Technical Field

The present invention relates to herbal compositions with anti-inflammatory and anti-microbial activities. Additionally, it also provides a process to prepare the synergistic combinations and its pharmaceutical formulation.

Background

Majority of the plants and natural agents show promising anti-inflammatory and anti-microbial activity. Synthetic anti-microbial agents are often active only against a narrow spectrum of bacteria/fungi and in cases where stronger doses are required the synthetic agents generally express side effects. The phenomenon of development of resistance by microbes is very much common with synthetic agents. Natural agents are generally safe and since the chemistry of the molecules are very complex compared to their synthetic counterparts; it becomes the more difficult for the microbes to develop resistance. Majority of the antimicrobial preparations available in the market are synthetic in origin and contain antibiotic compounds. These compounds generally have specific and narrow spectrum of antimicrobial activity. The risk of the microbes developing resistance to them, thus making the formulation ineffective is made us to look for novel herbal formulation. The present herbal composition contains natural ingredients having a broad spectrum activity against a range of microbes and is therefore preferable. Being natural substances, the chemistry is quite complex and risks of microbes developing resistance to these compounds is negligible. In short, there is a strong need to have herbal anti-inflammatory and antimicrobial compositions, which are effective against a broad range of bacteria and fungi, and also which possesses anti-inflammatory properties.

SUMMARY

Accordingly, the present invention provides for a synergistic combination comprising distillates of coleus, turmeric, lemon grass and eucalyptus; and is also provided for a pharmaceutical composition comprising synergistic combination comprising distillates of coleus, turmeric, lemon grass and eucalyptus, optionally along with pharmaceutically acceptable excipients; and is also provided for a process for preparing synergistic combination comprising distillates of coleus, turmeric, lemon grass and eucalyptus, wherein said process comprising steps of obtaining the distillates from plant sources; and mixing the obtained distillates to obtain a homogenous composition of the synergistic combination; and is also provided for a method of treating inflammation and microbial infections in a subject in need thereof, said method comprising step of administering acceptable amount of synergistic combination comprising distillates of coleus, turmeric, lemon grass and eucalyptus, optionally along with pharmaceutically acceptable additives to the subject.

DETAILED DESCRIPTION

Before explaining any one embodiment of the present disclosure by way of drawings, experimentation, results, and pertinent procedures, it is to be understood that the disclosure is not limited in its application to the details as explained in below embodiments set forth in the following description or illustrated in the drawings, experimentation and/or results. The disclosure is further capable of other embodiments which can be practiced or carried out in various ways. As such, the language used herein is intended to be given the broadest possible scope and meaning; and the embodiments are meant to be exemplary—not exhaustive. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

Definitions:

"Synergistic" or "synergy" is used herein to mean that the effect is more than its additive property. "Pharmaceutically acceptable excipients" is used herein according to art accepted meanings, and includes those ingredients needed to formulate a medicine for use in subjects, animals or any equivalent thereof. By use of "plants," what is meant herein is that the plant or its specific portion with medicinal activity is used to obtain the distillate.

Further, although plants are named here according to commonly used nomenclature, with improving taxonomy plants are often reclassified. Whenever a plant is referenced, it includes related species with similar active ingredients.

The present invention is in relation to a synergistic combination comprising distillates of coleus, turmeric, lemon grass and eucalyptus.

In first embodiment of the present invention, distillate of coleus is obtained from Coleus species, distillate of turmeric is obtained from Curcuma species, distillate of lemon grass obtained from Cymbopogon species and distillate of eucalyptus is obtained from Eucalyptus species.

In another embodiment of the present invention, said coleus and turmeric are each at a concentration ranging from about 1 % w/w to about 25 % w/w, lemon grass at a concentration ranging from about 0.5 % w/w to about 5% w/w, and eucalyptus oil at a concentration ranging from about 1 % w/w to about 3 % w/w.

In yet another embodiment of the present invention, said coleus and turmeric are each at a preferable concentration of about 5 % w/w, lemon grass at a preferable concentration of about 1% w/w and eucalyptus oil at a preferable concentration of about 2% w/w.

The present invention is in relation to a pharmaceutical composition comprising synergistic combination comprising distillates of coleus, turmeric, lemon grass and eucalyptus, optionally along with pharmaceutically acceptable excipients.

