WO2024171012A1

WO2024171012A1 - Thermo medico patch and its use in pain relief

Info

Publication number: WO2024171012A1
Application number: PCT/IB2024/051209
Authority: WO
Inventors: Hiren VORA; Rajesh KOKANE
Original assignee: Individual
Current assignee: Individual
Priority date: 2023-02-15
Filing date: 2024-02-09
Publication date: 2024-08-22
Anticipated expiration: 2025-08-15

Abstract

The present application relates to a patch, more precisely an adhesive/non-adhesive patch against orthopedic pain management The patch (100) of the present disclosure soothes general pain, including orthopedic pain, adapted to be detachably attached either to the epidermal layer or to the clothes of a user. The patch comprises a release paper (104) containing adhesive detachably attached to the first layer (101), wherein the first layer contains analgesic or volatile oil(s); a first layer (101), a second layer (102) and third layer (103) made of porous, nonporous woven or nonwoven fabric; a composition (200) placed in between the second (102) and third layer (103) that initiates an exothermic or endothermic reaction upon exposure to air. The present application also relates to a blending method for the preparation of a composition (200).

Description

THERMO MEDICO PATCH AND ITS USE IN PAIN RELIEF

FIELD

The present invention relates to a patch, more precisely an adhesive/ non-adhesive patch against orthopedic pain management.

BACKGROUND

The background information herein below relates to the present disclosure but is not necessarily prior art.

The present application is basically for general pain management, with a focus on orthopedic pain management. Pain results from the noxious stimulation of nerve endings. Nociceptive pain is caused by noxious stimulation of nociceptors, further transmitting impulses over intact neural pathways to the spinal neurons and then to the brain. Neuropathic pain is the result of damage to neural structures like peripheral nerve endings or nociceptors, which become so sensitive to stimulation that the impulses may even be in the absence of stimulation. Peripheral nerve damage may also lead to a pathological state with a threshold reduction of pain tolerance, an increased response to noxious stimuli, or increased response duration (Hardman JG et al; 1996).

Pain relief by topical drug administration offers distinct advantages over conventional administration methods including less pain, less demand of professional(s) to administer the medication, as well as restriction of the analgesic or the drug used only to the target area rather than allowing the said drug to circulate unnecessarily leading undesired side effects (Ghosh TK et al; 1997).

In general, topical drug administration is divided into transdermal administration; and intradermal administration. Whereas transdermal administration involves transport through the skin and into the bloodstream to treat conditions systemically, intradermal administration is intended to impart a cutaneous effect, while keeping the pharmacological effects of the drug localized to the intracutaneous regions of drug penetration and deposition (Ghosh TK et al, 1997).

Although it is universally accepted by physicians that opioids are among the drugs most effective for treating moderate to severe pain, several kinds of pains may be managed by medicines prescribed in traditional literature, and ethnobotanical documents, especially in a country like India with millennia-old history. Thus, opioids as well as plant extracts were used as analgesics and often the only treatment that provides significant relief of moderate to severe pain. Opioids do not act directly on the cause of pain and need to be given parenterally, which may limit their usefulness. Another class of drugs namely Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) with a similar objective, on the contrary, acts directly on prostaglandin release i.e. the main cause of pain, and is efficacious.

However, while administering such medications, the most important part is to take care of the dosage and dissipation of such medicine. This may be most efficiently done by a transdermal analgesic treatment provided through a patch, optionally with adhesive for the required fixation to the target topical area; the said analgesic may be selected from NSAIDs, opioids, non-opioids, or even compound one, combining the previously mentioned two or some taken from traditionally available options. This may even be combined with a local anesthetic or optionally, an antibiotic.

A slow and controlled release patch, releasing the desired medication over a period of time while attached to the target dermal area, should be the solution for pain relief, including orthopedic pains. As heat treatment enhances the permeability of the epidermal and dermal layers and has a general impact on the expansion of layers and opening of pores, in tandem with a soothing effect on the muscles and nerves, a heat patch in tandem with a sustained release analgesic selected from opioids or non-opioids or NSAIDs or traditional medicine should offer the best solution for the patients suffering from chronic as well as acute pains.

