Formulation and Evaluation of Polyherbal Gel

A. W. Baitule¹, M. G. Tawar², S. D. Pande¹

¹Associate Professor, Vidyabharati College of Pharmacy, Amravati, India.

¹Principal, Vidyabharati College of Pharmacy, Amravati.

²Principal P. R. Pote Patil College of pharmacy, Amravati.

*Corresponding Author E-mail: prof.ajaybaitule@gmail.com

ABSTRACT:

The present study has been undertaken with the aim to formulate and evaluate the new polyherbal gel formulation containing hydroalcoholic extract from Trigonella foenum-graecum and Glycyrrhiza glabra. The polyherbal gel formulation was designed by using Carbopol 934, Sodium CMC, Trigonella foenum-graecum, Glycyrrhiza glabra extract, ethanol, propylene glycol 400, methyl paraben, propyl paraben, and required amount of distilled water. The skin ph (6.8-7) was maintained by drop wise addition of tri- ethanolamine. The prepared gels were evaluated for physical appearance, pH, spreadability, HPTLC, skin irritation to observe side effect. It was inferred from the results that polyherbal gel formulations were good in appearance and homogeneity. The values of spreadability indicated that these polyherbal gels were easily spreadable by small amount of shear. Viscosity of polyherbal gels were determined by using Brookfield viscometer .Formulation F4 had good values of spreadability, viscosity, pH and during the accelerated stability studies the appearance was clear and no significant variation in spreadability and pH was observed. Hence 0.3 % hydroalcoholic extract from Trigonella foenum-graecum and Glycyrrhiza glabra gel was formulated . F4 formulation and its physiochemical study was found to be good.

KEYWORDS: Carbopol 934, Sodium CMC , Trigonella foenum-graecum, Glycyrrhiza glabra, HPTLC.

INTRODUCTION:

Topical drug delivery systems are gaining increased in popularity, and several drugs have been successfully delivered by this route for both local and systemic action.¹

Gels are semisolid systems in which a liquid phase is trapped within an inter locking, tree dimension polymer matrix of a natural or synthetic gum. Most gels, whether aqueous or non aqueous are prepared with the aid of heat and high shear agitation. Suspensions, milks, and magmas of clays and inorganic hydroxides are sometimes referred to as gels because of their high viscosity. ²The aim of research is to formulate and evaluate the new polyherbal gel preparation from two plants Trigonella foenum-graecum and Glycyrrhiza glabra which are potent and non toxic agent. These plants are traditional medicinal plants.

Normally herbal drugs are free from side effect / adverse effects and these are low cost medicines which will be beneficial for the people of this country.³

Ploy herbal preparation is such kind of preparation in which two or more than two herbal drug are incorporated in the preparation.

MATERIAL AND METHODS:

Collection and Authentification of Plant material Seeds of Trigonella foenum- graecum (fenugreek) and root and stolon of Glycyrrhiza glabra (Liquorice) were collected from local market and botanical identity was confirmed by Dr. S.N. Malode Professor and Head at Govt. Vidarbha Institute of Science and Humanities, Amravati.

Preparation of extracts:

The dried powder of plant was extracted with various solvents. Aqueous extract was prepared by cold maceration process. Hydro alcoholic, Ethanolic, chloroform, petroleum ether and ethyl acetate extract were obtained using Soxhlet apparatus.

About 250 gm of dried powder of plant sample was subjected to soxhlation. It was first defatted with petroleum ether then exhaustively extracted with solvent in a Soxhlet apparatus for 36 hours. The temperature was maintained at 40-50 degree centigrade. The solvents were removed by distillation under reduced pressure and the resulting semisolid mass was vacuum dried using rotary flash evaporator to obtain the extract.⁴

Preparation of Polyherbal Gel Containing hydroalcoholic extract of Trigonella foenum- graecum and Glycyrrhiza glabra.

