POLYHERBAL TRANSDERMAL PATCH FOR PAIN MANAGEMENT AND ITS PROCESS OF PREPARATION

Abstract

The present invention relates to composition of polyherbal transdermal patch comprising combination of natural herbal extracts as active ingredients and pharmaceutically acceptable excipients. The present invention relates to composition of polyherbal transdermal patch comprising combination of natural herbal extracts includes boswellia extract, evening primrose oil, blackcurrant seed oil, Ginger, Licorice, Cats claw and Devil's claw and other pharmaceutically acceptable excipients. The present invention also relates to composition of polyherbal transdermal patch comprising boswellia extract, evening primrose oil, blackcurrant seed oil, Ginger, Licorice, Cats claw and Devil's claw as natural herbal ingredients and pharmaceutically acceptable excipients for the treatment/management of pain. The present invention also relates to an efficient process for the preparation of polyherbal transdermal patch by using hot-melt coating technique (HMC), comprising the steps of melting, mixing, coating, laminating, cutting, pouching and labelling.

Claims

1. A polyherbal transdermal patch composition comprising combination of natural herbal extracts includes boswellia extract, evening primrose oil, blackcurrant seed oil, Ginger, Licorice, Cat's claw and Devil's claw and permeation enhancer, hot melt adhesives, tackifier, anti-oxidant and vehicle and other pharmaceutically acceptable excipients.

2. The polyherbal transdermal patch composition as claimed in claim 1, wherein the composition comprising permeation enhancer which is selected from azones, isopropyl myristate, fatty acids, menthol, essential oils, terpenes, terpenoids, N-methyl-2-pyrrolidone, 1-dodecyl-azacycloheptan-2-one, oleic acid, oleyl alcohol, linoleic acid, isopropyl linoleate, butanediol, lauryl alcohol, lauryl acetate, lauryl lactate, ethyl acetate, dimethyl isosorbide, isostearic acid.

3. The polyherbal transdermal patch composition as claimed in claim 1, wherein the composition comprising hot melt adhesives is combination of one or more hot melt adhesives and includes at least two adhesives selected from the group of ethylene-vinyl acetate copolymer series (EVA hot melt adhesive), synthetic rubber-based hot melt adhesives, polyolefin based hot melt adhesive, polyamide based hot melt adhesive, polyester-based hot melt adhesives, polyurethane-based hot melt adhesives, styrene isoprene thermoplastic elastomer.

4. The polyherbal transdermal patch composition as claimed in claim 1, wherein the composition comprising tackifier is selected from petroleum resins (e.g., aliphatic hydrocarbon resins, alicyclic hydrocarbon resins, and aromatic hydrocarbon resins), phenolic resins, xylene resins and coumarone indene resins rosin derivatives (e.g., rosin, glycerin esters of rosin, hydrogenated rosins, glycerin esters of hydrogenated rosin, pentaerythritol esters of rosin, etc.), saturated alicyclic hydrocarbon resins, aliphatic hydrocarbon resins, terpene resins, maleic acid resins and the like.

5. The polyherbal transdermal patch composition as claimed in claim 1, wherein the composition comprising anti-oxidant is selected from Alpha Tocopherol, tocopheryl acetate, vitamin E derivatives, Ascorbic acid, Ascorbyl Palmitate, vitamin C, Butylated Hydroxytoluene (BHT), Butylated Hydroxyanisole (BHA), Erythorbic acid, Lanolin, Citric acid monohydrate.

6. The polyherbal transdermal patch composition as claimed in claim 1, wherein the composition comprising vehicle is selected from water, ethanol, propanol, isopropanol, mineral oil, silicone, polyethylene glycol, polypropylene glycol, liquid sugars, waxes, petroleum jelly, aloe and polymeric materials along with polyacrylate, silicone, natural and synthetic rubbers or other adhesives.

7. The polyherbal transdermal patch composition as claimed in claim 1, wherein the composition comprising: 0.1% to 15% (w/w) of two or more natural herbal extracts as active ingredients, 0.5% to 5% (w/w) of permeation enhancer, 0.1% to 3% of anti-oxidant, 15% to 90% (w/w) of hot melt adhesives, 1% to 10% (w/w) of tackifying material, 0.5% to 20% (w/w) of vehicle, and 0.1% to 10% (w/w) other pharmaceutically acceptable ingredients.