Therefore, feeling the need, the present application thus relates to a patch allowing the release controlled in the epidermis of pharmaceutical or traditional compounds, cosmetically or dermo-pharmaceutically active, with optionally different solubilities i.e. water and lipid. The phrase “patch” refers to a structured composite in the form, ensuring the release of the said product.

OBJECTS

Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows:

One of the objects of the present disclosure is to present an adhesive or non-adhesive patch. Another object of the present disclosure is to present an adhesive patch that generates heat.

Yet another object of the present disclosure is to present an adhesive patch generating heat while adjoining either to the skin or to the clothes worn.

Yet another object of the present disclosure is to devise an adhesive or non-adhesive heat patch impregnated with pharmaceutical or chemical compounds, cosmetically or dermo- pharmaceutically active.

Still another object of the present disclosure is to present a pharmaceutically active heat patch for pain management.

Still another object of the present disclosure is to manufacture a pharmaceutically active heat patch for orthopedic pain management.

Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.

SUMMARY

In one embodiment, the present disclosure relates to a patch (100) adapted to be detachably attached either to the epidermal layer or to the clothes of a user. The patch comprises a release paper contained with an adhesive that is detachably attached to the first layer, a first layer made of porous/ nonporous woven or nonwoven fabric, a second layer, and a third layer made of porous/ nonporous woven or nonwoven fabric, a composition placed in between the second and third layer. The first woven or nonwoven fabric layer is essentially embedded with an analgesic selected from NSAIDs selected from diclofenac or aceclofenac, opioids, non-opioids, or even compound one, a volatile oil or any medicinal salt or cooling agent either standalone or in combination, and optionally a local anesthetic selected from lignocaine or lidocaine.

The patch is characterized by a composition impregnated in a pouch form within the second and third layer, which initiates an exothermic or endothermic reaction upon exposure to air, the second layer and third layer is impregnated to the composition, and the adhesive on the release paper is free of contact with the first layer. The first layer contains analgesic and/ or volatile oil(s) and/ or cooling agent(s). In a preferred embodiment, the reaction is exothermic.

In a preferred embodiment, the volatile oil may be selected from wintergreen oil, eucalyptus oil, clove oil, sesame oil, linseed oil, or even camphor.

In a preferred embodiment, carrier oil may be used selected from sesame oil, linseed oil, and coconut oil.

In an embodiment, the patch (100) is used to soothe general pain, including orthopedic pain.

In another embodiment, the present disclosure relates to a method for the preparation of a composition (200).

Dry ingredients such as iron 30-80 wt/wt, vermiculite 5-20% wt/wt, activated charcoal 3-10% wt/wt, salt 1-7% wt/wt, cellulose 0.1-5% wt/wt is transferred into a blender, further water 15- 30 % wt/wt is added and blended for 30 minutes to obtain a resultant mixture. The resultant mixture is discharged into the polyethylene liner air-tight bags and sealed with a cable tie.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

The present disclosure will now be described with the help of the accompanying drawing, in which:

Figure 1 illustrates a thermo medico patch, in accordance with the present disclosure.

Figure 2 illustrates layers of the thermo medico patch, in accordance with the present disclosure.

Reference Nos.:

100-Thermo medico patch

101-First Layer containing volatile oils

102-Second Layer

200-Composition (pouched between the second layer and third layer)

103 -Third Layer 104-Release paper containing adhesive

DETAILED DESCRIPTION

The present application relates to a patch, more precisely an adhesive/ non-adhesive patch against orthopedic pain management.

Embodiments are provided so as to thoroughly and fully convey the scope of the present disclosure to the person skilled in the art. Numerous details are set forth, relating to specific components, and methods, to provide a complete understanding of embodiments of the present disclosure. It will be apparent to the person skilled in the art that the details provided in the embodiments should not be construed to limit the scope of the present disclosure. In some embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail.

