A synergistic composition comprising frankincense oil and boswellic acid and a method of making the same

Abstract

The present invention provides a synergistic composition comprising Boswellia- derived Frankincense oil and boswellic acid as well as methods for the synthesis of the same. Said synergistic composition comprising Frankincense oil and boswellic acid is prepared by subjecting Boswellia serrata resin gum to hydro-steam distillation process at a slightly elevated pressure, and for a short period of time, without using any organic solvents for extraction. Said synergistic composition is also prepared by combining Boswellic extract comprising at least 5 % by weight of Boswellic acid with Frankincense oil, with the combined product remaining as a clear oil, and offering the benefits of both Boswellic extract containing boswellic acid, and Frankincense oil. Said synergistic composition comprising Frankincense oil and boswellic acid is administered through topical, transdermal or oral route for the treatment of skin cancer, breast cancer, arthritis, and IBS.

Description

[0001]TITLE OF THE INVENTION A synergistic composition comprising Frankincense oil and boswellic acid and a method of making the same. FIELD OF THE INVENTION The present invention relates to a synergistic composition comprising Frankincense oil and boswellic acid. The present invention also relates to a method for the synthesis of said synergistic composition comprising Frankincense oil and boswellic acid. BACKGROUND OF THE INVENTION Frankincense is a product of trees from the genus Boswellia which comprises more than 30 species, 16 of which grow in tropical Africa and Asia. Boswellia genus comprises of nearly 25 distinct species and some of the important species include Boswellia serrata, Boswellia sacra, Boswellia carterii, Boswellia papyrifera, Boswellia neglecta, Boswellia Carterii, Boswellia rivae, Boswellia frereana, and Boswellia ovalifoliolata, etc. The oleogum resin of Boswellia contains a highly complex mixture of more than 200 different chemical compounds, including terpenes, saponins, alkaloids, polyphenols, tannins, essential oils, mucus, sugars and other compounds. The major ingredients of Boswellia oleogum resin are 3-O-Acetyl-11-keto-β-boswellic acid (AKBA), incensole acetate, ursolic acid, lupeolic acid, cembrene A, α-amyrin, β-amyrin, and olibanumaol I. α-pinene, sclarene, thunbergol, octanol, octyl formate, secyl acetate, O- methylanisole, verticiol, 9-cis-retinal are some ingredients of Boswellia essential oil. The resinous part of Boswellia serrata comprises monoterpenes (α-thujene), diterpenes (macrocyclic diterpenoids such as incensole, incensole oxide, iso-incensole oxide, a diterpene alcohol [serratol]), triterpenes (such as α- and β-amyrins), pentacyclic triterpenic acids (boswellic acids), and tetracyclic triterpenic acids (tirucall-8,24-dien- 21-oic acids). The pharmacological activity of the oleogum resin is mainly due to the pentacyclic boswellic acid. Boswellia resin has been used through ages for the treatment of rheumatoid arthritis and other inflammatory diseases such as Crohn’s disease. The anti-inflammatory activity has been attributed to the resin's ability in regulating the production of immune cytokines and leukocyte infiltration. Additionally, it has been demonstrated that extracts from Boswellia species gum resins possess anti-cancer activities in rats, and human leukemia cell lines. Clinically, extract from the resin reduces the peritumoral edema in glioblastoma patients, and reverses multiple brain metastases in breast cancer patients. These results suggest that Boswellia resin contains active ingredients that control important biological activities. Frankincense is well known in Ayurvedic medicine throughout the Indian subcontinent. It has also been used in traditional Chinese medicine against bronchial, pancreatic or nasopharyngeal carcinomas. Frankincense was an approved remedy in Europe for the treatment of inflammation at the beginning of the 20th century. Frankincense and its ingredients possess anti-inflammatory effects and are active against immunological diseases. Frankincense oil , an extract prepared from Boswellia gum resin, is one of the most commonly used oils in aromatherapy. Considerable research has been done on the composition of Frankincense oil obtained from different species of Boswellia. It is observed that the constituents of Frankincense oil obtained depend on the climate, harvest conditions, and geographical sources of Boswellia resins. The chemical and physical properties of the Boswellia extract and oil components of the resin are vastly different. Therefore, different methods are used to separate the oil from the resin. Due to the polar nature of the extract components, solvents such as methanol and ethanol are used to separate the extract comprising of boswellic acids. The Boswellia extract finds use in varied applications. Due to the vast difference in the polarity of Boswellia extract and oil components, solvent extraction completely separates out the extract from the oil. The boswellic acids present in the extract are generally characterized as pentacyclic triterpentenes, which include four different boswellic acids namely: beta-boswellic acid, acetyl-beta-boswellic acid, 11-keto-beta-boswellic acid (KBA), and acetyl-11- keto-boswellic acid (AKBA). Said boswellic acid types are known to have anti- inflammatory properties. Of these, AKBA is the most potent inhibitor of the 5-LO enzyme responsible for inflammation. Frankincense oil is separated from the resins of Boswellia species of trees by steam distillation. The boiling point of boswellic acid is predicted to be high at 567oC which is much higher than the temperature of 80-150oC used for steam distillation. Thus, Frankincense oil which is derived from steam distillation has no boswellia extract component left in the residue. Thus, the mutually exclusive components that are separated from the boswellia resin are boswellia extract which contains no Frankincense oil, and Frankincense oil which contains no boswellia extract. In addition to the impossibility of these components being present together by virtue of their separation methods, the very purpose for which these are separated from the resin negate the necessity for them to be present together. Boswellia extract is a nutritional supplement taken orally, and Frankincense oil is used for aromatherapy and skin application. Also, several diseases such as osteoarthritis, rheumatoid arthritis, multiple sclerosis etc. are reported to have been successfully treated by boswellia extract and its phytochemicals while it has already been established that Frankincense oil exhibits anti-cancer activity. US 9511034B1 relates to a skin treatment composition comprising a synergistic skin treatment that addresses both the healing and cosmetic aspects of skin management. It discloses the preparation of a first mixture by combining a silicone platinum catalyst (1 to 2 gms. per Kg) with a silicone elastomer, a second mixture by combining amorphous fumed silica (0.0015 g / mL) with Boswellia serrata extract (0.005 gms per ml), and then combining said two mixtures in equal volumes. The resultant mixture is heated to 75-90oC, and subsequently cooled and mixed with gotu kola extract, chamomile extract, green tea extract, and tetrahydrocurcumoid. IN202041021739 discloses water-soluble boswellic acid compositions comprising 3- O-acetyl-11-keto-β-boswellic acid in combination with a metal ion selected from potassium or sodium in the form of metal salt or complex or chelate for the treatment of muscle soreness, delayed onset of muscle soreness (DOMS), muscle tenderness, muscle pain, muscle fatigue, muscle sprain, temporary loss of muscle strength and swelling in muscles. 687 / CHE / 2010 discloses a non-acidic extract / fraction selected from boswellia polar gum resin extract fraction, and boswellia oil fraction derived from the gum resin of boswellia species for improving the mental condition, brain health, and for treating cognition related disorders. The process for obtaining non-acidic boswellia oil fraction comprises extraction of the gum resin with a water immiscible organic solvent, filtering and washing the organic solvent extract with water and brine and evaporating the organic layer under vacuum and high temperature to obtain oily residue. Farah Itam et al. in their publication titled Phytochemistry and potential therapeutic actions of Boswellic acids: A mini-review, disclose the pharmacotherapeutic actions of boswellic acids. Boswellia serrata extract decreases redness and irritation in the skin and restores an even skin tone. In China, Frankincense is said to be used for treating skin bruises and infected sores. In addition, AKBA is reported to be an effective topical agent to soften facial lines and relax the skin. Boswellic acids contribute to skin whitening and wrinkle reduction. Different compositions of α-Boswellic acid and β- Boswellic acid could exhibit potent activities toward melanin synthesis collagenase. Fung et al., in their publication titled Management of basal cell carcinoma of the skin using frankincense (Boswellia sacra) essential oil: a case report, disclosed the preparation of frankincense essential oil by hydrodistillation of Boswellia sacra gum resins which also possess anti-cancer activity that can potentially provide non-surgical and non-invasive treatment option for Basal-cell carcinoma (BCC) by topical application. Mahmoud M Suhail et al. in their publication titled Boswellia sacra essential oil induces tumor cell - specific apoptosis and suppresses tumor aggressiveness in cultured human breast cancer cells, disclosed that essential oil was prepared from sacra gum resins collected in Oman, via hydrodistillation at 78oC or 100oC for 12 hours. Chemical profiles of these essential oils were analyzed and studied for their antitumor properties in a panel of human breast cancer cell lines and an immortalized normal breast epithelial cell line. However, none of the prior art cited above disclose a synergistic composition comprising Boswellia derived Frankincense oil and Boswellic acid, prepared using a simple method, and in a short duration of time, without using any chemicals or solvents. OBJECT OF THE INVENTION The primary object of the present invention is to provide a synergistic composition comprising Frankincense oil and boswellic acid. Another object of the invention is to provide a synergistic composition comprising Frankincense oil and Boswellic acid comprising 5 % to 50 % by weight of boswellic acid in combination with Frankincense oil. Yet another object of the invention is to provide a simple method of