8. The polyherbal transdermal patch composition as claimed in claim 7, wherein the composition comprising boswellia extract, evening primrose oil, blackcurrant seed oil, ginger, licorice, cat's claw and devil's claw are natural herbal extracts as active ingredients, isopropyl myristate as permeation enhancer, (styrene isoprene thermoplastic elastomer)-SIS 5002 and pressen 1471 as hot melt adhesives, Arkon-P 100 as tackifier, tocopheryl acetate as anti-oxidant and mineral oil as vehicle and other pharmaceutically acceptable excipients.

9. An improved/efficient manufacturing process for the preparation of polyherbal transdermal patch by using hot-melt coating technique (HMC) comprising the steps of melting, mixing, coating, laminating and cutting.

10. The process for preparing polyherbal transdermal patch as claimed in claim 9, wherein the process comprising steps of: a. melting hot melt adhesives under stirring at 100° C.-220° C., b. adding vehicle and tackifier to molten adhesive base under stirring at 100° C.-220° C., c. adding active ingredients along with permeation enhancer and anti-oxidant to molten adhesive blend under stirring to obtain homogenous material, d. coating on to the polyethylene terephthalate release liner e. laminating the obtained adhesive matrix, f. cutting into desired size to get transdermal patch, pouching and labelling.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0093] The term “comprising”, which is synonymous with “including”, “containing”, or “characterized by” here is defined as being inclusive or open-ended, and does not exclude additional, unrecited elements or method steps, unless the context clearly requires otherwise.

[0094] The present invention provides composition of polyherbal transdermal patch comprising natural herbal extracts as active ingredients and pharmaceutically acceptable excipients.

[0095] The present invention provides composition of polyherbal transdermal patch comprising natural herbal extracts includes boswellia extract, evening primrose oil, blackcurrant seed oil, Ginger, Licorice, Cat's claw and Devil's claw and pharmaceutically acceptable excipients.

[0096] The present invention provides composition of polyherbal transdermal patch comprising boswellia extract, Evening primrose oil, Blackcurrant seed oil, Ginger, Licorice, Cat's claw and Devil's claw as natural herbal extracts, Isopropyl myristate as permeation enhancer, (styrene isoprene thermoplastic elastomer)-SIS 5002 and pressen 1471 as hot melt adhesives, arkon-P 100 as tackifier, Tocopheryl acetate as anti-oxidant, mineral oil as vehicle and other pharmaceutically acceptable excipients.

[0097] The term “active ingredients” of the present invention is used to relieve from pain conditions. Preferably used active ingredients are boswellia extract, Evening primroseoil, Blackcurrant seed oil, Ginger, Licorice, Cat's claw and Devil's claw.

[0098] The combination of Boswellic acid, Evening primrose oil, Blackcurrant seed oil, Ginger, Licorice, Cat's claw and Devil's claw are selected as they possess the analgesic and anti-inflammatory properties and proven to be safe, effective and also produces synergistic action.

[0099] The term “hot melt adhesives” of the present invention includes combination of one or more hot melt adhesives and includes at least two adhesives selected from the group of ethylene-vinyl acetate copolymer series (EVA hot melt adhesive), synthetic rubber-based hot melt adhesives, polyolefin based hot melt adhesive, polyamide based hot melt adhesive, polyester-based hot melt adhesives, polyurethane-based hot melt adhesives, styrene isoprene thermoplastic elastomer. Preferably, hot melt adhesives are (styrene isoprene thermoplastic elastomer)-SIS 5002 and pressen 1471.

[0100] Hot melt adhesives used in the polyherbal transdermal patch is in the range of 15 to 90% (w/w).

[0101] Permeation enhancer used in the composition of the present invention include, but are not limited to azones, isopropyl myristate, fatty acids, menthol, essential oils, terpenes, terpenoids, N-methyl-2-pyrrolidone, 1-dodecyl-azacycloheptan-2-one, oleic acid, oleyl alcohol, linoleic acid, isopropyl linoleate, butanediol, lauryl alcohol, lauryl acetate, lauryl lactate, ethyl acetate, dimethyl isosorbide, isostearic acid. Preferably, the permeation enhancer is isopropyl myristate.