Polyherbal Gel

Different proportions of Carbopol 934 and Sodium CMC were dispersed in 50 ml of distilled water with continuous stirring. 5 ml of distilled water was taken and required quantity of methyl paraben and propyl paraben were dissolved by heating on water bath. The solution was cooled and then propylene glycol 5 % w/v was added and mixed with first solution. 0.3 gm quantity of hydroalcoholic extract from Trigonella foenum-graecum and Glycyrrhiza glabra . Fenugreek and Liquorice plant extracts was then mixed to the above polymer mixture. The volume was made up to 100 ml with distilled water.⁵ Finally all the ingredients were then mixed properly with Carbopol 934 gel with continuous stirring. Triethanolamine was added drop wise to the formulation for adjustment of required skin pH (6.8-7) and to obtain the gel of required consistency (Table- 1).

During the trial, the excipients concentrations of carbopol 934 and Sodium CMC were gradually increased and then decreased as several problems like homogeneity, spreadability and viscosity were encountered. These problems occurred in some of the batches (F1, F2, F3, F6, F7, F8 and F9 ) of polymer based gel containing Fenugreek and Liquorice Extract . Hence, these batches were discarded and remaining batches ( F4 and F5) were considered for further study. (Table.2)

Table 3 shows the evaluation of Polyherbal Gel Formulation Containing Hydroalcoholic Extract Of Fenugreek and Liquorice. Physical evaluation of all formulations.^6,7,8

Table 1: Formulations Polyherbal Gel Containing hydroalcoholic extract of Trigonella foenum- graecum and Glycyrrhiza glabra.

Ingredient	F₁	F₂	F₃	F₄	F₅	F₆	F₇	F₈	F₉
Carbopol 934 (gm)	3	2.75	2.50	2.25	2	1.75	1.50	1.25	1
Sodium CMC (gm)	1	1.25	1.50	1.75	2	2.25	2.50	2.75	3
Fenugreek Extract and Liquorice Extract (0.3g % w/w) each	0.3	0.3	0.3	0.3	0.3	0.3	0.3	0.3	0.3
Propylene glycol 400 (5%)	5 ml	5 ml	5 ml	5 ml	5 ml	5	5 ml	5 ml	5 ml
Methyl Paraben (0.5%) (ml)	0.2ml	0.2 ml	0.2 ml	0.2 ml	0.2 ml	0.2 ml	0.2 ml	0.2 ml	0.2 ml
Propyl Paraben (0.2%) (ml)	5 ml	5 ml	5 ml	5 ml	5 ml	5 ml	5 ml	5 ml	5 ml
Triethanolamine (ml)	q.s.	q.s.	q.s.	q.s.	q.s.	q.s.	q.s.	q.s.	q.s.
Distilled water (ml)	q.s. to 100ml	q.s. to 100ml	q.s. to 100ml	q.s. to 100ml	q.s. to 100ml	q.s. to 100ml	q.s. to 100ml	q.s. to 100ml	q.s. to 100ml

Each formulation contains distilled water up to 100 ml

Table 2: DOE Shows Formulations Of Gel Containing Fenugreek and Liquorice plant extracts with two factorial design methods.

Ingredient	F₄	F₅
Carbopol 934 (gm)	2.25	2
Sodium CMC (gm)	1.75	2
Fenugreek Extract and Liquorice Extract (0.3g % w/w) each	0.3	0.3
Propylene glycol 400 (5%)	5 ml	5 ml
Methyl Paraben (0.5%) (ml)	0.2 ml	0.2 ml
Propyl Paraben (0.2%) (ml)	5 ml	5 ml
Triethanolamine (ml)	q.s.	q.s.
Distilled water (ml)	q.s. to 100ml	q.s. to 100ml

Each formulation contains distilled water up to 100 ml

Table 3: Physical evaluation of all formulations

Batch	Color	Appearance	Spreadibility (gm.cm/sec)	Consistency (60 mm)	Viscosity (cps)	pH
F1	Ivery	Homogeneous	31.75	9	22410	7.00
F2	Ivery	Homogeneous	29.65	9	19380	7.00
F3	Ivery	Homogeneous	21.38	6	24180	7.00
^F4	Ivery	Homogeneous	21.45	6	22393	7.00
F5	Ivery	Homogeneous	23.96	8	17053	7.00
^F6	Ivery	Homogeneous	24.08	8	17862	7.00
F7	Ivery	Homogeneous	24.21	8	16915	7.00
^F8	Ivery	Homogeneous	24.42	8	16995	7.00
^F9	Ivery	Homogeneous	24.41	8	16996	7.00

Figure 1: Separation and identification of phytoconstituents by HPTLC

Glycyrrhizin std.