preparing a synergistic composition comprising Frankincense oil and boswellic acid. Still yet another object of the invention is to provide a method of preparing a synergistic composition comprising Frankincense oil and boswellic acid comprising hydro-steam distillation process. Yet another objective of the invention is to provide an environmentally-friendly method for the synthesis of a synergistic composition comprising Frankincense oil and boswellic acid. Further yet another object of the invention is to provide a method for the synthesis of a synergistic composition comprising Frankincense oil and boswellic acid comprising hydro-steam distillation process, within a short duration of time. Still further object of the invention is to provide a method for the synthesis of a synergistic composition comprising Frankincense oil and boswellic acid without using any organic solvents for extraction. Another object of the invention is to provide a method for the synthesis of a synergistic composition comprising Frankincense oil and boswellic acid using ultrafast distillation process. Yet another object of the present invention is to combine Frankincense oil with boswellic extract, wherein the combined product remains as an optically clear oil. Still yet another object of the present invention is to combine Boswellia-derived Frankincense oil with boswellic extract, wherein the combined product possesses the benefits of both the extract and the oil. Furthermore, another object of the present invention is to incorporate the Boswellia serrata extract with Frankincense oil extracted from other Boswellia species. Further yet another object of the present invention is to expand the range of possible routes to administer the boswellic acid constituents of said Boswellia extract. SUMMARY OF THE INVENTION The present invention provides a synergistic composition comprising Frankincense oil and boswellic acid. Said synergistic composition comprises Frankincense oil and atleast 5 % to 65 % by weight of boswellic acid. Said synergistic composition is obtained within a short duration of time, using a simple method comprising hydro- steam distillation using preheated water followed by dissolution of the extract into the distillate. Said hydro-steam distillation is ultra-fast and is performed at slightly elevated pressure to obtain synergistic composition comprising Frankincense oil and boswellic acid. Frankincense oil obtained from any Boswellia species is combined with Boswellic acid in the gum resin of said Boswellia serrata to obtain said synergistic composition. BRIEF DESCRIPTION OF THE DRAWINGS The summary of the present invention, as well as the detailed description, is better understood when read in conjunction with the accompanying drawings that illustrate one or more possible embodiments of the present invention, of which: Figure 1 illustrates a schematic representation of a synergistic composition comprising Frankincense oil and boswellic acid obtained directly through hydro-steam distillation process by combining Boswellia extract with Frankincense oil. Figure 2 illustrates a schematic representation of a method for the synthesis of a synergistic composition comprising Boswellia-derived Frankincense oil and boswellic acid using hydro-steam distillation process. Figure 3(a) and Figure 3(b) illustrate the GC-MS analysis of the Frankincense oil from Boswellia serrata produced by hydro-steam distillation process. Figure 4(a) and Figure 4(b) illustrate the clarity of virgin Boswellia neglecta oil and said synergistic composition comprising Boswellia neglecta oil and Boswellia serrata extract respectively. Figures 5(a) and Figure 5(b) illustrate the GC-MS spectrum and analysis report of Boswellia neglecta oil respectively. Figures 6 illustrates the GC-MS analysis report of commercial Frankincense oil, and Figures 7(a) and Figure 7(b) illustrate the clarity of virgin Boswellia serrata oil and syrupy synergistic composition comprising Boswellia-derived Frankincense oil and boswellic acid respectively. DETAILED DESCRIPTION OF THE INVENTION Various embodiments will now be described to provide an overall understanding of the principles, structure, function, manufacture, and use of the methods disclosed herein. Those with ordinary skill in the art will understand that the features described or illustrated in connection with one example embodiment can be combined with the features of other example embodiments without generalization from the present disclosure. The accompanying drawings, which are included to provide a further understanding of the invention constitute a part of this specification, illustrate the embodiments of the present invention, and together with the description explain the principles of the invention. The present invention is related to a novel synergistic composition comprising Boswellia-derived Frankincense oil and boswellic acid comprising 5 % to 50 % of boswellic acid, and a method for the synthesis of the same. The source of Boswellia for the synthesis of said synergistic composition comprises Boswellia serrata, Boswellia neglecta, Boswellia frereana, Boswellia sacra, Boswellia Carterii, Boswellia rivae, or any family of Boswellia species, or any combination thereof. The herbal extracts prepared from various species of Boswellia (family Burseraaceae) tree have been used for centuries in