[0102] Permeation enhancer used in the polyherbal transdermal patch composition is in the range of 0.5 to 5% (w/w), more preferably in the range of 0.5 to 3% of the total weight of the composition.

[0103] Tackifier used in the composition of the present invention include, but are not limited to petroleum resins (e.g., aliphatic hydrocarbon resins, alicyclic hydrocarbon resins, and aromatic hydrocarbon resins), phenolic resins, xylene resins and coumarone indene resins rosin derivatives (e.g., rosin, glycerin esters of rosin, hydrogenated rosins, glycerin esters of hydrogenated rosin, pentaerythritol esters of rosin, etc.), saturated alicyclic hydrocarbon resins (e.g., ARKON P-100), aliphatic hydrocarbon resins (e.g., Quintone B170) terpene resins (e.g., Clearon P-125), maleic acid resins and the like. Preferably, the tackifier is saturated alicyclic hydrocarbon resins arkon-P 100.

[0104] Tackifier used in the polyherbal transdermal patch composition is in the range of 1 to 10% (w/w) of the total weight of the composition, more preferably in the range of 1 to 5% (w/w) of the total weight of the composition.

[0105] Anti-oxidant used in the composition of the present invention includes, but not limited to Alpha Tocopherol, tocopheryl acetate, vitamin E derivatives, Ascorbic Acid, Ascorbyl Palmitate, vitamin C, Butylated Hydroxytoluene (BHT), Butylated Hydroxyanisole (BHA), Erythorbic Acid, Lanolin, Citric Acid Monohydrate. Preferably, the anti-oxidant is tocopheryl acetate.

[0106] Anti-oxidant used in the polyherbal transdermal patch composition is in the range of 0.1 to 3% (w/w) of the total weight of the composition, more preferably in the range of 0.1 to 0.6% (w/w) of the total weight of the composition.

[0107] “Vehicle” as used herein refer to carrier materials suitable for transdermal drug administration, and include any such materials known in the art, i.e., any liquid gel, solvent, liquid diluent, adhesive, or the like, which is nontoxic and which does not interact with other components of the composition in a deleterious manner. Vehicle, which also may function as solvents in some instances, are used to provide the compositions of the invention in their preferred form. Examples include, but not limited to, water, ethanol, propanol, isopropanol, mineral oil, silicone, polyethylene glycol, polypropylene glycol, liquid sugars, waxes, petroleum jelly and a variety of other oils, aloe and polymeric materials along with polyacrylate, silicone, natural and synthetic rubbers or other adhesives. Preferably, the vehicle is mineral oil.

[0108] Vehicle used in the polyherbal transdermal patch composition is in the range of 0.5 to 20% (w/w), more preferably in the range of 0.5 to 10% (w/w) of the total weight of the composition.

[0109] The polyherbal transdermal patch of the present invention has been prepared by hot melt coating technique. The advantage of this technique is simple and easy to manufacture, more economical and solvent free technique. Using HMC technique tuning drug release, adhesiveness (tack) and physical properties of patch is relatively good compared to solvent-based coating technique.

[0110] The polyherbal transdermal patch of the present invention has been prepared by hot melt coating technique using polyethylene terephthalate release liner and coated layer is laminated using nonwoven or woven fabric backing material.

[0111] The molten adhesive blend preparation comprising the SIS and pressen 1471 as hot melt adhesives. The physical & mechanical properties of adhesive matrix are achieved only with the combination of SIS 5002 and Pressen 1471 to get the desired adhesion & flexibility to adhesive matrix.

[0112] The content of SIS and pressen 1471 should contain 20% to 90% by mass with respect to total mass of transdermal patch. If the content falls within this range, the cohesive property and tack of adhesive layer can be maintained. Accordingly, favorable application properties can be obtained.

[0113] For the polyherbal transdermal patch preparation of present invention, it is preferred that the permeation enhancer used to enhance the permeation of active ingredients through the skin to provide better and fast therapeutic action. The concentration of permeation enhancer should be in the range of 0.1-3% by mass with respect to total mass of the adhesive matrix.