In another embodiment of the present disclosure, said synergistic combination comprises coleus and turmeric each at a concentration ranging from about 1 % w/w to about 25 % w/w, preferable concentration of about 5 % w/w, lemon grass at a concentration ranging from about 0.5 % w/w to about 5% w/w, preferable concentration of about 1% w/w and eucalyptus oil at a concentration ranging from about 1 % w/w to about 3 % w/w, preferable concentration of about 2% w/w. In another embodiment of the present invention, said pharmaceutical composition is formulated into a dosage forms selected from a group comprising but not limiting to creams, sprays, ointments, gels, oily suspensions using additives selected from a group comprising preservatives, suspending agents, emulsifying agents, plasticizers.

The present invention is in relation to a process for preparing synergistic combination as recited in the above embodiments, wherein said process comprising steps of obtaining the distillates from plant sources; and mixing the obtained distillates to obtain a homogenous composition of the synergistic combination.

In another embodiment of the present invention, said homogenous composition of the synergistic combination is formulated into a spray.

The present disclosure is in relation to a method of treating inflammation and microbial infections in a subject in need thereof, said method comprising step of administering acceptable amount of synergistic combination as recited in the above embodiments, optionally along with pharmaceutically acceptable additives to the subject.

Majority of the antimicrobial preparations available in the market are synthetic in origin and contain antibiotic compounds. These compounds generally have specific and narrow spectrum of antimicrobial activity. The risk of the microbes developing resistance to them, thus making the formulation ineffective makes a researcher to look for novel herbal formulation. The present herbal composition contains natural ingredients having a broad spectrum activity against a range of microbes and is therefore preferable. Being natural substances, the chemistry is quite complex and risks of microbes developing resistance to these compounds is negligible. The synergistic combination of instant invention consists of distillates of coleus, turmeric, lemon grass and eucalyptus. A description of each source is provided below:

Coleus forskohlii - member of the mint family, Lamiaceae. It is indigenous to India and is recorded in Ayurvedic Materia Medica under the Sanskrit name 'Makandi' and 'Mayani". In recent years the plant has gained pharmacological importance as the only known plant source of the adenylate cyclase activating compound, forskolin. Forskolin rich extracts are commercially obtained from the roots. The roots also yield a viscous, dark brown colored essential oil containing a range of aroma constituents that collectively impart a pleasing delicate aroma with a spicy note. The oil can be obtained as a valuable by-product of forskolin rich extract production, without detrimental effects on the yield of forskolin. Over forty compounds belonging to four classes of aroma compounds have been recovered from oils obtained from various indigenous genotypes of the plant. These include sesquiterpenes, sesquiterpene alcohols, monoterpenoids and diterpenoids.

Curcuma longa - It is well known that this plant is used in various diseases both externally internally. It is used in inflammations, ulcers, wounds and skin diseases. Curcumin isolated from rhizome was found to inhibit the carrageenan induced paw edema in rats as well as in mice. Cured turmeric rhizomes contain volatile oil, pigments, fixed oil, bitter principles, resin, protein, cellulose, etc. The yellow pigmented fraction contains curcuminoids.

Eucalyptus globules - (eucalyptus oil) contains are a-pinene, b-pinene, a-phellandrene, 1,8-cineole, limonene, terpinen-4-ol, aromadendrene, epiglobulol, piperitone and globulol. It possess analgesic, anti-bacterial, anti-inflammatory, anti-neuralgic, anti-rheumatic, antiseptic, antispasmodic, antiviral, astringent, balsamic, cicatrisant, decongestant, deodorant, depurative, diuretic, expectorant, febrifuge, hypoglycaemic, rubefacient, stimulant, vermifuge and vulnerary.

Cymbopogon citratus - Lemon grass oil contains myrcene, citronellal, geranyl acetate, nerol, geraniol, neral and traces of limonene and citral. It has been used widely as analgesic, anti-depressant, antimicrobial, antipyretic, antiseptic, astringent, bactericidal, carminative, deodorant, diuretic, febrifuge, fungicidal, insecticidal, nervine, nervous system sedative and tonic. The synergistic combination of instant invention is formulated as herbal topical care formulation comprising of the following ingredients along with their concentration is recited below:

a) Distillates of Coleus: 1 % w/w to 25% w/w
b) Distillates of Turmeric: 1 % w/w to 25% w/w
c) Distillates of lemon grass: 0.5% w/w to 5% w/w
d) Distillates of Eucalyptus globules: 1% w/w to 3%w/w
e) Emulsifier: 1% w/w to 5% w/w

According to the present invention, broadly speaking, a process for the manufacture an herbal formulation of a synergistic combination comprising coleus, turmeric, lemon grass and eucalyptus, comprises the following steps of preparation:

Step (1): Preparing distillates of coleus, turmeric, lemon grass and eucalyptus from various plant parts of respective biological sources.