The terminology used, in the present disclosure, is only for the purpose of explaining a particular embodiment and such terminology shall not be considered to limit the scope of the present disclosure. As used in the present disclosure, the forms "a,” "an," and "the" may be intended to include the plural forms as well, unless the context suggests otherwise. The terms "comprises," "comprising," “including,” and “having,” are open-ended transitional phrases and therefore specify the presence of stated features, integers, steps, operations, elements, modules, units, and/ or components, but do not forbid the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. The particular order of steps disclosed in the method and process of the present disclosure is not to be construed as necessarily requiring their performance as described or illustrated. It is also to be understood that additional or alternative steps may be employed.

When an element is referred to as being "mounted on," “engaged to,” "connected to," or "coupled to" another element, it may be directly on, engaged, connected, or coupled to the other element. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed elements.

The terms first, second, third, etc., should not be construed to limit the scope of the present disclosure as the aforementioned terms may be only used to distinguish one element, component, region, layer, or section from another component, region, layer, or section. Terms such as first, second, third, etc., when used herein do not imply a specific sequence or order unless suggested by the present disclosure.

As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed elements.

Terms such as “inner,” “outer,” "beneath," "below," "lower," "above," "upper," and the like may be used in the present disclosure to describe relationships between different elements as depicted from the figures.

In addition, phrases written in British English such as “Colour”, “Odour”, “litre”, “fibre”, “flavour”, “orthopaedic” or “characterised”, are also interchangeably used with their American counterparts, such as “Color”, “Odor”, “liter”, fiber”, “flavor”, “orthopedic” or “characterized”, and for all purposes of the present invention, those phrases would mean the same.

Patches generally have a structure comprising several successive layers in the given order; however, the said order may be modified owing to the objectives. There may be the first layer, which may be referred to as layer support, generally occlusive, i.e. made of an impermeable material to the active compound to prevent evaporation; then a second layer, called a layer of polymer or any natural or synthetic fiber or fabric, fixed on the support layer and containing the active compound, come directly into contact with the skin; possibly for facilitating attachment of the patch to the skin, then a layer of adhesive material applied to the surface of the polymer layer and permeable to the compound active; and finally, a removable protective layer, covering hermetic the polymer layer, to protect it from any external contamination during the storage time before the use of the patch.

The usage of patches especially for alleviating physical pains is the desired method owing to the benefits offered in the form not on of efficacy, but also for the ease of handling while setting the right microenvironment for the pharmaceuticals to work.

This may be done by cooling the body part by applying an ice pack near the relevant body part to alleviate swelling, inflammation, and/ or myalgia. This may also be performed by using heating pads to apply heat to parts of the body to treat symptoms such as stiffness, muscle pain, cold hands and feet, back pain, rheumatism, and neuralgia.

Therapies may also include applying analgesics in the form of opioids or non-opioids or NSAIDs or volatile cooling substances traditionally known, optionally coupled to an anesthetic, optionally combined further with an antibiotic.

Thus, a solution to pain management lies in using easily available NSAIDs as well as opioids/non-opioids, optionally with antibiotics/ anti-inflammatory compounds/ local anesthetics, in tandem with the application of heat or cold. There is no such solution available in the literature that may synergistically alleviate pain and orthopedic discomfort.

The principal problem associated with using an external heating pad or cooling pad is logistics. In addition, the synergistic treatment as mentioned earlier, demands the juxtaposition of different mentioned solutions in one core for at least some continuous hours that are too attached to a person’s body, the said body is dynamic, except for some moments of deep sleep. In addition, there is a specific force needed to be exerted on the skin to establish proper contact between the outer layer of the patch and the outer layer of the skin, said force may demand the holding of the injured area for a substantial period of time, which may be improbable. In the absence of such a mechanism, merely holding a heat or cold bag in place is not feasible for a normal person, let alone a person suffering from certain pain and/ or injury.

Therefore, the present application suggests using a cooling or heating patch, in this case, a heating patch, by applying heat to the body part, typically attached directly or indirectly to body parts using adhesives or any other mechanism for attachment. Any standard medication from standard allopathic or natural or alternative medicine may also be impregnated into these patches to treat the site for pain and/ or infection.