Sample Name : Test1/Glycyrrhizin std.

Rf Value : 0.1 to 1.00

Peak Rf Value : 0.63

AU : 0.10-0.60

Solvent Condition : Methanol:Ethyl acetate:Water:7:2:1

Figure 2-Formulation Gel (300mg )

Sample Name : Test1/Formulation 300 mg

Rf Value : 0.1 to 1.00

Peak Rf value : 0.34,0.36,0.40,0.53,0.63,0.72, 0.84

AU : 0.10-0.60

Solvent Condition : Ethylacetate:methanol:water (90:9:1)v/v/v

Figure 3- Trigonelline std. 100 ppm

Sample Name : Test1/Trigonelline std. 100 ppm

Rf Value : 0.1 to 1.00

Peak Rf value : 0.40

AU : 0.10-0.60

Solvent Condition : n-propanol:methanol:water:ammonia (6:1.5:3:1.5,v/v)

Skin Irritation Study:

The skin irritation test was conducted for a period of seven days in M/s. Vineet Analytical Research Laboratories, Pune and the results are shown in following Table - 4. The results indicated that the control preparation, test gel, and marketed products did not cause any skin reaction.

Table – 4: Skin Irritation Study

Sr no	Treat ment	Day 2	Day 3	Day 4	Day 5	Day 6	Day 7	Day 8
1.	Con trol	A	A	A	A	A	A	A
2.	Formulation	A	A	A	A	A	A	A
3.	Stan dard	A	A	A	A	A	A	A

A – No reaction

The skin irritation test was carried out in accordance with the Guidelines of the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA).

RESULTS:

The result showed that the developed poly herbal gel was Fenugreek Extract and Liquorice Extract (F4 and F5) yellowish green in color, translucent in appearance and showed good homogeneity with absence of lumps. Formulation F4 and F5 had good values of spread ability, viscosity, pH, and during the accelerated stability studies the appearance was clear and no significant variation in spread ability and pH was observed. Hence 0.3% hydroalcoholic extract from Trigonella foenum-graecum and Glycyrrhiza glabra gel was formulated. F4 formulation and its physiochemical study was found to be good.

DISCUSSION:

Topical route for Trigonella foenum-graecum and Glycyrrhiza glabra was selected up to avoid GIT irritation and to maximize the drug concentration at the site of action. In the present study an attempts were made to formulate and evaluate topical polyherbal gels of Trigonella foenum-graecum and Glycyrrhiza glabra. In our preliminary study the standardization of Trigonella foenum-graecum and Glycyrrhiza glabra was carried out for purity and identity. The authentication and taxonomical identification done by Dr.S N.Malode . Professor and Head at Govt.Vidarbha Institute of Science and Humanities, Amravati. The Preformulation studies include identification, phytochemical evaluation, physicochemical evaluation, extraction, solubility were carried out. All the developed polyherbal gels were evaluated for their physicochemical properties like appearance, pH values and spreadability, skin irritation test, stability studies and HPTLC methods.

CONCLUSION:

Thus from the results obtain during this research it can be concluded that the prepared polyherbal gel are having desirable physical characteristics and found to be stable and safe.

In conclusion, the overall result of this study the prepared new polyherbal gel F4 formulation containing 0.3% hydroalcoholic extract from Trigonella foenum-graecum and Glycyrrhiza glabra and its physiochemical study was found to be good.

ACKNOWLEDGEMENT:

I am thankful to the Principal, Management Vidyabharati College of Pharmacy, Camp Amravati and M/s. Vineet Analytical Research Laboratories ,Pune for providing the necessary facilities. I am also grateful to Dr. Satish N. Malode. Professor and Head at Govt.Vidarbha Institute of Science and Humanities, Amravati for assisting in the identification of plant materials.

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