traditional medicine worldwide. The tree is commonly grown in gulf countries viz. Oman, Yemen and Southern Saudi Arabia, in East Africa (Somalia and Ethiopia), South Asia. It also grows abundantly in dry hilly tracts of India. The Indian states where it is grown widely include Rajasthan, Gujarat, Maharashtra, Madhya Pradesh, Bihar, Orissa and some parts of Western Himalayas. The dried exudate from the bark of Boswellia serrata tree is an oleo-gum resin which is commonly known as Indian Frankincense, Indian olibanum, Incense or Salai guggal. The dried gum appears in the form of lumps or tears which are white- yellow in color. The different species of Boswellia possess about 200 phytochemicals in oleo-gum-resin mixture. These compounds include essential oil, pure resin, and mucus. The content and composition of the oleo gum resin may vary from species to species depending on the age of the tree, quality of resin, and geographical conditions. The resins of Boswellia species mainly contain higher terpenoids, i.e., pentacyclic triterpenes and tetracyclic triterpenes but the former are mainly considered to be responsible for their pharmacological effects. Chemically, boswellic acid is 3-hydroxyurs-12-ene-23-oic acid. The boswellic acids are a common chemical characteristic feature of all species of genus Boswellia. The six major boswellic acids namely alpha and beta boswellic acids (BA, 10–21 %), acetylated alpha and beta-boswellic acids (ABA, 0.05–6 %), 11- keto-beta-boswellic acid (KBA, 2.5–7.5 %) and 3-O-acetyl-11-keto-beta-boswellic acid (AKBA, 0.1–3 %) are present in all Boswellia species but in varying quantities. Commercial Frankincense oil available in the market generally contains no detectable boswellic acid. Furthermore, there are no literature reports of Frankincense oil with greater than 5 % boswellic acid. However, the applicant has developed a novel method by which synergistic composition of Frankincense oil comprising higher concentrations of boswellic acid was synthesized (Figure 1). Commercially available Serrata Frankincense oil has an α-thujene content of 30 % to 75 % and α-pinene content of 4 % to 8 %. The α-thujene content of the Frankincense oil is noted to be the signature of the Boswellia serrata species, and the beneficial properties of the Serrata Frankincense oil are attributed to the α-thujene which is present in the Serrata Frankincense Soil. The α-pinene which is present in the Frankincense oil offers the beneficial effect of adding a pleasant aroma to the oil. According to an embodiment of the present invention, Frankincense oil was prepared by a hydro-steam distillation process in a home-built distillation apparatus (Figure 2). A commercial 12-liter aluminum pressure cooker (1) was used as the cooking vessel which was heated using a gas stove (2). A food grade silicone rubber hose (3) was fixed on top of the pressure cooker lid which was connected to a 3 / 8” OD soft copper tube (4) wound into a 10-inch diameter helical coil. The entire copper helical coil was immersed in a circulating water bath constructed out of a stainless steel vessel (5), and fresh tap water was circulated continuously during the distillation process. The present invention is better explained through the representative examples disclosed herein. Example 1 Boswellia serrata resin gum was acquired from Maya Aromatics based out of Chattarpur district located in Madhya Pradesh, India. The resin was freshly tapped by the tribals living in the Panna National Forest in Chattarpur district of Madhya Pradesh. As the resin was freshly tapped, it was neither dry nor granular, but was highly gummy. 3 litres of water was preheated to its boiling point in a separate vessel, and added to 1 kg of the Boswellia serrata resin gum which was previously loaded onto a perforated strainer bowl and placed inside the pressure cooker. The upper lid of the pressure cooker was secured. Once the distillation process started, the Boswellia serrata oil and steam vapors from the pressure cooker started condensing into liquid within 15 minutes. The condensed mixture of the oil and water was collected as a stream of liquid from the end of the helical copper tube immersed in the water circulation bath. The mixture of oil and water was collected in a stainless steel vessel, and transferred to an oil-water separator at 30 minutes and 90 minutes into the run. The heating was stopped once the amount of condensate reduced drastically. The volume of Boswellia serrata oil, also called the Frankincense oil, that condensed within the first 30 minutes, was 110 ml, and during the subsequent 30 minutes, 26 ml of Frankincense oil was condensed, and in the final 30 minutes, 14 ml of Frankincense oil was condensed, that is, a total of 150 ml of Frankincense oil collected at the 90-minute mark. The corresponding weight of the condensed Frankincense oil was calculated to be 93.28 gm, 22.05 gm, and 11.87 gm during the first, second, and third 30-minute time periods, adding up to a total of 127.2 gm at the end of 90 minutes of distillation, corresponding to a Frankincense oil of 9.33 % by weight, 2.21 % by weight, and 1.19 % by weight during the first, second, and third 30-minute time periods respectively. The total yield of Frankincense oil was 12.72 % by weight after 90 minutes of distillation. The yield of Frankincense oil was higher than