A cold patch may generate cooling through endothermic reactions occurring within the cold patch, generally including solutes and liquids, stored in enclosures. The liquid and solute are initially isolated from each other in the enclosure and then mixed in the enclosure to form an endothermic solution that lowers the temperature of the cold patch. Alternatively, the components may be mixed and compartmentalized and put in an air-tight condition, wherein the reaction may start as and when the patch is exposed to the environment.

As against that, a heat patch may generate heat through exothermic reactions occurring within the heat patch. Heat patches that generate heat using an exothermic reaction generally comprise an enclosure and a heating composition stored within the enclosure. Alternatively, the components may be mixed and compartmentalized and put in an air-tight condition, wherein the reaction may start as and when the patch is exposed to the environment. At least one zone of the enclosure is breathable, causing the heating composition to be exposed to air resulting in an exothermic reaction that raises the temperature of the heat patch.

In an aspect, the present disclosure provides a patch (100), adapted to be detachably attached either to the epidermal layer or to the clothe(s) of a user.

In accordance with the present application, the patch (100) is flexible to apply to the body part of a subject with different degrees of flexion and extension.

In an exemplary embodiment, the patch provides therapy to an individual. The patch is a body for applying therapy to an individual when the patch is placed on the said individual. In another embodiment, the patch has one or more cut portions within the body of the patch, through which the body may be separated, making the patch more flexible at the said cut. In some embodiments, the body of the patch comprises a perimeter and the cut portion extends into the body from the perimeter of the body.

In an embodiment, the patch has different shapes, selected from geographical shapes in three dimensions such as square, rectangle, rhomboidal, parabolic, circular, hyperbolic, oval, triangular, and in strip form. In another embodiment, the shape is irregularly matched according to the contour of the body.

In an exemplary embodiment, the present application provides therapy to a subject. It includes selecting a patch that provides therapy to the subject. The patch includes a body and one or more cut portions within the body, whereby applying a patch to the subject, wherein when the patch is applied to the subject the cut in the body causes the patch to conform to the subject while considering the application area; the shape of the patch may be decided. In another example embodiment, the present application relates to making a patch that provides therapy to a subject. It involves forming a body that provides therapy to a subject when the patch is placed directly or indirectly on the subject. Further includes forming one or more cut portions within the body such that the body may be detached from the cut portions so that the patch is easily mounted on the object.

In another exemplary embodiment, the patch is impregnated with an analgesic selected from NSAIDs, opioids, non-opioids, or even compound one, combining the previously mentioned two or some taken from traditionally available options. In another exemplary embodiment, this is combined with a local anesthetic or optionally, an antibiotic and/ or an antiinflammatory agent.

The product is described in detail:

In accordance with the present application, the patch (100) soothes general pain, including orthopedic pain, adapted to be detachably attached either to the epidermal layer or to the clothe(s) of a user, comprises:

- a release paper (104) containing adhesive detachably attached to the first layer (101),

- a first layer (101) made of porous/ nonporous woven or nonwoven fabric,

- a second layer (102) and third layer (103) made of porous/ nonporous woven or nonwoven fabric, a composition (200) placed in between the second (102) and third layer (103), and the first woven or nonwoven fabric layer (101) essentially embedded with an analgesic selected from NSAIDs selected from diclofenac or aceclofenac, opioids, non-opioids, or even compound one, a volatile oil or any medicinal salt or cooling agent either standalone or in combination, and optionally a local anesthetic selected from lignocaine or lidocaine;

In accordance with the present application, characterized in that said composition (200) initiates an exothermic or endothermic reaction upon exposure to air, said second layer (102) and third layer (103) impregnating the composition (200) within, and said adhesive on the release paper (104) is free of contact with the first layer (101) containing the analgesic and/ or volatile oil(s) and/ or cooling agent(s). In an embodiment, the composition (200) comprises essentially iron, salt, vermiculite, activated charcoal, cellulose, and water.

The composition (200) comprising iron in case the reaction desired, is exothermic through the oxidation of iron to form iron oxide i.e. a reaction responsible for the oxidation of iron-based materials. This composition (200) is stationed right between the first and second layers.