Step (2): Making a specified concentration mixture of distillate of coleus 1% w/w to 25% w/w, distillate of curcumin 1% w/w to 25% w/w, distillate of eucalyptus 1% w/w to 3% w/w and distillates of lemon grass 0.5% w/w to 5% w/w.

Step (3): Mixing the said homogenous synergistic combination with a base as herein described and filling the final composition in a container to obtain a suitable pharmaceutical formulation which can be readily delivered to subjects in need thereof.

Additionally, the disclosure is further illustrated by the following examples, which are not to be construed in any way as imposing limitations upon the scope of the present invention. On the contrary, it is to be clearly understood that various other embodiments, modifications, and equivalents thereof, after reading the description herein in conjunction with the appended claims, may suggest themselves to those skilled in the art without departing from the spirit and scope of the presently disclosed and claimed invention.

Example 1: Preparation of synergistic combination

As a first step towards the preparation of a synergistic combination of instant invention one needs to carefully identity the biological source of coleus, turmeric, eucalyptus and lemon grass. Upon identification the suitable plant parts are used to obtain distillates by any known conventional methods of distillation. The distillates obtained from respective biological sources namely distillate of coleus is obtained from Coleus species, distillate of turmeric is obtained from Curcuma species, distillate of lemon grass obtained from Cymbopogon species and distillate of eucalyptus is obtained from Eucalyptus species. The concentration of the synergistic combination include - coleus and turmeric are each at a concentration ranging from about 1 % w/w to about 25 % w/w, lemon grass at a concentration ranging from about 0.5 % w/w to about 5% w/w, and eucalyptus oil at a concentration ranging from about 1 % w/w to about 3 % w/w. The specific preferable concentration of the synergistic combination includes but not limiting to - coleus and turmeric are each at a preferable concentration of about 5 % w/w, lemon grass at a preferable concentration of about 1% w/w and eucalyptus oil at a preferable concentration of about 2% w/w. Additionally, yet another preferable concentration of the synergistic combination could be prepared at the concentrations recited as follows:

Example 2: Experimental studies on synergistic combination

The synergistic combination prepared as per the example 1 was subjected to experimental studies to understand its synergistic nature. Anti-bacterial studies were carried out on individual components of the synergistic combination and also for the synergistic combination per se. The studies were carried out using the well diffusion method. The test microorganisms were seeded into respective medium by spread plate method. Respective controls were also maintained during the course of the study. After incubation the diameters of the inhibition zones were measured in mm. The results obtained the study confirmed that the ingredients of the synergistic combination are indeed associated with anti-bacterial properties. On the other hand the anti-bacterial activity of the individual components of the synergistic combination was not more than 10 mm. Hence, it confirms that the synergistic combination of instant invention is indeed associated with synergy and is effective against bacteria.

Minimum Inhibitory Concentrations (MICs) By well diffusion Method;

• Minimum Inhibitory Concentration Tests were conducted by using MTCC Strains by well diffusion method.

• Strains were maintained and cultured under appropriate growth condition.

• Appropriate Agar media poured into sterile petri plates. After solidification make well on the media at the center of the agar plate by using sterile cork borer.

• Swab the test organisms of different strains on different plates by using inoculation loop or swabs.

• Pour the test sample into the well by using micropipette. The volume of the Test samples is lOOul and 200ul.

• Plates were kept for appropriate time in Incubator under optimum growth condition.

• Inhibition zone diameter was measured after the completion of incubation period.

DIFFERENT ORGANISMS USED FOR TESTING:

1. E.coli (MTCC1687)

2. Staphylococcus aureus (MTCC737)

3. Salmonella (MTCC1251)

4. Pseudomonas aeruginosa (MTCC424)

Effect of synergistic combination and individual components showing the Inhibition Zone Diameter (mm) in strain

Observation:

• The synergistic combination used for Minimum Inhibitory Concentration test showed appropriate zone of inhibition under the experimental condition for different organisms.