that obtained typically by conventional distillation processes which use much longer distillation time of 8-12 hours. In the present invention, the vast difference in the boiling points of the components of Boswellia extract, interchangeably called the Boswellic extract, and Frankincense oil is used to separate the two constituents entirely. The unique aspects of the distillation process include using a slightly elevated pressure of 1 bar to 2 bars while cooking in the pressure cooker, preheating the water to its boiling point, and quenching the distillation process rather early. These aspects of said distillation enabled fast evaporation and condensation of the compounds with lower boiling points without contamination associated with the higher boiling points, higher molecular weight species, which are known to render an unpleasant aroma to the distilled oil. After cooling the remaining mass in the pressure cooker, the residual water in the pressure cooker was drained out, and the solidified Boswellia extract remaining in the pressure cooker was washed with water and weighed.428 gms of the Boswellia extract was collected at the end of the run, corresponding to an extract yield of 42.8 % by weight. Said boswellic extract appeared to be an off-white glossy mass of globules with a small fraction of tree bark fragments incorporated within said globules. The Boswellia serrata oil, also called Frankincense oil, produced from the distillation process of the present invention, was analyzed for its chemical constituents using the GC-MS technique. The results are presented in Figures 3(a) and 3(b). It is observed that no heavy molecules with retention time longer than 22 minutes are present in said Frankincense oil, as seen in the mass spectrum. This demonstrates the efficiency of the modified hydro-steam distillation process, which eliminates long chain molecules with high boiling points in said Frankincense oil. Furthermore, the primary constituent of said Frankincense oil was α-thujene which was 62.7 % by weight, and α-pinene at a relatively lower concentration of 6.7 % by weight. The α-thujene is attributed, and preferred by many because of its anti-inflammatory, and other medicinal properties. Said boswellic extract produced by said hydro-steam distillation process was evaluated for the total boswellic acid content present in said extract by acid titrimetric method. The total boswellic acid content of said Boswellia extract produced by the hydro-steam distillation process is presented in Table 1. The boswellic acid content in said Boswellia extract was analyzed, and was found to be 65 % by weight which was a very high concentration of boswellic acid in the as-prepared extract without any further purification process. This is believed to be due to the modified hydro-steam distillation process wherein, said process comprises use of excess amount of water and minimal duration of heating. Table 1 According to an embodiment of the present invention, said Boswellia serrata extract produced by said process was crushed into powder, mixed with said Boswellia serrata oil, also called Frankincense oil, and heated in a microwave oven to make said oil mildly warm. The resulting oil is the synergistic composition comprising Frankincense oil and boswellic acid synthesized by the process of the present invention. Example 2 4 gms of Boswellia serrata extract obtained in said example 1, was dissolved in 60 ml of said Boswellia serrata oil, also called Frankincense oil, from said example 1, to produce a synergistic composition comprising Frankincense oil and boswellic acid, which was slightly darker in color but completely clear and transparent (Figure 4 (b)). Said Boswellia serrata extract comprised 65 % by weight of said boswellic acid, which corresponds to 43.3 mg / ml on volume basis, and 36.8 mg / g on weight basis with respect to said Boswellia serrata oil, as summarized in Table 2. Table 2 Density Concentration of Boswellic acid aid example 2 is said synergistic composition comprising Boswellia-derived Frankincense oil and boswellic acid. Thus, said synergistic composition of said Example 2 comprises 5.1 % by weight of the total boswellic acids. Although the chemical polarities of the two components are very different from each other, it has been found that 6 % by weight of said boswellic extract dissolves in boswellic acid of said Boswellia serrata oil, without the use of any other solvent. The resulting synergistic composition of the present invention possesses all the health benefits of said boswellic acids which are generally not available from the commercially available boswellia oil. Said synergistic composition comprising Boswellia-derived Frankincense oil and boswellic acid can be used in topical skin applications while at the same time realizing the benefits of the boswellic acid constituents of the extract. Said synergistic composition of the present invention can be administered for the treatment of skin autoimmune conditions including but not limited to eczema, psoriasis, and rosacea. Said composition can be used topically for the treatment of chronic inflammatory disease. Said synergistic composition can also be administered for the treatment of skin cancer, breast cancer, arthritis, and irritable bowel syndrome. Said synergistic composition can be administered by various routes but not