medical and psychiatric practice for such conditions as: chronic chest problems, pneumonia, arthritis and rheumatic conditions and anxiety. Transdermal drug delivery (TDD) began as an allopathic pharmaceutical nearly thirty 25 years ago in the USA. The first transdermal patch to be approved by the Federal Drug Agency was scopolamine, which was used to treat nausea and vomiting associated with motion sickness. TDD provided an alternative administration route to the oral and injection methods because it had the advantage of less systemic side effects, stronger compliance and a potentially sustained, controlled delivery over a prolonged period of time. The 30 primary limitation for TDD is the characteristics of the normal skin barrier. To penetrate normal skin a molecular weight less than 500 Da, with adequate aqueous and lipid solubility is necessary. The principle barrier to TDD is claimed to be the upper layer of the skin known as the stratum corneum. Enhancers, such as essential oils and alcohol are found - 13 effective in enabling percutaneous skin penetration. In vitro experiments with animal tissue indicate essential oils extract lipids from the stratum corneum and loosen hydrogen bonds, leading to increased fluidisation of the lipid layers. TDD is increasingly used as an effective means of absorbing medication into the bloodstream directly via the epidermis 5 layer of the skin. In TDD a solute is diffused through percutaneous layers of the skin and enters the systemic circulation in order that a therapeutic effect be exerted. Gingerols and shogaols, the active principle of ginger, have a molecular weight 150-190 Da, a lipophilicity log P range 3.5 and moderate solubility in water and oil and thus are 10 suitable for skin penetration and absorption. Gingerol enriched dry Zingiber officinale extract patches, when applied to human epidermis in vivo show gingerols permeate the epidermis. As mentioned this invention pertains to the use of Zingiber officinale rhizome (Zingiber 15 officinale rhizome commonly known as 'ginger') in particular to a transdermal patch having Zingiber officinale as the only active agent that is applied externally to lower back region immediately adjacent the kidneys of a-recipient having an arthritis condition (such as osteoarthritis). 20 The Zingiber officinale transdermal patch 10 of this invention as shown in figure 1 and consists of an absorbent material that is rectangular shaped having longitudinal side edges 12 of a length Y and top and bottom edges 11 of a length X. Preferably the patch is approximately 15cm by 20 cm. The patch 10 has a series of fold lines 13 to allow the patch to be folded (figure 2) to a size suitable for being placed in a sealed package (figure 3) 25 prior to use. The patch 10 is saturated in an extract of Zingiber officinale rhizome (Zingiber officinale rhizome commonly known as 'ginger'). The Zingiber officinale is the sole active ingredient. Each patch 10 contains approximately 0.5 - 8 gm Zingiber officinale rhizome in 30 a fluid extract of a suitable carrier agent, preferably consisting of any organic agent, such as ethanol. Where the carrier agent contains ethanol the content of ethanol is between 25% - 90%.

- 14 The Zingiber officinale extract is prepared from dried Zingiber officinale rhizome using cold percolation. The percolate is made from a solvent (ethanol and water) that is mixed with powdered Zingiber officinale root and then the liquid is slowly drained of in a similar fashion that of a coffee percolator. 5 Alternatively the Zingiber officinale rhizome can be fresh and in this instance the Zingiber officinale rhizome carrier agent is a supercritical fluid extraction (SFE) of carbon dioxide