[0114] For the polyherbal transdermal patch preparation of present invention, it is preferred that the tackifier play a key role to maintain optimum sticking to skin. The physical and mechanical properties of transdermal patch are achieved only with the optimized concentration of tackifier to get the desired tackiness & flexibility. The concentration of tackifier should be in the range of 1-10% by mass with respect to total mass of adhesive matrix.

[0115] For the transdermal patch preparation of present invention, it is preferred that the vehicle should be in the range of 0.5-20%.

[0116] Various properties associated with each component of the transdermal patch compositions may affect the properties of the final product. Properties associated with the selection of raw materials, molecular weight, concentration and viscosity may influence the adhesive matrix formation, adhesion and therapeutic effect.

[0117] The invention disclosed herein is process for the preparation of transdermal patch useful for treatment/management of pain.

Manufacturing Process for Polyherbal Transdermal Patch:

[0118] 1. Preparation of Hot Melt Adhesive Blend

[0119] The hot melt adhesive blend is prepared by melting of Pressen 1471 and SIS under stirring preferably at 100° C.-220° C. temperature. Later, to the molten adhesive mineral oil and Arkon were added under stirring to obtain homogenous adhesive blend. Preferably, the concentration of pressen 1471 should be in the range of 20-80% (w/w), preferably, SIS should be in the range of 5-30% (w/w), preferably, mineral oil should be in the range of 0.5-20% (w/w), preferably, Arkon should be in the range of 1-10% (w/w).

[0120] 2. Addition of Active Ingredients

[0121] Boswellia extract, evening primrose oil, blackcurrant seed oil, ginger, licorice, cat's claw and devil's claw were added along with isopropyl myristate and tocopheryl acetate to the molten adhesive blend. Preferably, the concentration of boswellia extract should be in the range of 0.1-5% (w/w), preferably, the concentration of evening primrose oil should be in the range of 0.1-5% (w/w), preferably, the concentration of black currant seed oil should be in the range of 0.1-5% (w/w), preferably, the concentration of licorice should be in the range of 0.1-5% (w/w), preferably, the concentration of ginger should be in the range of 0.1-5% (w/w), preferably, the concentration of cat's claw should be in the range of 0.1-5% (w/w), preferably, the concentration of devil's claw should be in the range of 0.1-5% (w/w), preferably, the concentration of isopropyl myristate should be in the range of 0.5-5% (w/w), preferably, the concentration of tocopheryl acetate should be in the range of 0.1-3% (w/w).

[0122] 3. Coating

[0123] The hot melt adhesive blend was uniformly coated with desired thickness on to the polyethylene terephthalate release liner.

[0124] 4. Lamination and Cutting and Packaging

[0125] Then coated adhesive matrix was laminated using Nonwoven fabric.

[0126] 5. Cutting and Packaging

[0127] Then the resulting product cut into a desired size to produce transdermal patch and finally packed in triple laminated aluminum pouch.

[0128] Formulations were developed using different concentrations of pressen 1471, SIS, and Arkon. The formulations prepared with different variations were evaluated for their description, adhesion (tack), peel test, assay.

[0129] The following examples describes the nature of the invention and are given only for the purpose of illustrating the present invention in more detail and are not limitative and relate to solutions, which have been particularly effective on bench scale.

EXAMPLE 1

[0130]

TABLE-US-00001 Concen- S. tration mg/ No. Ingredients (%) patch 1. Sallaki (Boswellia Serrata) 0.706 12 2. Evening primrose oil (Oenothera biennis) 1.471 25 3. Blackcurrant seed oil (Ribes nigrum) 1.471 25 4. licorice (Glycyrrhiza glabra) 0.412 7 5. Ginger (Zingiber officinale) 1.471 25 6. Cat's claw (Uncaria tomentosa) 0.176 3 7. Devil's claw (Harpagophytum procumbens) 0.353 6 8. Isopropyl myristate 3.000 51 9. (Styrene Isoprene styrene thermoplastic 19.118 325 elastomer) - SIS 5002 10. Pressen 1471 65.882 1120 11. Arkon-P 100 4.529 77 12. Mineral oil 0.882 15 13. Tocopheryl acetate 0.529 9

EXAMPLE 2

[0131]