limited to topical route, transdermal route and oral route. Said synergistic composition can be readily mixed with other carrier oils and administered topically. Additionally, in certain cases, said synergistic composition can be used in tallow, or vegetable fat based skin- care cream formulations. According to another example of the present invention, Boswellia neglecta resin from the Mombasa, Kenya region was subjected to said hydro-steam distillation process. The resulting Frankincense oil produced by hydro-steam distillation of said Boswellia neglecta was mixed with said Boswellia serrata extract to produce the synergistic composition of the present invention. Said Boswellia neglecta oil was subjected to GC- MS analysis, the results of which are presented in Figure 5(a) and Figure 5(b) respectively. According to said analysis, said Boswellia neglecta oil comprised 48.75 % of α-pinene and 10.87 % of α-thujene based on the area % of the peaks in the chromatogram. Example 3 20.06 gms. of Frankincense oil extracted from Boswellia neglecta species was weighed into a beaker, and heated gently on a hot plate with a magnetic stirrer bar placed in the beaker. Powdered Boswellia serrata extract containing 65 % by weight of boswellic acid was added in progressively larger amounts as presented in Table 3 until said Frankincense oil became saturated with said Boswellia serrata extract. Said synergistic composition having as much as 28.58 % of said boswellic acid was prepared with excellent clarity. Table 3 Progressive addition Concentration of Boswellic acid in Clarity of of extract of powdered Boswellia serrata extract synergistic Said synergistic composition comprising said Boswellia neglecta oil, and said Boswellia serrata extract comprising 28.58 wt % of boswellic acids has been compared with the virgin Boswellia neglecta oil for its clarity in Figure 4. Said synergistic composition with said Boswellia serrata extract comprising 28.58 wt. % of boswellic acids, and the balance comprising said Boswellia neglecta oil is seen to be significantly more brownish yellow than the virgin Boswellia neglecta oil. The GC-MS spectrum of said Boswellia neglecta oil is presented in Figure 5(a) and the analysis is presented in Figure 5(b). In yet another embodiment, a commercially available Frankincense oil labelled as Indian Boswellia serrata oil sourced from Bulk Apothecary, Aurora, OH 44202, USA, was mixed with Boswellia Serrata extract produced by said hydro-steam distillation method to produce said synergistic composition comprising Frankincense oil and boswellic acid. The GC-MS analysis of said commercial Frankincense oil is presented in Figure 6. Said synergistic composition produced by mixing about 6.4 gms. of Boswellia serrata extract in 50 gms. of Boswellia serrata oil was characterized by acid titrimetry. Said synergistic composition was dissolved in 50 ml of methanol, and titrated with 0.01N sodium hydroxide solution using phenolphthalein as an indicator. The weight percentage of the total acids was calculated using the titre volume of said sodium hydroxide. Said procedure was repeated four times, the values of which are summarized in Table 4. The average value of said boswellic acid is 10.02 % by weight with a standard deviation of 0.36 %. Table 4: Acid titrimetry results of synergistic composition Weight of NaOH (gms) 0.6 0.6 0.6 0.6 0.6 H2O (lit) 1.5 1.5 1.5 1.5 1.5 9 7 20.09 gms. of commercial Boswellia serrata oil, also called Frankincense oil, was heated gently in a beaker by placing it on a hot plate with a magnetic stirrer. Said powdered Boswellia serrata extract comprising 65 % by weight of boswellic acids was added in progressively larger amounts until said Boswellia serrata oil became too syrupy with a honey-like viscosity, making it difficult to stir. The amount of said Boswellia extract added to said commercial Boswellia serrata oil is presented in Table 5. Translucent synergistic composition of Frankincense oil having 45.75 % of said boswellic acids is thus obtained. The visual appearance of said virgin Boswellia serrata oil and said syrupy synergistic composition obtained by said method is presented in Figure 7(a) and Figure 7(b) respectively. Table 5 Progressive Concentration of Boswellic acid in Clarity of commercial Boswellia serrata oil To expand the range of said boswellic acid in commercial Boswellia serrata oil, also called Frankincense oil, 1.10 grams of the oil was heated gently in an aluminum dish, and Boswellia extract was added to it in two increments of 1100 mg each, to produce the synergistic Frankincense oil having 65 % and 130 % by weight of said boswellic acid. While said synergistic composition comprising 5% Boswellic acid was a clear oil, adding Boswellic acid upto 65% transformed it into a translucent syrup. Adding 130 % by weight of boswellic acid produced a syrupy paste, rather than a free flowing syrupy liquid. The results are presented in Table 6. Table 6 Boswellia extract Concentration of Boswellic acid in Clarity of commercial Boswellia serrata oil The makeup of the different boswellic acids in said synergistic composition may be characterized by any one of the analytical techniques such as HPLC, GC-MS, r Ultra Performance Liquid Chromatography (UPLC), Time-of-flight mass spectrometry (ToF-MS) and Mass Spectrometry. Additional work is currently in progress to