(CO

2 ). 10 The moist Zingiber officinale patch 10 is then folded as shown in figure 2 having dimensions X' and Y', preferably 3.75cm by 5cm. The moist patch 10 is then is enclosed and sealed in a aluminium foil laminate package 20 as shown in figure 3 having dimensions U x V x W, preferably approximately 8 x 6 x 0.5cm. The aluminium foil laminate package 20 is at least 0.025mm thick to ensure it is impermeable to light, oxygen 15 and water and able to be heated to 100*C, preferably up to 40*C. The inside of the aluminium foil package is finished with a material such as a polymer or resin. Prior to treating, a Zingiber officinale patch with in an aluminium foil laminate package 20 containing the Zingiber officinale patch is heated. Different options to heat the Zingiber 20 officinale patch are possible such as: the package may be placed under the hot water bottle for 10 min while warming the facecloth and towel, the package may be placed in a cup of hot water (no more than 700C) for 10 minutes while the facecloth and towel are warming or the patch is removed from the package and placed on the pre-warmed towel and facecloth with the hot water bottle directly on the patch for approximately 1 minute prior to 25 lying back on it. This last method is found to be the simplest and most effective. When the Zingiber officinale patch is warmed in the package it must be then removed from the package 20 and applied to the skin of the mid-back of the recipient H, preferably in the area of the kidneys K as shown in figure 4. The patch 10 is held in situ by a pre-warmed cloth 30 (e.g. face cloth) and towel 40 that wraps around the entire torso of the recipient H. 30 It is envisaged that the patch 10 could be placed and held in place by plaster tape or the patch could be pre made with suitable adhesive strips situated around and along the side edges 11, 12 of the patch 10.

- 15 Once the patch 10 has been applied to the recipient H, the recipient H rests on their back for approximately 10 to 30 minutes. This treatment is ideally then repeated daily for seven consecutive days and thereafter as needed to manage osteoarthritis symptoms. However the length of time for the application of the patch and the frequency of application will 5 vary depending on the recipient and the condition being treated. The absorbent sheet material is preferably a non-woven substrate manufactured from a natural material, naturally derived material. However the absorbent sheet material could be manufactured from a synthetic material or a mixture of natural and synthetic materials. 10 The natural materials suitable can be selected from the group consisting of the cotton, flax, linen, paper or cellulose families. The synthetic materials suitable can be selected from the group consisting of the polyamide, polyester, polyolefin, polyurethane or polyacrylate families. Another alternative is for the absorbent sheet material to consist of a laminate having at least two layers, one being and inner layer of absorbent material and the other 15 being an outer layer, wherein the inner layer is adapted when in use to be applied and contact the skin of the recipient. The outer layer can be a non-occlusive film selected from the group consisting of polypropylene, polyurethane and polyethylene. The inner layer could also have along its side edges a releasable adhesive tape so that the patch is able to be adhered to the skin of the recipient. 20 This treatment using the Zingiber officinale patch is a viable, non-invasive treatment for osteoarthritis and additionally has a beneficial effect of managing anxiety/depression symptoms. 25 The sole active ingredients of the Zingiber officinale patch 10, namely the gingerols and shogaols permeate the human epidermis, which explains the significant impact of the Zingiber officinale patch. The fact that the Zingiber officinale patch has only one active ingredient and its placement on the lower back region of the back adjacent the kidneys is a key important and inventive feature of the Zingiber officinale patch. The absorption of the 30 Zingiber officinale from the Zingiber officinale patch through the skin adjacent the kidneys leads to a more effective systemic treatment, than applying Zingiber officinale extract directly to the arthritic joint or than taking Zingiber officinale orally.