In an embodiment, the composition (200) includes iron, salt, vermiculite, activated charcoal, cellulose, and water. In an exemplary embodiment, iron is 30-80 wt/wt %, vermiculite is 5-20 wt/wt %, activated charcoal is 3-10 wt/ wt %, salt is 1-7 wt/wt %, cellulose is 0.1-5 wt/wt %, and the rest is water 15-30 wt/wt %.

In an exemplary embodiment, iron is 45 wt/wt %, vermiculite is 16 wt/wt %, activated charcoal is 5.5 wt/ wt %, salt is 4.5 wt/wt %, cellulose is 2 wt/wt %, and the rest is water 27 wt/wt %.

In an embodiment, the first woven or nonwoven fabric layer (101) comprises volatile oils, volatile salts of acid, and/or cooling agents.

In an embodiment, the volatile oil is selected from wintergreen oil, peppermint oil, turmeric oil, lavender oil, rosemary oil, eucalyptus oil, clove oil, bergamot oil, chamomile oil, ginger oil, ratanjot oil, lemongrass oil, nutmeg oil, camphor oil, coconut oil, sesame oil and virgin linseed oil. In a further embodiment, said volatile salt of acid is methyl salicylate and the cooling agent is menthol.

In another embodiment, the volatile oil is wintergreen oil, eucalyptus oil, clove oil, sesame oil, and camphor oil.

In yet another embodiment, the volatile oil may be at least one selected from wintergreen oil, peppermint oil, turmeric oil, lavender oil, rosemary oil, eucalyptus oil, clove oil, bergamot oil, chamomile oil, ginger oil, ratanjot oil, lemongrass oil, nutmeg oil, camphor oil, coconut oil, sesame oil and virgin linseed oil.

In another exemplary embodiment of the present application, any other volatile oils can be replaced from wintergreen oil, peppermint oil, turmeric oil, lavender oil, rosemary oil, eucalyptus oil, clove oil, bergamot oil, chamomile oil, ginger oil, ratanjot oil, lemongrass oil, nutmeg oil, camphor oil, coconut oil, sesame oil and linseed oil. Volatile oils are a complex mixture of organic compounds, hydrocarbons, oxygenated compounds, aromatic benzenoids, and compounds containing nitrogen or sulfur, present in droplets of cell sap and in glandular hairs. Each volatile oil has specific properties and thus is used to reduce/ suppress/ relieve various pain. For example, chamomile reduces stress; peppermint boosts alertness and reduces headaches. The active ingredient in wintergreen oil, methyl salicylate, is closely related to aspirin and has analgesic and anti-inflammatory properties. As such, products containing wintergreen oil are often used as an antiinflammatory and topical pain reliever.

In an embodiment of the present application, the patch (100) comprising composition (200) with volatile oil(s) in the first layer (101), wherein the volatile oil may be selected depending upon the type of therapy or type of pain to be relieved.

In an embodiment, said volatile oil comprises 1-10 % wt/wt, methyl salicylate 5-20 % wt/wt, and menthol 1-10 % wt/wt. In an exemplary embodiment, volatile oil is 0.1-10 % wt/wt, methyl salicylate is 5-20 % wt/wt, and menthol is 1-10 % wt/wt.

In an embodiment, the fabric is a woven or nonwoven laminated fabric having the structure of PP/ PET/ any natural or synthetic woven / nonwoven fabric with polyethylene/ polymer lamination, characterized in that the fabric/ fabric with laminate is moulded in the form of a pouch having the capacity to allow air inside at a controlled rate.

In an embodiment, the fabrics may be characterized by a degree of airflow or moisture vapor transmission rate (MVTR). Usually, a higher MVTR value corresponds to a higher temperature and vice versa.

In an embodiment, the patch (100) may be used to soothe general pain, including orthopedic pain.