alter the concentration of said boswellic acids by varying the parameters of said distillation process, and by using vacuum distillation. Other chemical separation methods are also being considered to identify the concentrations of different boswellic acids. It is noted that the makeup of the boswellic acids may be further altered by additional processing to enrich the AKBA content of said synergistic composition to any desired level. Said synergistic composition of the present invention comprising Boswellia-derived Frankincense oil and boswellic acid expands the range of possible routes to administer said boswellic acid constituents of said boswellia extract. According to an aspect of the present invention, said composition can be administered through the skin. The surface area of the skin being much larger than the digestive tract, the oil is readily absorbed into the skin. This presents an efficacious vehicle of administration of the ingredients. Transdermal delivery allows for the therapeutic ingredients to be absorbed directly into the bloodstream, and avoid initially passing through the intestinal tract and liver where it is metabolized. Thus, a rapid transdermal delivery of the said oil may be a faster and more effective delivery, over the normal oral delivery of Boswellic acid extract. By avoiding the metabolism processes of the GI system in oral delivery, there should be increased bioavailability of the therapeutic compounds of the said oil. Cancerous tumors such as breast cancer, or skin cancer can be treated via synergistic composition comprising Frankincense oil and boswellic acid-containing skin formulations. In cases such as radiation therapy where the skin is badly affected by radiation, skin care formulations containing the synergistic composition of the present invention may be used to maintain and restore skin health. Said synergistic composition can also be used to treat irritable bowel syndrome (IBS) due to its anti-inflammatory properties. Said synergistic composition can be used to treat breast cancer as it can significantly reduce the growth of cancerous cells. Example 4 Soft gel capsules of said synergistic composition comprising Frankincense oil and boswellic acid can be used in formulations for making soft gel capsules of various sizes. Said synergistic composition comprising Frankincense oil containing 70 wt % of boswellic extract, corresponding to 45 wt % of boswellic acid, is used for making soft gel capsules of various sizes, the details of which are presented in Table 7. The Arthritis Foundation describes a nutritional supplement containing 300-400 mg of boswellic extract containing 60 wt % of boswellic acid three times per day. Said supplemental dosage is enabled by using an Oval Gel Capsule size of 12. Another suggested guideline of 100-250 mg of boswellic extract per day can be obtained with an Oval gel capsule size of 6. If a higher concentration of the boswellic acid is desired, said synergistic composition of this invention can be made with a higher concentration of said boswellic extract in Frankincense oil. Table 7 Volume of synergistic Boswellic extract Boswellic acid Oval Gel composition (ml) (ml) (mg) x. According to the various embodiments of the present invention, the objects of the present invention are achieved through a synergistic composition comprising Boswellia-derived Frankincense oil and boswellic acid, and a method for the synthesis of the same. Said synergistic composition comprises Frankincense oil from any Boswellia species, including Boswellia serrata, Boswellia neglecta, Boswellia frereana, Boswellia sacra, Boswellia carterii, and Boswellia rivae, mixed with boswellic acid greater than 5 % by weight. Said Boswellia-derived Frankincense oil comprises 40 % to 80 % by weight of α-pinene or 40 % to 80 % by weight of α-thujene, or a combination of 40 % to 80 % by weight of said α-thujene and 4 % to 8 % by weight of said α- pinene. Said synergistic composition is synthesized using a hydro-steam distillation process, wherein, one part of boswellia resin gum and three parts of boiling water are loaded in a pressure vessel, and said pressure vessel is subjected to a pressure of 1 bar to 2 bars. The condensate comprising Frankincense oil and water is collected for upto 90 minutes after which the remaining solution in said pressure vessel is cooled. The residual water in the pressure vessel is drained, and the solidified boswellic extract containing atleast 5 % by weight boswellic acid is washed with water. Said method yields 12 % to 14 % by weight of Frankincense oil and the yield of said solidified boswellic extract is 40 % to 85 % by weight. Said solidified boswellic extract is crushed and mixed with Frankincense oil and warmed slightly using any heating technique known to a person skilled in the art. Said synergistic composition comprising 5% to 65 % by weight of boswellic acid is a clear to translucent liquid while said composition comprising 65 % to 130 % by weight of boswellic acid is a translucent paste. It is to be understood, however, that the present invention would not be limited by any means to the components, arrangements, materials and techniques that are not specifically described, and any change to the materials, variations, and modifications can be made without departing from the scope described in the present invention.