- 16 The warmed Zingiber officinale patch's unique qualities of heat, stimulation, anti inflammation and analgesia help relieve the symptoms of osteoarthritis. The transdennal Zingiber officinale patch is a very effective form of heat and relaxation therapy that works systemically, rather than topically. The Zingiber officinale patch is conveniently pre 5 packaged and each pack easily heated prior to application and is able to be applied to the recipient by a health practitioner or even the recipient themselves. The Zingiber officinale within the Zingiber officinale patch, when placed on the skin in the region of the kidneys accentuates the potency of the wannth, stimulated submerged 10 thoughts and emotions, enlivened the sensory perception and activated internal processes. Initially, the application of the patch causes a sensation of tingling, prickly, heat that penetrates the back. The Zingiber officinale from the patch realised into the recipient via skin absorption enters the blood stream allowing the gingers inherent qualities of heat, stimulation, vitality, anti-inflammation and analgesia to be directed throughout the entire 15 body, releasing blockages and tensions and alleviating the pain associated with the osteoarthritic joints. The Zingiber officinale patch treatment benefits people with osteoarthritis by stimulating and intensifying warmth, relaxation, overall vitality, as well as relieving the symptoms of osteoarthritis. 20 The kidneys are responsible for maintaining fluid balance in the body. The Zingiber officinale patch treatment is used to assist and strengthen the kidneys function as there is an apparent relationship between the functioning of the kidneys and the effects of osteoarthritis. A poorly functioning kidney can result in blockages in the circulation of fluids causing pain and tension, a sense of cold, and a lack of energy, which in turn can 25 impact on the joints and the severity of the osteoarthritis condition. The Zingiber officinale patch creates wannth in and around the kidneys and thus improves circulation, which in turn improves the well being of the person with osteoarthritis by stimulating activity, physically, mentally and emotionally, and allowing the potential for 30 movement and change. The impact of intense heat on the kidney region of the back as generated from the Zingiber officinale patch treatment has been found to have a significant impact on osteoarthritis - 17 symptoms, activating relief of muscular-skeletal pain and tension, as well as mental and emotional agitation. Steadily during the treatment, heat radiated and penetrated the entire body, leading to a state of total body warmth, which encompassed the organs and joints. 5 Upon treatment with the Zingiber officinale patch the recipient begins to move in a more relaxed, balanced manner, with fewer posture problems. The Zingiber officinale patch is applied to the kidney region of the back for the treatment of osteoarthritis because the ginger's active warmth quality stimulates movement in the body and shifts blockages and tensions in the metabolic/limb regions. During and after a Zingiber officinale patch 10 treatment regime, those with osteoarthritis experience a sense of relief as body warmth increases and pain in and around the joints significantly subsides leading to painless freedom of movement. The size of the transdermal Zingiber officinale patch could be increased or decreased 15 without an impact on the treatment. The patch material could be any type of natural fibre, which carries the required quantity of the tincture of ginger. The Zingiber officinale could be sourced organically, biodynamically or conventionally. The tincture of Zingiber officinale could be obtained by either extraction or distillation of the fresh or dried Zingiber officinale rhizome. The tincture base of ethanol could be replaced by another 20 suitable preservative, with the quantity of Zingiber officinale/active ingredients remaining constant. The packaging material could vary so long as it is impermeable to light, oxygen and water and can be heated to 1000 Celsius, however it is not essential for the packaging to be able to be heated as high as 1000 C. 25 Advantages a) Novel, non-invasive treatment for osteoarthritis b) Uses a natural, non-toxic, organic substance. c) A treatment managing osteoarthritis, musculoskeletal tension and anxiety symptoms. 30 d) No known side effects for people with osteoarthritis, co-morbidities may impact on side effects. e) Pre-packaged Zingiber officinale patch avoids errors in preparation. f) Simple convenient instructions to prepare the Zingiber officinale patch.

- 18 g) Hygienic, light and portable. h) Economical to use in comparison to other treatments; CAM, medications, invasive procedures. i) Delays and/or replaces need for conventional management. 5 j) Provides a convenient and simple means of symptom management that can be both self-administered and used by healthcare practitioners in the wider healthcare setting. k) Has wide commercial value in the care of the elderly because it increases independence and mobility of those with osteoarthritis. 10 1) Reduces costs in facilities for the elderly due to increased independence and quality of life for people with osteoarthritis m) Has wide commercial value in the care of those with musculoskeletal pain and tension and anxiety. 15 Variations Throughout the description of this specification, the word "comprise" and variations of that word such as "comprising" and "comprises", are not intended to exclude other additives, components, integers or steps. 20 It will of course be realised that while the foregoing has been given by way of illustrative example of this invention, all such and other modifications and variations thereto as would be apparent to persons skilled in the art are deemed to fall within the broad scope and ambit of this invention as is herein defined in the appended claims.