In another embodiment, a blending method for the composition (200) of iron, salt, vermiculite, activated charcoal, cellulose, and water comprise weighing all the ingredients into definite ratios, transferring the ingredients the dry ingredients iron 30-80 wt/wt, vermiculite 5-20% wt/wt, activated charcoal 3-10% wt/ wt, salt 1-7% wt/wt, cellulose 0.1- 5% wt/wt into a blender and starting the blending for a prescribed period of time, and allowing the blender to mix for a definite period of time; further discharging the resultant mixture into polyethylene liner bags, followed by sealing of the bags with cable tie with definite batch size.

In an embodiment, the patch (100) may be used for 5 minutes to 240 minutes to soothe pain. In an exemplary embodiment, patch (100) may be used for 15 minutes to 60 minutes.

The foregoing description of the embodiments has been provided for purposes of illustration and is not intended to limit the scope of the present disclosure. Individual components of a particular embodiment are generally not limited to that particular embodiment, but, are interchangeable. Such variations are not to be regarded as a departure from the present disclosure, and all such modifications are considered to be within the scope of the present disclosure.

The present disclosure is further illustrated herein below with the help of the following nonlimiting examples. The experiments disclosed under these examples herein are intended merely to facilitate an understanding of how the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the experiments should not be constmed as limiting the scope of embodiments herein. These laboratory-scale experiments can be scaled up to an industrial/ commercial scale and the results obtained can be extrapolated to industrial/ commercial scale.

EXAMPLES

Example 1:

The patch (100) of the present application comprising composition (200), comprises: 45 wt/wt % iron,

16 wt/wt % vermiculite,

5.5 wt/wt % activated charcoal,

4.5 wt/wt % salt,

2 wt/wt % cellulose, and

27 wt/wt % water.

The first woven or nonwoven fabric layer (101) comprises:

0.1 - 5 % wt/wt volatile oil, 5 - 20 % wt/wt methyl salicylate, and

1 - 10 % wt/wt menthol.

Wintergreen oil, peppermint oil, turmeric oil, lavender oil, rosemary oil, eucalyptus oil, clove oil, bergamot oil, chamomile oil, ginger oil, ratanjot oil, lemongrass oil, nutmeg oil, camphor oil, coconut oil, sesame oil, linseed oil and menthol was procured from Pune, Maharashtra, India.

The volatile oils are wintergreen oil 2.50%, eucalyptus oil 0.65%, clove oil 0.65%, camphor oil 0.65%, and sesame oil 2%.

In another, patch (100) the volatile oil may be at least one selected from wintergreen oil, peppermint oil, turmeric oil, lavender oil, rosemary oil, eucalyptus oil, clove oil, bergamot oil, chamomile oil, ginger oil, ratanjot oil, lemongrass oil, nutmeg oil, camphor oil, coconut oil, sesame oil and virgin linseed oil.

While fabricating the patch (100), care is taken to ensure that the first layer (101) comprising the volatile oil part is free from contact with the adhesive layer (104), so that the volatile oil(s) doesn’t mix up with the adhesive (Figure: 1).

Example 2:

Method steps for the preparation of composition (200) for the patch (100)

First, adding iron, salt, vermiculite, activated charcoal, cellulose, and water in the amount mentioned in the above example: ! into a blender. The ingredients are blended for about 30 minutes to obtain a composition mixture.

Further, discharging the resultant mixture into a polyethylene liner bag and further air-tight sealing the bag with a cable tie. The pouch comprising the composition (200) may be prepared from time to time by taking a predetermined amount of the prepared composition (200) in a pouch formed with the second layer 102 and third layer 103.

Example 3:

The patch (100) as shown in Figure:!, is layered as described below and as shown in Figure:!. The release paper (104) layer containing adhesive is detachably attached to the first layer (101). The first layer comprises the volatile oil made of porous/ nonporous woven or nonwoven fabric. Hie adhesive on the release paper (104) is free of contact with the first layer (101) containing the analgesic or volatile oil(s).

The composition (200) prepared by the method steps described in Examples 2/3 is placed in between the second (102) and third layer (103). The composition (200) initiates an exothermic or endothermic reaction upon exposure to air. The second layer (102) and third layer (103) impregnate the composition (200).