TABLE-US-00002 Concen- S. tration mg/ No. Ingredients (%) patch 1. Sallaki (Boswellia Serrata) 1.471 25 2. Evening primrose oil (Oenothera biennis) 1.471 25 3. Blackcurrant seed oil (Ribes nigrum) 1.471 25 4. licorice (Glycyrrhiza glabra) 0.412 7 5. Ginger (Zingiber officinale) 1.471 25 6. Cat's claw (Uncaria tomentosa) 0.176 3 7. Devil's claw (Harpagophytum procumbens) 0.353 6 8. Isopropyl myristate 3.000 51 9. (Styrene Isoprene styrene thermoplastic 17.647 300 elastomer) - SIS 5002 10. Pressen 1471 66.941 1138 11. Arkon-P 100 4.529 77 12. Mineral oil 0.529 9 13. Tocopheryl acetate 0.529 9

EXAMPLE 3

[0132]

TABLE-US-00003 Concen- S. tration mg/ No. Ingredients (%) patch 1. Sallaki (Boswellia Serrata) 2.206 37.5 2. Evening primrose oil (Oenothera biennis) 1.471 25 3. Blackcurrant seed oil (Ribes nigrum) 1.471 25 4. licorice (Glycyrrhiza glabra) 0.412 7 5. Ginger (Zingiber officinale) 1.471 25 6. Cat's claw (Uncaria tomentosa) 0.176 3 7. Devil's claw (Harpagophytum procumbens) 0.353 6 8. Isopropyl myristate 3 51 9. (Styrene Isoprene styrene thermoplastic 19.147 325.5 elastomer) - SIS 5002 10. Pressen 1471 64.706 1100 11. Arkon-P 100 4.529 77 12. Mineral oil 0.529 9 13. Tocopheryl acetate 0.529 9

EXAMPLE 4

[0133]

TABLE-US-00004 Concen- S. tration mg/ No. Ingredients (%) patch 1. Sallaki (Boswellia Serrata) 1.471 25 2. Evening primrose oil (Oenothera biennis) 0.147 2.5 3. Blackcurrant seed oil (Ribes nigrum) 2.794 47.5 4. licorice (Glycyrrhiza glabra) 0.412 7 5. Ginger (Zingiber officinale) 1.471 25 6. Cat's claw (Uncaria tomentosa) 0.176 3 7. Devil's claw (Harpagophytum procumbens) 0.353 6 8. Isopropyl myristate 3.000 51 9. (Styrene Isoprene styrene thermoplastic 17.765 302 elastomer) - SIS 5002 10. Pressen 1471 66.471 1130 11. Arkon-P 100 4.529 77 12. Mineral oil 0.882 15 13. Tocopheryl acetate 0.529 9

EXAMPLE 5

[0134]

TABLE-US-00005 Concen- S. tration mg/ No. Ingredients (%) patch 1. Sallaki (Boswellia Serrata) 1.471 25 2. Evening primrose oil (Oenothera biennis) 2.794 47.5 3. Blackcurrant seed oil (Ribes nigrum) 0.147 2.5 4. licorice (Glycyrrhiza glabra) 0.412 7 5. Ginger (Zingiber officinale) 1.471 25 6. Cat's claw (Uncaria tomentosa) 0.176 3 7. Devil's claw (Harpagophytum procumbens) 0.353 6 8. Isopropyl myristate 3.000 51 9. (Styrene Isoprene styrene thermoplastic 17.882 304 elastomer) - SIS 5002 10. Pressen 1471 66.706 1134 11. Arkon-P 100 4.529 77 12. Mineral oil 0.529 9 13. Tocopheryl acetate 0.529 9

EXAMPLE 6

[0135]

TABLE-US-00006 Concen- S. tration mg/ No. Ingredients (%) patch 1. Sallaki (Boswellia Serrata) 1.471 25 2. Evening primrose oil (Oenothera biennis) 1.471 25 3. Blackcurrant seed oil (Ribes nigrum) 1.471 25 4. licorice (Glycyrrhiza glabra) 0.412 7 5. Ginger (Zingiber officinale) 1.471 25 6. Cat's claw (Uncaria tomentosa) 0.176 3 7. Devil's claw (Harpagophytum procumbens) 0.353 6 8. Isopropyl myristate 3 51 9. (Styrene Isoprene styrene thermoplastic 18.235 310 elastomer) - SIS 5002 10. Pressen 1471 66.353 1128 11. Arkon-P 100 4.529 77 12. Mineral oil 0.529 9 13. Tocopheryl acetate 0.529 9