• The individual components used for Minimum Inhibitory Concentration test showed appropriate zone of inhibition under the experimental condition for different organisms.

• E.coli, Salmonella and S.aureus organisms showed that synergistic combination has better sensitivity when compared to other individual components in both 100 and 200 concentration.

• P.aeruginosa was found to be resistant with all the test substances.

Example 3: Preparing a pharmaceutical formulation of the synergistic combination

The synergistic combination obtained in example 1 is mixed thoroughly and then mix them with a suitable solubiliser, emulsifier and excipients. The said active mix is filled in metal cans by using L.P.G as the propellant to get the final formulation in the form of spray. For better understanding an illustration is provided in the below table with list of ingredients and the preferable concentrations:

The synergistic combination is mixed thoroughly with respective solubilizer, and emulsifier to get an uniform liquid called emulsified mixture. Then this color mixture is added to the emulsified mixture to get an active mix (AM). The Liquefied Petroleum Gas (L.P.G) was used as propellant base. This active mix is filled in metal cans by using L.P.G. as the propellant to get the final product in the form of spray. A person skilled in the art would be able to vary the concentrations of the ingredients as proposed in the instant invention and would be able to arrive at a pharmaceutical formulation which is suitable for delivering it to the subjects in need thereof.

Example: 4 Field study using synergistic composition

A field study was carried out using the synergistic combination of instant invention, as explained in example 1 and in claims part of the specification. The study was focused towards the anti-inflammatory properties of the synergistic combination which was formulated into a spray using suitable pharmaceutical excipients. The details and the results of the field study are recited below:

The present invention is a very potent anti-inflammatory and anti-microbial preparation. It effectively kills the microbes and helps to reduce the inflammation and pain associated with infection.

While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the following claims.

We claim;

1) A synergistic combination comprising distillates of coleus, turmeric, lemon grass and eucalyptus.

2) The combination as claimed in claim 1, wherein said distillate of coleus is obtained from Coleus species, distillate of turmeric is obtained from Curcuma species, distillate of lemon grass obtained from Cymbopogon species and distillate of eucalyptus is obtained from Eucalyptus species.

3) The combination as claimed in claim 1, wherein said coleus and turmeric are each at a concentration ranging from about 1 % w/w to about 25 % w/w, lemon grass at a concentration ranging from about 0.5 % w/w to about 5% w/w, and eucalyptus oil at a concentration ranging from about 1 % w/w to about 3 % w/w.

4) The combination as claimed in claim 2, wherein said coleus and turmeric are each at a preferable concentration of about 5 % w/w, lemon grass at a preferable concentration of about 1% w/w and eucalyptus oil at a preferable concentration of about 2% w/w.

5) A pharmaceutical composition comprising synergistic combination comprising distillates of coleus, turmeric, lemon grass and eucalyptus, optionally along with pharmaceutically acceptable excipients.

6) The composition as claimed in claim 5, wherein said synergistic combination comprises coleus and turmeric each at a concentration ranging from about 1 % w/w to about 25 % w/w, preferable concentration of about 5 % w/w, lemon grass at a concentration ranging from about 0.5 % w/w to about 5% w/w, preferable concentration of about 1% w/w and eucalyptus oil at a concentration ranging from about 1 % w/w to about 3 % w/w, preferable concentration of about 2% w/w.

7) The composition as claimed in claim 5, wherein said pharmaceutical composition is formulated into a dosage forms selected from a group comprising but not limiting to creams, sprays, ointments, gels, oily suspensions using additives selected from a group comprising preservatives, suspending agents, emulsifying agents, plasticizers,

8) A process for preparing synergistic combination as claimed in claims 1 to 4, wherein said process comprising steps of:

(a) obtaining the distillates from plant sources; and

(b) mixing the obtained distillates to obtain a homogenous composition of the synergistic combination.

9) The process as claimed in claim 8, wherein said homogenous composition of the synergistic combination is formulated into a spray.

10) A method of treating inflammation and microbial infections in a subject in need thereof, said method comprising step of administering acceptable amount of synergistic combination as claimed in claims 1 to 4, optionally along with pharmaceutically acceptable additives to the subject.