Example 4:

Provided below are anecdotal studies involving the use of the patch (100) as described in the present disclosure:

Four studies were made with different pain relief products and conditions and finally compared with the patch of the present disclosure. Patients with various leg pains ranging from cramps, knee pain, hamstring strain, fracture pains, and the like were used as the subject matter for the study.

1. Fifteen patients aged 45-75 years with leg pain were prescribed to apply a Disposable exothermic pain relief heat patch on the left leg for about an hour and Pain relief herbal oil on the right leg. After an hour, the patient’s remarks, and relief level were asked and recorded. Some improvement was observed in the patients. Following is the summarized table:

Table 1: Comparative Study between Disposable exothermic pain relief heat patch and Pain relief herbal oils.

*Score 0 to 10, wherein 0= no relief, 5= moderate relief, 10= excellent relief. A group of senior citizens were considered the subject matter from an old age home. Fifteen senior citizens with constant leg pain complaints were given to apply Pain relief herbal oil without heating heat on the left leg and Herbal oil with heating on their right leg. After a duration of one hour, their remarks, and relief level were asked and recorded. Following is the summarized table:

Table 2: Comparative study between Pain relief herbal oil without heat and Herbal oil with heat.

*Score 0 to 10, wherein 0= no relief, 5= moderate relief, 10= excellent relief. Fifteen men with knee pain aged 40-50 years were provided to apply Heated herbal oil at temperature more than room temperature and Herbal pain relief oil along with external heating devices like a hot water bag, and electric heating patch on their left and right knee, respectively. After a duration of one hour, their remarks, and relief level were asked and recorded. Many of the men showed significant relief. Following is the summarized table:

Table 3: Comparative study between Heated herbal oil at a temperature more than room temperature and Herbal pain relief oil along with external heating devices like hot water bags, electric heating patches, etc.

*Score 0 to 10, wherein 0= no relief, 5= moderate relief, 10= excellent relief. Lastly, fifteen orthopedic patients were prescribed Heated herbal oil at a temperature more than room temperature to be applied on their left leg and a Herbal pain relief heat patch (Thermo medico heat patch) on their right leg and were observed for duration of one hour. Their remarks, and relief level were recorded. There was a remarkable improvement. Following is the summarized table:

Table 4: Comparative study between Heated herbal oil at a temperature more than room temperature and Herbal pain relief heat patch (Thermo medico heat patch, as disclosed in the present application).

*Score 0 to 10, wherein 0= no relief, 5= moderate relief, 10= excellent reliefs.

The thermo medico patch (100) may be applied for 15 minutes to 60 minutes depending on the severity of the pain.

TECHNICAL ADVANCEMENTS

The present disclosure described herein above has several technical advantages including, but not limited to, the realization of a pain-relief solution using synergy possibly of all the available treatment methods for a substantial period of time, including heat or cold therapy, therapy using medications and analgesic selected from NSAIDs, opioids, non-opioids or even compound one, combining the previously mentioned two or some taken from traditionally available options. This may even be combined with a local anesthetic or optionally, an antibiotic and/ or an anti-inflammatory agent. This offers rapid relief and may allow an outright omission of the consumable medication circulating all over the body, giving rise to severe side effects, especially on the liver and/ or kidney. The logistics part is completely addressed while offering the solution of the present application to a person suffering from a form of pain. The embodiments herein and the various features and advantageous details thereof are explained with reference to the non-limiting embodiments in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein.

The foregoing description of the specific embodiments so fully reveals the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the embodiments as described herein.

The use of the expression “at least” or “at least one” suggests the use of one or more elements or ingredients or quantities, as the use may be in the embodiment of the disclosure to achieve one or more of the desired objects or results.

Any discussion of documents, acts, materials, devices, articles, or the like that has been included in this specification is solely for the purpose of providing a context for the disclosure. It is not to be taken as an admission that any or all of these matters form a part of the prior art base or were common general knowledge in the field relevant to the disclosure as it existed anywhere before the priority date of this application.