EXAMPLE 7

[0136]

TABLE-US-00007 Concen- S. tration mg/ No. Ingredients (%) patch 1. Sallaki (Boswellia Serrata) 1.471 25 2. Evening primrose oil (Oenothera biennis) 0.735 12.5 3. Blackcurrant seed oil (Ribes nigrum) 2.206 37.5 4. licorice (Glycyrrhiza glabra) 0.412 7 5. Ginger (Zingiber officinale) 1.471 25 6. Cat's claw (Uncaria tomentosa) 0.176 3 7. Devil's claw (Harpagophytum procumbens) 0.353 6 8. Isopropyl myristate 3 51 9. (Styrene Isoprene styrene thermoplastic 19.147 325.5 elastomer) - SIS 5002 10. Pressen 1471 65.441 1112.5 11. Arkon-P 100 4.529 77 12. Mineral oil 0.529 9 13. Tocopheryl acetate 0.529 9

EXAMPLE 8

[0137]

TABLE-US-00008 Concen- S. tration mg/ No. Ingredients (%) patch 1. Sallaki (Boswellia Serrata) 1.471 25 2. Evening primrose oil (Oenothera biennis) 2.206 37.5 3. Blackcurrant seed oil (Ribes nigrum) 0.735 12.5 4. licorice (Glycyrrhiza glabra) 0.412 7 5. Ginger (Zingiber officinale) 1.471 25 6. Cat's claw (Uncaria tomentosa) 0.176 3 7. Devil's claw (Harpagophytum procumbens) 0.353 6 8. Isopropyl myristate 3 51 9. (Styrene Isoprene styrene thermoplastic 20.588 350 elastomer) - SIS 5002 10. Pressen 1471 64.000 1088 11. Arkon-P 100 4.529 77 12. Mineral oil 0.529 9 13. Tocopheryl acetate 0.529 9

EXAMPLE 9

[0138]

TABLE-US-00009 Concen- S. tration mg/ No. Ingredients (%) patch 1. Sallaki (Boswellia Serrata) 1.471 25 2. Evening primrose oil (Oenothera biennis) 1.471 25 3. Blackcurrant seed oil (Ribes nigrum) 1.471 25 4. licorice (Glycyrrhiza glabra) 0.206 3.5 5. Ginger (Zingiber officinale) 0.735 12.5 6. Cat's claw (Uncaria tomentosa) 0.088 1.5 7. Devil's claw (Harpagophytum procumbens) 0.235 4 8. Isopropyl myristate 3 51 9. (Styrene Isoprene styrene thermoplastic 18.676 317.5 elastomer) - SIS 5002 10. Pressen 1471 67.059 1140 11. Arkon-P 100 4.529 77 12. Mineral oil 0.529 9 13. Tocopheryl acetate 0.529 9

EXAMPLE 10

[0139]

TABLE-US-00010 Concen- S. tration mg/ No. Ingredients (%) patch 1. Sallaki (Boswellia Serrata) 1.471 25 2. Evening primrose oil (Oenothera biennis) 1.471 25 3. Blackcurrant seed oil (Ribes nigrum) 1.471 25 4. licorice (Glycyrrhiza glabra) 0.588 10 5. Ginger (Zingiber officinale) 2.206 37.5 6. Cat's claw (Uncaria tomentosa) 0.265 4.5 7. Devil's claw (Harpagophytum procumbens) 0.471 8 8. Isopropyl myristate 3 51 9. (Styrene Isoprene styrene thermoplastic 17.941 305 elastomer) - SIS 5002 10. Pressen 1471 65.529 1114 11. Arkon-P 100 4.529 77 12. Mineral oil 0.529 9 13. Tocopheryl acetate 0.529 9

Manufacturing Process for Polyherbal Transdermal Patch:

[0140] Required quantity of pressen 1471 and SIS, were molten in hot vessel at 100° C.-220° C. under stirring.