Claims

CLAIMS We claim:

1. A synergistic composition comprising of Frankincense oil and boswellic acid, wherein said synergistic composition comprises 5 % to 65 % by weight of said boswellic acid.

2. The synergistic composition as claimed in claim 1, wherein said Frankincense oil is derived from Boswellia species.

3. The synergistic composition as claimed in claim 1, wherein said Frankincense oil comprises 40 % to 80 % by weight of α-thujene.

4. The synergistic composition as claimed in claim 1, wherein said Frankincense oil comprises 40 % to 80 % by weight of α-pinene.

5. The synergistic composition as claimed in claim 1, wherein said Frankincense oil comprises 40 % to 80 % by weight of α-thujene, and 4 % to 8 % by weight of α-pinene.

6. The synergistic composition as claimed in claim 1, wherein said composition is in the form of clear oil or translucent syrup.

7. A synergistic composition comprising of Frankincense oil and boswellic acid, wherein said synergistic composition comprises 5 % to 130 % by weight of Boswellic acid.

8. The synergistic composition as claimed in claim 7, wherein said composition is in the form of clear oil or translucent paste.

19. A method for the synthesis of a synergistic composition comprising Frankincense oil and boswellic acid comprising of: subjecting Boswellia resin gum to hydro-steam distillation process wherein, one part of boswellia resin gum and three parts of boiling water are loaded in a pressure vessel; said pressure vessel is subjected to a pressure of 1 bar to 2 bars; the condensate comprising Frankincense oil and water is collected for upto 90 minutes; the residual solution in said pressure vessel is cooled; the residual water is drained, and the solidified boswellic extract is washed with water, wherein, said boswellic extract in water comprises of boswellic acid.

10. The method as claimed in claim 6, wherein said Boswellia resin gum is derived from Boswellia species.

11. The method as claimed in claim 6, wherein said boswellic extract in water comprises atleast 5 % by weight of boswellic acid.

12. The method as claimed in claim 6, wherein the boswellic acid content of said solidified Boswellic extract is 40 % to 85 % by weight.

13. The method as claimed in claim 6, wherein the yield of said Frankincense oil is 12 % to 14 % by weight.

214. The synergistic composition as claimed in claim 1, wherein said composition is administered for the treatment of a disease selected from skin autoimmune conditions, skin cancer, breast cancer, arthritis, and irritable bowel syndrome.

15. The synergistic composition as claimed in claim 7, wherein said composition is administered for the treatment of a disease selected from skin autoimmune conditions, skin cancer, breast cancer, arthritis, and irritable bowel syndrome.

16. The synergistic composition as claimed in claim 1, wherein said composition is administered through topical route, transdermal route, or oral route.

17. The synergistic composition as claimed in claim 7, wherein said composition is administered through topical route, transdermal route, or oral route. 3

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