Formulation and evaluation of herbal anti-inflammatory Emulgel prepared from V itex neugondo leaves extract

Topical drug delivery system is dosage forms which are applied directly to skin to cure various disease. In comparison with the other semisolid formulation the use of gel seen to be more advantages both in cosmetics and pharmaceutical preparation. Emulgel have emerged as a promising drug delivery system for the delivery of hydrophobic drugs. The objective of the study was to prepare from the leaves of Vitex negundo plant using Carbopol 940 as a gelling agent. Eucalyptus oil and menthe oil were used as penetration enhancers. Propylene glycol amount of distilled water. The skin pH was maintained by addition of tri-ethanolamine. The formulation was evaluated for spread ability, Viscosity, in vitro release drug content pH, physical stability etc. On this experimental work prevalent that the herbal gel of leaves extract from leaves of Vitex negundo found good gelling property and it will be useful as anti-inflammatory gel as per the literature.


Introduction
The drug isadministered to a human body through different route such as oral, parenteral, rectal, and sublingual etc.The oral route is the best route for the administration of the drug but the topical route is preferable to avoid the first pass metabolism.Emulgel are the basically emulsion which are w/o or o/w type that are gel in which gelling agent is use for mixing.Emulgel are the best vehicle for the hydrophobic drug.The emulgel has an ability to deliver both lipophilic as well as hydrophobic drug as they contained to phase, aqueous and oily phase.The emulgel are apply to the skin suitably as it non-greasy easily spreadable as compared to other topical formulation that require excess rubbing.(1) Gel which are used for dermatological properties have a few positive properties for example being emollient, greaseless, easily removable, non-staining, and compatible with various excipient.The emulgel may provide a better option when it is concerned with topical delivery of poorly water-soluble drug.It is provided better and stable vehicle for poorly water soluble or hydrophobic drug.(2) The topical drug delivery system has followed the first pass metabolism there the chances of degradation of medicament.From the gastro intestinal tract and the bother of intravenous therapy in avoided emulgel formulation has been fruitful importance in the pharmaceutical field under the category of semisolid dosage form.(3) The Gel formulation topically show higher drug release than ointment and creams.It has many advantages of emulsion and gels.Major disadvantages are their inability to deliver hydrophobic drug and instability during storage.Such type of problem can be overcome by using the emulsion-based approach that is emulgel preparation and thereby hydrophobic drug are successfully incorporated and have a unique property of gel.(4) Several analgesic preparations are available in the market as different topical preparation.Vitex negundo are effective and use as an anti-inflammatory and analgesic agent.The Vitex negundo contain an essential oil isolated from the leaves and contain a β-caryophilene, viridifloral 4-terpeniol are the chemical constituent which produce anti-inflammatory and analgesic effect.The emulgel prepare from natural ingredient hence it is completely free from irritation or side effect as compared to the synthetic gel.This emulgel contain peppermint oil and eucalyptus oi lit enhance the penetration and menthol increase the cooling effect.As compared to ointment and cream the gel formulation faster drug release.There is no marketed topical formulation of Vitex nigundo available.It is available in the form of oil only not any pharmaceutical preparation is available in market.The emulgel have many advantages like greaseless, easily spreadable, easily removable, emollient and have good skin penetration long shelf life.( 5

Introduction about Vitex negundo
Vitex negundo is a woody, aromatic shrub growing to a small tree and is a much-branched shrub up to 5 m tall or sometimes a small, slender tree with thin, gray bark.Vitex negundo is mentioned in Ayurveda as useful in treatment of arthritic disorders.Ayurveda mentions several plants acting as anti-inflammatory agents in arthritic disorders.V. negundo is a reputed drug in Ayurveda and is beneficial in inflammatory disorders.V. negundo, commonly known as Nirgundi is a widely available plant all over India.The leaves were washed and dried in oven at a temperature not exceeding 50°C and ground to obtained from sieve no.40# powder.Vitex negundo is a much-branched shrub up to 5 m tall or sometimes a small, slender tree with thin, gray bark.[6]  Family: -Lamiaceae  Genus: -vitex  Species: -V.negundo  Kingdom: -Plantae

Plants materials
The plant of Vitex negundo was obtained from the farm.

Vehicle
The vehicle use for the formulation of emulgel must possess properties such as should effectively deposit and evenly distribute the drug.E.g.: -Water, and alcohol.

Aqueous phase
The aqueous phase of the emulsion is formed by using aqueous material alcohol and water are commonly used.