The numerical values mentioned for the various physical parameters, dimensions, or quantities are only approximations and it is envisaged that the values higher/lower than the numerical values assigned to the parameters, dimensions or quantities fall within the scope of the disclosure, unless there is a statement in the specification specific to the contrary. While considerable emphasis has been placed herein on the components and parts of the preferred embodiments, it will be appreciated that many embodiments can be made and that many changes can be made in the preferred embodiments without departing from the principles of the disclosure. These and other changes in the preferred embodiment as well as other embodiments of the disclosure will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation.

Claims

CLAIMS:

1. A patch (100) for pain-relief, adapted to be detachably attached either to the epidermal layer or to the clothes of a user, said patch (100) comprises:

- a first layer (101) made of porous/ nonporous woven or nonwoven fabric,

- a second layer (102) and third layer (103) made of porous/ nonporous woven or nonwoven fabric, a composition (200) placed in between the second (102) and third layer (103), and the first woven or nonwoven fabric layer (101) essentially embedded with an analgesic selected from NSAIDs selected from diclofenac or aceclofenac, opioids, non-opioids, or even compound one, a volatile oil or any medicinal salt or cooling agent either standalone or in combination, and optionally a local anesthetic selected from lignocaine or lidocaine; characterized in that:

• the composition (200) initiates an exothermic or endothermic reaction upon exposure to air,

• the second layer (102) and third layer (103) impregnating the composition (200) within, and

• the adhesive on the release paper (104) is free of contact with the first layer (101) containing the analgesic or volatile oil(s) or cooling agent(s).

2. The patch (100) as claimed in claim 1, wherein said composition (200) comprises essentially of iron, salt, vermiculite, activated charcoal, cellulose, and water.

3. The patch (100) as claimed in claim 1, wherein said composition (200) initiates an exothermic reaction.

4. The patch (100) as claimed in claim 1, wherein said composition (200) constitutes iron 30- 80% wt/wt, vermiculite 5-20% wt/wt, activated charcoal 3-10% wt/ wt, salt 1-7% wt/wt, cellulose 0.1-5% wt/wt, and water 15-30% wt/wt.

5. The patch (100) as claimed in claim 1, wherein said first woven or nonwoven fabric layer (101) comprises volatile oils or volatile salts of acid or cooling agents.

6. The patch (100) as claimed in claim 5, wherein said volatile oil is selected from wintergreen oil, peppermint oil, turmeric oil, lavender oil, rosemary oil, eucalyptus oil, clove oil, bergamot oil, chamomile oil, ginger oil, ratanjot oil, lemongrass oil, nutmeg oil, camphor oil, coconut oil, sesame oil, and virgin linseed oil; said volatile salt of acid is methyl salicylate and said cooling agent is menthol.

7. The patch (100) as claimed in claims 5, wherein said volatile oil comprises 1-10 % wt/wt, methyl salicylate 5-20 % wt/wt, and menthol 1-10 % wt/wt.

8. The patch (100) as claimed in claim 1, wherein said fabric is a woven or nonwoven laminated fabric, having the structure of PP/ PET/ any natural or synthetic woven/ nonwoven fabric with polyethylene/ polymer lamination, characterized in that the fabric/ fabric with laminate is molded in the form of a pouch having the capacity to allow air inside with a controlled rate.

9. Use of the patch as claimed in claim 1, to soothe general pain, including orthopedic pain.

10. A blending method for the preparation of a composition (200) of iron, salt, vermiculite, activated charcoal, cellulose, and water comprising the steps of: transferring said dry ingredients iron 30-80 wt/wt, vermiculite 5-20% wt/wt, activated charcoal 3-10% wt/ wt, salt 1-7% wt/wt, cellulose 0.1-5% wt/wt into a blender, adding water in 15-30 % wt/wt, and allowing said water to mix with the rest of the blended ingredients for up to 30 minutes; discharging the resultant mixture into the polyethylene liner bags; air-tight sealing of the bags with a cable tie; and pouching a predetermined amount of the prepared composition (200) with the second layer 102 and the third layer 103 of the patch (100), followed by the fabrication of additional layers.