[0141] Required quantity of arkon and mineral oil were added to molten adhesive blend under stirring at 100° C.-220° C. temperature to obtain homogenous blend.

[0142] Required quantity of all herbal extracts, boswellia, evening primrose oil, blackcurrant seed oil, licorice, ginger, cat's claw and devil's claw along with isopropyl myristate and tocopheryl acetate were added to above molten adhesive base under stirring to obtain homogenous mixture of active ingredients in blend for coating.

[0143] Polyherbal transdermal patch prepared as per the Example no. 5 of the present invention has shown good stability among all of the examples given of the present invention under different stability conditions. The Polyherbal transdermal patch was evaluated at different stability conditions i.e., at 40° C./75% RH, 30° C./75% RH and 25° C./60% RH, The observed for physical properties of patch, examined its total content of boswellic acids by assay, uniformity of Dosage Units (by Content Uniformity), Tack Test, Peel Test, Microbial Enumeration Limit and Total Aerobic Microbial Count (cfu/gm) including Total yeasts and molds count (cfu/gm), Pseudomonas aeruginosa (gm) and Staphylococcus aureus (gm) ans data is given below tables 1, 2 & 3:

TABLE-US-00011 TABLE 1 Stability Condition: 40° C./75% RH (Example 5) Test Specification Initial 3 Month 6 Month Description Brown to dark brown Complies Complies Complies coloured matrix type transdermal patch that is rectangular shape patch Assay Each patch contains 25 100.02 97.7 98.5 Total boswellic acids mg of boswellic acids Limit: 22.5 mg to 27.5 mg i.e 90% to 110% of label claim Uniformity of Dosage Units L1 ≤15 3.1 3.8 4.2 (by Content Uniformity) Tack Test NLT 2.0 N 4.1 3.8 3.6 Peel Test NLT 6.0 N 9.7 9.2 9.5 Microbial Enumeration Limit: Total Aerobic Microbial Count Not more than 100 Absent NA Absent (cfu/gm) Total yeasts and molds count Not more than 10 Absent Absent (cfu/gm) Pseudomonas aeruginosa (gm) Absent Absent Absent Staphylococcus aureus (gm) Absent Absent Absent

TABLE-US-00012 TABLE 2 Stability Condition: 30° C./75% RH (Example 5) Test Specification Initial 3 Month 6 Month Description Brown to dark brown Complies Complies Complies coloured matrix type transdermal patch that is rectangular shape patch Assay Each patch contains 25 100.02 98.3 99.2 Total boswellic acids mg of boswellic acids Limit: 22.5 mg to 27.5 mg i.e 90% to 110% of label claim Uniformity of Dosage Units L1 ≤15 3.1 3.6 3.8 (by Content Uniformity) Tack Test NLT 2.0 N 4.1 3.1 3.8 Peel Test NLT 6.0 N 9.7 9.1 8.2 Microbial Enumeration Limit Total Aerobic Microbial Count Not more than 100 Absent NA Absent (cfu/gm) Total yeasts and molds count Not more than 10 Absent Absent (cfu/gm) Pseudomonas aeruginosa (gm) Absent Absent Absent Staphylococcus aureus (gm) Absent Absent Absent

TABLE-US-00013 TABLE 3 Stability Condition: 25° C./60% RH (Example 5) Test Specification Initial 3 Month 6 Month Description Brown to dark brown Complies Complies Complies coloured matrix type transdermal patch that is rectangular shape patch Assay Each patch contains 25 100.2 98.7 99.3 Total boswellic acids mg of boswellic acids Limit: 22.5 mg to 27.5 mg i.e 90% to 110% of label claim Uniformity of Dosage Units L1 ≤15 3.1 3.2 3.5 (by Content Uniformity) Tack Test NLT 2.0 N 4.1 3.7 3.9 Peel Test NLT 6.0 N 9.7 8.5 8.9 Microbial Enumeration Limit Total Aerobic Microbial Count Not more than 100 Absent NA Absent (cfu/gm) Total yeasts and molds count Not more than 10 Absent Absent (cfu/gm) Pseudomonas aeruginosa (gm) Absent Absent Absent Staphylococcus aureus (gm) Absent Absent Absent