Oil phase
Eucalyptus oil & menthol oil are used in oily phase to enhance the penetration.

Emulsifier
The emulsifying agent are used to reduce interfacial tension between two phases such as water oil.E.g., Span 60, tween 80.

Gelling agent
e.g.Consistency and the gelling property can be increase by using various gelling such as Carbopol 940.

Preservative
e.g.The substance which preserves the preparation for long period such as Methyl paraben and propyl paraben.

Extraction Method
40g of dried leaves sample weighed and extracted in an extracted in a Soxhlet device with 250 ml solvent at room temperature for 8 hours.

Method of preparation of Emulgel
Emulgel are prepared by incorporating gel and emulsion the emulsion & gel prepared separately and mixed.
Firstly, Prepare the aqueous phase then prepare an oily phase, both are mix and prepare the emulsion after preparing the emulsion then prepare a gel phase and gel is incorporated in emulsion and finally emulgel are prepare.
Aqueous phase: -Dissolve Tween 60 in purified water then methyl and propyl paraben dissolved in propylene glycol whereas extract of Vitex negundo or dissolve in water prepare the aqueous phase.
Oily phase: -The oily phase of the emulsion was prepared by dissolving span 20 in liquid paraffin and added the castor oil and menthe oil & prepare the oily phase.
Gel phase: -The gel phase information was prepared by using Carbopol 940 in purified water with constant stirring.Both oily &aqueous phase are heated separately at 70 ℃-80℃firstlyprepare emulsion, aqueous phase is dispersed into oil phase and make emulsion.
After making the emulsion then added the gel phase with constant staring and emulsion as prepare & transfer into the container with direction external used only.(7)  q.s q.s q.s

Physical Evaluation
Measurement of pH determination pH of the emulgel was measured by using pH meter.1g of each formulation dispersed in 10ml of purified water separately all the dispersion were shaken properly and determine the pH using a digital pH meter.

Color
The color of the formulation checked against white background green color was observed.

Odor
The odor of the gel was checked by mixing the gel in water and smelling it.Odorless gel was found.

Consistency
The Consistency was checked by applying the gel on skin.The best Consistency gel was found.

Greasiness
The greasiness was checked by applying the gel on skin.The non-oily was found.

Homogeneity
The homogeneity was tested by visual inspection after allowing them to get in a container homogenizes mater was found.

Spread ability
Spread ability is checked by two slides put anemulgel on first slide and cover this by second slide and these are easily spread.

Stability study
The formulation gel was filled in the collapsible tube and store at the different temperature and humidity condition then checked appearance, pH and spread ability.

Skin irritancy test
Mark the location on the dorsal surface of the hand applies the gel to the designated area and check the irritancy

Type of emulsion
Little amount of water is mixed with emulsion.If water distributes uniformly, it is O/W type of emulsion and if water separates out as a layer than it is W/O type of emulsion.
The emulsion was determined by using a dilution method

Results and discussion
The herbal gel was prepared and subjected to evaluation of the various parameter.The herbal gel was dark greenish in color and had a cool smooth feeling after application.The pH of gel was 6-7.The gel was found non-oil, non-irritant, and easily removable after application through a water and cotton gauze.
The herbal gel was dark greenish colorand translucent in appearance and had a cool smooth feeling on application.PH alsomaintains constant through the study which was found 6-7.Spread ability were also measure and found to be less variant than the initially prepare gel after performing stability study.
The gel isnon-greasy, non-sticky and nontoxic.These are easily removed after application through water and cotton gauze.
Stability study: -All the prepare emulgel formulation were found to be stable upon storage for 3 week at room temperature no change was observed in their physical appearance, pH Spread ability, viscosity, phase separation are not observe.

Conclusion
we can concluded hereby that it is a most effective drug delivery system.The herbal formulation having demand in the market.Because having best therapeutic effect and without having any adverse effect.This formulated gel is having anti-inflammatory properties with therapeutic effect.
In the experiment we can conclude and proven to be one of the most effective, better, and convenient drug delivery system.Emulgel is non-greasy, non-sticky and easily applicable.Herbal formulation has grooving demand in the market.Establish the herbal gel containing Vitex negundo leaves extract.Emulgel can be considered as an emerging novel drug delivery system with enhanced characteristics and advantages.

Table 1
Formulation table of Emulgel Preparation

Table 2
Emulsion Type

Solubility of Vitex negundo ExtractTable 3
Solubility of Vitex negundo in various solvents

Table 5
Physical Properties of Formulation